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105th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES

 1st Session                                                    105-310
_______________________________________________________________________


 
    PRESCRIPTION DRUG USER FEE REAUTHORIZATION AND DRUG REGULATORY 
                       MODERNIZATION ACT OF 1997
_______________________________________________________________________


October 7, 1997.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

  Mr. Bliley, from the Committee on Commerce, submitted the following

                              R E P O R T

                             together with

                            ADDITIONAL VIEWS

                        [To accompany H.R. 1411]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Commerce, to whom was referred the bill 
(H.R. 1411) to amend the Federal Food, Drug, and Cosmetic Act 
and the Public Health Service Act to facilitate the development 
and approval of new drugs and biological products, and for 
other purposes, having considered the same, report favorably 
thereon with an amendment and recommend that the bill as 
amended do pass.

                                CONTENTS

                                                                   Page
Amendment........................................................     2
Purpose and Summary..............................................    33
Background and Need for Legislation..............................    34
Hearings.........................................................    35
Committee Consideration..........................................    36
Rollcall Votes...................................................    36
Committee Oversight Findings.....................................    43
Committee on Government Reform and Oversight.....................    43
New Budget Authority and Tax Expenditures........................    43
Committee Cost Estimate..........................................    43
Congressional Budget Office Estimate.............................    43
Federal Mandates Statement.......................................    49
Advisory Committee Statement.....................................    49
Constitutional Authority Statement...............................    49
Applicability to Legislative Branch..............................    49
Section-by-Section Analysis of the Legislation...................    50
Changes in Existing Law Made by the Bill, As Reported............    81
Additional Views of Hon. Edward J. Markey........................   142
Additional Views of Hon. Bobby L. Rush...........................   143

  The amendment is as follows:
  Strike out all after the enacting clause and insert in lieu 
thereof the following:

SECTION 1. SHORT TITLE; REFERENCES; TABLE OF CONTENTS.

  (a) Short Title.--This Act may be cited as the ``Prescription Drug 
User Fee Reauthorization and Drug Regulatory Modernization Act of 
1997''.
  (b) References.--Except as otherwise specified, whenever in this Act 
an amendment is expressed in terms of an amendment to a section or 
other provision, the reference shall be considered to be made to that 
section or other provision of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 321 et seq.).
  (c) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; references; table of contents.
Sec. 2. Fees relating to drugs.
Sec. 3. Pediatric studies of drugs.
Sec. 4. Expediting study and approval of fast track drugs.
Sec. 5. Expanded access to investigational therapies.
Sec. 6. Information program on clinical trials for serious or life-
threatening diseases.
Sec. 7. Dissemination of information on new uses.
Sec. 8. Studies and reports.
Sec. 9. Approval of supplemental applications for approved products.
Sec. 10. Health care economic information.
Sec. 11. Clinical investigations.
Sec. 12. Manufacturing changes for drugs.
Sec. 13. Streamlining clinical research on drugs.
Sec. 14. Data requirements for drugs.
Sec. 15. Content and review of applications.
Sec. 16. Scientific advisory panels.
Sec. 17. Dispute resolution.
Sec. 18. Informal agency statements.
Sec. 19. Positron emission tomography.
Sec. 20. Requirements for radiopharmaceuticals.
Sec. 21. Modernization of regulation.
Sec. 22. Pilot and small scale manufacture.
Sec. 23. Insulin and antibiotics.
Sec. 24. FDA mission and annual report.
Sec. 25. Information system.
Sec. 26. Education and training.
Sec. 27. Centers for education and research on drugs.
Sec. 28. Harmonization.
Sec. 29. Environmental impact review.
Sec. 30. National uniformity.
Sec. 31. FDA study of mercury compounds in drugs and food.
Sec. 32. Notification of discontinuance of a life saving product.

SEC. 2. FEES RELATING TO DRUGS.

  (a) Findings.--Congress finds that--
          (1) prompt approval of safe and effective new drugs and other 
        therapies is critical to the improvement of the public health 
        so that patients may enjoy the benefits provided by these 
        therapies to treat and prevent illness and disease;
          (2) the public health will be served by making additional 
        funds available for the purpose of augmenting the resources of 
        the Food and Drug Administration that are devoted to the 
        process for review of human drug applications;
          (3) the provisions added by the Prescription Drug User Fee 
        Act of 1992 have been successful in substantially reducing 
        review times for human drug applications and should be--
                  (A) reauthorized for an additional 5 years, with 
                certain technical improvements; and
                  (B) carried out by the Food and Drug Administration 
                with new commitments to implement more ambitious and 
                comprehensive improvements in regulatory processes of 
                the Food and Drug Administration; and
          (4) the fees authorized by amendments made in this title will 
        be dedicated toward expediting the drug development process and 
        the review of human drug applications as set forth in the goals 
        identified in the letters of ______________, and 
        ______________, from the Secretary of Health and Human Services 
        to the chairman of the Committee on Commerce of the House of 
        Representatives and the chairman of the Committee on Labor and 
        Human Resources of the Senate, as set forth at ____ Cong. Rec. 
        ________ (daily ed. __________, 1997).
  (b) Definitions.--Section 735 (21 U.S.C. 379g) is amended--
          (1) in the second sentence of paragraph (1)--
                  (A) by striking ``Service Act, and'' and inserting 
                ``Service Act,''; and
                  (B) by striking ``September 1, 1992.'' and inserting 
                the following: ``September 1, 1992, does not include an 
                application for a licensure of a biological product for 
                further manufacturing use only, and does not include an 
                application or supplement submitted by a State or 
                Federal Government entity for a drug that is not 
                distributed commercially. Such term does include an 
                application for licensure, as described in subparagraph 
                (D), of a large volume biological product intended for 
                single dose injection for intravenous use or 
                infusion.'';
          (2) in the second sentence of paragraph (3)--
                  (A) by striking ``Service Act, and'' and inserting 
                ``Service Act,''; and
                  (B) by striking ``September 1, 1992.'' and inserting 
                the following: ``September 1, 1992, does not include a 
                biological product that is licensed for further 
                manufacturing use only, and does not include a drug 
                that is not distributed commercially and is the subject 
                of an application or supplement submitted by a State or 
                Federal Government entity. Such term does include a 
                large volume biological product intended for single 
                dose injection for intravenous use or infusion.'';
          (3) in paragraph (4), by striking ``without'' and inserting 
        ``without substantial'';
          (4) by amending the first sentence of paragraph (5) to read 
        as follows:
          ``(5) The term `prescription drug establishment' means a 
        foreign or domestic place of business which is at one general 
        physical location consisting of one or more buildings all of 
        which are within 5 miles of each other and at which one or more 
        prescription drug products are manufactured in final dosage 
        form.''.
          (5) in paragraph (7)(A)--
                  (A) by striking ``employees under contract'' and all 
                that follows through ``Administration,'' the second 
                time it occurs and inserting ``contractors of the Food 
                and Drug Administration,''; and
                  (B) by striking ``and committees,'' and inserting 
                ``and committees and to contracts with such 
                contractors,'';
          (6) in paragraph (8)--
                  (A) in subparagraph (A)--
                          (i) by striking ``August of '' and inserting 
                        ``April of ''; and
                          (ii) by striking ``August 1992'' and 
                        inserting ``April 1997'';
                  (B) in subparagraph (B), by striking ``1992'' and 
                inserting ``1997''; and
                  (C) by striking the second sentence; and
          (7) by adding at the end the following:
          ``(9) The term `affiliate' means a business entity that has a 
        relationship with a second business entity if, directly or 
        indirectly--
                  ``(A) one business entity controls, or has the power 
                to control, the other business entity; or
                  ``(B) a third party controls, or has power to 
                control, both of the business entities.''.
  (c) Authority to Assess and Use Drug Fees.--
          (1) Types of fees.--Section 736(a) (21 U.S.C. 379h(a)) is 
        amended--
                  (A) by striking ``Beginning in fiscal year 1993'' and 
                inserting ``Beginning in fiscal year 1998'';
                  (B) in paragraph (1)--
                          (i) by striking subparagraph (B) and 
                        inserting the following:
                  ``(B) Payment.--The fee required by subparagraph (A) 
                shall be due upon submission of the application or 
                supplement.'';
                          (ii) in subparagraph (D)--
                                  (I) in the subparagraph heading, by 
                                striking ``not accepted'' and inserting 
                                ``refused'';
                                  (II) by striking ``50 percent'' and 
                                inserting ``75 percent'';
                                  (III) by striking ``subparagraph 
                                (B)(i)'' and inserting ``subparagraph 
                                (B)''; and
                                  (IV) by striking ``not accepted'' and 
                                inserting ``refused''; and
                          (iii) by adding at the end the following:
                  ``(E) Exception for designated orphan drug or 
                indication.--A human drug application for a 
                prescription drug product that has been designated as a 
                drug for a rare disease or condition pursuant to 
                section 526 shall not be subject to a fee under 
                subparagraph (A), unless the human drug application 
                includes indications for other than rare diseases or 
                conditions. A supplement proposing to include a new 
                indication for a rare disease or condition in a human 
                drug application shall not be subject to a fee under 
                subparagraph (A), if the drug has been designated 
                pursuant to section 526 as a drug for a rare disease or 
                condition with regard to the indication proposed in 
                such supplement.
                  ``(F) Exception for supplements for pediatric 
                indications.--A supplement to a human drug application 
                for an indication for use in pediatric populations 
                shall not be assessed a fee under subparagraph (A).
                  ``(G) Refund of fee if application withdrawn.--If an 
                application or supplement is withdrawn after the 
                application or supplement is filed, the Secretary may 
                waive and refund the fee or a portion of the fee if no 
                substantial work was performed on the application or 
                supplement after the application or supplement was 
                filed. The Secretary shall have the sole discretion to 
                waive and refund a fee or a portion of the fee under 
                this subparagraph. A determination by the Secretary 
                concerning a waiver or refund under this paragraph 
                shall not be reviewable.'';
                  (C) by striking paragraph (2) and inserting in lieu 
                the following:
          ``(2) Prescription drug establishment fee.--
                  ``(A) In general.--Except as provided in subparagraph 
                (B), each person that is named as the applicant in a 
                human drug application, and after September 1, 1992, 
                had pending before the Secretary a human drug 
                application or supplement, shall be assessed an annual 
                fee established in subsection (b) for each prescription 
                drug establishment listed in its approved human drug 
                application as an establishment that manufactures the 
                prescription drug product named in the application. The 
                annual establishment fee shall be assessed in each 
                fiscal year in which the prescription drug product 
                named in the application is assessed a fee under 
                paragraph (3) unless the prescription drug 
                establishment listed in the application does not engage 
                in the manufacture of the prescription drug product 
                during the fiscal year. The establishment fee shall be 
                payable on or before January 31 of each year. Each such 
                establishment shall be assessed only one fee per 
                establishment, notwithstanding the number of 
                prescription drug products manufactured at the 
                establishment. In the event an establishment is listed 
                in a human drug application by more than 1 applicant, 
                the establishment fee for the fiscal year shall be 
                divided equally and assessed among the applicants whose 
                prescription drug products are manufactured by the 
                establishment during the fiscal year and assessed 
                product fees under paragraph (3).
                  ``(B) Exception.--If, during the fiscal year, an 
                applicant initiates or causes to be initiated the 
                manufacture of a prescription drug product at an 
                establishment listed in its human drug application--
                          ``(i) that did not manufacture the product in 
                        the previous fiscal year; and
                          ``(ii) for which the full establishment fee 
                        has been assessed in the fiscal year at a time 
                        before manufacture of the prescription drug 
                        product was begun;
                the applicant will not be assessed a share of the 
                establishment fee for the fiscal year in which the 
                manufacture of the product began.''.
                  (D) in paragraph (3)--
                          (i) in subparagraph (A)--
                                  (I) in clause (i), by striking ``is 
                                listed'' and inserting ``has been 
                                submitted for listing''; and
                                  (II) by striking ``Such fee shall be 
                                paid'' and all that follows through 
                                ``section 510.'' and inserting the 
                                following: ``Such fee shall be payable 
                                for the fiscal year in which the 
                                product is first submitted for listing 
                                under section 510, or for relisting 
                                under section 510 if the product has 
                                been withdrawn from listing and 
                                relisted. After such fee is paid for 
                                that fiscal year, such fee shall be 
                                payable on or before January 31 of each 
                                year. Such fee shall be paid only once 
                                for each product for a fiscal year in 
                                which the fee is payable.''; and
                          (ii) in subparagraph (B), by striking 
                        ``505(j).'' and inserting the following: 
                        ``505(j), under an abbreviated application 
                        filed under section 507, or under an 
                        abbreviated new drug application pursuant to 
                        regulations in effect prior to the 
                        implementation of the Drug Price Competition 
                        and Patent Term Restoration Act of 1984.''.
          (2) Fee amounts.--Section 736(b) (21 U.S.C. 379h(b)) is 
        amended to read as follows:
  ``(b) Fee Amounts.--Except as provided in subsections (c), (d), (f), 
and (g), the fees required under subsection (a) shall be determined and 
assessed as follows:
          ``(1) Application and supplement fees.--
                  ``(A) Full fees.--The application fee under 
                subsection (a)(1)(A)(i) shall be $250,704 in fiscal 
                year 1998, $256,338 in each of fiscal years 1999 and 
                2000, $267,606 in fiscal year 2001, and $258,451 in 
                fiscal year 2002.
                  ``(B) Other fees.--The fee under subsection 
                (a)(1)(A)(ii) shall be $125,352 in fiscal year 1998, 
                $128,169 in each of fiscal years 1999 and 2000, 
                $133,803 in fiscal year 2001, and $129,226 in fiscal 
                year 2002.
          ``(2) Fee revenues for establishment fees.--The total fee 
        revenues to be collected in establishment fees under subsection 
        (a)(2) shall be $35,600,000 in fiscal year 1998, $36,400,000 in 
        each of fiscal years 1999 and 2000, $38,000,000 in fiscal year 
        2001, and $36,700,000 in fiscal year 2002.
          ``(3) Total fee revenues for product fees.--The total fee 
        revenues to be collected in product fees under subsection 
        (a)(3) in a fiscal year shall be equal to the total fee 
        revenues collected in establishment fees under subsection 
        (a)(2) in that fiscal year.''.
          (3) Increases and adjustments.--Section 736(c) (21 U.S.C. 
        379h(c)) is amended--
                  (A) in the subsection heading, by striking 
                ``Increases and'';
                  (B) in paragraph (1)--
                          (i) by striking ``(1) Revenue'' and all that 
                        follows through ``increased by the Secretary'' 
                        and inserting the following: ``(1) Inflation 
                        adjustment.--The fees and total fee revenues 
                        established in subsection (b) shall be adjusted 
                        by the Secretary'';
                          (ii) in subparagraph (A), by striking 
                        ``increase'' and inserting ``change'';
                          (iii) in subparagraph (B), by striking 
                        ``increase'' and inserting ``change''; and
                          (iv) by adding at the end the following flush 
                        sentence:
        ``The adjustment made each fiscal year by this subsection will 
        be added on a compounded basis to the sum of all adjustments 
        made each fiscal year after fiscal year 1997 under this 
        subsection.'';
                  (C) in paragraph (2), by striking ``October 1, 
                1992,'' and all that follows through ``such schedule.'' 
                and inserting the following: ``September 30, 1997, 
                adjust the establishment and product fees described in 
                subsection (b) for the fiscal year in which the 
                adjustment occurs so that the revenues collected from 
                each of the categories of fees described in paragraphs 
                (2) and (3) of subsection (b) shall be set to be equal 
                to the revenues collected from the category of 
                application and supplement fees described in paragraph 
                (1) of subsection (b).''; and
                  (D) in paragraph (3), by striking ``paragraph (2)'' 
                and inserting ``this subsection''.
          (4) Fee waiver or reduction.--Section 736(d) (21 U.S.C. 
        379h(d)) is amended--
                  (A) by redesignating paragraphs (1), (2), (3), and 
                (4) as subparagraphs (A), (B), (C), and (D), 
                respectively and indenting appropriately;
                  (B) by striking ``The Secretary shall grant a'' and 
                all that follows through ``finds that--'' and inserting 
                the following:
          ``(1) In general.--The Secretary shall grant a waiver from or 
        a reduction of one or more fees assessed under subsection (a) 
        where the Secretary finds that--'';
                  (C) in subparagraph (C) (as so redesignated by 
                subparagraph (A)), by striking ``, or'' and inserting a 
                comma;
                  (D) in subparagraph (D) (as so redesignated by 
                subparagraph (A)), by striking the period and inserting 
                ``, or'';
                  (E) by inserting after subparagraph (D) (as so 
                redesignated by subparagraph (A)) the following:
                  ``(E) the applicant is a small business submitting 
                its first human drug application to the Secretary for 
                review.''; and
                  (F) by striking ``In making the finding in paragraph 
                (3),'' and all that follows through ``standard costs.'' 
                and inserting the following:
          ``(2) Use of standard costs.--In making the finding in 
        paragraph (1)(C), the Secretary may use standard costs.
          ``(3) Rules relating to small businesses.--
                  ``(A) Definition.--In paragraph (1)(E), the term 
                `small business' means an entity that has fewer than 
                500 employees, including employees of affiliates.
                  ``(B) Waiver of application fee.--The Secretary shall 
                waive under paragraph (1)(E) the application fee for 
                the first human drug application that a small business 
                or its affiliate submits to the Secretary for review. 
                After a small business or its affiliate is granted such 
                a waiver, the small business or its affiliate shall 
                pay--
                          ``(i) application fees for all subsequent 
                        human drug applications submitted to the 
                        Secretary for review in the same manner as an 
                        entity that does not qualify as a small 
                        business; and
                          ``(ii) all supplement fees for all 
                        supplements to human drug applications 
                        submitted to the Secretary for review in the 
                        same manner as an entity that does not qualify 
                        as a small business.''.
          (5) Assessment of fees.--Section 736(f)(1) (21 U.S.C. 
        379h(f)(1)) is amended--
                  (A) by striking ``fiscal year 1993'' and inserting 
                ``fiscal year 1997''; and
                  (B) by striking ``fiscal year 1992'' and inserting 
                ``fiscal year 1997 (excluding the amount of fees 
                appropriated for such fiscal year)''.
          (6) Crediting and availability of fees.--Section 736(g) (21 
        U.S.C. 379h(g)) is amended--
                  (A) in paragraph (1), by adding at the end the 
                following: ``Such sums as may be necessary may be 
                transferred from the Food and Drug Administration 
                salaries and expenses appropriation account without 
                fiscal year limitation to such appropriation account 
                for salaries and expenses with such fiscal year 
                limitation. The sums transferred shall be available 
                solely for the process for the review of human drug 
                applications within the meaning of section 735(6).'';
                  (B) in paragraph (2)--
                          (i) in subparagraph (A), by striking ``Acts'' 
                        and inserting ``Acts, or otherwise made 
                        available for obligation,''; and
                          (ii) in subparagraph (B), by striking ``over 
                        such costs for fiscal year 1992'' and inserting 
                        ``over such costs, excluding costs paid from 
                        fees collected under this section, for fiscal 
                        year 1997''; and
                  (C) by striking paragraph (3) and inserting the 
                following:
          ``(3) Authorization of appropriations.--There is authorized 
        to be appropriated for fees under this section--
                  ``(A) $106,800,000 for fiscal year 1998;
                  ``(B) $109,200,000 for fiscal year 1999;
                  ``(C) $109,200,000 for fiscal year 2000;
                  ``(D) $114,000,000 for fiscal year 2001; and
                  ``(E) $110,100,000 for fiscal year 2002,
        as adjusted to reflect adjustments in the total fee revenues 
        made under this section and changes in the total amounts 
        collected by application, supplement, establishment, and 
        product fees.
          ``(4) Offset.--Any amount of fees collected for a fiscal year 
        which exceeds the amount of fees specified in appropriation 
        Acts for such fiscal year shall be credited to the 
        appropriation account of the Food and Drug Administration as 
        provided in paragraph (1), and shall be subtracted from the 
        amount of fees that would otherwise be authorized to be 
        collected under appropriation Acts for a subsequent fiscal 
        year.''.
          (7) Requirement for written requests for waivers, reductions, 
        and fees.--Section 736 (21 U.S.C. 379h) is amended--
                  (A) by redesignating subsection (i) as subsection 
                (j); and
                  (B) by inserting after subsection (h) the following:
  ``(i) Written Requests for Waivers, Reductions, and Refunds.--To 
qualify for consideration for a waiver or reduction under subsection 
(d), or for a refund of any fee collected in accordance with subsection 
(a), a person shall submit to the Secretary a written request for such 
waiver, reduction, or refund not later than 180 days after such fee is 
due.''.
          (8) Special rule for waiver, refunds, and exceptions.--Any 
        requests for waivers, refunds, or exceptions for fees assessed 
        prior to the date of enactment of this Act shall be submitted 
        in writing to the Secretary of Health and Human Services within 
        1 year after the date of enactment of this Act.
  (d) Annual Reports.--
          (1) Performance report.--Beginning with fiscal year 1998, not 
        later than 60 days after the end of each fiscal year during 
        which fees are collected under part 2 of subchapter C of 
        chapter VII of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 379g et seq.), the Secretary of Health and Human 
        Services shall prepare and submit to the Committee on Commerce 
        of the House of Representatives and the Committee on Labor and 
        Human Resources of the Senate a report concerning the progress 
        of the Food and Drug Administration in achieving the goals 
        identified in the letter described in subsection (a)(4) during 
        such fiscal year and the future plans of the Food and Drug 
        Administration for meeting the goals.
          (2) Fiscal report.--Beginning with fiscal year 1998, not 
        later than 120 days after the end of each fiscal year during 
        which fees are collected under the part described in subsection 
        (a), the Secretary of Health and Human Services shall prepare 
        and submit to the Committee on Commerce of the House of 
        Representatives and the Committee on Labor and Human Resources 
        of the Senate a report on the implementation of the authority 
        for such fees during such fiscal year and the use, by the Food 
        and Drug Administration, of the fees collected during such 
        fiscal year for which the report is made.
  (e) Effective Date.--The amendments made by this section shall take 
effect October 1, 1997.
  (f) Termination of Effectiveness.--The amendments made by subsections 
(b) and (c) cease to be effective October 1, 2002, and subsection (d) 
ceases to be effective 120 days after such date.

SEC. 3. PEDIATRIC STUDIES OF DRUGS.

  Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after 
section 505 the following:
                      ``pediatric studies of drugs
  ``Sec. 505A. (a) Market Exclusivity for New Drugs.--If, prior to 
approval of an application that is submitted under section 505(b)(1), 
the Secretary determines that information relating to the use of a drug 
in the pediatric population may produce health benefits in that 
population, the Secretary makes a written request for pediatric studies 
(which shall include a timeframe for completing such studies), and such 
studies are completed within any such timeframe and the reports thereof 
submitted in accordance with subsection (d)(2) or accepted in 
accordance with subsection (d)(3)--
          ``(1)(A) the period during which an application may not be 
        submitted under subsections (c)(3)(D)(ii) and (j)(4)(D)(ii) of 
        section 505 shall be five years and six months rather than five 
        years, and the references in subsections (c)(3)(D)(ii) and 
        (j)(4)(D)(ii) of section 505 to four years, to forty-eight 
        months, and to seven and one-half years shall be deemed to be 
        four and one-half years, fifty-four months, and eight years, 
        respectively; or
          ``(B) the period of market exclusivity under subsections 
        (c)(3)(D)(iii) and (iv) and (j)(4)(D)(iii) and (iv) of section 
        505 shall be three years and six months rather than three 
        years; and
          ``(2)(A) if the drug is the subject of--
                  ``(i) a listed patent for which a certification has 
                been submitted under subsections (b)(2)(A)(ii) or 
                (j)(2)(A)(vii)(II) of section 505 and for which 
                pediatric studies were submitted prior to the 
                expiration of the patent (including any patent 
                extensions); or
                  ``(ii) a listed patent for which a certification has 
                been submitted under subsections (b)(2)(A)(iii) or 
                (j)(2)(A)(vii)(III) of section 505,
        the period during which an application may not be approved 
        under section 505(c)(3) or section 505(j)(4)(B) shall be 
        extended by a period of six months after the date the patent 
        expires (including any patent extensions); or
          ``(B) if the drug is the subject of a listed patent for which 
        a certification has been submitted under subsection 
        (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in the 
        patent infringement litigation resulting from the certification 
        the court determines that the patent is valid and would be 
        infringed, the period during which an application may not be 
        approved under section 505(c)(3) or section 505(j)(4)(B) shall 
        be extended by a period of six months after the date the patent 
        expires (including any patent extensions).
  ``(b) Secretary To Develop List of Drugs for Which Additional 
Pediatric Information May Be Beneficial.--Not later than 180 days after 
the date of enactment of this section, the Secretary, after 
consultation with experts in pediatric research shall develop, 
prioritize, and publish an initial list of approved drugs for which 
additional pediatric information may produce health benefits in the 
pediatric population. The Secretary shall annually update the list.
  ``(c) Market Exclusivity for Already-Marketed Drugs.--If the 
Secretary makes a written request to the holder of an approved 
application under section 505(b)(1) for pediatric studies (which shall 
include a timeframe for completing such studies) concerning a drug 
identified in the list described in subsection (b), the holder agrees 
to the request, the studies are completed within any such timeframe and 
the reports thereof are submitted in accordance with subsection (d)(2) 
or accepted in accordance with subsection (d)(3)--
          ``(1)(A) the period during which an application may not be 
        submitted under subsection (c)(3)(D)(ii) or (j)(4)(D)(ii) of 
        section 505 shall be five years and six months rather than five 
        years, and the references in subsections (c)(3)(D)(ii) and 
        (j)(4)(D)(ii) of section 505 to four years, to forty-eight 
        months, and to seven and one-half years shall be deemed to be 
        four and one-half years, fifty-four months, and eight years, 
        respectively; or
          ``(B) the period of market exclusivity under subsections 
        (c)(3)(D)(iii) and (iv) and (j)(4)(D)(iii) and (iv) of section 
        505 shall be three years and six months rather than three 
        years; and
          ``(2)(A) if the drug is the subject of--
                  ``(i) a listed patent for which a certification has 
                been submitted under subsection (b)(2)(A)(ii) or 
                (j)(2)(A)(vii)(II) of section 505 and for which 
                pediatric studies were submitted prior to the 
                expiration of the patent (including any patent 
                extensions); or
                  ``(ii) a listed patent for which a certification has 
                been submitted under subsection (b)(2)(A)(iii) or 
                (j)(2)(A)(vii)(III) of section 505,
        the period during which an application may not be approved 
        under section 505(c)(3) or section 505(j)(4)(B) shall be 
        extended by a period of six months after the date the patent 
        expires (including any patent extensions); or
          ``(B) if the drug is the subject of a listed patent for which 
        a certification has been submitted under subsection 
        (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in the 
        patent infringement litigation resulting from the certification 
        the court determines that the patent is valid and would be 
        infringed, the period during which an application may not be 
        approved under section 505(c)(3) or section 505(j)(4)(B) shall 
        be extended by a period of six months after the date the patent 
        expires (including any patent extensions).
  ``(d) Conduct of Pediatric Studies.--
          ``(1) Agreement for studies.--The Secretary may, pursuant to 
        a written request for studies, after consultation with--
                  ``(A) the sponsor of an application for an 
                investigational new drug under section 505(i);
                  ``(B) the sponsor of an application for a drug under 
                section 505(b)(1); or
                  ``(C) the holder of an approved application for a 
                drug under section 505(b)(1),
        agree with the sponsor or holder for the conduct of pediatric 
        studies for such drug.
          ``(2) Written protocols to meet the studies requirement.--If 
        the sponsor or holder and the Secretary agree upon written 
        protocols for the studies, the studies requirement of 
        subsection (a) or (c) is satisfied upon the completion of the 
        studies and submission of the reports thereof in accordance 
        with the original written request and the written agreement 
        referred to in paragraph (1). Not later than 60 days after the 
        submission of the report of the studies, the Secretary shall 
        determine if such studies were or were not conducted in 
        accordance with the original written request and the written 
        agreement and reported in accordance with the requirements of 
        the Secretary for filing and so notify the sponsor or holder.
          ``(3) Other methods to meet the studies requirement.--If the 
        sponsor or holder and the Secretary have not agreed in writing 
        on the protocols for the studies, the studies requirement of 
        subsection (a) or (c) is satisfied when such studies have been 
        completed and the reports accepted by the Secretary. Not later 
        than 90 days after the submission of the reports of the 
        studies, the Secretary shall accept or reject such reports and 
        so notify the sponsor or holder. The Secretary's only 
        responsibility in accepting or rejecting the reports shall be 
        to determine, within the 90 days, whether the studies fairly 
        respond to the written request, whether such studies have been 
        conducted in accordance with commonly accepted scientific 
        principles and protocols, and whether such studies have been 
        reported in accordance with the requirements of the Secretary 
        for filing.
  ``(e) Delay of Effective Date for Certain Applications; Period of 
Market Exclusivity.--If the Secretary determines that the acceptance or 
approval of an application under section 505(b)(2) or 505(j) for a drug 
may occur after submission of reports of pediatric studies under this 
section, which were submitted prior to the expiration of the patent 
(including any patent extension) or market exclusivity protection, but 
before the Secretary has determined whether the requirements of 
subsection (d) have been satisfied, the Secretary shall delay the 
acceptance or approval under section 505(b)(2) or 505(j), respectively, 
until the determination under subsection (d) is made, but such delay 
shall not exceed 90 days. In the event that requirements of this 
section are satisfied, the applicable period of market exclusivity 
referred to in subsection (a) or (c) shall be deemed to have been 
running during the period of delay.
  ``(f) Notice of Determinations on Studies Requirement.--The Secretary 
shall publish a notice of any determination that the requirements of 
subsection (d) have been met and that submissions and approvals under 
section 505(b)(2) or (j) for a drug will be subject to the provisions 
of this section.
  ``(g) Definitions.--As used in this section, the term `pediatric 
studies' or `studies' means at least one clinical investigation (that, 
at the Secretary's discretion, may include pharmacokinetic studies) in 
pediatric age groups in which a drug is anticipated to be used.
  ``(h) Limitation.--The holder of an approved application for a new 
drug that has already received six months of market exclusivity under 
subsection (a) or (c) may, if otherwise eligible, obtain six months of 
market exclusivity under subsection (c)(1)(B) for a supplemental 
application, except that the holder is not eligible for exclusivity 
under subsection (c)(2).
  ``(i) Relationship to Regulations.--Notwithstanding any other 
provision of law, if any pediatric study is required pursuant to 
regulations promulgated by the Secretary, such study shall be deemed to 
satisfy the requirement for market exclusivity pursuant to this 
section.
  ``(j) Sunset.--No period of market exclusivity shall be granted under 
this section based on studies commenced after January 1, 2002. The 
Secretary shall conduct a study and report to Congress not later than 
January 1, 2001, based on the experience under the program. The study 
and report shall examine all relevant issues, including--
          ``(1) the effectiveness of the program in improving 
        information about important pediatric uses for approved drugs;
          ``(2) the adequacy of the incentive provided under this 
        section;
          ``(3) the economic impact of the program on taxpayers and 
        consumers, including the impact of the lack of lower cost 
        generic drugs on lower income patients; and
          ``(4) any suggestions for modification that the Secretary 
        deems appropriate.''.

SEC. 4. EXPEDITING STUDY AND APPROVAL OF FAST TRACK DRUGS.

  (a) In General.--Chapter VII is amended by adding at the end the 
following:

                  ``Subchapter D--Fast Track Products

``SEC. 741. FAST TRACK PRODUCTS.

  ``(a) Designation of Drug as a Fast Track Product.--
          ``(1) In general.--The Secretary shall facilitate the 
        development and expedite the review of new drugs that are 
        intended for the treatment of serious or life-threatening 
        conditions and that demonstrate the potential to address unmet 
        medical needs for such conditions. In this section, such 
        products shall be known as `fast track products'.
          ``(2) Request for designation.--The sponsor of a drug may 
        request the Secretary to designate the drug as a fast track 
        product. A request for the designation may be made concurrently 
        with, or at any time after, submission of an application for 
        the investigation of the drug under section 505(i) or section 
        351(a)(4) of the Public Health Service Act.
          ``(3) Designation.--Within 30 calendar days after the receipt 
        of a request under paragraph (2), the Secretary shall determine 
        whether the drug that is the subject of the request meets the 
        criteria described in paragraph (1). If the Secretary finds 
        that the drug meets the criteria, the Secretary shall designate 
        the drug as a fast track product and shall take such actions as 
        are appropriate to expedite the development and review of the 
        application for approval of such product.
  ``(b) Approval of Application for a Fast Track Product.--
          ``(1) In general.--The Secretary may approve an application 
        for approval of a fast track product under section 505(b) or 
        section 351 of the Public Health Service Act (21 U.S.C. 262) 
        upon a determination that the product has an effect on a 
        clinical endpoint or a surrogate endpoint that is reasonably 
        likely to predict clinical benefit.
          ``(2) Limitation.--Approval of a fast track product under 
        this subsection may be subject to the requirements--
                  ``(A) that the sponsor conduct appropriate post-
                approval studies to validate the surrogate endpoint or 
                otherwise confirm the effect on the clinical endpoint; 
                and
                  ``(B) that the sponsor submit copies of all 
                promotional materials related to the fast track product 
                during the preapproval review period and, following 
                approval and for such period thereafter as the 
                Secretary deems appropriate, at least 30 days prior to 
                dissemination of the materials.
          ``(3) Expedited withdrawal of approval.--The Secretary may 
        withdraw approval of a fast track product using expedited 
        procedures (as prescribed by the Secretary in regulations which 
        shall include an opportunity for an informal hearing), if--
                  ``(A) the sponsor fails to conduct any required post-
                approval study of the fast track drug with due 
                diligence;
                  ``(B) a post-approval study of the fast track product 
                fails to verify clinical benefit of the product;
                  ``(C) other evidence demonstrates that the fast track 
                product is not safe or effective under the conditions 
                of use; or
                  ``(D) the sponsor disseminates false or misleading 
                promotional materials with respect to the product.
  ``(c) Review of Incomplete Applications for Approval of a Fast Track 
Product.--
          ``(1) In general.--If the Secretary determines, after 
        preliminary evaluation of clinical data submitted by the 
        sponsor, that a fast track product may be effective the 
        Secretary shall evaluate for filing, and may commence review of 
        portions of, an application for the approval of the product 
        before the sponsor submits a complete application. The 
        Secretary shall commence such review only if the applicant (A) 
        provides a schedule for submission of information necessary to 
        make the application complete, and (B) pays any fee that may be 
        required under section 736.
          ``(2) Exception.--Any time period for review of human drug 
        applications that has been agreed to by the Secretary and that 
        has been set forth in goals identified in letters of the 
        Secretary (relating to the use of fees collected under section 
        736 to expedite the drug development process and the review of 
        human drug applications) shall not apply to an application 
        submitted under paragraph (1) until the date on which the 
        application is complete.
  ``(d) Awareness Efforts.--The Secretary shall--
          ``(1) develop and disseminate to physicians, patient 
        organizations, pharmaceutical and biotechnology companies, and 
        other appropriate persons a description of the provisions 
        applicable to fast track products established under this 
        section; and
          ``(2) establish a program to encourage the development of 
        surrogate endpoints that are reasonably likely to predict 
        clinical benefit for serious or life-threatening conditions for 
        which there exist significant unmet medical needs.''.
  (b) Guidance.--Within 1 year after the date of enactment of this Act, 
the Secretary shall issue guidance for fast track products (as defined 
in section 741(a)(1) of the Federal Food, Drug, and Cosmetic Act) that 
describes the policies and procedures that pertain to section 741 of 
such Act.

SEC. 5. EXPANDED ACCESS TO INVESTIGATIONAL THERAPIES.

  Chapter V (21 U.S.C. 351 et seq.) is amended by adding at the end the 
following:

          ``Subchapter D--Unapproved Therapies and Diagnostics

``SEC. 551. EXPANDED ACCESS TO UNAPPROVED THERAPIES AND DIAGNOSTICS.

  ``(a) Emergency Situations.--The Secretary may, under appropriate 
conditions determined by the Secretary, authorize the shipment of 
investigational drugs (as defined in regulations prescribed by the 
Secretary) for the diagnosis or treatment of a serious disease or 
condition in emergency situations.
  ``(b) Individual Patient Access to Investigational Products Intended 
for Serious Diseases.--Any person, acting through a physician licensed 
in accordance with State law, may request from a manufacturer or 
distributor, and any manufacturer or distributor may provide to such 
physician after compliance with the provisions of this subsection, an 
investigational drug (as defined in regulations prescribed by the 
Secretary) for the diagnosis or treatment of a serious disease or 
condition if--
          ``(1) the licensed physician determines that the person has 
        no comparable or satisfactory alternative therapy available to 
        diagnose or treat the disease or condition involved, and that 
        the risk to the person from the investigational drug is not 
        greater than the risk from the disease or condition;
          ``(2) the Secretary determines that there is sufficient 
        evidence of safety and effectiveness to support the use of the 
        investigational drug in the case described in paragraph (1);
          ``(3) the Secretary determines that provision of the 
        investigational drug will not interfere with the initiation, 
        conduct, or completion of clinical investigations to support 
        marketing approval; and
          ``(4) the sponsor, or clinical investigator, of the 
        investigational drug submits to the Secretary a clinical 
        protocol consistent with the provisions of section 505(i) and 
        any regulations promulgated under section 505(i) describing the 
        use of investigational drugs in a single patient or a small 
        group of patients.
  ``(c) Treatment INDs.--Upon submission by a sponsor or a physician of 
a protocol intended to provide widespread access to an investigational 
drug for eligible patients, the Secretary shall permit such 
investigational drug to be made available for expanded access under a 
treatment investigational new drug application if the Secretary 
determines that--
          ``(1) under the treatment investigational new drug 
        application, the investigational drug is intended for use in 
        the diagnosis or treatment of a serious or immediately life-
        threatening disease or condition;
          ``(2) there is no comparable or satisfactory alternative 
        therapy available to diagnose or treat that stage of disease or 
        condition in the population of patients to which the 
        investigational drug is intended to be administered;
          ``(3)(A) the investigational drug is under investigation in a 
        controlled clinical trial for the use described in paragraph 
        (1) under an effective investigational new drug application; or
          ``(B) all clinical trials necessary for approval of that use 
        of the investigational drug have been completed;
          ``(4) the sponsor of the controlled clinical trials is 
        actively pursuing marketing approval of the investigational 
        drug for the use described in paragraph (1) with due diligence;
          ``(5) the provision of the investigational drug will not 
        interfere with the enrollment of patients in ongoing clinical 
        investigations under section 505(i);
          ``(6) in the case of serious diseases, there is sufficient 
        evidence of safety and effectiveness to support the use 
        described in paragraph (1); and
          ``(7) in the case of immediately life-threatening diseases, 
        the available scientific evidence, taken as a whole, provides a 
        reasonable basis to conclude that the product may be effective 
        for its intended use and would not expose patients to an 
        unreasonable and significant risk of illness or injury.
A protocol submitted under this subsection shall be subject to the 
provisions of section 505(i) and regulations promulgated under section 
505(i). The Secretary may inform national, State, and local medical 
associations and societies, voluntary health associations, and other 
appropriate persons about the availability of an investigational drug 
under expanded access protocols submitted under this subsection. The 
information provided by the Secretary, in accordance with the preceding 
sentence, shall be of the same type of information that is required by 
section 402(j)(3) of the Public Health Service Act.
  ``(d) Termination.--The Secretary may, at any time, with respect to a 
sponsor, physician, manufacturer, or distributor described in this 
section, terminate expanded access provided under this section for an 
investigational drug if the requirements under this section are no 
longer met.''.

SEC. 6. INFORMATION PROGRAM ON CLINICAL TRIALS FOR SERIOUS OR LIFE-
                    THREATENING DISEASES.

  (a) In General.--Section 402 of the Public Health Service Act (42 
U.S.C. 282) is amended--
          (1) by redesignating subsections (j) and (k) as subsections 
        (k) and (l), respectively; and
          (2) by inserting after subsection (i), the following:
  ``(j)(1) The Secretary, acting through the Director of the National 
Institutes of Health, shall establish, maintain, and operate a program 
with respect to information on research relating to the treatment, 
detection, and prevention of serious or life-threatening diseases and 
conditions. The program shall, with respect to the agencies of the 
Department of Health and Human Services, be integrated and coordinated, 
and, to the extent practicable, coordinated with other data banks 
containing similar information.
  ``(2)(A) After consultation with the Commissioner of Food and Drugs, 
the directors of the appropriate agencies of the National Institutes of 
Health (including the National Library of Medicine), and the Director 
of the Centers for Disease Control and Prevention, the Secretary shall, 
in carrying out paragraph (1), establish a data bank of information on 
clinical trials for drugs for serious or life-threatening diseases and 
conditions.
  ``(B) In carrying out subparagraph (A), the Secretary shall collect, 
catalog, store, and disseminate the information described in such 
subparagraph. The Secretary shall disseminate such information through 
information systems, which shall include toll-free telephone 
communications, available to individuals with serious or life-
threatening diseases and conditions, to other members of the public, to 
health care providers, and to researchers.
  ``(3) The data bank shall include the following:
          ``(A) A registry of clinical trials (whether federally or 
        privately funded) of experimental treatments for serious or 
        life-threatening diseases and conditions under regulations 
        promulgated pursuant to sections 505 of the Federal Food, Drug, 
        and Cosmetic Act that provides a description of the purpose of 
        each experimental drug, either with the consent of the protocol 
        sponsor, or when a trial to test effectiveness begins. 
        Information provided shall consist of eligibility criteria, a 
        description of the location of trial sites, and a point of 
        contact for those wanting to enroll in the trial, and shall be 
        in a form that can be readily understood by members of the 
        public. Such information must be forwarded to the data bank by 
        the sponsor of the trial not later than 21 days after trials to 
        test clinical effectiveness have begun.
          ``(B) Information pertaining to experimental treatments for 
        serious or life-threatening diseases and conditions that may be 
        available--
                  ``(i) under a treatment investigational new drug 
                application that has been submitted to the Food and 
                Drug Administration under section 551(c) of the Federal 
                Food, Drug, and Cosmetic Act; or
                  ``(ii) as a Group C cancer drug (as defined by the 
                National Cancer Institute).
          The data bank may also include information pertaining to the 
        results of clinical trials of such treatments, with the consent 
        of the sponsor, including information concerning potential 
        toxicities or adverse effects associated with the use or 
        administration of such experimental treatments.
  ``(4) The data bank shall not include information relating to an 
investigation if the sponsor has provided a detailed certification to 
the Secretary that disclosure of such information would substantially 
interfere with the timely enrollment of subjects in the investigation, 
unless the Secretary, after the receipt of the certification, provides 
the sponsor with a detailed written determination that such disclosure 
would not substantially interfere with such enrollment.
  ``(5) For the purpose of carrying out this subsection, there are 
authorized to be appropriated such sums as may be necessary. Fees 
collected under section 736 of the Federal Food, Drug, and Cosmetic Act 
shall not be used in carrying out this subsection.''.
  (b) Collaboration and Report.--
          (1) In general.--The Secretary of Health and Human Services, 
        the Director of the National Institutes of Health, and the 
        Commissioner of Food and Drugs shall collaborate to determine 
        the feasibility of including device investigations within the 
        scope of the registry requirements set forth in section 402(j) 
        of the Public Health Service Act.
          (2) Report.--Not later than 2 years after the date of 
        enactment of this section, the Secretary of Health and Human 
        Services shall prepare and submit to the Committee on Labor and 
        Human Resources of the Senate and the Committee on Commerce of 
        the House of Representatives a report--
                  (A) of the public health need, if any, for inclusion 
                of device investigations within the scope of the 
                registry requirements set forth in section 402(j) of 
                the Public Health Service Act;
                  (B) on the adverse impact, if any, on device 
                innovation and research in the United States if 
                information relating to such device investigation is 
                required to be publicly disclosed; and
                  (C) on such other issues relating to such section 
                402(j) as the Secretary may deem appropriate.

 SEC. 7. DISSEMINATION OF INFORMATION ON NEW USES.

  (a) In General.--Chapter VII (21 U.S.C. 371 et seq.), as amended by 
section 4, is amended by adding at the end the following:

        ``Subchapter E--Dissemination of Treatment Information 

``SEC. 745. REQUIREMENTS FOR DISSEMINATION OF TREATMENT INFORMATION ON 
                    DRUGS.

  ``(a) In General.--Notwithstanding sections 301(d), 502(f), and 505 
and section 351 of the Public Health Service Act (42 U.S.C. 262), a 
manufacturer may disseminate to--
          ``(1) a health care practitioner,
          ``(2) a pharmacy benefit manager,
          ``(3) a health insurance issuer,
          ``(4) a group health plan, or
          ``(5) a Federal or State governmental agency,
written information concerning the safety, effectiveness, or benefit of 
a use not described in the approved labeling of a drug if the 
manufacturer meets the requirements of subsection (b).
  ``(b) Specific Requirements.--A manufacturer may disseminate 
information about a new use of a drug under subsection (a) only if--
          ``(1) there is in effect for such drug an application filed 
        under section 505(b) or a biologics license issued under 
        section 351 of the Public Health Service Act;
          ``(2) the information meets the requirements of section 746;
          ``(3) the information to be disseminated is not derived from 
        clinical research conducted by another manufacturer or if it 
        was derived from research conducted by another manufacturer, 
        the manufacturer disseminating the information has the 
        permission of such other manufacturer to make the 
        dissemination;
          ``(4) the manufacturer has, 60 days before such 
        dissemination, submitted to the Secretary--
                  ``(A) a copy of the information disseminated; and
                  ``(B) any clinical trial information the manufacturer 
                has relating to the safety or effectiveness of the new 
                use, any reports of clinical experience pertinent to 
                the safety of the new use, and a summary of such 
                information;
          ``(5) the manufacturer has complied with the requirements of 
        section 748 (relating to certification that the manufacturer 
        will submit a supplemental application with respect to such 
        use);
          ``(6) the manufacturer agrees to include along with the 
        information disseminated under this subsection--
                  ``(A) a prominently displayed statement that 
                discloses--
                          ``(i) that the information concerns a use of 
                        a drug that has not been approved by the Food 
                        and Drug Administration;
                          ``(ii) if applicable, that the information is 
                        being disseminated at the expense of the 
                        manufacturer;
                          ``(iii) if applicable, the name of any 
                        authors of the information who are employees 
                        of, consultants to, or have received 
                        compensation from, the manufacturer, or who 
                        have a significant financial interest in the 
                        manufacturer;
                          ``(iv) the official labeling for the drug and 
                        all updates with respect to the labeling;
                          ``(v) if applicable, a statement that there 
                        are products or treatments that have been 
                        approved for the use that is the subject of the 
                        information being disseminated pursuant to 
                        subsection (a)(1); and
                          ``(vi) the identification of any person that 
                        has provided funding for the conduct of a study 
                        relating to the new use of a drug for which 
                        such information is being disseminated; and
                  ``(B) a bibliography of other articles from a 
                scientific reference publication or scientific or 
                medical journal that have been previously published 
                about the such use of the drug covered by the 
                information disseminated (unless the information 
                already includes such bibliography).
  ``(c) Additional Information.--If the Secretary determines, after 
providing notice of such determination and an opportunity for a meeting 
with respect to such determination, that the information submitted by a 
manufacturer under subsection (b)(3)(B), with respect to the use of a 
drug for which the manufacturer is disseminating information, fails to 
provide data, analyses, or other written matter that is objective and 
balanced, the Secretary may require the manufacturer to disseminate--
          ``(1) additional objective and scientifically sound 
        information that pertains to the safety or effectiveness of the 
        use and is necessary to provide objectivity and balance, 
        including any information that the manufacturer has submitted 
        to the Secretary or, where appropriate, a summary of such 
        information or any other information that the Secretary has 
        authority to make available to the public; and
          ``(2) an objective statement of the Secretary, based on data 
        or other scientifically sound information available to the 
        Secretary, that bears on the safety or effectiveness of the new 
        use of the drug.

``SEC. 746. INFORMATION AUTHORIZED TO BE DISSEMINATED.

  ``(a) Authorized Information.--A manufacturer may disseminate the 
information on the new use of a drug under section 745 only if the 
information--
          ``(1) is in the form of an unabridged--
                  ``(A) reprint or copy of an article, peer-reviewed by 
                experts qualified by scientific training or experience 
                to evaluate the safety or effectiveness of the drug, 
                which was published in a scientific or medical journal 
                (as defined in section 750(6)), which is about a 
                clinical investigation with respect to the drug, and 
                which would be considered to be scientifically sound by 
                such experts; or
                  ``(B) reference publication, described in subsection 
                (b), that includes information about a clinical 
                investigation with respect to the drug that would be 
                considered to be scientifically sound by experts 
                qualified by scientific training or experience to 
                evaluate the safety or effectiveness of the drug that 
                is the subject of such a clinical investigation; and
          ``(2) is not false or misleading and would not pose a 
        significant risk to the public health.
  ``(b) Reference Publication.--A reference publication referred to in 
subsection (a)(1)(B) is a publication that--
          ``(1) has not been written, edited, excerpted, or published 
        specifically for, or at the request of, a manufacturer of a 
        drug;
          ``(2) has not been edited or significantly influenced by a 
        such a manufacturer;
          ``(3) is not solely distributed through such a manufacturer 
        but is generally available in bookstores or other distribution 
        channels where medical textbooks are sold;
          ``(4) does not focus on any particular drug of a manufacturer 
        that disseminates information under section 745 and does not 
        have a primary focus on new uses of drugs that are marketed or 
        under investigation by a manufacturer supporting the 
        dissemination of information; and
          ``(5) presents materials that are not false or misleading.

``SEC. 747. ESTABLISHMENT OF LIST OF ARTICLES AND PUBLICATIONS 
                    DISSEMINATED AND LIST OF PROVIDERS THAT RECEIVED 
                    ARTICLES AND REFERENCE PUBLICATIONS.

  ``(a) In General.--A manufacturer may disseminate information under 
section 745 only if the manufacturer prepares and submits to the 
Secretary biannually--
          ``(1) a list containing the titles of the articles and 
        reference publications relating to the new use of drugs that 
        were disseminated by the manufacturer to a person described in 
        section 745(a) for the 6-month period preceding the date on 
        which the manufacturer submits the list to the Secretary; and
          ``(2) a list that identifies the categories of providers (as 
        described in section 745(a)) that received the articles and 
        reference publications for the 6-month period described in 
        paragraph (1).
  ``(b) Records.--A manufacturer that disseminates information under 
section 745 shall keep records that may be used by the manufacturer 
when, pursuant to section 749, such manufacturer is required to take 
corrective action and shall be made available to the Secretary, upon 
request, for purposes of ensuring or taking corrective action pursuant 
to such section. Such records, at the Secretary's discretion, may 
identify the recipient of information provided pursuant to section 745 
or the categories of such recipients.

``SEC. 748. REQUIREMENT REGARDING SUBMISSION OF SUPPLEMENTAL 
                    APPLICATION FOR NEW USE; EXEMPTION FROM 
                    REQUIREMENT.

  ``(a) In General.--A manufacturer may disseminate information under 
section 745 on a new use only if--
          ``(1) the manufacturer meets the condition described in 
        subsection (b) or in subsection (c); or
          ``(2) there is in effect for the manufacturer an exemption 
        under subsection (d) from the requirement of paragraph (1).
  ``(b) Supplemental Application; Condition in Case of Completed 
Studies.--For purposes of subsection (a)(1), a manufacturer may 
disseminate information on a new use if the manufacturer has submitted 
to the Secretary an application containing a certification that--
          ``(1) the studies needed for the submission of a supplemental 
        application for the new use have been completed; and
          ``(2) the supplemental application will be submitted to the 
        Secretary not later than 6 months after the date of the initial 
        dissemination of information under section 745.
  ``(c) Supplemental Application; Condition in Case of Planned 
Studies.--
          ``(1) In general.--For purposes of subsection (a)(1), a 
        manufacturer may disseminate information on a new use if--
                  ``(A) the manufacturer has submitted to the Secretary 
                an application containing--
                          ``(i) a proposed protocol and schedule for 
                        conducting the studies needed for the 
                        submission of a supplemental application for 
                        the new use; and
                          ``(ii) a certification that the supplemental 
                        application will be submitted to the Secretary 
                        not later than 36 months after the date of the 
                        initial dissemination of information under 
                        section 745 (or, as applicable, not later than 
                        such date as the Secretary may specify pursuant 
                        to an extension under this paragraph or 
                        paragraph (3)); and
                  ``(B) the Secretary has determined that the proposed 
                protocol is adequate and that the schedule for 
                completing such studies is reasonable.
        The Secretary may grant a longer period of time for a 
        manufacturer to submit a supplemental application if the 
        Secretary determines that the studies needed to submit such an 
        application cannot be completed and submitted within 36 months.
          ``(2) Progress reports on studies.--A manufacturer that 
        submits to the Secretary an application under paragraph (1) 
        shall submit to the Secretary periodic reports describing the 
        status of the studies involved.
          ``(3) Extension of time regarding planned studies.--The 
        period of 36 months authorized in paragraph (1)(A)(ii) for the 
        completion of studies may be extended by the Secretary if the 
        manufacturer involved submits to the Secretary a written 
        request for the extension and the Secretary determines that the 
        manufacturer has acted with due diligence to conduct the 
        studies in a timely manner. Such extension may not provide more 
        than 24 additional months.
  ``(d) Exemption From Requirement of Supplemental Application.--
          ``(1) In general.--For purposes of subsection (a)(2), a 
        manufacturer may disseminate information on a new use if--
                  ``(A) the manufacturer has submitted to the Secretary 
                an application for an exemption from meeting the 
                requirement of subsection (a)(1); and
                  ``(B)(i) the Secretary has approved the application 
                in accordance with paragraph (2); or
                  ``(ii) the application is deemed under paragraph 
                (3)(A) to have been approved (unless such approval is 
                terminated pursuant to paragraph (3)(B)).
          ``(2) Conditions for approval.--The Secretary may approve an 
        application under paragraph (1) for an exemption only if the 
        Secretary determines that--
                  ``(A) it would be economically prohibitive with 
                respect to such drug for the manufacturer to incur the 
                costs necessary for the submission of a supplemental 
                application for reasons, as defined by the Secretary, 
                such as the lack of availability under law of any 
                period during which the manufacturer would have 
                exclusive marketing rights with respect to the new use 
                involved or that the population expected to benefit 
                from approval of the supplemental application is small; 
                or
                  ``(B) it would be unethical to conduct the studies 
                necessary for the supplemental application for a reason 
                such as the new use involved is the standard of medical 
                care for a health condition.
          ``(3) Time for consideration of application; deemed 
        approval.--
                  ``(A) In general.--The Secretary shall approve or 
                deny an application under paragraph (1) for an 
                exemption not later than 60 days after the receipt of 
                the application. If the Secretary does not comply with 
                the preceding sentence, the application is deemed to be 
                approved.
                  ``(B) Termination of deemed approval.--If pursuant to 
                a deemed approval under subparagraph (A) a manufacturer 
                disseminates written information under section 745 on a 
                new use, the Secretary may at any time terminate such 
                approval and under section 749(b)(3) order the 
                manufacturer to cease disseminating the information.
  ``(e) Requirements Regarding Applications.--Applications under this 
section shall be submitted in the form and manner prescribed by the 
Secretary.
  ``(f) Transition Rule.--For purposes of this section, in any case in 
which a manufacturer has submitted to the Secretary a supplemental 
application for which action by the Secretary is pending as of the date 
of the enactment of the Prescription Drug User Fee Reauthorization and 
Drug and Biological Products Regulatory Modernization Act of 1997, the 
application is deemed to be a supplemental application submitted under 
subsection (b).

``SEC. 749. CORRECTIVE ACTIONS; CESSATION OF DISSEMINATION.

  ``(a) Postdissemination Data Regarding Safety and Effectiveness.--
          ``(1) Corrective actions.--With respect to data received by 
        the Secretary after the dissemination of information under 
        section 745 by a manufacturer has begun (whether received 
        pursuant to paragraph (2) or otherwise), if the Secretary 
        determines that the data indicate that the new use involved may 
        not be effective or may present a significant risk to public 
        health, the Secretary shall, in consultation with the 
        manufacturer, take such action regarding the dissemination of 
        the information as the Secretary determines to be appropriate 
        for the protection of the public health, which may include 
        ordering that the manufacturer cease the dissemination of the 
        information.
          ``(2) Responsibilities of manufacturers to submit data.--
        After a manufacturer disseminates information pursuant to 
        section 745, the manufacturer shall submit to the Secretary a 
        notification of any additional knowledge of the manufacturer on 
        clinical research or other data that relate to the safety or 
        effectiveness of the new use involved. If the manufacturer is 
        in possession of the data, the notification shall include the 
        data. The Secretary shall by regulation establish the scope of 
        the responsibilities of manufacturers under this paragraph, 
        including such limits on the responsibilities as the Secretary 
        determines to be appropriate.
  ``(b) Cessation of Dissemination.--
          ``(1) Failure of manufacturer to comply with requirements.--
        The Secretary may order a manufacturer to cease the 
        dissemination of information pursuant to section 745 if the 
        Secretary determines that the information being disseminated 
        does not comply with the requirements established in this 
        subchapter. Such an order may be issued only after the 
        Secretary has provided notice to the manufacturer of the intent 
        of the Secretary to issue the order and has provided an 
        opportunity for a meeting with respect to such intent unless 
        paragraph (2)(B) applies. If the failure of the manufacturer 
        constitutes a minor violation of this subchapter, the Secretary 
        shall delay issuing the order and provide to the manufacturer 
        an opportunity to correct the violation.
          ``(2) Supplemental applications.--The Secretary may order a 
        manufacturer to cease the dissemination of information pursuant 
        to section 745 if the Secretary determines that--
                  ``(A) in the case of a manufacturer to which section 
                748(b) applies, the Secretary determines that the 
                supplemental application received under such section 
                does not contain adequate information for approval of 
                the new use with respect to which the application was 
                submitted; or
                  ``(B) in the case of a manufacturer to which section 
                748(c) applies, the Secretary determines, after an 
                informal hearing, that the manufacturer is not acting 
                with due diligence to complete the studies involved.
          ``(3) Termination of deemed approval of exemption regarding 
        supplemental applications.--If under section 748(d)(3) the 
        Secretary terminates a deemed approval of an exemption, the 
        Secretary may order the manufacturer involved to cease 
        disseminating the information. A manufacturer shall comply with 
        an order under the preceding sentence not later than 60 days 
        after the receipt of the order.
  ``(c) Corrective Actions by Manufacturers.--
          ``(1) In general.--In any case in which under this section 
        the Secretary orders a manufacturer to cease disseminating 
        information, the Secretary may order the manufacturer to take 
        action to correct the information that has been disseminated, 
        except as provided in paragraph (2).
          ``(2) Termination of deemed approval of exemption regarding 
        supplemental applications.--In the case of an order under 
        subsection (b)(3) to cease disseminating information, the 
        Secretary may not order the manufacturer involved to take 
        action to correct the information that has been disseminated 
        unless the Secretary determines that the new use described in 
        the information would pose a significant risk to the public 
        health.

``SEC. 750. DEFINITIONS.

  ``For purposes of this subchapter:
          ``(1) The term `health care practitioner' means a physician, 
        or other individual who is a provider of health care, who is 
        licensed under the law of a State to prescribe drugs.
          ``(2) The terms `health insurance issuer' and `group health 
        plan' have the meaning given such terms under section 2791 of 
        the Public Health Service Act.
          ``(3) The term `manufacturer' means a person who manufactures 
        a drug, or who is licensed by such person to distribute or 
        market the drug.
          ``(4) The term `new use', with respect to a drug, means a use 
        that is not included in the approved labeling of the drug.
          ``(5) The term `pharmacy benefit manager' means an 
        organization that--
                  ``(A) manages pharmaceutical costs through--
                          ``(i) pharmacy benefit administration, 
                        including claims processing adjudication, 
                        pharmacy networks, mail service, and data 
                        reporting;
                          ``(ii) formulary management and contracting, 
                        including evaluating drugs for formulary 
                        status, negotiations of contracts with 
                        manufacturers, and disbursement of rebates; and
                          ``(iii) utilization management, including 
                        communicating and enforcing therapy guidelines 
                        and drug use principles to physicians, 
                        pharmacists, and patients; and
                  ``(B) serves 2 principal types of customers which 
                are--
                          ``(i) employers, both private- and public-
                        sector, who use either self-funded health 
                        benefits through a third party administrator's 
                        insurance carrier or use traditional indemnity 
                        coverage, using providers from a preferred 
                        provider network or in a fee-for-service 
                        capacity; and
                          ``(ii) health maintenance organizations.
          ``(6) The term `scientific or medical journal' means a 
        scientific or medical publication--
                  ``(A) that is published by an organization--
                          ``(i) that has an editorial board;
                          ``(ii) that utilizes experts, who have 
                        demonstrated expertise in the subject of an 
                        article under review by the organization and 
                        who are independent of the organization, to 
                        review and objectively select, reject, or 
                        provide comments about proposed articles; and
                          ``(iii) that has a publicly stated policy, to 
                        which the organization adheres, of full 
                        disclosure of any conflict of interest or 
                        biases for all authors or contributors involved 
                        with the journal or organization;
                  ``(B) whose articles are peer-reviewed and published 
                in accordance with the regular peer-review procedures 
                of the organization;
                  ``(C) that is generally recognized to be of national 
                scope and reputation;
                  ``(D) that is indexed in the Index Medicus of the 
                National Library of Medicine of the National Institutes 
                of Health; and
                  ``(E) that is not in the form of a special supplement 
                that has been funded in whole or in part by 1 or more 
                manufacturers.

``SEC. 751. RULES OF CONSTRUCTION.

  ``(a) Unsolicited Request.--Nothing in section 745 shall be construed 
as prohibiting a manufacturer from disseminating information in 
response to an unsolicited request from a health care practitioner.
  ``(b) Dissemination of Information on Drugs Not Evidence of Intended 
Use.--Notwithstanding subsection (a), (f), or (o) of section 502, or 
any other provision of law, the dissemination of information relating 
to a new use of a drug, in accordance with section 745, shall not be 
construed by the Secretary as evidence of a new intended use of the 
drug that is different from the intended use of the drug set forth in 
the official labeling of the drug. Such dissemination shall not be 
considered by the Secretary as labeling, adulteration, or misbranding 
of the drug.
  ``(c) Patent Protection.--Nothing in section 745 shall affect patent 
rights in any manner.
  ``(d) Authorization for Dissemination of Articles and Fees for 
Reprints of Articles.--Nothing in section 745 shall be construed as 
prohibiting an entity that publishes a scientific journal (as defined 
in section 750(6)) from requiring authorization from the entity to 
disseminate an article published by such entity or charging fees for 
the purchase of reprints of published articles from such entity.''.
  (b) Prohibited Act.--Section 301 (21 U.S.C. 331) is amended by adding 
at the end the following:
  ``(x) The dissemination of information in violation of section 
745.''.
  (c) Regulations.--Not later than 1 year after the date of enactment 
of this Act, the Secretary of Health and Human Services shall 
promulgate regulations to implement the amendments made by this 
section.
  (d) Effective Date.--The amendments made by this section shall take 
effect 1 year after the date of enactment of this Act, or upon the 
Secretary's issuance of final regulations pursuant to subsection (c), 
whichever is sooner.
  (e) Sunset.--The amendments made by this section cease to be 
effective September 30, 2006, or 7 years after the date on which the 
Secretary promulgates the regulations described in subsection (c), 
whichever is later.

SEC. 8. STUDIES AND REPORTS.

  (a) In General.--The Comptroller General of the United States shall 
conduct a study--
          (1) to determine the impact of the amendments made by section 
        7 on the resources of the Department of Health and Human 
        Services; and
          (2) of the scientific issues raised as a result of the 
        amendments made by section 7, including issues relating to--
                  (A) the effectiveness of such amendments with respect 
                to the provision of useful scientific information to 
                health care practitioners;
                  (B) the quality of the information being disseminated 
                pursuant to such amendments;
                  (C) the quality and usefulness of the information 
                provided, in accordance with such amendments, by the 
                Secretary or by a manufacturer at the request of the 
                Secretary; and
                  (D) the impact of such amendments on research in the 
                area of new uses of drugs, indications for new uses, or 
                dosages of drugs for new uses, particularly the impact 
                on pediatric indications and rare diseases.
  (b) Report.--Not later than January 1, 2002, the Comptroller General 
of the United States shall prepare and submit to the Committee on Labor 
and Human Resources of the Senate and the Committee on Commerce of the 
House of Representatives a report of the results of the study under 
subsection (a).

SEC. 9. APPROVAL OF SUPPLEMENTAL APPLICATIONS FOR APPROVED PRODUCTS.

  (a) Performance Standards.--Not later than 180 days after the date of 
enactment of this Act, the Secretary shall publish in the Federal 
Register performance standards for the prompt review of supplemental 
applications submitted for approved drugs under the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321 et seq.) or section 351 of the Public 
Health Service Act (42 U.S.C. 262).
  (b) Guidance to Industry.--Not later than 180 days after the date of 
enactment of this Act, the Secretary shall issue final guidances to 
clarify the requirements for, and facilitate the submission of data to 
support, the approval of supplemental applications for the approved 
articles described in subsection (a). The guidances shall--
          (1) clarify circumstances in which published matter may be 
        the basis for approval of a supplemental application;
          (2) specify data requirements that will avoid duplication of 
        previously submitted data by recognizing the availability of 
        data previously submitted in support of an original 
        application; and
          (3) define supplemental applications that are eligible for 
        priority review.
  (c) Responsibilities of Centers.--The Secretary shall designate an 
individual in each center within the Food and Drug Administration which 
is responsible for the review of applications for approval of drugs 
for--
          (1) encouraging the prompt review of supplemental 
        applications for approved articles; and
          (2) working with sponsors to facilitate the development and 
        submission of data to support supplemental applications.
  (d) Collaboration.--The Secretary shall implement programs and 
policies that will foster collaboration between the Food and Drug 
Administration, the National Institutes of Health, professional medical 
and scientific societies, and other persons, to identify published and 
unpublished studies that may support a supplemental application, and to 
encourage sponsors to make supplemental applications or conduct further 
research in support of a supplemental application based, in whole or in 
part, on such studies.

SEC. 10. HEALTH CARE ECONOMIC INFORMATION.

  Section 502(a) (21 U.S.C. 352(a)) is amended by adding at the end the 
following: ``Health care economic information provided to a formulary 
committee, or other similar entity, in the course of the committee or 
the entity carrying out its responsibilities for the selection of drugs 
for managed care or other similar organizations, shall not be 
considered to be false or misleading if the health care economic 
information directly relates to an indication approved under section 
505 or 507 or section 351(a) of the Public Health Service Act (42 
U.S.C. 262(a)) for such drug and is based on competent and reliable 
scientific evidence. The requirements set forth in section 505(a), 507, 
or section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)) 
shall not apply to health care economic information provided to such a 
committee or entity in accordance with this paragraph. Information that 
is relevant to the substantiation of the health care economic 
information presented pursuant to this paragraph shall be made 
available to the Secretary upon request. In this paragraph, the term 
`health care economic information' means any analysis that identifies, 
measures, or compares the economic consequences, including the costs of 
the represented health outcomes, of the use of a drug to the use of 
another drug, to another health care intervention, or to no 
intervention.''.

SEC. 11. CLINICAL INVESTIGATIONS.

  (a) Clarification of the Number of Required Clinical Investigations 
for Approval.--Section 505(d) (21 U.S.C. 355(d)) is amended by adding 
at the end the following: ``If the Secretary determines, based on 
relevant science, that data from one adequate and well-controlled 
clinical investigation and confirmatory evidence (obtained prior to or 
after such investigation) are sufficient to establish effectiveness, 
the Secretary may consider such data and evidence to constitute 
substantial evidence for purposes of the preceding sentence.''.
  (b) Women and Minorities.--Section 505(b)(1) (21 U.S.C. 355(b)(1)) is 
amended by adding at the end the following: ``The Secretary shall, in 
consultation with the Director of the National Institutes of Health, 
review and develop guidance, as appropriate, on the inclusion of women 
and minorities in clinical trials required by clause (A).''.

SEC. 12. MANUFACTURING CHANGES FOR DRUGS.

  (a) In General.--Chapter VII (21 U.S.C. 371 et seq.), as amended by 
section 7, is amended by adding at the end the following subchapter:

                 ``Subchapter F--Manufacturing Changes

``SEC. 755. MANUFACTURING CHANGES.

  ``(a) In General.--With respect to a drug for which there is in 
effect an approved application under section 505 or 512 or a license 
under section 351 of the Public Health Service Act, a change from the 
manufacturing process approved pursuant to such application or license 
may be made, and the drug as made with the change may be distributed, 
if--
          ``(1) the holder of the approved application or license 
        (referred to in this section as a `holder') has validated the 
        effects of the change in accordance with subsection (b); and
          ``(2)(A) in the case of a major manufacturing change, the 
        holder has complied with the requirements of subsection (c); or
          ``(B) in the case of a change that is not a major 
        manufacturing change, the holder complies with the applicable 
        requirements of subsection (d).
  ``(b) Validation of Effects of Changes.--For purposes of subsection 
(a)(1), a drug made with a manufacturing change (whether a major 
manufacturing change or otherwise) may be distributed only if, before 
distribution of the drug as so made, the holder involved validates the 
effects of the change on the identity, strength, quality, purity, and 
potency of the drug as the identity, strength, quality, purity, and 
potency may relate to the safety, bioequivalence, bioavailability, or 
effectiveness of the drug.
  ``(c) Major Manufacturing Changes.--
          ``(1) Requirement of supplemental application.--For purposes 
        of subsection (a)(2)(A), a drug made with a major manufacturing 
        change may be distributed only if, before the distribution of 
        the drug as so made, the holder involved submits to the 
        Secretary a supplemental application for such change and the 
        Secretary approves the application. The application shall 
        contain such information as the Secretary determines to be 
        appropriate, and shall include the information developed under 
        subsection (b) by the holder in validating the effects of the 
        change.
          ``(2) Changes qualifying as major changes.--For purposes of 
        subsection (a)(2)(A), a major manufacturing change is a 
        manufacturing change that--
                  ``(A) is determined by the Secretary to have 
                substantial potential to adversely affect the identity, 
                strength, quality, purity, or potency of the drug as 
                they may relate to the safety, bioequivalence, 
                bioavailability, or effectiveness of a drug; and
                  ``(B)(i) is made in the qualitative or quantitative 
                formulation of the drug involved or in the 
                specifications in the approved application or license 
                referred to in subsection (a) for the drug (unless 
                exempted by the Secretary from the requirements of this 
                subsection);
                  ``(ii) is determined by the Secretary by regulation 
                or guidance to require completion of an appropriate 
                clinical study demonstrating equivalence of the drug to 
                the drug as manufactured without the change; or
                  ``(iii) is determined by the Secretary by regulation 
                or guidance to have a substantial potential to 
                adversely affect the safety or effectiveness of the 
                drug.
  ``(d) Other Manufacturing Changes.--
          ``(1) In general.--For purposes of subsection (a)(2)(B), the 
        Secretary may regulate drugs made with manufacturing changes 
        that are not major manufacturing changes as follows:
                  ``(A) The Secretary may authorize holders to 
                distribute such drugs without prior approval by the 
                Secretary.
                  ``(B) The Secretary may require that, prior to the 
                distribution of such drugs, holders submit to the 
                Secretary supplemental applications for such changes.
                  ``(C) The Secretary may establish categories of such 
                changes and designate categories to which subparagraph 
                (A) applies and categories to which subparagraph (B) 
                applies.
          ``(2) Changes not requiring supplemental application.--
                  ``(A) Submission of report.--A holder making a 
                manufacturing change to which paragraph (1)(A) applies 
                shall submit to the Secretary a report on the change, 
                which shall contain such information as the Secretary 
                determines to be appropriate, and which shall include 
                the information developed under subsection (b) by the 
                holder in validating the effects of the change. The 
                report shall be submitted by such date as the Secretary 
                may specify.
                  ``(B) Authority regarding annual reports.--In the 
                case of a holder that during a single year makes more 
                than one manufacturing change to which paragraph (1)(A) 
                applies, the Secretary may in carrying out subparagraph 
                (A) authorize the holder to comply with such 
                subparagraph by submitting a single report for the year 
                that provides the information required in such 
                subparagraph for all the changes made by the holder 
                during the year.
          ``(3) Changes requiring supplemental application.--
                  ``(A) Submission of supplemental application.--The 
                supplemental application required under paragraph 
                (1)(B) for a manufacturing change shall contain such 
                information as the Secretary determines to be 
                appropriate, which shall include the information 
                developed under subsection (b) by the holder in 
                validating the effects of the change.
                  ``(B) Authority for distribution.--In the case of a 
                manufacturing change to which paragraph (1)(B) applies:
                          ``(i) The holder involved may commence 
                        distribution of the drug involved 30 days after 
                        the Secretary receives the supplemental 
                        application under such paragraph, unless the 
                        Secretary notifies the holder within such 30-
                        day period that prior approval of the 
                        application is required before distribution may 
                        be commenced.
                          ``(ii) The Secretary may designate a category 
                        of such changes for the purpose of providing 
                        that, in the case of a change that is in such 
                        category, the holder involved may commence 
                        distribution of the drug involved upon the 
                        receipt by the Secretary of a supplemental 
                        application for the change.
                          ``(iii) If the Secretary disapproves the 
                        supplemental application, the Secretary may 
                        order the manufacturer to cease the 
                        distribution of the drugs that have been made 
                        with the manufacturing change.''.
  (b) Transition Rule.--The amendment made by subsection (a) takes 
effect upon the effective date of regulations promulgated by the 
Secretary of Health and Human Services to implement such amendment, or 
upon the expiration of the 24-month period beginning on the date of the 
enactment of this Act, which occurs first.

SEC. 13. STREAMLINING CLINICAL RESEARCH ON DRUGS.

  Section 505(i) (21 U.S.C. 355(i)) is amended by adding ``(1)'' before 
``The Secretary'', by redesignating paragraphs (1), (2), and (3) as 
subparagraphs (A), (B), and (C), respectively, by striking the last two 
sentences, and by adding the following new paragraphs:
  ``(2) Subject to paragraph (3), a clinical investigation of a new 
drug may begin 30 days after the Secretary has received from the 
manufacturer or sponsor of the investigation a submission containing 
such information about the drug and the clinical investigation, 
including--
          ``(A) information on design of the investigation and adequate 
        reports of basic information, certified by the applicant to be 
        accurate reports, necessary to assess the safety of the drug 
        for use in clinical investigation; and
          ``(B) adequate information on the chemistry and manufacturing 
        of the drug, controls available for the drug, and primary data 
        tabulations from animal or human studies.
  ``(3)(A) At any time, the Secretary may prohibit the sponsor of an 
investigation from conducting the investigation (referred to in this 
paragraph as a `clinical hold') if the Secretary makes a determination 
described in subparagraph (B). The Secretary shall specify the basis 
for the clinical hold, including the specific information available to 
the Secretary which served as the basis for such clinical hold, and 
confirm such determination in writing.
  ``(B) For purposes of subparagraph (A), a determination described in 
this subparagraph with respect to a clinical hold is that--
          ``(i) the drug involved represents an unreasonable risk to 
        the safety of the persons who are the subject of the clinical 
        investigation, taking into account the qualifications of the 
        clinical investigators, information about the drug, the design 
        of the clinical investigation, the condition for which the drug 
        is to be investigated, and the health status of the subjects 
        involved; or
          ``(ii) the clinical hold should be issued for such other 
        reasons as the Secretary may by regulation establish (including 
        reasons established by regulation before the date of the 
        enactment of the Prescription Drug User Fee Reauthorization and 
        Drug Regulatory Modernization Act of 1997).
Such regulations shall provide that such exemption shall be conditioned 
upon the manufacturer, or the sponsor of the investigation, requiring 
that experts using such drugs for investigational purposes certify to 
such manufacturer or sponsor that they will inform any human beings to 
whom such drugs, or any controls used in connection therewith, are 
being administered, or their representatives, that such drugs arebeing 
used for investigational purposes and will obtain the consent of such 
human beings or their representatives, except where they deem it not 
feasible or, in their professional judgment, contrary to the best 
interests of such human beings. Nothing in this subsection shall be 
construed to require any clinical investigator to submit directly to 
the Secretary reports on the investigational use of drugs.
  ``(C) Any request to the Secretary from the sponsor of an 
investigation that a clinical hold be removed shall receive a decision, 
in writing and specifying the reasons therefor, within 30 days after 
receipt of such request. Any such request shall include sufficient 
information to support the removal of such clinical hold.''.

SEC. 14. DATA REQUIREMENTS FOR DRUGS.

  Within 12 months after the date of enactment of this Act, the 
Secretary of the Health and Human Services, acting through the 
Commissioner of Food and Drugs, shall issue guidance that describes, 
for certain types of studies, when abbreviated study reports may be 
submitted, in lieu of full reports, with a new drug application under 
section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) 
and with a biologics license application under section 351 of the 
Public Health Service Act (42 U.S.C. 262). Such guidance shall describe 
the kinds of studies for which abbreviated reports are appropriate and 
the appropriate abbreviated report formats.

SEC. 15. CONTENT AND REVIEW OF APPLICATIONS.

  (a) Section 505(b).--Section 505(b) (21 U.S.C. 355(b)) is amended by 
adding at the end the following:
  ``(4)(A) The Secretary shall issue guidance for the review of 
applications submitted under paragraph (1) relating to promptness, 
technical excellence, lack of bias and conflict of interest, and 
knowledge of regulatory and scientific standards which shall apply 
equally to all individuals who review such applications.
  ``(B) The Secretary shall meet with a sponsor of an investigation or 
an applicant for approval under this section or section 351 of the 
Public Health Service Act if the sponsor or applicant makes a 
reasonable request for a meeting, for the purpose of reaching agreement 
on the design and size of clinical trials. Minutes of any such meeting 
shall be prepared by the Secretary and made available to the sponsor or 
applicant upon request.
  ``(C) Agreement regarding the parameters of the design and size of 
clinical trials of a new drug that are reached between the Secretary 
and a sponsor or applicant shall be reduced to writing and made part of 
the administrative record by the Secretary. Such agreement shall not be 
changed after the testing begins, except--
          ``(i) with the written agreement of the sponsor or applicant; 
        or
          ``(ii) pursuant to a decision, made in accordance with 
        subparagraph (D) by the director of the division in which the 
        drug is reviewed, that a substantial scientific issue essential 
        to determining the safety or effectiveness of the drug has been 
        identified after the testing has begun.
  ``(D) A decision under subparagraph (C)(ii) by the director shall be 
in writing and the Secretary shall provide to the sponsor or applicant 
an opportunity for a meeting at which the director and the sponsor or 
applicant will be present and at which the director documents the 
scientific issue involved.
  ``(E) The written decisions of the reviewing division shall be 
binding upon, and may not directly or indirectly be changed by, the 
field or compliance division personnel unless such field or compliance 
division personnel demonstrate to the reviewing division why such 
decision should be modified. For purposes of this paragraph, the 
reviewing division is the division responsible for the review of an 
application for approval of a drug (including all scientific and 
medical matters, chemistry, manufacturing, and controls).
  ``(F) No action by the reviewing division may be delayed because of 
the unavailability of information from or action by field personnel 
unless the reviewing division determines that a delay is necessary to 
assure the marketing of a safe and effective drug.''.
  (b) Section 505(j).--
          (1) Amendment.--Section 505(j) (21 U.S.C 355(j)) is amended 
        by redesignating paragraphs (3) through (8) as paragraphs (4) 
        through (9), respectively, and by adding after paragraph (2) 
        the following:
  ``(3)(A) The Secretary shall issue guidance for the review of 
applications submitted under paragraph (1) relating to promptness, 
technical excellence, lack of bias and conflict of interest, and 
knowledge of regulatory and scientific standards which shall apply 
equally to all individuals who review such applications.
  ``(B) The Secretary shall meet with an applicant for approval of a 
drug under this subsection if the applicant makes a reasonable request 
for a meeting for the purpose of reaching agreement on the design and 
size of studies needed for approval of such application. Minutes of any 
such meeting shall be prepared by the Secretary and made available to 
the sponsor or applicant.
  ``(C) Agreements regarding the parameters of design and size of 
bioavailability and bioequivalence trials of a drug under this 
subsection that are reached between the Secretary and a sponsor or 
applicant shall be reduced to writing and made part of the 
administrative record by the Secretary. Such agreement shall not be 
changed after the testing begins, except--
          ``(i) with the written agreement of the sponsor or applicant; 
        or
          ``(ii) pursuant to a decision, made in accordance with 
        subparagraph (D) by the director of the division in which the 
        drug is reviewed, that a substantial scientific issue essential 
        to determining the safety or effectiveness of the drug has been 
        identified after the testing has begun.
  ``(D) A decision under subparagraph (C)(ii) by the director shall be 
in writing and the Secretary shall provide to the sponsor or applicant 
an opportunity for a meeting at which the director and the sponsor or 
applicant will be present and at which the director documents the 
scientific issue involved.
  ``(E) The written decisions of the reviewing division shall be 
binding upon, and may not directly or indirectly be changed by, the 
field or compliance office personnel unless such field or compliance 
office personnel demonstrate to the reviewing division why such 
decision should be modified. For purposes of this paragraph, the 
reviewing division is the division responsible for the review of an 
application under this subsection (including scientific matters, 
chemistry, manufacturing, and controls).
  ``(F) No action by the reviewing division may at any time be delayed 
because of the unavailability of information from or action by field 
personnel unless the reviewing division determines that a delay is 
necessary to assure the marketing of a safe and effective drug.''.
          (2) Conforming amendments.--Section 505(j) (21 U.S.C. 
        355(j)), as amended by paragraph (1), is amended--
                  (A) in paragraph (2)(A)(i), by striking ``(6)'' and 
                inserting ``(7)'';
                  (B) in paragraph (4), by striking ``(4)'' and 
                inserting ``(5)'';
                  (C) in paragraph (4)(I), by striking ``(5)'' and 
                inserting ``(6)''; and
                  (D) in paragraph (7)(C), by striking ``(5)'' each 
                place it occurs and inserting ``(6)''.

SEC. 16. SCIENTIFIC ADVISORY PANELS.

  Section 505 (21 U.S.C. 355) is amended by adding at the end the 
following:
  ``(n)(1) For the purpose of providing expert scientific advice and 
recommendations to the Secretary regarding a clinical investigation of 
a drug or the approval for marketing of a drug under section 505 or 
section 351 of the Public Health Service Act, the Secretary shall 
establish panels of experts or use panels of experts established before 
the date of the enactment of this subsection, or both.
  ``(2) The Secretary may delegate the appointment and oversight 
authority granted under section 904 to a director of a center or 
successor entity within the Food and Drug Administration.
  ``(3) The Secretary shall make appointments to each panel established 
under paragraph (1) so that each panel shall consist of--
          ``(A) members who are qualified by training and experience to 
        evaluate the safety and effectiveness of the drugs to be 
        referred to the panel and who, to the extent feasible, possess 
        skill and experience in the development, manufacture, or 
        utilization of such drugs;
          ``(B) members with diverse expertise in such fields as 
        clinical and administrative medicine, pharmacy, pharmacology, 
        pharmacoeconomics, biological and physical sciences, and other 
        related professions;
          ``(C) a representative of consumer interests and a 
        representative of interests of the drug manufacturing industry 
        not directly affected by the matter to be brought before the 
        panel; and
          ``(D) 2 or more members who are specialists or have other 
        expertise in the particular disease or condition for which the 
        drug under review is proposed to be indicated.
Scientific, trade, and consumer organizations shall be afforded an 
opportunity to nominate individuals for appointment to the panels. No 
individual who is in the regular full-time employ of the United States 
and engaged in the administration of this Act may be a voting member of 
any panel. The Secretary shall designate one of the members of each 
panel to serve as chairman thereof.
  ``(4) Each member of a panel shall publicly disclose all conflicts of 
interest that member may have with the work to be undertaken by the 
panel. No member of a panel may vote on any matter where the member or 
the immediate family of such member could gain financially from the 
advice given to the Secretary. The Secretary may grant a waiver of any 
conflict of interest upon public disclosure of such conflict of 
interest if such waiver is necessary to afford the panel essential 
expertise, except that the Secretary may not grant a waiver for a 
member of a panel when the member's own scientific work is involved.
  ``(5) The Secretary shall provide education and training to each new 
panel member before such member participates in a panel's activities, 
including education regarding requirements under this Act and related 
regulations of the Secretary, and the administrative processes and 
procedures related to panel meetings.
  ``(6) Panel members (other than officers or employees of the United 
States), while attending meetings or conferences of a panel or 
otherwise engaged in its business, shall be entitled to receive 
compensation for each day so engaged, including traveltime, at rates to 
be fixed by the Secretary, but not to exceed the daily equivalent of 
the rate in effect for positions classified above grade GS-15 of the 
General Schedule. While serving away from their homes or regular places 
of business, panel members may be allowed travel expenses (including 
per diem in lieu of subsistence) as authorized by section 5703 of title 
5, United States Code, for persons in the Government service employed 
intermittently.
  ``(7) The Secretary shall ensure that scientific advisory panels meet 
regularly and at appropriate intervals so that any matter to be 
reviewed by such panel can be presented to the panel not more than 60 
days after the matter is ready for such review. Meetings of the panel 
may be held using electronic communication to convene the meeting.
  ``(8) Within 60 days after a scientific advisory panel makes 
recommendations on any matter under its review, the Food and Drug 
Administration official responsible for the matter shall review the 
conclusions and recommendations of the panel, and notify the affected 
persons of the final decision on the matter, or of the reasons that no 
such decision has been reached. Each such final decision shall be 
documented including the rationale for the decision.
  ``(9) A scientific advisory panel under this subsection shall not be 
subject to the annual chartering and annual report requirements of the 
Federal Advisory Committee Act.''.

SEC. 17. DISPUTE RESOLUTION.

  Chapter V (21 U.S.C. 351 et seq.), as amended by section 3, is 
amended by inserting after section 505A the following:
                          ``dispute resolution
  ``Sec. 506. If, regarding an obligation under this Act, there is a 
scientific controversy between the Secretary and a person who is a 
sponsor, applicant, or manufacturer and no specific provision of this 
Act or regulation promulgated under this Act provides a right of review 
of the matter in controversy, the Secretary shall, by regulation, 
establish a procedure under which such sponsor, applicant, or 
manufacturer may request a review of such controversy by an appropriate 
scientific advisory panel under section 505(n). Such review shall take 
place in a timely manner. The Secretary shall promulgate such 
regulations within 180 days of the date of the enactment of the 
Prescription Drug User Fee Reauthorization and Medical Device 
Regulatory Modernization Act of 1997.''.

SEC. 18. INFORMAL AGENCY STATEMENTS.

  Section 701 (21 U.S.C. 371) is amended by adding at the end the 
following:
  ``(h)(1)(A) The Secretary shall develop guidance documents with 
public participation and ensure that the existence of such documents 
and the documents themselves are made available to the public both in 
written form and through electronic means. Such documents shall not 
create or confer any rights for or on any person, although they present 
the views of the Secretary on matters under the jurisdiction of the 
Food and Drug Administration.
  ``(B) Although guidance documents shall not be binding on the 
Secretary, the Secretary shall ensure that employees of the Food and 
Drug Administration do not deviate from such guidances without 
appropriate justification and supervisory concurrence.
  ``(C) For guidance documents that set forth initial interpretations 
of statute or regulation, changes in interpretation or policy that are 
of more than a minor nature, complex scientific issues, or highly 
controversial issues, the Secretary shall ensure public participation 
prior to implementation of any guidance documents, unless the Secretary 
determines that for reasons of the public health need, such prior 
public participation is not feasible. In such cases, the Secretary 
shall provide for public comment upon implementation, and take such 
comment into account.
  ``(D) For guidance documents that set forth existing practices or 
minor changes in policy, the Secretary shall provide for public comment 
upon implementation.
  ``(2) In developing guidance documents, the Secretary shall ensure 
uniform nomenclature and uniform internal procedures for approval of 
such documents. The Secretary shall ensure that guidance documents and 
revisions of such documents are properly dated and indicate the 
nonbinding nature of the documents.
  ``(3) The Secretary, through the Food and Drug Administration, shall 
maintain electronically and publish periodically in the Federal 
Register a list of guidance documents. Such list shall be updated 
quarterly. All such documents shall be made available to the public.
  ``(4) The Secretary shall report to the Committee on Commerce of the 
House of Representatives and the Committee on Labor and Human Resources 
of the Senate no later than July 1, 2000, on the implementation of 
these practices.''.

SEC. 19. POSITRON EMISSION TOMOGRAPHY.

  (a) Regulation of Compounded Positron Emission Tomography Drugs.--
          (1) Definition.--Section 201 (21 U.S.C. 321) is amended by 
        adding at the end the following:
  ``(ii) The term `compounded positron emission tomography drug'--
          ``(1) means a drug that--
                  ``(A) exhibits spontaneous disintegration of unstable 
                nuclei by the emission of positrons and is used for the 
                purpose of providing dual photon positron emission 
                tomographic diagnostic images; and
                  ``(B) has been compounded by or on the order of a 
                practitioner who is licensed by a State to compound or 
                order compounding for a drug described in subparagraph 
                (A), and is compounded in accordance with that State's 
                law, for a patient or for research, teaching, or 
                quality control; and
          ``(2) includes any nonradioactive reagent, reagent kit, 
        ingredient, nuclide generator, accelerator, target material, 
        electronic synthesizer, or other apparatus or computer program 
        to be used in the preparation of such a drug.''.
  (b) Adulteration.--
          (1) In general.--Section 501(a)(2) (21 U.S.C. 351(a)(2)) is 
        amended by striking ``; or (3)'' and inserting the following: 
        ``; or (C) if it is a compounded positron emission tomography 
        drug and the methods used in, or the facilities and controls 
        used for, its compounding, processing, packing, or holding do 
        not conform to or are not operated or administered in 
        conformity with the positron emission tomography compounding 
        standards and the official monographs of the United States 
        Pharmacopeia to assure that such drug meets the requirements of 
        this Act as to safety and has the identity and strength, and 
        meets the quality and purity characteristics, that it purports 
        or is represented to possess; or (3)''.
          (2) Sunset.--Section 501(a)(2)(C) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 351(a)(2)(C)) shall not apply 4 
        years after the date of enactment of this Act or 2 years after 
        the date on which the Secretary of Health and Human Services 
        establishes the requirements described in subsection (c)(1)(B), 
        whichever is later.
  (c) Requirements for Review of Approval Procedures and Current Good 
Manufacturing Practices for Positron Emission Tomography.--
          (1) Procedures and requirements.--
                  (A) In general.--In order to take account of the 
                special characteristics of compounded positron emission 
                tomography drugs and the special techniques and 
                processes required to produce these drugs, not later 
                than 2 years after the date of enactment of this Act, 
                the Secretary of Health and Human Services shall 
                establish--
                          (i) appropriate procedures for the approval 
                        of compounded positron emission tomography 
                        drugs pursuant to section 505 of the Federal 
                        Food, Drug, and Cosmetic Act (21 U.S.C. 355); 
                        and
                          (ii) appropriate current good manufacturing 
                        practice requirements for such drugs.
                  (B) Considerations and consultation.--In establishing 
                the procedures and requirements required by 
                subparagraph (A), the Secretary of Health and Human 
                Services shall take due account of any relevant 
                differences between not-for-profit institutions that 
                compound the drugs for their patients and commercial 
                manufacturers of the drugs. Prior to establishing the 
                procedures and requirements, the Secretary of Health 
                and Human Services shall consult with patient advocacy 
                groups, professional associations, manufacturers, and 
                physicians and scientists licensed to make or use 
                compounded positron emission tomography drugs.
          (2) Submission of new drug applications and abbreviated new 
        drug applications.--
                  (A) In general.--Except as provided in subparagraph 
                (B), the Secretary of Health and Human Services shall 
                not require the submission of new drug applications or 
                abbreviated new drug applications under subsection (b) 
                or (j) of section 505 (21 U.S.C. 355), for compounded 
                positron emission tomography drugs that are not 
                adulterated drugs described in section 501(a)(2)(C) of 
                the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                351(a)(2)(C)) (as amended by subsection (b)), for a 
                period of 4 years after the date of enactment of this 
                Act, or for 2 years after the date on which the 
                Secretary establishes procedures and requirements under 
                paragraph (1), whichever is later.
                  (B) Exception.--Nothing in this Act shall prohibit 
                the voluntary submission of such applications or the 
                review of such applications by the Secretary of Health 
                and Human Services. Nothing in this Act shall 
                constitute an exemption for a compounded positron 
                emission tomography drug from the requirements of 
                regulations issued under section 505(i) of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) for 
                such drugs.
  (d) Revocation of Certain Inconsistent Documents.--Within 30 days 
after the date of enactment of this Act, the Secretary of Health and 
Human Services shall publish in the Federal Register a notice 
terminating the application of the following notices and rule, to the 
extent the notices and rule relate to compounded positron emission 
tomography drugs:
          (1) A notice entitled ``Regulation of Positron Emission 
        Tomographic Drug Products: Guidance; Public Workshop'', 
        published in the Federal Register on February 27, 1995.
          (2) A notice entitled ``Guidance for Industry: Current Good 
        Manufacturing Practices for Positron Emission Tomographic (PET) 
        Drug Products; Availability'', published in the Federal 
        Register on April 22, 1997.
          (3) A final rule entitled ``Current Good Manufacturing 
        Practice for Finished Pharmaceuticals; Positron Emission 
        Tomography'', published in the Federal Register on April 22, 
        1997.
  (e) Definition.--As used in this section, the term ``compounded 
positron emission tomography drug'' has the meaning given the term in 
section 201 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321).

SEC. 20. REQUIREMENTS FOR RADIOPHARMACEUTICALS.

  (a) Requirements.--
          (1) Regulations.--
                  (A) Proposed regulations.--Not later than 180 days 
                after the date of enactment of this Act, the Secretary 
                of Health and Human Services, after consultation with 
                patient advocacy groups, associations, physicians 
                licensed to use radiopharmaceuticals, and the regulated 
                industry, shall issue proposed regulations governing 
                the approval of radiopharmaceuticals designed for 
                diagnosis and monitoring of diseases and conditions. 
                The regulations shall provide that the determination of 
                the safety and effectiveness of such a 
                radiopharmaceutical under section 505 of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 355) or section 
                351 of the Public Health Service Act (42 U.S.C. 262) 
                shall include consideration of the proposed use of the 
                radiopharmaceutical in the practice of medicine, the 
                pharmacological and toxicological activity of the 
                radiopharmaceutical (including any carrier or ligand 
                component of the radiopharmaceutical), and the 
                estimated absorbed radiation dose of the 
                radiopharmaceutical.
                  (B) Final regulations.--Not later than 18 months 
                after the date of enactment of this Act, the Secretary 
                shall promulgate final regulations governing the 
                approval of the radiopharmaceuticals.
          (2) Special rule.--In the case of a radiopharmaceutical 
        intended to be used for diagnostic or monitoring purposes, the 
        indications for which such radiopharmaceutical is approved for 
        marketing may, in appropriate cases, refer to manifestations of 
        disease (such as biochemical, physiological, anatomic, or 
        pathological processes) common to, or present in, one or more 
        disease states.
  (b) Definition.--In this section, the term ``radiopharmaceutical'' 
means--
          (1) an article--
                  (A) that is intended for use in the diagnosis or 
                monitoring of a disease or a manifestation of a disease 
                in humans; and
                  (B) that exhibits spontaneous disintegration of 
                unstable nuclei with the emission of nuclear particles 
                or photons; or
          (2) any nonradioactive reagent kit or nuclide generator that 
        is intended to be used in the preparation of any such article.

SEC. 21. MODERNIZATION OF REGULATION.

  (a) Licenses.--
          (1) In general.--Section 351(a) of the Public Health Service 
        Act (42 U.S.C. 262(a)) is amended to read as follows:
  ``(a)(1) No person shall introduce or deliver for introduction into 
interstate commerce any biological product unless--
          ``(A) a biologics license is in effect for the biological 
        product; and
          ``(B) each package of the biological product is plainly 
        marked with--
                  ``(i) the proper name of the biological product 
                contained in the package;
                  ``(ii) the name, address, and applicable license 
                number of the manufacturer of the biological product; 
                and
                  ``(iii) the expiration date of the biological 
                product.
  ``(2)(A) The Secretary shall establish, by regulation, requirements 
for the approval, suspension, and revocation of biologics licenses.
  ``(B) The Secretary shall approve a biologics license application--
          ``(i) on the basis of a demonstration that--
                  ``(I) the biological product that is the subject of 
                the application is safe, pure, and potent; and
                  ``(II) the facility in which the biological product 
                is manufactured, processed, packed, or held meets 
                standards designed to assure that the biological 
                product continues to be safe, pure, and potent; and
          ``(ii) if the applicant (or other appropriate person) 
        consents to the inspection of the facility that is the subject 
        of the application, in accordance with subsection (c).
  ``(3) The Secretary shall prescribe requirements under which a 
biological product undergoing investigation shall be exempt from the 
requirements of paragraph (1).''.
          (2) Elimination of existing license requirement.--Section 
        351(d) of the Public Health Service Act (42 U.S.C. 262(d)) is 
        amended--
                  (A) by striking ``(d)(1)'' and all that follows 
                through ``of this section.'';
                  (B) in paragraph (2)--
                          (i) by striking ``(2)(A) Upon'' and inserting 
                        ``(d)(1) Upon'' and
                          (ii) by redesignating subparagraph (B) as 
                        paragraph (2); and
                  (C) in paragraph (2) (as so redesignated by 
                subparagraph (B)(ii))--
                          (i) by striking ``subparagraph (A)'' and 
                        inserting ``paragraph (1)''; and
                          (ii) by striking ``this subparagraph'' each 
                        place it appears and inserting ``this 
                        paragraph''.
  (b) Labeling.--Section 351(b) of the Public Health Service Act (42 
U.S.C. 262(b)) is amended to read as follows:
  ``(b) No person shall falsely label or mark any package or container 
of any biological product or alter any label or mark on the package or 
container of the biological product so as to falsify the label or 
mark.''.
  (c) Inspection.--Section 351(c) of the Public Health Service Act (42 
U.S.C. 262(c)) is amended by striking ``virus, serum,'' and all that 
follows and inserting ``biological product.''.
  (d) Definition; Application.--Section 351 of the Public Health 
Service Act (42 U.S.C. 262) is amended by adding at the end the 
following:
  ``(i) In this section, the term `biological product' means a virus, 
therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or 
derivative, allergenic product, or analogous product, or arsphenamine 
or derivative of arsphenamine (or any other trivalent organic arsenic 
compound), applicable to the prevention, treatment, or cure of a 
disease or condition of human beings.''.
  (e) Conforming Amendment.--Section 503(g)(4) (21 U.S.C. 353(g)(4)) is 
amended--
          (1) in subparagraph (A)--
                  (A) by striking ``section 351(a)'' and inserting 
                ``section 351(i)''; and
                  (B) by striking ``262(a)'' and inserting ``262(i)''; 
                and
          (2) in subparagraph (B)(iii), by striking ``product or 
        establishment license under subsection (a) or (d)'' and 
        inserting ``biologics license application under subsection 
        (a)''.
  (f) Special Rule.--The Secretary of Health and Human Services shall 
take measures to minimize differences in the review and approval of 
products required to have approved biologics license applications under 
section 351 of the Public Health Service Act (42 U.S.C. 262) and 
products required to have approved newdrug applications under section 
505(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(b)(1)).
  (g) Examinations and Procedures.--Paragraph (3) of section 353(d) of 
the Public Health Service Act (42 U.S.C. 263a(d)) is amended to read as 
follows:
          ``(3) Examinations and procedures.--The examinations and 
        procedures identified in paragraph (2) are laboratory 
        examinations and procedures which have been approved by the 
        Food and Drug Administration for home use or which, as 
        determined by the Secretary, are simple laboratory examinations 
        and procedures which have an insignificant risk of an erroneous 
        result, including those which--
                  ``(A) employ methodologies that are so simple and 
                accurate as to render the likelihood of erroneous 
                results by the user negligible, or
                  ``(B) the Secretary has determined pose no reasonable 
                risk of harm to the patient if performed 
                incorrectly.''.

SEC. 22. PILOT AND SMALL SCALE MANUFACTURE.

  (a) Human Drugs.--Section 505(c) (21 U.S.C. 355(c)) is amended by 
adding at the end thereof the following:
  ``(4) A drug manufactured in a pilot or other small facility may be 
used to demonstrate the safety and effectiveness of the drug and to 
obtain approval prior to scaling up to a larger facility, unless the 
Secretary makes a determination that a full scale production facility 
is necessary to ensure the safety or effectiveness of the drug.''.
  (b) Animal Drugs.--Section 512(c) (21 U.S.C. 360b(c)) is amended by 
adding at the end the following:
  ``(4) A drug manufactured in a pilot or other small facility may be 
used to demonstrate the safety and effectiveness of the drug and to 
obtain approval prior to scaling up to a larger facility, unless the 
Secretary makes a determination that a full scale production facility 
is necessary to ensure the safety or effectiveness of the drug.''.

SEC. 23. INSULIN AND ANTIBIOTICS.

  (a) Certification of Drugs Containing Insulin.--
          (1) Amendment.--Section 506 (21 U.S.C. 356), as in effect 
        before the date of the enactment of this Act, is repealed.
          (2) Conforming amendments.--
                  (A) Section 301(j) (21 U.S.C. 331(j)) is amended by 
                striking ``506, 507,''.
                  (B) Subsection (k) of section 502 (21 U.S.C. 352) is 
                repealed.
                  (C) Sections 301(i)(1), 510(j)(1)(A), and 
                510(j)(1)(D) (21 U.S.C. 331(i)(1), 360(j)(1)(A), 
                360(j)(1)(D)) are each amended by striking ``, 506, 
                507,''.
                  (D) Section 801(d)(1) (21 U.S.C. 381(d)(1)) is 
                amended by inserting after ``503(b)'' the following: 
                ``or composed wholly or partly of insulin''.
                  (E) Section 8126(h)(2) of title 38, United States 
                Code, is amended by inserting ``or'' at the end of 
                subparagraph (B), by striking ``; or'' at the end of 
                subparagraph (C) and inserting a period, and by 
                striking subparagraph (D).
  (b) Certification of Antibiotics.--
          (1) Amendment.--Section 507 (21 U.S.C. 357) is repealed.
          (2) Conforming amendments.--
                  (A) Section 201(aa) (21 U.S.C. 321(aa)) is amended by 
                striking out ``or 507'', section 201(dd) (21 U.S.C. 
                321(dd)) is amended by striking ``507,'', and section 
                201(ff)(3)(A) (21 U.S.C. 321(ff)(3)(A)) is amended by 
                striking ``, certified as an antibiotic under section 
                507,''.
                  (B) Section 301(e) (21 U.S.C. 331(e)) is amended by 
                striking ``507(d) or (g),''.
                  (C) Section 306(d)(4)(B)(ii) (21 U.S.C. 
                335a(d)(4)(B)(ii)) is amended by striking ``or 507''.
                  (D) Section 502 (21 U.S.C. 352) is amended by 
                striking subsection (l).
                  (E) Section 520(l) (21 U.S.C. 360j(l)) is amended by 
                striking paragraph (4) and by striking ``or Antibiotic 
                Drugs'' in the subsection heading.
                  (F) Section 525(a) (21 U.S.C. 360aa(a)) is amended by 
                inserting ``or'' at the end of paragraph (1), by 
                striking paragraph (2), and by redesignating paragraph 
                (3) as paragraph (2).
                  (G) Section 525(a) (21 U.S.C. 360aa(a)) is amended by 
                striking ``, certification of such drug for such 
                disease or condition under section 507,''.
                  (H) Section 526(a)(1) (21 U.S.C. 360bb) is amended by 
                striking ``the submission of an application for 
                certification of the drug under section 507,'', by 
                inserting ``or'' at the end of subparagraph (A), by 
                striking subparagraph (B), and by redesignating 
                subparagraph (C) as subparagraph (B).
                  (I) Section 526(b) (21 U.S.C. 360bb(b)) is amended--
                          (i) in paragraph (1), by striking ``, a 
                        certificate was issued for the drug under 
                        section 507,''; and
                          (ii) in paragraph (2) by striking ``, a 
                        certificate has not been issued for the drug 
                        under section 507,'' and by striking ``, 
                        approval of an application for certification 
                        under section 507,''.
                  (J) Section 527(a) (21 U.S.C. 360cc(a)) is amended by 
                inserting ``or'' at the end of paragraph (1), by 
                striking paragraph (2), by redesignating paragraph (3) 
                as paragraph (2), and by striking ``, issue another 
                certificate under section 507,''.
                  (K) Section 527(b) (21 U.S.C. 360cc(b)) is amended by 
                striking ``, if a certification is issued under section 
                507 for such a drug, or'', ``of the issuance of the 
                certification under section 507,'', and ``issue another 
                certification under section 507, or''.
                  (L) Section 704(a)(1) (21 U.S.C. 374(a)(1)) is 
                amended by striking ``, section 507 (d) or (g)''.
                  (M) Section 735(1) (21 U.S.C. 379g(1)(C)) is amended 
                by inserting ``or'' at the end of subparagraph (B), by 
                striking subparagraph (C), and by redesignating 
                subparagraph (D) as subparagraph (C).
                  (N) Subparagraphs (A)(ii) and (B) of sections 5(b)(1) 
                of the Orphan Drug Act (21 U.S.C. 360ee(b)(1)(A), 
                360ee(b)(1)(B)) are each amended by striking ``or 
                507''.
                  (O) Section 45C(b)(2)(A)(ii)(II) of the Internal 
                Revenue Code of 1986 is amended by striking ``or 507''.
                  (P) Section 156(f)(4)(B) of title 35, United States 
                Code, is amended by striking ``507,'' each place it 
                occurs.
  (c) Exportation.--Section 802 (21 U.S.C. 382) is amended by adding at 
the end thereof the following:
  ``(i) Insulin and antibiotics may be exported without regard to the 
requirements in this section if the insulin and antibiotics meet the 
requirements of section 801(e)(1).''.
  (d) Application.--An antibiotic drug which was certified or exempted 
from certification under section 507 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 357) before the date of the enactment of this 
Act shall, after such date, be considered to be a drug for which an 
application was filed under section 505(b) of such Act (21 U.S.C. 
355(b)), and approved for safety and effectiveness under section 505(c) 
of such Act (21 U.S.C. 355(c)), except that if such antibiotic drug was 
approved under an abbreviated application under such section 507, such 
drug shall be considered to have been approved under section 505(j) of 
such Act.
  (e) Effect.--In the application of section 505 of the Federal Food, 
Drug, and Cosmetic Act after the date of enactment of this Act to a 
drug that contains an active ingredient (including any ester or salt of 
the active ingredient) that was an antibiotic drug within the meaning 
of section 507 of such Act and was the subject of an approved or 
pending application for marketing approval (exemption from 
certification) before the date of the enactment of such Act, none of 
the patent or market exclusivity provisions of section 505 shall apply 
to such a drug.

SEC. 24. FDA MISSION AND ANNUAL REPORT.

  (a) Mission.--Section 903 (21 U.S.C. 393) is amended by redesignating 
subsections (b) and (c) as subsections (c) and (d), respectively, and 
by adding after subsection (a) the following:
  ``(b) Mission.--The Food and Drug Administration shall promote the 
public health by promptly and efficiently reviewing clinical research 
and taking appropriate action on the marketing of regulated products in 
a timely manner, and with respect to such products shall protect the 
public health by ensuring that--
          ``(1) foods are safe, wholesome, sanitary, and properly 
        labeled;
          ``(2) human and veterinary drugs are safe and effective;
          ``(3) there is reasonable assurance of safety and 
        effectiveness of devices intended for human use;
          ``(4) cosmetics are safe and properly labeled; and
          ``(5) public health and safety are protected from electronic 
        product radiation.
The Food and Drug Administration shall participate with other countries 
to reduce the burden of regulation, harmonize regulatory requirements, 
and achieve appropriate reciprocal arrangements.''.
  (b) Annual Report.--Section 903 (21 U.S.C. 393), as amended by 
subsection (a), is amended by adding at the end the following:
  ``(e) Annual Report.--The Secretary shall, simultaneously with the 
submission each year of the budget for the Food and Drug 
Administration, submit to the Committee on Commerce of the House of 
Representatives and the Committee on Labor and Human Resources of the 
Senate an annual report which shall--
          ``(1) review the performance of the Food and Drug 
        Administration in meeting its mission and the development of 
        Food and Drug Administration policies to implement such 
        mission;
          ``(2) review the performance of the Food and Drug 
        Administration in meeting its own performance standards, 
        including its own outcome measurements, and statutory deadlines 
        for the approval of products or for other purposes contained in 
        this Act;
          ``(3) describe the staffing and resources of the Food and 
        Drug Administration; and
          ``(4)(A) list each bilateral and multinational meeting held 
        by the Food and Drug Administration to address methods and 
        approaches to reduce the burden of regulation, to harmonize 
        regulation, and to seek appropriate reciprocal arrangements, 
        (B) describe the goals, activities, and accomplishments of the 
        Food and Drug Administration in such meetings, and (C) list 
        issues that the Food and Drug Administration is considering or 
        has presented for each such meeting.''.

SEC. 25. INFORMATION SYSTEM.

  Chapter IX is amended by adding at the end the following section:

``SEC. 906. INFORMATION SYSTEM.

  ``The Secretary shall establish and maintain an information system to 
track the status and progress of each application or submission 
(including a petition, notification, or other similar form of request) 
submitted to the Food and Drug Administration requesting agency 
action.''.

SEC. 26. EDUCATION AND TRAINING.

  Chapter IX, as amended by section 25, is amended by adding at the end 
the following sections:

``SEC. 907. EDUCATION.

  ``The Secretary shall conduct training and education programs for the 
employees of the Food and Drug Administration relating to the 
regulatory responsibilities and policies established by this Act, 
including programs for scientific training and training in 
administrative process and procedure and integrity issues.''.

SEC. 27. CENTERS FOR EDUCATION AND RESEARCH ON DRUGS.

  Chapter IX, as amended by section 26, is amended by adding at the end 
the following section:

``SEC. 908. DEMONSTRATION PROGRAM REGARDING CENTERS FOR EDUCATION AND 
                    RESEARCH ON DRUGS.

  ``(a) In General.--The Secretary, acting through the Commissioner of 
Food and Drugs, shall establish a demonstration program for the purpose 
of making one or more grants for the establishment and operation of one 
or more centers to carry out the activities specified in subsection 
(b).
  ``(b) Required Activities.--The activities referred to in subsection 
(a) are the following:
          ``(1) The conduct of state-of-the-art clinical and laboratory 
        research for the following purposes:
                  ``(A) To increase awareness of new uses of drugs and 
                the unforeseen risks of new uses of drugs.
                  ``(B) To provide objective clinical information to 
                the following entities:
                          ``(i) Health care practitioners or other 
                        providers of health care goods or services.
                          ``(ii) Pharmacy benefit managers.
                          ``(iii) Health maintenance organizations or 
                        other managed health care organizations.
                          ``(iv) Health care insurers or governmental 
                        agencies.
                  ``(C) To improve the quality of health care while 
                reducing the cost of health care through the prevention 
                of adverse effects of drugs and the consequences of 
                such effects, such as unnecessary hospitalizations.
          ``(2) The conduct of research on the comparative 
        effectiveness and safety of drugs.
          ``(3) Such other activities as the Secretary determines to be 
        appropriate, except that the grant may not be expended to 
        assist the Secretary in the review of new drugs.
  ``(c) Application for Grant.--A grant under subsection (a) may be 
made only if an application for the grant is submitted to the Secretary 
and the application is in such form, is made in such manner, and 
contains such agreements, assurances, and information as the Secretary 
determines to be necessary to carry out this section.
  ``(d) Peer Review.--A grant under subsection (a) may be made only if 
the application for the grant has undergone appropriate technical and 
scientific peer review.
  ``(e) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated $2,000,000 
for fiscal year 1998, and $3,000,000 for fiscal year 1999.''.

SEC. 28. HARMONIZATION.

  Section 803 (21 U.S.C. 383) is amended by adding at the end the 
following:
  ``(c) The Secretary shall participate in meetings with 
representatives of other countries to discuss methods and approaches to 
reduce the burden of regulation and harmonize regulatory requirements 
if the Secretary determines that such harmonization continues consumer 
protections consistent with the purposes of this Act. The Secretary 
shall report to the Committee on Commerce of the House of 
Representatives and the Committee on Labor and Human Resources of the 
Senate at least 60 days before executing any bilateral or multilateral 
agreement under subsection (b).''.

SEC. 29. ENVIRONMENTAL IMPACT REVIEW.

  Chapter VII, as amended by section 12, is amended by adding at the 
end the following:

              ``Subchapter G--Environmental Impact Review

``SEC. 761. ENVIRONMENTAL IMPACT REVIEW.

  ``Notwithstanding any other provision of law, an environmental impact 
statement prepared in accordance with the regulations published at part 
25 of 21 C.F.R. (as in effect on August 31, 1997) in connection with an 
action carried out under (or a recommendation or report relating to) 
this Act, shall be considered to meet the requirements for a detailed 
statement under section 102(2)(C) of the National Environmental Policy 
Act.''.

SEC. 30. NATIONAL UNIFORMITY.

  (a) Nonprescription Drugs.--Chapter VII (21 U.S.C. 371 et seq.), as 
amended by section 29, is further amended by adding at the end the 
following:

``Subchapter H--National Uniformity for Nonprescription Drugs for Human 
       Use and Preemption for Labeling or Packaging of Cosmetics

``SEC. 771. NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS FOR HUMAN 
                    USE.

  ``(a) In General.--Except as provided in subsection (b), (c)(1), (d), 
(e), or (f), no State or political subdivision of a State may establish 
or continue in effect any requirement--
          ``(1) that relates to the regulation of a drug intended for 
        human use that is not subject to the requirements of section 
        503(b)(1); and
          ``(2) that is different from or in addition to, or that is 
        otherwise not identical with, a requirement under this Act, the 
        Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et 
        seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 
        et seq.).
  ``(b) Exemption.--Upon application of a State or political 
subdivision thereof, the Secretary may by regulation, after notice and 
opportunity for written and oral presentation of views, exempt from 
subsection (a), under such conditions as may be prescribed in such 
regulation, a State or political subdivision requirement that--
          ``(1) protects an important public interest that would 
        otherwise be unprotected;
          ``(2) would not cause any drug to be in violation of any 
        applicable requirement or prohibition under Federal law; and
          ``(3) would not unduly burden interstate commerce.
  ``(c) Scope.--
          ``(1) In general.--This section shall not apply to--
                  ``(A) any State or political subdivision requirement 
                that relates to the practice of pharmacy; or
                  ``(B) any State or political subdivision requirement 
                that a drug be dispensed only upon the prescription of 
                a practitioner licensed by law to administer such drug.
          ``(2) Safety or effectiveness.--For purposes of subsection 
        (a), a requirement that relates to the regulation of a drug 
        shall be deemed to include any requirement relating to public 
        information or any other form of public communication relating 
        to a warning of any kind for a drug.
  ``(d) Exceptions.--
          ``(1) In general.--In the case of a drug described in 
        subsection (a)(1) that is not the subject of an application 
        approved under section 505 or 507 or a final regulation 
        promulgated by the Secretary establishing conditions under 
        which the drug is generally recognized as safe and effective 
        and not misbranded, subsection (a) shall apply only with 
        respect to a requirement of a State or political subdivision of 
        a State that relates to the same subject as, but is different 
        from or in addition to, or that is otherwise not identical 
        with--
                  ``(A) a regulation in effect with respect to the drug 
                pursuant to a statute described in subsection (a)(2); 
                or
                  ``(B) any other requirement in effect with respect to 
                the drug pursuant to an amendment to such a statute 
                made on or after the date of enactment of this section.
          ``(2) State initiatives.--This section shall not apply to a 
        State public initiative enacted prior to the date of enactment 
        of this section.
  ``(e) No Effect on Product Liability Law.--Nothing in this section 
shall be construed to modify or otherwise affect any action or the 
liability of any person under the product liability law of any State.
  ``(f) State Enforcement Authority.--Nothing in this section shall 
prevent a State or political subdivision thereof from enforcing, under 
any relevant civil or other enforcement authority, a requirement that 
is identical to a requirement of this Act.''.
  (b) Inspections.--Section 704(a)(1) (21 U.S.C. 374(a)(1)) is amended 
by striking ``prescription drugs'' each place it appears and inserting 
``prescription drugs, nonprescription drugs intended for human use,''.
  (c) Misbranding.--Paragraph (1) of section 502(e) (21 U.S.C. 
352(e)(1)) is amended to read as follows:
  ``(1)(A) If it is a drug, unless its label bears, to the exclusion of 
any other nonproprietary name (except the applicable systematic 
chemical name or the chemical formula)--
          ``(i) the established name (as defined in subparagraph (3)) 
        of the drug, if there is such a name;
          ``(ii) the established name and quantity or, if deemed 
        appropriate by the Secretary, the proportion of each active 
        ingredient, including the quantity, kind, and proportion of any 
        alcohol, and also including whether active or not the 
        established name and quantity or if deemed appropriate by the 
        Secretary, the proportion of any bromides, ether, chloroform, 
        acetanilide, acetophenetidin, amidopyrine, antipyrine, 
        atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis 
        glucosides, mercury, ouabain, strophanthin, strychnine, 
        thyroid, or any derivative or preparation of any such 
        substances, contained therein, except that the requirement for 
        stating the quantity of the active ingredients, other than the 
        quantity of those specifically named in this subclause, shall 
        not apply to nonprescription drugs not intended for human use; 
        and
          ``(iii) the established name of each inactive ingredient 
        listed in alphabetical order on the outside container of the 
        retail package and, if deemed appropriate by the Secretary, on 
        the immediate container, as prescribed in regulation 
        promulgated by the Secretary, but nothing in this clause shall 
        be deemed to require that any trade secret be divulged, except 
        that the requirements of this subclause with respect to 
        alphabetical order shall apply only to nonprescription drugs 
        that are not also cosmetics and this subclause shall not apply 
        to nonprescription drugs not intended for human use.
  ``(B) For any prescription drug the established name of such drug or 
ingredient, as the case may be, on such label (and on any labeling on 
which a name for such drug or ingredient is used) shall be printed 
prominently and in type at least half as large as that used thereon for 
any proprietary name or designation for such drug or ingredient, except 
that to the extent that compliance with the requirements of clause 
(A)(ii) or (iii) or this subparagraph is impracticable, exemptions 
shall be established by regulations promulgated by the Secretary.''.
  (d) Cosmetics.--Subchapter H of chapter VII, as amended by subsection 
(a), is further amended by adding at the end the following:

``SEC. 772. PREEMPTION FOR LABELING OR PACKAGING OF COSMETICS.

  ``(a) In General.--Except as provided in subsection (b), (d), or (e), 
a State or political subdivision of a State shall not impose or 
continue in effect any requirement for labeling or packaging of a 
cosmetic that is different from or in addition to, or that is otherwise 
not identical with a requirement that is specifically applicable to a 
particular cosmetic or class of cosmetics under this Act, the Poison 
Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair 
Packaging and Labeling Act (15 U.S.C. 1451 et seq.).
  ``(b) Exemption.--Upon application of a State or political 
subdivision thereof, the Secretary may by regulation after notice and 
opportunity for written and oral presentation of views, exempt from 
subsection (a), under such conditions as may be prescribed in such 
regulation, a State or political subdivision requirement for labeling 
and packaging that--
          ``(1) protects an important public interest that would 
        otherwise be unprotected;
          ``(2) would not cause a cosmetic to be in violation of any 
        applicable requirements or prohibition under Federal law; and
          ``(3) would not unduly burden interstate commerce.
  ``(c) Scope.--For purposes of subsection (a), a reference to a State 
requirement that relates to the packaging or labeling of a cosmetic 
means any specific requirement relating to the same aspect of such 
cosmetic as a requirement specifically applicable to that particular 
cosmetic or class of cosmetics under this Act for packaging or 
labeling, including any State requirement relating to public 
information or any other form of public communication.
  ``(d) No Effect on Product Liability Law.--Nothing in this section 
shall be construed to modify or otherwise affect any action or the 
liability of any person under the product liability law of any State.
  ``(e) State Initiative.--This section shall not apply to a State 
requirement adopted by a State public initiative or referendum enacted 
prior to September 1, 1997.''.

SEC. 31. FDA STUDY OF MERCURY COMPOUNDS IN DRUGS AND FOOD.

  (a) List and Analysis.--The Secretary of Health and Human Services 
shall, through the Food and Drug Administration--
          (1) compile a list of drugs and foods that contain 
        intentionally introduced mercury compounds, and
          (2) provide a quantitative and qualitative analysis of the 
        mercury compounds in the list under paragraph (1).
The Secretary shall compile the list required by paragraph (1) within 2 
years after the date of the enactment of this section and shall provide 
the analysis required by paragraph (2) within 2 years of such date of 
enactment.
  (b) Study.--The Secretary of Health and Human Services, acting 
through the Food and Drug Administration, shall conduct a study of the 
effect on humans of the use of mercury compounds in nasal sprays. Such 
study shall include data from other studies that have been made of such 
use.
    (c) Study of Mercury Sales.--
          (1) Study.--The Secretary of Health and Human Services, 
        acting through the Food and Drug Administration and subject to 
        appropriations, shall conduct, or shall contract with the 
        Institute of Medicine of the National Academy of Sciences to 
        conduct, a study of the effect on humans of the use 
ofelemental, organic or inorganic mercury when offered for sale as a 
drug or dietary supplement. Such study shall, among other things, 
evaluate--
                  (A) the scope of mercury use as a drug or dietary 
                supplement; and
                  (B) the adverse effects on health of children and 
                other sensitive populations resulting from exposure to, 
                or ingestion or inhalation of, mercury when so used.
        In conducting such study, the Secretary shall consult with the 
        Administrator of the Environmental Protection Agency, the Chair 
        of the Consumer Product Safety Commission, and the 
        Administrator of the Agency for Toxic Substances and Disease 
        Registry, and, to the extent the Secretary believes necessary 
        or appropriate, with any other Federal or private entity.
          (2) Regulations.--If, in the opinion of the Secretary, the 
        use of elemental, organic or inorganic mercury offered for sale 
        as a drug or dietary supplement poses a threat to human health, 
        the Secretary shall promulgate regulations restricting the sale 
        of mercury intended for such use. At a minimum, such 
        regulations shall be designed to protect the health of children 
        and other sensitive populations from adverse effects resulting 
        from exposure to, or ingestion or inhalation of, mercury. Such 
        regulations, to the extent feasible, should not unnecessarily 
        interfere with the availability of mercury for use in religious 
        ceremonies.

SEC. 32. NOTIFICATION OF DISCONTINUANCE OF A LIFE SAVING PRODUCT.

  Chapter VII (21 U.S.C. 371 et seq.), as amended by section 30, is 
further amended by adding at the end the following:

  ``Subchapter I--Notification of the Discontinuance of a Life Saving 
                                Product

``SEC. 781. DISCONTINUANCE OF A LIFE SAVING PRODUCT.

  ``(a) In General.--A manufacturer that is the sole manufacturer of a 
drug (including a biological product) or device--
          ``(1) that is--
                  ``(A) life supporting;
                  ``(B) life sustaining; or
                  ``(C) intended for use in the prevention of a 
                debilitating disease or condition; and
          ``(2) for which an application has been approved under 
        section 505(b), 505(j), or 515(d),
shall notify the Secretary of a discontinuance of the manufacture of 
the drug or device at least 6 months prior to the date of the 
discontinuance.
  ``(b) Reduction in Notification Period.--On application of a 
manufacturer, the Secretary may reduce the notification period required 
under subsection (a) for the manufacturer if good cause exists for the 
reduction, such as a situation in which--
          ``(1) a public health problem may result from continuation of 
        the manufacturing for the 6-month period;
          ``(2) a biomaterials shortage prevents the continuation of 
        the manufacturing for the 6-month period;
          ``(3) a liability problem may exist for the manufacturer if 
        the manufacturing is continued for the 6-month period;
          ``(4) continuation of the manufacturing for the 6-month 
        period may cause substantial economic hardship for the 
        manufacturer; or
          ``(5) the manufacturer has filed for bankruptcy under chapter 
        7 or 11 of title 11, United States Code.
          ``(6) the Secretary determines that there would be no adverse 
        impact from the discontinuance of a drug or device.
  ``(c) Distribution.--To the maximum extent practicable, the Secretary 
shall distribute information on the discontinuation of the drugs and 
devices described in subsection (a) to appropriate physician and 
patient organizations.''.

                          Purpose and Summary

    H.R. 1411, the Prescription Drug User Fee Reauthorization 
and Drug Regulatory Modernization Act of 1997, is a 
comprehensive proposal to revise the Nation's laws governing 
the review of drug and biological products. It reauthorizes the 
Prescription Drug User Fee Act (PDUFA) for five years and 
amends the Federal Food, Drug, and Cosmetic Act (FFDCA) in an 
effort to change several of the Food and Drug Administration's 
(FDA's) current policies and practices regarding product review 
and approval. The legislation seeks to encourage pharmaceutical 
research and accelerate the availability of new products.

                  Background and Need for Legislation

                      A. REAUTHORIZATION OF PDUFA

    In 1992, Congress enacted the Prescription Drug User Fee 
Act (PDUFA), which required companies to pay user fees to the 
FDA to improve the agency's review of drug and biologic 
applications. The law expired on September 30, 1997, although 
the FDA has sufficient resources to maintain current levels of 
operations for an additional 90 days following that date.
    Reauthorization of PDUFA is widely viewed as necessary to 
continue the progress that has been made toward reducing the 
FDA's review time for new pharmaceutical products. At present, 
the PDUFA landscape is as follows:
    User fees paid by drug companies to FDA, 1993-1997: $327 
million.
    Additional reviewers hired by FDA with user fee funds: 600.
    Reduction in drug review times due to user fees: 13.7 
months (from an average of 29.2 months in 1992 to an average of 
15.5 months in 1996).
    Increase in annual number of drugs approved since user fees 
began: 27 (there were 53 new medicines approved in 1996, up 
from 26 in 1992).
    Number of new medicines in development ``pipeline'': At 
least 1,000, including more than 317 for cancer, 122 for AIDS, 
96 for heart disease and stroke, 146 for diseases that affect 
children, 118 for neurologic disorders such as Alzheimer's and 
Lou Gehrig's disease, 125 for infectious diseases, and 64 for 
mental illness.
    While pharmaceutical manufacturers have benefited from 
speedier drug approvals, the primary beneficiaries are patients 
and providers who have gained access to the medicines they need 
sooner. For example, in 1996, the FDA approved a new medicine 
for multiple sclerosis (MS) after a review time of 14.3 months. 
This will benefit many of the 300,000 Americans with MS. A new 
medicine for asthma was approved in 15 months, a positive 
development for the 12 million Americans with this disease. And 
a new medicine that could help some of the 4 million Americans 
suffering from Alzheimer's was approved in 7.7 months. As 
described above, the net result of PDUFA is that new drugs have 
moved from the laboratory to the patient 13.7 months faster. 
For some patients, that 13.7 months could mean the difference 
between life and death.

           B. THE NEED TO ADDRESS STRUCTURAL AGENCY PROBLEMS

    As important as the reauthorization of PDUFA is, the manner 
in which the FDA approves and regulates pharmaceuticals and 
biologics remains an issue of concern impacting millions of 
patients and providers alike. Currently, it takes nearly 15 
years to develop a new drug--twice the time required in the 
1960s. New scientific knowledge can produce effective new 
treatments for uncured diseases, but a drug development process 
slowed by outmoded regulation may mean that cures come too late 
for many patients.
    Although the United States has long led the world in drug 
discovery, too many medicines are introduced in other countries 
before they are made available to American patients. In fact, 
the majority of drugs approved by the FDA since 1990 were 
approved first in another country. Of additional concern is the 
fact that lengthy drug development times in the United States 
have served as a barrier to pharmaceutical innovation. A 1996 
Tufts University study found that the percentage of drug tests 
in humans initiated in the United States by American firms 
dropped from 61 percent in the 1970s to 36 percent in the 
1990s, as companies moved testing programs to other nations.
    Although medical progress has relegated many diseases to 
the history books, other diseases remain undiagnosed, 
untreated, or uncured. As the American population ages, 
diseases such as Alzheimer's, arthritis, cancer, and 
Parkinson's will take an increasing human and financial toll. 
AIDS continues to ravage, antibiotic resistance is on the rise, 
and new and deadly infectious diseases are emerging.
    Armed with new knowledge of the mechanisms of disease and 
new tools, researchers are taking up the challenge of uncured 
diseases. Unfortunately, many patients do not have the time to 
wait the nearly 15 years it now takes to bring a new drug or 
biologic from the laboratory to the pharmacy shelf. According 
to recent testimony before the Subcommittee on Health and 
Environment, drug development times have steadily increased--
from 8.1 years in the 1960s to 11.6 years in the 1970s to 14.2 
years in the 1980s to approximately 15 years for drugs approved 
in the 1990s.
    Part of the reason for this growing development time is the 
increasing complexity of the diseases researchers are 
targeting. But an undeniable part of the delay in getting 
medicines to patients lies in the rules and regulations imposed 
by the FDA--requirements that add to development and approval 
time without enhancing the safety and effectiveness of new 
drugs and biologics.
    In order to address these concerns, H.R. 1411, the 
Prescription Drug User Fee Reauthorization and Drug Regulatory 
Modernization Act of 1997, achieves two important objectives: 
(1) it reauthorizes the Prescription Drug User Fee Act, and (2) 
it includes commonsense provisions enabling the FDA not only to 
better ensure the safety and efficacy of new biomedical 
technologies but also to better ensure that individuals and the 
Nation as a whole have timely access to those technologies, now 
and in the future.

                                Hearings

    In preparation for action on modernization of the Food and 
Drug Administration, the Committee held 17 hearings over the 
last 30 months, including an April 23, 1997, hearing entitled, 
``Reauthorization of the Prescription Drug User Fee Act and FDA 
Reform.'' The Subcommittee on Health and Environment received 
testimony from the following witnesses: Dr. Michael A. 
Friedman, Lead Deputy Commissioner, Food and Drug 
Administration; Dr. Raymond L. Woosley, Professor and Chairman, 
Department of Pharmacology, Georgetown University Medical 
Center; Dr. Joseph A DiMasi, Director of Economic Analysis, 
Tufts Center for the Study of Drug Development, Tufts 
University; Dr. Samuel Broder, Senior Vice President for 
Research and Development and Chief Scientific Officer, IVAX 
Corporation; Mr. Gordon M. Binder, Chairman & CEO, Amgen, Inc., 
representing the Pharmaceutical Research &Manufacturers; of 
America and the Biotechnology Industry Organization; Mr. Bruce Downey, 
Chairman & CEO, Barr Laboratories, Inc., representing the Generic 
Pharmaceutical Industry Association and the National Pharmaceutical 
Alliance; Mr. David Holveck, President & CEO, Centocor, Inc.; The 
Honorable Martha Keys, Senior Public Policy Advisor, National Multiple 
Sclerosis Society; Ms. Susan L. Weiner, Executive Director, Children's 
Brain Tumor Foundation; Mr. Jeff Bloom, representing The Patients' 
Coalition; and Dr. Sanford Cohen, Pediatrician, representing the 
American Academy of Pediatrics.

                        Committee Consideration

    On September 17, 1997, the Subcommittee on Health and 
Environment met in an open markup session and approved H.R. 
1411 for Full Committee consideration, amended, by a voice 
vote. On September 25, 1997, the Full Committee met in an open 
markup session and ordered H.R. 1411, reported to the House, 
amended, by a rollcall vote of 43 yeas to 0 nays.

                             Rollcall Votes

    Clause 2(l)(2)(B) of rule XI of the Rules of the House 
requires the Committee to list the recorded votes on the motion 
to report legislation and amendments thereto. The following are 
the recorded votes on the motion to report H.R. 1411 and on 
amendments offered to the measure, including the names of those 
Members voting for and against.


                      Committee Oversight Findings

    Pursuant to clause 2(l)(3)(A) of rule XI of the Rules of 
the House of Representatives, the Committee has held an 
oversight hearing on issues addressed in this legislation.

              Committee on Government Reform and Oversight

    Pursuant to clause 2(l)(3)(D) of rule XI of the Rules of 
the House of Representatives, no oversight findings have been 
submitted to the Committee by the Committee on Government 
Reform and Oversight.

               New Budget Authority and Tax Expenditures

    In compliance with clause 2(l)(3)(B) of rule XI of the 
Rules of the House of Representatives, the Committee finds that 
H.R. 1411 would result in no new or increased budget authority 
or tax expenditures or revenues.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate prepared 
by the Director of the Congressional Budget Office pursuant to 
section 403 of the Congressional Budget Act of 1974.

                  Congressional Budget Office Estimate

    Pursuant to clause 2(l)(3)(C) of rule XI of the Rules of 
the House of Representatives, the following is the cost 
estimate provided by the Congressional Budget Office pursuant 
to section 403 of the Congressional Budget Act of 1974:

                                     U.S. Congress,
                               Congressional Budget Office,
                                   Washington, DC, October 1, 1997.
Hon. Tom Bliley,
Chairman, Committee on Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 1411, the 
Prescription Drug User Fee Reauthorization and Drug Regulatory 
Modernization Act of 1997.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Anne Hunt.
            Sincerely,
                                         June E. O'Neill, Director.
    Enclosure.

H.R. 1411--Prescription Drug User Fee Reauthorization and Drug 
        Regulatory Modernization Act of 1997

    Summary: H.R. 1411 would reauthorize the Prescription Drug 
User Fee Act (PDUFA) of 1992, which empowers the Food and Drug 
Administration (FDA) to collect user fees from the 
pharmaceutical industry. The user fee program would be 
reauthorized, with some modifications, for an additional five 
years. The bill would also amend the Food, Drug and Cosmetic 
Act (FD&CA;) and the Public Health Service Act to reform the 
FDA's regulatory and approval processes for drugs, biologics, 
and antibiotics. One provision would grant a six-month 
extension of market exclusivity for pharmaceutical 
manufacturers who conduct pediatric studies on select 
prescription drugs. Another would make certain antibiotics 
eligible for patent extensions under the 1984 Drug Price 
Competition and Patent Term Restoration Act (Hatch-Waxman Act).
    CBO estimates that enacting H.R. 1411 would result in net 
additional discretionary spending of $9 million in 1998 and 
$214 million over the 1998-2002 period, assuming appropriation 
of the authorized amounts. Reauthorizing the user fee program 
would yield $601 million in offsetting collections over five 
years; these amounts would also be authorized to be spent, 
subject to appropriation. Extending market exclusivity for 
certain drugs would increase direct spending by $65 million and 
reduce revenues by $61 million over the 1998-2002 period. The 
direct cost implications of the provision extending eligibility 
for Hatch-Waxman extensions to some antibiotics cannot be 
estimated at this time.
    By preempting state and local laws that regulate 
nonprescription drugs and labeling of cosmetics differently 
than federal law, H.R. 1411 would impose an intergovernmental 
mandate as defined in the Unfunded Mandates Reform Act (UMRA). 
CBO estimates that compliance with this mandate would result in 
no significant costs for state and local governments.
    Estimated cost to the Federal Government: The estimated 
budgetary impact of H.R. 1411 is shown in the following table. 
For the purposes of this estimate, CBO assumes that all amounts 
authorized in the bill would be appropriated by the start of 
each fiscal year and that outlays would follow the historical 
spending patterns for the FDA. The costs of this legislation 
fall within budget function 550 (Health).

----------------------------------------------------------------------------------------------------------------
                                                                  By fiscal years, in millions of dollars--     
                                                           -----------------------------------------------------
                                                              1997     1998     1999     2000     2001     2002 
----------------------------------------------------------------------------------------------------------------
                                        SPENDING SUBJECT TO APPROPRIATION                                       
                                                                                                                
Spending Under Current Law:                                                                                     
    Estimated Authorizations:                                                                                   
        Authorization Level...............................      887      919      949      982    1,106    1,050
        Estimated Outlays.................................      880      905      937      971    1,005    1,038
    Collection of User Fees:                                                                                    
        Authorization Level...............................      -88        0        0        0        0        0
        Estimated Outlays.................................      -88        0        0        0        0        0
    Spending of User Fees:                                                                                      
        Authorization Level...............................       88        0        0        0        0        0
        Estimated Outlays.................................       87       22        4        0        0        0
Proposed Changes:                                                                                               
    Estimated Authorizations:                                                                                   
        Authorization Level...............................        0       26       64       68       70       70
        Estimated Outlays.................................        0        9       31       46       60       68
    Collection of User Fees:                                                                                    
        Authorization Level...............................        0     -110     -116     -119     -128     -128
        Estimated Outlays.................................        0     -110     -116     -119     -128     -128
    Spending of User Fees:                                                                                      
        Authorization Level...............................        0      110      116      119      128      128
        Estimated Outlays.................................        0       82      109      118      126      127
Spending Under H.R. 1411:                                                                                       
    Estimated Authorizations:                                                                                   
        Authorization Level \1\...........................      887      945    1,103    1,050    1,086    1,120
        Estimated Outlays.................................      895      923      968    1,017    1,065    1,106
    Collection of User Fees:                                                                                    
        Authorization Level \1\...........................      -88     -110     -116     -119     -128     -128
        Estimated Outlays.................................      -88     -110     -116     -119     -128     -128
    Spending of User Fees:                                                                                      
        Authorization Level \1\...........................       88      110      116      119      128      128
        Estimated Outlays.................................       87      104      113      118      126      127
                                                                                                                
                                          DIRECT SPENDING AND REVENUES                                          
                                                                                                                
Direct Spending:                                                                                                
    Estimated Budget Authority............................        0        0        7       18       28       11
    Estimated Outlays.....................................        0        0        7       18       28       11
Revenues:                                                                                                       
    Estimated Revenues....................................        0        0       -6      -15      -25      -15
----------------------------------------------------------------------------------------------------------------
\1\ The 1997 level is the amount appropriated for that year.                                                    

Basis of estimate

            Estimated authorizations
    The bill would reform the FDA's approval and regulatory 
processes with the intent of accelerating product approvals and 
reducing regulatory requirements. H.R. 1411 would require the 
FDA, in coordination with the National Institutes of Health 
(NIH) and the Centers for Disease Control (CDC), to establish a 
program to provide information on treatment, detection, and 
prevention of serious diseases and on clinical trials currently 
studying these conditions. Other provisions would result in 
small budgetary savings.
    Information Program on Clinical Trials. H.R. 1411 would 
require the Director of the NIH in coordination with the FDA 
and the CDC to establish a program to provide information in 
treatment, detection, and prevention of serious diseases and on 
clinical trials currently studying these conditions. This 
program would include establishing a database of all federally 
and private funded clinical trials and a toll-free telephone 
information line available to health care providers, 
researchers, individuals with serious diseases, and all other 
members of the public.
    The NIH already has such a program for clinical trials that 
it funds for cancer, AIDS, and rare diseases. Privately-funded 
clinical trials are also included in these databases on a 
voluntary basis. The FDA would be able to disclose information 
in clinical trials, and NIH would be required to expand its 
current database significantly to accommodate the increase in 
volume of trials and information. After the system was set up, 
additional maintenance costs would be incurred to keep up with 
the status and results of clinical trials, and with new 
protocols on treatment and prevention of serious diseases and 
conditions. Costs would also arise to operate the telephone 
information line, which would be staffed by health 
professionals.
    CBO based its estimate on the cost of maintaining the 
current data banks and information networks, the estimated 
portion of clinical trials currently contained in NIH's 
databases, and on conversations with professionals experienced 
in this area. CBO assumes that it would take two years to 
create a system that would meet the minimum requirements 
specified in the bill, at a cost of $20 million in 1998 and $45 
million in 1999. For each year thereafter, CBO estimated a cost 
of $50 million for maintenance and quality improvement. Costs 
would total $215 million over the 1998-2002 period.
    Dissemination of Off-Label Use Information. H.R. 1411 would 
permit manufacturers, within one year of enactment, to 
disseminate to select professional audiences information on a 
product use not described in the approved labeling of the drug. 
The only information that could be disseminated would be copies 
of articles in a peer-reviewed journal or in a reference 
publication. The manufacturer must also certify that a 
supplemental application for the product will be submitted to 
the Secretary within a specified time. The manufacturer must 
submit to the Secretary biannually a list of the titles of the 
articles disseminated and a list of the categories of health 
care providers receiving this information. CBO estimates that 
this provision would have no federal costs in 1998 but would 
cost $59 million through 2002.
    Regulation of Positron Emission Tomography (PET) and 
Radiopharmaceuticals. H.R. 1411 would require the FDA to 
establish an approval process and good manufacturing practice 
requirements for PET. The agency also could not require the 
submission of new drug applications or abbreviated new drug 
applications for PET products that are not adulterated for four 
years after enactment of the bill. Three FDA notices and 
rulings regarding the regulation of PET products would also be 
revoked. Finally, the bill would direct the FDA to issue 
regulations for the approval of radiopharmaceuticals used for 
diagnostic or monitoring purposes. The cost of fulfilling these 
requirements would be $300,000 in 1998 and approximately $1 
million over five years.
    Information Systems. The FDAS would be required to 
establish and maintain an information system that would allow 
the agency to track product applications and systems. 
Fulfilling these requirements would cost $4 million in 1998 and 
$13 million over five years.
            User fees
    The bill would reauthorize current prescription drug user 
fees through September 30, 2002. The current authorization 
expired at the end of fiscal year 1997. Proceeds from these 
fees would be available for spending, subject to appropriation.
    Reauthorization of the Prescription Drug User Fee Act of 
1992. As with prior law, the reauthorized program would levy 
three types of user fees on pharmaceutical manufacturers: 
application and supplement fees, establishment fees, and 
product fees. Aggregate amounts of such fees are specified in 
the bill for each fiscal year through 2002; these amounts would 
be adjusted to reflect cumulative inflation since 1997. CBO's 
estimate assumes that the inflation adjustment would apply to 
the specified authorization, not to the prior year's actual 
authorization. The amounts collected are authorized to be 
spent, subject to appropriation. CBO estimates that the FDA 
would collect $110 million in 1998 and $601 million over five 
years.
    Any fees collected in excess of the amount specified in the 
appropriations act for a given year would be credited to the 
FDA appropriations account and subtracted from the amount of 
fees authorized for the following year. The FDA could not 
assess the user fees unless appropriations for FDA salaries and 
expenses, excluding any user fees, were at least equal to 
appropriations for 1997, adjusted for inflation.
            Direct spending
    The bill would grant an additional six months of market 
exclusivity to pharmaceutical manufacturers that conduct 
pediatric studies on select drugs. This provision would affect 
direct spending because it would increase costs of the Medicaid 
rebate program and the Federal Employees Health Benefit Program 
(FEHBP). This provision would apply to pediatric studies 
commenced before January 1, 2002.
    The Secretary of Health and Human Services, through the 
Commissioner of the FDA, would issue a list of drugs for which 
additional pediatric information may yield a health benefit. 
The Secretary of Health and Human Services, through the 
Commissioner of the FDA, would issue a list of drugs for which 
additional, pediatric information may yield a health benefit. 
If manufacturers of targeted drugs submitted pediatric studies 
to the FDA, their product would receive an additional six 
months of market exclusivity. This benefit would accrue to both 
approved drugs and those awaiting approval. Manufacturers of an 
approved drug that received an extension under this provision 
could, if eligible, receive an additional six months of 
exclusivity for a supplemental application.
    By extending the market exclusivity of certain drugs, this 
proposal would increase prescription drug costs for Medicaid, 
FEHBP, Veterans Affairs (VA) facilities, the Department of 
Defense, and the Public Health Service for the six months of 
the extension. In the absence of this provision, these programs 
may have had access to less expensive generic products. In the 
case of Medicaid and FEHBP, the additional costs of this 
provision would represent direct spending. At this time, the 
costs to the VA, the Department of Defense and the Public 
Health Service cannot be determined. CBO estimates that this 
provision would have no net budgetary effect in 1998 but would 
increase federal outlays for Medicaid and FEHBP by $68 million 
over the 1998-2002 period. This provision would also reduce 
revenues to the federal government. Private insurers would 
raise premiums in response to higher pharmaceutical prices. 
Because individuals would have to pay higher insurance 
premiums, their taxable income would decrease. Total revenue 
reductions over five years are estimated at $61 million.
    Finally, section 23 of the bill would make certain 
antibiotics eligible for a patent extension under the Hatch-
Waxman Act. Although this provision would increase costs to 
Medicaid, FEHBP, and other federal programs and would reduce 
federal revenues, these changes cannot be estimated at this 
time.
    Pay-as-you-go considerations: The Balanced Budget and 
Emergency Deficit Control Act of 1985 sets up pay-as-you-go 
procedures for legislation affecting direct spending or 
receipts. Because the bill would affect direct spending and 
receipts, pay-as-you-go procedures would apply. The projected 
changes in direct spending and receipts are summarized in the 
following table for fiscal years 1998-2007. For purposes of 
enforcing pay-as-you-go procedures, only the effects in the 
budget year and the succeeding four years are counted.

                                        SUMMARY OF PAY-AS-YOU-GO EFFECTS                                        
----------------------------------------------------------------------------------------------------------------
                                                     By fiscal years, in millions of dollars--                  
                                 -------------------------------------------------------------------------------
                                   1998    1999    2000    2001    2002    2003    2004    2005    2006    2007 
----------------------------------------------------------------------------------------------------------------
Change in outlays...............       0       7      18      28      11       0       0       0       0       0
Change in receipts..............       0      -6     -15     -25     -15       0       0       0       0       0
----------------------------------------------------------------------------------------------------------------

    Estimated impact on State, local, and tribal governments: 
By preempting state and local laws that regulate 
nonprescription drugs and cosmetics differently than federal 
law, H.R. 1411 would impose an intergovernmental mandate as 
defined in UMRA. CBO estimates that compliance with this 
mandate would result in no significant costs for state and 
local governments. Consequently, the threshold established in 
UMRA ($50 million in 1996, adjusted annually for inflation) 
would not be exceeded. This mandate would not affect tribal 
governments.
    By granting certain drug manufacturers a six-month 
extension of market exclusivity for their products, the bill 
would make prescription drugs provided under Medicaid more 
expensive. CBO estimates that states' share of these costs 
would total about $28 million over the next five years. Another 
provision in the bill would make certain antibiotics eligible 
for patent extension under the Hatch-Waxman Act. This provision 
also would result in increased costs for Medicaid; however, CBO 
is unable at this time to estimate the magnitude of these 
costs. In any event, these provisions would not constitute 
mandates under UMRA because prescription drugs under Medicaid 
are provided at a state's option.
    Estimated impact on the private sector: H.R. 1411 would 
impose some new private-sector mandates, and in several 
instances would replace existing mandates with new, less 
burdensome requirements. In addition, the bill would 
reauthorize application fees and certain other fees paid by 
pharmaceutical companies. However, since these fees do not 
become effective until Congress appropriates them, they do not 
constitute a private-sector mandate. Thus, the direct costs of 
all private-sector mandates in this bill that could be 
estimated are minimal and the total effect could be a net 
reduction in mandate costs imposed on the private sector.
    Sections 6 and 32 would impose new mandates on the private 
sector. Section 6 would direct the Secretary of Health and 
Human Services to establish ``a data bank of information on 
clinical trials for drugs for serious or life-threatening 
diseases and conditions.'' This provision would impose a new 
mandate on sponsors of such clinical trials by requiring them 
to forward to the data bank information about eligibility 
criteria for participation in the trial, the location of the 
trial, and a point of contact within 21 days after the clinical 
trials have begun. Section 32 would require manufacturers of 
drugs, biological products and class III medical devices that 
are life supporting or prevent a debilitating disease to notify 
the Secretary of any discontinuation in the manufacture of the 
product, 6 months in advance. CBO estimates that the costs of 
these mandates would be minimal.
    Section 31 would require the Secretary to promulgate 
regulations restricting the sale of mercury for use as a drug 
or dietary supplement if the Secretary believes that the use of 
the product poses a threat to human health. Because such 
regulations are contingent on an analysis that has not yet been 
performed, the FDA was unable to provide any information that 
would clarify whether the restriction on the sale of mercury 
would be needed. Thus, CBO is unable to estimate the impact of 
this section on the private sector.
    Several new mandates would cost no more and perhaps less 
than the current regulatory requirements that they would 
replace. Section 19 would set new quality standards for 
positron emission tomography drugs but relieve them of the new 
drug application process and certain other requirements. 
Section 21 would establish a single licensing requirement for 
biological products that would replace current licensing 
requirements.
    Estimate prepared by: Federal Cost: Anne Hunt (FDA) and 
Cyndi Dudzinski (NIH). Impact on State, Local, and Tribal 
Governments: Leo Lex. Impact on the Private Sector: Anna Cook.
    Estimate approved by: Paul N. Van de Water, Assistant 
Director for Budget Analysis.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

                      Advisory Committee Statement

    No new advisory committees within the meaning of section 
5(b) of the Federal Advisory Committee Act were created by this 
legislation. The bill, however, statutorily establishes 
existing scientific advisory panels and states that such panels 
shall not be subject to annual chartering and annual reporting 
requirements under the Federal Advisory Committee Act.

                   Constitutional Authority Statement

    Pursuant to clause 2(l)(4) of rule XI of the Rules of the 
House of Representatives, the Committee finds that the 
Constitutional authority for this legislation is provided in 
article I, section 8, clause 3, which grants Congress the power 
to regulate commerce with foreign nations, among the several 
States, and with the Indian tribes.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation

Section 1. Short title; references; table of contents

    Section 1 provides that the Act may be cited as the 
Prescription Drug User Fee Reauthorization and Drug Regulatory 
Modernization Act of 1997, and unless otherwise specified, all 
references are to sections or provisions of the Federal Food, 
Drug, and Cosmetic Act (FFDCA: 21 U.S.C. 321 et seq.). It also 
contains the table of contents.

Sec. 2. Fees relating to drugs

    Section 2(a) sets forth four Congressional findings: (1) 
the prompt approval of safe and effective new drugs and other 
therapies is critical to improve public health; (2) the public 
health is served by making additional funds available for the 
purpose of augmenting resources of the FDA that are devoted to 
the process for human drug application review; (3) the 
provisions added by PDUFA have substantially reduced drug 
review times, should be reauthorized for an additional 5 years, 
and should be carried out by the FDA with new commitments to 
implement more ambitious and comprehensive improvements in the 
agency's regulatory processes; and (4) fees authorized by these 
amendments will be used to expedite the drug development and 
application review process through goals identified in letters 
from the Secretary of Health and Human Services to the Chairman 
of the House Committee on Commerce and the Chairman of the 
Senate Committee on Labor and Human Resources, to be set forth 
in the Congressional Record.
    Section 2(b) augments several definitions in section 735 
(21 U.S.C. 379(g)). Currently, section 735 defines what 
applications, products, and establishments will be assessed 
user fees. New section 735 defines certain applications and 
products that will not be assessed user fees, including 
biological license applications for products that will only be 
used for further manufacturing, and applications submitted by 
State or Federal governmental entities for products that will 
not be distributed commercially. User fees would be assessed on 
applications for large volume biological products used for 
single dose intravenous injection or infusion.
    Section 735(5) is amended to define the term ``prescription 
drug establishment'' to mean a foreign or domestic place of 
business which is at one general physical location consisting 
of one or more buildings all of which are within 5 miles of 
each other and at which one or more prescription drug products 
are manufactured in final dosage form. Section 735(7)(A) is 
amended to allow expenses of contractors of FDA to be paid with 
PDUFA funds even if the contractors are not working in FDA 
facilities. Section 735(8) is amended by replacing August 1992 
with April 1997 and updating from Fiscal Year 1992 to Fiscal 
Year 1997 when defining how the ``adjustment factor'' will now 
be calculated. It will now be the lower of either the Consumer 
Price Index for all urban consumers for April of the preceding 
fiscal year divided by such Index for April 1997, or the total 
discretionary domestic spending budget authority for the 
preceding fiscal year divided by such budget authority for 
Fiscal Year 1997.
    Section 2(c) contains the authority to assess and use the 
drug user fees. It amends section 736(a) (21 U.S.C. 379h(a)) 
establishing types of fees. PDUFA reauthorization will begin in 
Fiscal Year 1998. It will require payment of fees on submission 
of an application or supplement, instead of in two parts, one-
half when the application is submitted and the second half when 
an action is taken on the application. This section also 
contains other conforming changes necessitated by this change.
    New section 736(a)(1)(E) exempts from application fees 
applications or supplements for orphan drugs designated under 
section 526 for treatment of a rare disease or condition. To 
qualify for an exemption, an application cannot include any 
uses other than for rare diseases or conditions. Supplements 
qualify for an exemption if the drug has been designated under 
section 526 for the indication proposed in the supplement. 
Section 736(a)(1)(F) adds an exemption for a supplement to an 
application that provides for use of the drug product in the 
pediatric population.
    New section 736(a)(2)(B) provides exceptions to the 
establishment fee. If, during the fiscal year, the 
establishment begins manufacturing a drug that it did not 
manufacture in the previous year, and if the establishment paid 
the full establishment fee before the manufacturing of this new 
drug began, the applicant initiating the manufacture will not 
be assessed a share of the establishment fee for that fiscal 
year.
    Section 2(c)(1)(D) amends section 736(a)(3)(B) of the 
FFDCA, the prescription drug product fee, to make minor 
technical changes to the payment procedures and to correct an 
anomaly regarding antibiotics contained in PDUFA as enacted in 
1992. Under the amended section, a fee will be paid for the 
fiscal year in which the product is first submitted for listing 
under section 510 of the FFDCA or for relisting if the product 
had been withdrawn. After the fee is paid in the first year, it 
must be paid on or before January 31 of each year thereafter.
    Under PDUFA as enacted in 1992, innovator products approved 
under section 505 that were the same generic drugs approved 
under section 505(b)(2) or 505(j) of the FFDCA did not pay user 
fees. However, antibiotic drugs, which were approved under 
section 507, continued to pay fees even after a generic product 
was approved, and even though the generic product was not 
assessed fees. Under section 2(c)(1)(D), innovator antibiotic 
products approved under section 507 would not be required to 
pay user fees once a comparable generic product was approved. 
Thus, innovator antibiotics would be treated like other types 
of drugs with respect to user fees.
    Section 2(c)(2)(b) amends section 736(b) relating to fee 
amounts with a new application fee schedule ($205,704 in FY 
1998; $256,338 in each of FY 1999 and FY 2000; $267,606 in FY 
2001; and $258,451 in FY 2002), and new target establishment 
fee revenues for each of five fiscal years ($35.6 million in FY 
1998; $36.4 million in each of FY 1999 and FY 2000; $38 million 
in FY 2001; and $36.7 million in FY 2002). The supplement fee 
is set at approximately one-half of the application fee.
    Section 2(c)(3) amends section 736 of the FFDCA to provide 
for annual workload and inflation adjustments. Under the 
provision as amended, beginning in FY 1998, the Secretary may 
adjust the fees each year cumulatively for inflation since FY 
1997 and also may adjust the establishment and product fees so 
that the amount of revenue collected in each category will 
equal the amount the FDA expects to collect as application 
fees. This amendment is designed to allow the Secretary to 
adjust the fees to account for changes in workload. Section 
2(c)(3) provides that these adjustments are compounded 
annually.
    Section 2(c)(4)(A) amends section 736(d) on fee waivers and 
reductions to change the way the small business exception is 
administered. Under PDUFA as enacted in 1992, a small business 
qualifying for the exception was assessed one-half the 
application user fee for the first application it submitted and 
was permitted to defer payment of the fee until one year after 
the date the application was submitted. Under the new section 
(E)(1), a small business qualifying for the exception will not 
be assessed any fee on the first application it submits, 
although supplements to the application and other applications 
will be assessed fees.
    Section 2(c)(5) updates section 736(f)(1) (21 U.S.C. 
379g(f)(1)) to FY 1997. Section 2(c)(6)(A) amends section 
736(g) (21 U.S.C. 379h(g)) of the FFDCA to allow the transfer 
of appropriated funds from the salaries and expenses account 
without fiscal year limitation to the appropriations account 
with fiscal year limitation, if the funds are available solely 
for reviewing human drug applications. It also amends the 
statute to allow funds to be collected in each fiscal year in 
an amount specified in appropriation Acts or otherwise be made 
available for obligation. Section 2(c)(6)(B) specifies that 
fees shall only be collected and be available to defray 
increases in the costs of the resources allocated for the 
review process for human drugs over such costs, excluding costs 
paid for fees collected under this section, for FY 1997 and 
multiplied by the adjustment factor.
    Section 2(c)(6)(C) amends section 736(g)(3) of the FFDCA 
and authorizes to be appropriated for fees: $106,800,000 for FY 
1998; and $109,200,000 for each of FY 1999 and FY 2000; 
$114,000,000 for FY 2001; and $110,100,000 for FY 2002. These 
amounts may be further adjusted for workload and inflation.
    This section also adds a new section 736(g)(4) to require 
that any collected fees over the appropriated amount be 
credited to the appropriation account of the FDA and be 
subtracted from the subsequent fiscal year authorization to 
collect fees.
    Section 2(c)(7) amends section 736 (21 U.S.C. 379h) to 
create a new requirement for written requests for waivers, 
reductions, or refunds of fees. It redesignates subsection (i) 
as subsection (j) and provides in subsection (i) that, to 
qualify for consideration of a waiver or fee reduction or 
refund, a person must submit a written request to the Secretary 
for this action within 180 days after the fee is due.
    Section 2(c)(8) amends section 736 (21 U.S.C. 379h) to 
create a subsection providing for a special rule for waivers, 
refunds, and exceptions. It requires that any requests for 
waivers, refunds, or exceptions for fees paid prior to the date 
of enactment be submitted in writing to the Secretary within 
one year after enactment of this Act.
    Section 2(d) requires two annual reports to be submitted by 
the Secretary of Health and Human Services to the House 
Committee on Commerce and the Senate Committee on Labor and 
Human Resources. The first will report, within 60 days after 
the end of the fiscal year, on the progress the FDA achieved in 
meeting the performance goals identified in the letters 
described in subsection 2(a)(4). The second will report within 
120 days on the implementation of the authority for such fees 
during the fiscal year and FDA's use of the fees.
    Section 2(e) states that the amendments made by this 
section shall take effect October 1, 1997.
    Section 2(f) sunsets the amendments made by section 2(b) 
and (2)(c) on October 1, 2002, and the amendments made by 
section 2(d) requiring annual reports 120 days thereafter.

Sec. 3. Pediatric studies of drugs

    Section 3 amends Chapter V (21 U.S.C. 351 et seq.) of the 
FFDCA by creating a new section 505A, ``Pediatric Studies of 
Drugs.'' Subsection 505A(a) provides that if, prior to the 
approval of a new drug, the Secretary determines that 
information about the drug will produce health benefits in a 
pediatric population, and makes a written request for pediatric 
studies (including a time frame for completing the studies), 
and the studies are completed and accepted by the Secretary, 
then the sponsor or manufacturer can qualify for up to 6 months 
of extra market exclusivity. The Committee has authorized the 
Secretary to determine the time frame for completing the 
studies, although the Committee emphasizes that such studies 
should be sought, conducted, and completed at the earliest 
possible opportunity. The Committee does not intend that such 
studies be artificially timed for market advantage.
    Subsection (b) directs the Secretary to develop a list of 
already-approved drugs for which additional pediatric 
information may produce health benefits. In doing so, the 
Secretary is to set priorities among these drugs and to publish 
this list and the priorities. The list is to be updated 
annually.
    Subsection (c) creates the authority for the Secretary to 
award exclusivity to drugs that are on the list developed under 
subsection (b). After the list has been published, the 
Secretary may make a request for pediatric studies of drugs on 
the list. This request must include a time frame for the 
completion of such studies. As with new drugs under subsection 
(a), if the manufacturer completes such studies in accordance 
with other provisions of Section 3, the manufacturer may be 
awarded six additional months of market exclusivity. The 
additional exclusivity would be over and above the period of 
exclusivity currently provided to the drug, whether it is 
derived from patent or Waxman-Hatch exclusivity.
    Subsection (d) specifies two possible means of conducting 
studies requested under subsections (a) or (c). If the sponsor 
and the Secretary agree on written protocols, the requirement 
is satisfied if the studies are conducted according to those 
protocols. If, however, the sponsor and the Secretary do not 
agree on written protocols, the Secretary is to evaluate 
whether the studies conducted fairly respond to the request, 
have been conducted according to commonly accepted scientific 
principles and protocols, and have been adequately reported.
    Subsection (e) deals with the circumstances in which a 
study report has been submitted before the expiration of a 
patent (or other form of exclusivity), but has not been 
accepted or rejected by the Secretary at the time of such 
expiration. In that case, the Secretary is to delay the 
approval of another drug until the Secretary determines whether 
the study is accepted, although this delay may not exceed 90 
days. If the study is subsequently accepted and exclusivity 
granted, the period of additional exclusivity will be 
considered to have begun on the date of the expiration of the 
previous exclusivity. The Committee has made this provision for 
exceptional circumstances.
    Subsection (f) requires the Secretary to publish a notice 
of acceptance of studies under subsection (d).
    Subsection (g) defines the term ``pediatric studies'' to 
mean ``at least one clinical investigation'' in appropriate age 
groups. This definition has been chosen to ensure that the 
studies requested will be those requiring some substantial 
work, and not merely a review of existing data.
    Subsection (h) limits the availability of exclusivity to 
one award per product except in the case of a drug supplemental 
application for a new use. In that case, the Secretary may 
award yet another six months of exclusivity to be added to any 
exclusivity for the use of the drug that is available under 
Waxman-Hatch authorities. Such additional exclusivity is not 
awarded in any other case.
    Subsection (i) provides that if, under regulations 
promulgated under other authorities of law, the Secretary 
requires pediatric studies, those studies are to be deemed to 
satisfy the requirements of section 3 and to be the basis for 
the award of exclusivity.
    Subsection (j) terminates the authority of section 3 on 
January 1, 2002. Moreover, the subsection requires that a study 
be conducted on the program and be submitted by January 1, 
2001. That study is to include all aspects of the program, as 
well as the impact of the program on the price and availability 
of drugs. The Committee expects the Secretary to include in 
this report a specific assessment of the impact of this program 
on the availability of generic drugs.

Sec. 4. Expediting study and approval of fast track drugs

    This section creates a new mechanism for facilitating the 
development and expediting the approval of drugs and biological 
products that demonstrate the potential to address unmet 
medical needs for serious and life-threatening conditions. This 
new mechanism, known as the fast track program, builds upon 
existing FDA programs for orphan drugs and accelerated approval 
products.
    All drugs and biological products, including fast track 
products, must be shown to be safe and effective prior to 
receiving marketing approval. Ordinarily, a drug must have an 
effect on a clinical endpoint, such as morbidity or mortality, 
or on a validated surrogate endpoint, such as blood pressure or 
cholesterol levels, to demonstrate effectiveness. A fast track 
product that meets this standard would ordinarily receive a 
regular approval and would not be subject to the requirements 
or limitations (i.e., post-approval study requirement, pre-
approval of promotional materials, and expedited withdrawal of 
approval) included in new FFDCA subsection 741(b).
    New FFDCA subsection 741(b) provides an alternative basis 
for approving fast track products that essentially codifies 
FDA's accelerated approval regulation. Under this regulation, a 
product may be approved if it has an effect on a surrogate 
endpoint that is reasonably likely to predict clinical benefit. 
Such surrogate endpoints are considered not to be validated 
because,while suggestive of clinical benefit, their 
relationship to clinical outcomes, such as morbidity or mortality, is 
not proven. For example, if a drug can be shown to reduce the amount of 
human immunodeficiency virus (HIV) detectable in the blood of an 
acquired immunodeficiency syndrome (AIDS) patient, it can be approved 
on the basis of its effect on this surrogate endpoint, even though the 
drug's ultimate effect on health and survival requires more study to 
determine.
    Accelerated approval based on surrogate endpoints, 
therefore, results in much quicker patient access to important 
new drugs, often reducing the pre-approval clinical trial 
process by several years. The FDA has approved 22 products, 
mostly for AIDS and cancer, under the accelerated approval 
regulation since it was adopted in 1992. This legislation makes 
it clear that surrogate endpoints that are reasonably likely to 
predict clinical benefit may serve as the basis for approval of 
drugs for any serious or life-threatening condition.
    The Committee is aware that there are occasions when the 
evidence of a drug's effect on a clinical endpoint strongly 
suggests effectiveness, but is not sufficiently conclusive with 
respect to the ultimate outcome to warrant ordinary approval. 
The legislation authorizes the Secretary to approve such 
products under subsection 741(b), so that ultimate clinical 
benefit can be verified on the same post-approval basis as for 
accelerated approval products. This would allow the Secretary 
to facilitate patient access to promising drugs while retaining 
the right to require confirmation of the clinical benefit 
through an appropriate post-approval study, preapprove any 
promotional materials, and expeditiously withdraw approval if 
the post-approval study fails to confirm clinical benefit.
    The Committee intends that the Secretary, in using the 
authority of this new subsection, apply the definition of 
``serious and life-threatening condition'' that was published 
in the preamble to the final rule on the accelerated approval 
of new drugs and biologics for serious and life threatening 
diseases (57 Federal Register 58942 (December 11, 1992)). The 
definition is as follows:

          The seriousness of a disease is a matter of 
        judgement, but generally is based on its impact on such 
        factors as survival, day-to-day functioning, or the 
        likelihood that the disease, if left untreated, will 
        progress from a less severe condition to a more serious 
        one. Thus, acquired immunodeficiency syndrome (AIDS), 
        all other stages of human immunodeficiency virus (HIV) 
        infection, Alzheimer's dementia, angina pectoris, heart 
        failure, cancer, and many other diseases are clearly 
        serious in their full manifestations. Further, many 
        chronic illnesses that are generally well-managed by 
        available therapy can have serious outcomes. For 
        example, inflammatory bowel disease, asthma, rheumatoid 
        arthritis, diabetes mellitus, systematic lupus 
        erythematosus, depression, psychoses, and many other 
        diseases can be serious for certain populations in some 
        or all of their phases (57 Federal Register 13235).

    Drug sponsors may request that the Secretary designate 
drugs for fast track consideration, and the designation may be 
made concurrently with, or at any time after, the submission of 
the investigational application. Within 30 days of the request, 
the Secretary will determine if the drug meets the fast track 
criteria, and, if so, will designate the drug as a fast track 
product and take action to expedite its development and review.
    Currently, under FDA's accelerated approval regulation, 
sponsors are required to conduct post-approval studies and to 
submit copies of promotional materials prior to dissemination. 
Subsection 741(b) provides the Secretary with the authority to 
impose such requirements but does not require this. However, 
the Committee expects that post-approval studies will routinely 
be required. With respect to prior approval of promotional 
materials, the Committee believes that the requirement should 
be imposed when appropriate and for a period of time necessary 
for the sponsor to demonstrate that it understands and will 
comply with the FDA's promotional material requirements. 
Preapproval of promotional materials may terminate, even if 
post-approval studies have not been completed, as soon as the 
Secretary determines that the sponsor is compliant with the 
agency's requirements.
    The approval of a fast track drug may be withdrawn using 
expedited procedures, including an informal hearing, if the 
sponsor fails to exercise diligence in conducting the post-
approval studies; a post-approval study fails to verify a 
clinical benefit; other evidence demonstrates that the drug is 
not safe or effective for its intended use; or the manufacturer 
disseminates false or misleading promotional materials.
    This provision also provides for the Secretary to initiate 
review of an application before the application is complete. If 
early evaluation of clinical data for a fast track drug shows 
evidence of effectiveness, the Secretary will evaluate for 
filing and may commence review of portions of an application, 
if the sponsor provides a schedule for submitting the 
information necessary for a complete application and pays any 
required user fee. In situations where the fast track drug's 
application is incomplete, the time periods for review of human 
drug applications agreed to in the letters referred to in 
Section (2)(a)(4) will not apply until a completed application 
is submitted.
    The Secretary must develop and widely distribute to 
physicians, patient organizations, and pharmaceutical and 
biotechnology companies a comprehensive description of the 
provisions applicable to fast track drugs, and establish an 
ongoing program to encourage the development of surrogate 
endpoints that are reasonably likely to predict clinical 
benefit. Within 1 year of enactment, the Secretary must issue 
guidance that describes FDA's policies and procedures required 
for implementing this provision.

Sec. 5. Expanded access to investigational therapies

    New FFDCA Section 551(a) provides that in emergency 
situations the Secretary may authorize the shipment of 
investigational drugs (as defined in regulations prescribed by 
the Secretary) for the diagnosis or treatment of a serious 
disease or condition.
    New FFDCA section 551(b) would permit any person, acting 
through a licensed physician, to request an investigational 
drug from a manufacturer or distributor, and permit a 
manufacturer or distributor to provide to such physician an 
investigational drug for the diagnosis or treatment of a 
serious disease or condition. Access is conditional on (1) a 
licensed physician determining that the person has no 
comparable or satisfactory alternative therapy and that the 
risk to the patient from the investigational product is not 
greater than that of the risk from the disease or condition; 
(2) the Secretary determining that there is sufficient evidence 
of the investigational drug's safety and effectiveness; (3) the 
Secretary determining that provision of the investigational 
drug will not interfere with the initiation, conduct, or 
completion of clinical investigation to support marketing 
approval; and (4) the sponsor or clinical investigator 
submitting to the Secretary a clinical protocol consistent with 
regulations promulgated describing the use of investigational 
drugs in a single patient or a small group of patients.
    New FFDCA section 551(c) authorizes the Secretary, upon 
submission by a sponsor or a physician of a protocol intended 
to provide widespread access to an investigational drug, to 
permit the drug to be made available for expanded access if it 
is determined that under the treatment investigational new drug 
application, the investigational drug is intended for use in 
the diagnosis or treatment of a serious or immediately life-
threatening disease or condition, and there is no comparable 
alternative therapy available to diagnose or treat that stage 
of disease or condition in the intended patient population.
    The Secretary must also determine that the investigational 
drug is under investigation in a controlled clinical trial or 
that all clinical trials necessary for approval of the use of 
the drug have been completed; the sponsor of the clinical trial 
is actively pursuing marketing approval; the availability of 
the investigational drug would not interfere with the 
enrollment of patients in ongoing clinical investigations; in 
the case of a serious disease, there is sufficient safety and 
effectiveness evidence to support the drug's use; and, in the 
case of immediately life-threatening diseases, whether there is 
scientific evidence available to provide a reasonable basis to 
conclude that the product may be effective for its intended use 
and would not expose patients to significant risk or injury. 
The protocol is also subject to the provisions of Section 
505(i) and implementing regulations. The Secretary is 
authorized to inform National, State, and local medical 
associations and societies and voluntary health organizations 
about the availability of the investigational drug under the 
expanded protocol.
    Under new FFDCA section 551(d), the Secretary may, at any 
time, terminate expanded access for investigational drugs if 
the requirements of this section are no longer met.

Sec. 6. Information program on clinical trials for serious or life-
        threatening diseases

    This section amends the Public Health Service Act (PHSA) by 
adding a new section 402(j) that directs the Secretary, acting 
through the Director of the National Institutes of Health 
(NIH), to establish, maintain, and operate a program providing 
information on research relating to the treatment, detection, 
and prevention of serious and life-threatening diseases and 
conditions. The program is to be coordinated with other data 
banks containing similarinformation. After consultation with 
the Commissioner of the Food and Drug Administration, the directors of 
the appropriate components of the National Institutes of Health 
(including the National Library of Medicine), and the Director of the 
Centers for Disease Control and Prevention (CDC), the Secretary is 
required to establish a data bank of information on clinical trials for 
drugs for serious or life-threatening diseases and conditions. The 
Secretary must disseminate this data bank information through 
information systems, including toll-free telephone communications, made 
available to individuals with serious or life-threatening diseases, 
members of the public, health care providers, and researchers.
    The data bank must include a registry of clinical trials 
that describes the purpose of the experimental drug, either 
with the consent of the protocol sponsor or when a trial to 
test effectiveness begins. The information provided must 
include eligibility criteria, location of the trial sites, and 
points of contact for those wanting to enroll. The information 
must be provided in a form that is readily understood by the 
general public, and it must be forwarded to the data bank by 
the sponsor of the trials not later than 21 days after the 
trials for clinical effectiveness begin.
    The data bank must also include information pertaining to 
experimental treatments for life-threatening diseases that may 
be available under a treatment investigational new drug 
application or as a Group C cancer drug. The data bank may also 
include information pertaining to results of clinical trials of 
such treatments, with the consent of the sponsor, including 
information concerning potential toxicities or adverse effects. 
The data bank may not include information relating to an 
investigation if the sponsor has provided a detailed 
certification to the Secretary that the disclosure of the 
information would interfere with the enrollment of subjects, 
unless the Secretary, after receiving such a certification, 
provides the sponsor with a written determination that the 
disclosure would not interfere with the enrollment.
    To carry out the provisions of this section there are 
authorized to be appropriated such sums as may be necessary. 
However, fees collected under the drug user fee section of the 
FFDCA may not be used to carry out this subsection. Further, 
the Secretary, the Director of NIH, and the Commissioner of the 
FDA must collaborate to determine the feasibility of including 
device investigations within the scope of the registry 
requirements. In addition, no later than 2 years after 
enactment, the Secretary must prepare and submit to Congress a 
report of the need for inclusion of device investigations; the 
adverse impact (if any) on device innovation in the U.S. if 
information relating to such device investigations is required 
to be disclosed publicly; and such other issues as the 
Secretary may deem appropriate.

Sec. 7. Dissemination of information on new uses

    Section 7 amends Chapter VII of the FFDCA (21 U.S.C. 371 et 
seq.) by adding a new subchapter E, which lays out the 
requirements for the dissemination of treatment information on 
off-label uses of drugs. New FFDCA section 745(a) provides that 
a drug manufacturer may disseminate to health care 
practitioners, pharmacy benefit managers, health insurance 
issuers, group health plans, or Federal or State governmental 
agencies, written information concerning the safety, 
effectiveness, or benefit of a use not described in a product's 
FDA approved labeling, if the manufacturer meets the 
requirements of 745(b), which are:
          (1) a new drug application filed under section 
        505(b), or a biologics license issued under section 351 
        of the PHSA is in effect;
          (2) the information meets the requirements of section 
        746;
          (3) the disseminated information is not derived from 
        clinical research conducted by another manufacturer or, 
        if it was derived from such research, the manufacturer 
        disseminating the information has the permission of the 
        other manufacturer to make the dissemination;
          (4) 60 days before dissemination, the manufacturer 
        has submitted to the Secretary a copy of the 
        information to be disseminated, any clinical trial 
        information relating to the safety and effectiveness of 
        the unapproved use, any reports of clinical experience 
        pertinent to the safety of the unapproved use, and a 
        summary of such use;
          (5) the manufacturer has complied with section 748 
        relating to the certification that the manufacturer 
        will file a supplemental application with respect to 
        the unapproved use; and
          (6) the manufacturer agrees to include, along with 
        the disseminated information, a prominently displayed 
        statement that the information concerns a use of a drug 
        that has not been approved by the FDA; if applicable, 
        that the information being disseminated is being paid 
        for by the manufacturer; if applicable, the names of 
        authors of the information who have received financial 
        compensation from the manufacturer; the drug's official 
        label (with updates); if applicable, a statement that 
        there are other products or treatments that have been 
        approved for the use for which the information is being 
        disseminated; and identification of any person that has 
        provided funding for a study relating to the unapproved 
        new use. The manufacturer also must provide a 
        bibliography of other articles from scientific or 
        medical journals that have been published previously 
        about the unapproved use.
    Section 745(c) provides that if the Secretary determines, 
after providing a notice and an opportunity for a meeting, that 
the off-label use information being disseminated fails to 
provide data, analyses, or other written matter that is 
objective and balanced, the Secretary may require the 
manufacturer to disseminate additional objective and 
scientifically sound information that pertains to the safety or 
effectiveness of the unapproved use and is necessary to provide 
objectivity and balance. Further, the Secretary may require the 
manufacturer to disseminate an objective statement of the 
Secretary, based on data or scientifically sound information, 
that bears on the safety and effectiveness of the drug's 
unapproved use.
    The principal policy considerations that underlie this 
provision are the facilitation of greater access to timely and 
accurate information by health care providers. Coupled with 
this goal is a recognition that the FDA has a responsibility to 
protect the public health. Thus, these provisions preserve the 
discretionary authority of the Secretary to offer objective 
statements on the proposed dissemination and to require the 
manufacturer to disseminate additional information to achieve 
objectivity and balance.
    The Committee emphasizes that it has been the long held 
view of Congress that the FDA should not regulate the practice 
of medicine. In general, the FDA has no authority to regulate 
how physicians prescribe approved drugs in the context of their 
medical practice. Physicians prescribing off-label uses of 
approved drugs is not within the jurisdiction of the FDA. 
However, in the case where a physician is receiving information 
from a drug sponsor (whose activities are within the 
jurisdiction of the FDA), the FDA has a role to play with 
respect to assuring balance and objectivity and to protecting 
the public health. Nevertheless, health care providers retain 
the responsibility of making decisions about treatment of 
individual patients, and the FDA's role with respect to such 
individual treatment decisions based on information derived 
from peer-reviewed articles and textbooks, is advisory. In that 
advisory capacity, the FDA will take steps to make sure that 
the amount of information given to the provider is useful, 
useable, sufficient, and otherwise in compliance with this 
section. This does not mean that the FDA must comment on every 
proposed dissemination. Rather, the Committee expects that the 
authority of the Secretary to include an objective statement 
likely will be used in limited circumstances in which balance 
cannot be fully met by appending other journal articles, or 
data or analyses. The intent is that such a statement by the 
Secretary be limited to objective and scientific information. 
The Committee does not intend this to be an opportunity for the 
Secretary to editorialize based on independently derived 
scientific information. Any statement of the Secretary should 
provide significant scientific information to health care 
providers.
    Section 746(a) provides that a manufacturer may disseminate 
information about an unapproved new use if the information is 
in the form of an unabridged reprint or copy of an article 
peer-reviewed by experts or in a reference publication, is not 
false or misleading, and would not pose a significant risk to 
the public health. The information must have been published in 
a scientific or medical journal and be about a clinical 
investigation which would be considered by the experts to be 
scientifically sound. The information can also be from an 
unabridged reference publication that includes information 
about a scientifically sound clinical investigation. A 
reference publication is a publication that:
          (1) has not been written, edited, or published 
        specifically for a manufacturer;
          (2) has not been edited or significantly influenced 
        by a manufacturer;
          (3) is not solely distributed through a manufacturer, 
        but is generally available in bookstores or 
        distribution channels where medical texts are sold;
          (4) does not focus on any particular drug of a 
        manufacturer and does not have primary focus on 
        unapproved uses of drugs that are marketed or under 
        investigation by a manufacturer supporting the 
        dissemination; and
          (5) presents materials that are not false or 
        misleading.
    Section 747 establishes that a manufacturer may disseminate 
information under section 745 only if the manufacturer prepares 
and submits to the Secretary biannually a list containing the 
titles of the articles and reference publications relating to 
the unapproved use of drugs that were disseminated by the 
manufacturer for the 6-month period preceding the date on which 
the manufacturer submits the list to the Secretary. 
Additionally, the manufacturer must submit a list that 
identifies the categories of providers that received the 
articles and reference publications for the same 6-month 
period. A manufacturer that disseminates information under 
section 745 must keep records that may be used should the 
manufacturer be required to take corrective action. These 
records must be made available to the Secretary upon request, 
and at the Secretary's discretion, the records may identify the 
recipient of the information.
    Section 748 establishes that a manufacturer may disseminate 
information under section 745 only if the manufacturer submits 
an application to the Secretary, containing a certification 
that a supplemental application will be filed for the 
unapproved use or the manufacturer is granted an exemption from 
this requirement. The application may contain a certification 
that the studies needed for the submission of a supplemental 
application for the unapproved use have been completed and that 
the supplement will be filed with the Secretary no later than 6 
months after the date of the initial dissemination.
    Alternatively, if the studies have not been completed but 
are planned, a manufacturer may disseminate information on an 
unapproved use if the manufacturer has submitted to the 
Secretary an application containing: a proposed protocol and 
schedule for conducting the studies needed for the supplemental 
application; and a certification that the supplemental 
application will be submitted to the Secretary no later than 3 
years after the date of the initial dissemination of 
information (or, as applicable, not later than a date the 
Secretary may specify pursuant to an extension). The Secretary 
must determine that the proposed protocol is adequate and that 
the completion schedule is reasonable. A longer time for 
submitting a supplemental application may be granted if the 
Secretary determines that the studies needed cannot be 
completed and submitted within 3 years. Manufacturers must 
submit periodic reports describing the status of their studies. 
The proposal authorizes an extension of the 3-year period for 
the completion of studies if the Secretary determines that the 
manufacturer has shown due diligence in conducting the studies. 
Such extensions may not be longer than 2 years.
    The proposal also provides for exemptions from the 
requirement for supplemental applications if the Secretary 
determines that conducting the studies necessary for the 
supplemental application would be economically prohibitive, or 
unethical.
    The Committee recognizes that there may be cases where the 
size of a patient population may be cause for the Secretary to 
determine that a supplemental application should not be filed. 
However, this is intended to be the exception, rather than the 
rule, in the case of populations suffering from orphan or rare 
disorders. For many years, this Committee has sought to 
encourage research into orphan diseases and the approval of 
innovative drugs for their treatment. The Secretary should 
examine very carefully whether an exemption from filing a 
supplemental application might hinder such research and 
recognize the vital importance of encouraging application for 
new drugs and new drug uses intended to treat rare disorders.
    Manufacturers may disseminate information if they have 
filed an application for an exemption and the Secretary has 
approved the application, or the application is deemed to have 
been approved.
    If the Secretary does not act on an application for an 
exemption within 60 days, the application will be deemed 
approved. Under a situation where the application is deemed 
approved and the manufacturer disseminates information on an 
unapproved use, the Secretary may at any time terminate 
approval and order the manufacturer to cease disseminating the 
information. A transition rule provides that for supplemental 
applications pending on the date of enactment, the application 
is deemed to be a supplemental application submitted under this 
provision.
    Section 749 provides for circumstances where corrective 
action is necessary when the Secretary determines that the 
unapproved use may not be effective or may present a 
significant risk to the public health. The proposal specifies 
when manufacturers, after disseminating information, are 
responsible for reporting additional knowledge of clinical 
research related to the safety and effectiveness of the 
unapproved use. The Secretary may order a manufacturer to cease 
the dissemination of information if the Secretary determines 
that the information does not comply with the provisions of 
this subchapter. In addition, the Secretary may order a 
manufacturer to cease the dissemination of information if the 
Secretary determines that a supplemental application does not 
contain adequate information for approval of the unapproved 
use. In certain situations where the Secretary orders a 
manufacturer to cease disseminating information, the Secretary 
may order the manufacturer to take action to correct the 
information disseminated. In the case of an order to cease 
dissemination which was based on the termination of a deemed 
approval of an application for an exemption from the 
requirement to file a supplemental application, the Secretary 
may not order the manufacturer to take corrective action unless 
the unapproved use would pose a significant risk to public 
health.
    New section 751(a) provides that nothing in section 745 
shall be construed as prohibiting a manufacturer from 
disseminating information in response to an unsolicited request 
from a health care practitioner. The Committee wants to 
emphasize that current FDA policies that encourage scientific 
exchange are not being modified by section 745. At the same 
time, insofar as the Secretary may currently have authority 
under other sections of the FFDCA to restrict a manufacturer's 
dissemination of information in response to an unsolicited 
request from a health care practitioner, nothing in section 745 
is intended to change or limit that authority.
    New FFDCA section 751(e) provides that the amendments by 
this section shall cease to be effective September 30, 2006, or 
7 years after the date on which the Secretary promulgates the 
regulations to implement the provisions, whichever is later.

Sec. 8. Studies and reports

    This section directs the General Accounting Office (GAO) to 
study the impact of the amendments made by section 7 on the 
resources of the Department of Health and Human Services (HHS), 
and of the scientific issues raised by the amendments of 
section 7. Issues to be addressed include the effectiveness of 
the amendments in getting useful information to health care 
practitioners; the quality of the information being 
disseminated; the quality and usefulness of the information 
provided; and the impact the amendments have had on research on 
new uses of drugs, indications for new uses, dosages for new 
uses, and the impact on pediatric indications and rare 
diseases. The GAO report will be submitted no later than 
January 1, 2002, to the House Committee on Commerce and the 
Senate Committee on Labor and Human Resources.

Sec. 9. Approval of supplemental applications for approved products

    Once a new drug or biological product is approved for 
marketing by the FDA, the medical profession immediately begins 
to determine its proper place in the pharmaceutical 
armamentarium through clinical use and investigation. New uses 
of approved products often become known and widely followed. 
Although the use of an approved product for an unapproved use 
does not violate the law, it is important to encourage the 
addition of new uses to the FDA-approved product labeling in 
order to keep that labeling current with medical practice.
    New uses of approved products can be added to the product 
label if the sponsor submits a supplemental new drug 
application (NDA) to the FDA, and the FDA approves that 
application. In many instances, however, there is no incentive 
for the submission of a supplemental application, and in fact 
there may be disincentives. The cost of clinical studies to 
support a supplemental NDA can be substantial. When the patent 
and market exclusivity periods are short or expired, no one 
company is prepared to make the investment necessary to obtain 
FDA approval of a supplemental NDA. Market exclusivity for a 
new use provides little protection where generic products 
already exist. Administrative requirements and regulatory 
delays at the FDA have also contributed to this problem. As a 
result, a significant number of drugs in the United States are 
prescribed in a manner which differs in some respect from the 
labeling approved by the FDA. Studies have shown that most 
cancer drugs and AIDS drugs are used in this manner.
    Recognizing that current policy has resulted in the 
labeling for most prescription drugs to become obsolete, the 
FDA has begun to address this matter. Recent draft guidance 
from the agency has identified ways to approve a supplemental 
NDA on the basis of evidence different from the adequate and 
well controlled clinical trial usually required to support 
initial approval of an NDA. The Committee agrees that a 
supplemental NDA, in appropriate circumstances, may be approved 
on the basis of literature reports without duplication of 
previously submitted data. This legislation requires the FDA to 
issue final guidance that will clarify the circumstances under 
which such evidence will be sufficient for approval of a 
supplemental application in order to encourage the regulated 
industry to submit supplemental applications whenever feasible.
    This provision directs the FDA to determine new policy in 
order to reduce the disincentives to the submissions of these 
applications, by reducing the cost and increasing the 
efficiency of handling these matters within the agency. By 
reducing the overall burden of submitting supplemental 
applications and obtaining their approval, the legislation will 
increase the incentive for industry to increase the appropriate 
use of important prescription drugs and reduce the risks of 
unsafe or inappropriate use.
    The legislation will accomplish these important purposes in 
three ways. First, the FDA is required to issue final guidance 
that will reduce the administrative and regulatory requirements 
for supplemental applications. Second, the FDA must designate 
an individual, and establish a procedure, that will facilitate 
the development and submission of supplemental NDAs and 
encourage their prompt review. Third, the FDA must establish 
programs and policies in collaboration with NIH and 
professional medical and scientific societies to identify 
existing data, foster further research, and encourage sponsors 
to submit supplemental applications. Thus, the legislation 
establishes a comprehensive approach that will reduce the gap 
between the approved labeling and the actual use of 
prescription drugs.
    Specifically, Section 9(a) requires that, within 180 days 
of enactment, the Secretary must publish in the Federal 
Register performance standards for the prompt review of 
supplemental applications for previously approved drugs. 
Section 9(b) provides that within this same time frame, the 
Secretary also must issue final guidance to industry to clarify 
requirements and facilitate the submission of data to support 
the approval of supplemental applications. The guidance must: 
(1) clarify the circumstances that will permit published 
material to qualify as the basis for approval; (2) specify data 
requirements that will avoid duplication by recognizing the 
availability of data previously submitted; and (3) define 
supplemental applications that are eligible for priority 
review.
    Section 9(c) requires the Secretary to designate someone in 
each FDA Center (except the Center for Food Safety and Applied 
Nutrition) who will be responsible for encouraging prompt 
review of supplemental applications, and who will work with 
sponsors to facilitate the development and submission of data 
to support supplemental applications. Section 9(d) requires 
that in addition, the Secretary must implement programs and 
policies that will foster collaboration among the FDA, the NIH, 
professional medical and scientific societies, and others to 
identify published and unpublished studies that could support a 
supplemental application. Moreover, the Secretary must 
encourage sponsors to submit supplemental applications or 
conduct further research based on these studies.

Sec. 10. Health care economic information

    This section amends section 502(a) (21 U.S.C. 352(a)) of 
the FFDCA to specify that health care economic information will 
not be considered false and misleading if the information 
directly relates to an approved indication for such drug and is 
based on competent and reliable information. It establishes 
that a health care economic statement may be submitted to a 
formulary committee, managed care organization, or similar 
entity with drug selection responsibilities.
    The proposal defines ``health care economic statement as'' 
any analysis that identifies, measures, or compares the 
economic consequences, including the costs of the represented 
health outcomes, of the use of a drug to the use of another 
drug, to another health care intervention, or to no 
intervention.''
    The purpose of section 10 is to make it possible for drug 
companies to provide information about the economic 
consequences of the use of their products to parties that are 
charged with making medical product selection decisions for 
managed care or similar organizations. Such parties include 
formulary committees, drug information centers, and other 
multidisciplinary committees within health care organizations 
that review scientific studies and technology assessments and 
recommend drug acquisition and treatment guidelines. The 
provision is limited to analyses provided to such entities 
because such entities are constituted to consider this type of 
information through a deliberative process and are expected to 
have the appropriate range of expertise to interpret health 
care economic information presented to them to inform their 
decision-making process, and to distinguish facts from 
assumptions. This limitation is important because it will 
ensure that the information is presented only to parties who 
have established procedures and skills to interpret the methods 
and limitations of economic studies. The provision is not 
intended to permit manufacturers to provide such health care 
economic information to medical practitioners who are making 
individual patient prescribing decisions nor is it intended to 
permit the provision of such information in the context of 
medical education.
    Health care economic information is defined as an analysis 
that identifies, measures, or compares the economic 
consequences of the use of the drug to the use of another drug, 
another health care intervention, or no intervention. 
Incorporated into economic consequences are the costs of health 
outcomes. Data about health outcomes associated with the use of 
a drug, other treatments, or no treatment are therefore 
incorporated into the economic analysis. This provision limits 
such incorporation to health outcomes that are directly related 
to the approved use of the drug and are determined based on 
competent and reliable scientific evidence. The provision 
presumes that the current standard practice of including full 
disclosure of all assumptions and health outcomes used in the 
economic analysis will continue.
    The type of health care economic information that can be 
provided pursuant to this section is that which is directly 
related to an approved labeled indication. To illustrate this 
point, economic claims based on preventing disease progression 
would ordinarily not be considered to be directly related to an 
approved indication for the treatment of symptoms of a disease, 
for a drug for which the use in prevention of disease 
progression has not been approved. For example, rheumatoid 
arthritis drugs are approved for the treatment of symptoms and 
not for the prevention of deformity. Therefore, economic claims 
based in part on an assumption of prevention of deformity would 
not be considered directly related to the approved indications 
for these drugs.
    Similarly, economic claims based on prolonging patient 
survival would not be considered directly related and would 
not, therefore, be permitted under this subsection, for agents 
approved for the symptomatic treatment of heart failure, but 
not approved for prolonging survival in heart failure patients. 
This provision also is not intended to provide manufacturers a 
path for promoting off-label indications or claiming clinical 
advantages of one drug over another when such claims do not 
satisfy FDA's evidentiary standards for such claims.
    However, the provision would permit health care economic 
information that includes reasonable assumptions about health 
care economic consequences derived from, but not explicitly 
cited in, the approved indication that are supported by 
competent and reliable scientific evidence. The nature of the 
evidence needed will depend on how closely related the 
assumptions are to the approved indication and to the health 
significance of the assumptions. For example, modeling the 
resource savings of insulin therapy to achieve tight control of 
blood sugar in Type 1 diabetes could include cost savings 
associated with the prevention of retinopathy (an eye disease) 
and nephropathy (kidney disease), based on well-controlled 
study(ies) that demonstrate that control of blood sugar levels 
with insulin leads to a reduction of such consequences. Because 
prevention of retinopathy and nephropathy could not simply be 
assumed to be a result of blood sugar control, these prevention 
claims would have to be shown by well-controlled study(ies) 
before inclusion as health care outcome assumptions.
    In contrast, economic claims that model, based on 
observational studies in a population of women, the economic 
consequences of prevention of fractures due to osteoporosis 
would be permitted for drugs already approved for prevention of 
fractures due to osteoporosis. This is possible because 
observational data may be considered competent and reliable for 
making an assumption about the secondary consequences of an 
osteoporotic fracture once the primary prevention has been 
established. Similarly, the long-term economic consequences of 
the prevention of meningitis by haemophilus b influenza vaccine 
could be modeled using population-based data once the primary 
prevention claim is established.
    The standard of competent and reliable scientific evidence 
(49 Federal Register 30, 999, (August 2, 1984)) supporting 
health care economic information provided under this subsection 
takes into account the current scientific standards for 
assessing the various types of data and analyses that underlie 
such information. Thus, the nature of the evidence required to 
support various components of health care economic analyses 
depends on which component of theanalysis is involved. For 
example, the methods for establishing the economic costs and 
consequences used to construct the health care economic information 
would be assessed using standards widely accepted by economic experts. 
The methods used in establishing the clinical outcome assumptions used 
to construct the health care economic analysis would be evaluated using 
standards widely accepted by experts familiar with evaluating the 
merits of clinical assessments. In addition, the evidence needed could 
be affected by other pertinent factors. The competent and reliable 
standard is not intended to supplant the current FFDCA definition of 
``false and misleading.''
    Under the FDA's current postmarketing reporting 
regulations, health care economic information as defined in 
this section must be submitted to the FDA at the time it is 
initially provided to a formulary committee or other similar 
entity. In addition, pursuant to this provision, the FDA will 
have access, upon request, to any data or other information 
related to the substantiation of the health care economic 
information. Such information will be evaluated by the 
Secretary to determine if the health care economic information 
meets the requirements of this section. This includes, for 
example, health outcome data, health resource utilization data, 
and other information related to the economic consequences of 
the use of the drug. It would not include, for example, 
confidential corporate financial data, including confidential 
pricing data.

Sec. 11. Clinical investigations

    In 1962, Congress amended the new drug provisions of the 
law to require that the FDA approve the marketing of a new drug 
on the basis of substantial evidence of effectiveness. The 
statutory definition of substantial evidence requires adequate 
and well-controlled investigations, including clinical 
investigations, on the basis of which experts qualified by 
training and experience may fairly and responsibly conclude 
that the drug will have the effect it is represented to have 
under the conditions of use set forth in the labeling. On some 
occasions in the past, the FDA has stated that this always 
requires at least two well-controlled investigations. On other 
occasions, the FDA has stated that it requires only one well-
controlled investigation in appropriate circumstances. In 
practice, the agency has approved many new drugs on the basis 
of one well-controlled investigation, where other evidence was 
available to confirm the effectiveness of the drug.
    This legislation amends the law to codify current FDA 
practice. It authorizes the FDA, in its discretion, to approve 
an NDA on the basis of one adequate and well-controlled 
clinical investigation and confirmatory evidence obtained prior 
to or after that investigation, where the FDA concludes that 
such data and evidence are sufficient to constitute substantial 
evidence of effectiveness. The FDA will also retain its 
inherent administrative discretion to waive this requirement 
completely, as it has done in the past, where it would be 
unethical or unnecessary.
    The FDA has itself recognized in recent guidance that 
substantial evidence of effectiveness may consist of one 
adequate and well-controlled investigation and confirmatory 
evidence consisting of earlier clinical trials, pharmacokinetic 
data, or other appropriate scientific studies. The Committee 
agrees that the quality of the data and information available 
about a drug, rather than the number of studies performed, 
should determine the standard for FDA approval of a new drug. 
Authorizing the FDA to approve a drug on the basis of one well-
controlled investigation will reduce the number of patients 
required to undergo clinical trials and the possibility of 
receiving a placebo; reduce the cost of drug development, and 
thus, the ultimate cost of a new drug to the public; reduce the 
total time needed to obtain FDA approval of a new drug; 
increase the number of new drugs that can be investigated; and 
thus speed the development and availability of important new 
drugs to help improve the public health.
    The codification applies to all drugs, including those that 
are and are not for serious and life-threatening disease. Each 
disease is important to those who suffer from it, and every 
disease has a debilitating effect both on the patient and on 
the family and caretakers. This statutory standard will assure 
that the rights of all patients are recognized in the 
development of new drugs intended to alleviate their suffering. 
There is no scientific or public health basis for imposing 
different standards for approval of drugs for different 
categories of diseases.
    This section amends section 505(d) of the FFDCA by 
clarifying that if the Secretary determines, based on relevant 
science, that the data from one adequate and well-controlled 
clinical investigation and confirmatory evidence (obtained 
prior to or after such investigation) are sufficient to 
establish effectiveness, the Secretary may consider such data 
and evidence to constitute substantial evidence of 
effectiveness.
    The Committee considers confirmatory evidence to comprise 
scientifically sound data (as defined by the Secretary) from 
any investigation in the new drug application that provides 
substantiation as to the safety and effectiveness of the new 
drug.
    This section also amends section 505(b)(1) to require that 
the Secretary, in consultation with the Director of the 
National Institutes of Health, review and develop guidance as 
appropriate on the inclusion of women and minorities in 
clinical trials.

Sec. 12. Manufacturing changes for drugs

    Section 12 amends Chapter VII (21 U.S.C. 371) of the FFDCA, 
by establishing a new section 755 under new Subchapter F, 
``Manufacturing Changes.'' It describes the types of 
manufacturing changes the manufacturer of a new drug or 
biologic may make under section 505 or 512 of the FFDCA or 
section 351 of the PHSA. Section 755(b) requires that before 
distributing a new drug or biologic made after a manufacturing 
change (whether a major manufacturing change or otherwise), the 
holder involved must validate the effect of the change on the 
product's identity, strength, quality, purity, and potency as 
they relate to its safety, bioequivalence, bioavailability, or 
effectiveness.
    Under section 755(c)(1), a drug made with a major 
manufacturing change may be distributed only if, before 
distribution, the holder submits to the Secretary a 
supplemental application for the change and the Secretary 
approves the application. The application must contain such 
information as the Secretary determines is appropriate, and 
shall include the information developed under subsection (b). 
Drugs made after these changes may not be distributed until the 
Secretary approves the supplement.
    Section 755(c)(2) specifies the types of manufacturing 
changes that qualify as major changes. Such changes would be 
those determined to have substantial potential to adversely 
affect the identity, strength, quality, purity, or potency of 
the drug as they relate to the drug's safety, bioequivalence, 
bioavailability, or effectiveness (section 755(c)(2)(A)). Major 
manufacturing changes also are changes in the qualitative or 
quantitative formulation of the drug or in specifications in 
the approved application or license, changes the Secretary 
determines require an appropriate clinical study, and changes 
which the Secretary determines would have an adverse effect on 
the drug's safety or effectiveness (Sections 755(c)(2)(B)).
    Manufacturing changes other than major changes, as 
determined by the Secretary must be reported annually with 
supporting data, or in a supplemental application. Drugs for 
which a minor manufacturing change has been made may be 
distributed 30 days after the Secretary receives a supplemental 
application, unless the applicant is notified that prior 
approval of the supplement is required (section 755(d)). After 
notification to the applicant, the Secretary must approve or 
disapprove each supplement. Section 755(d) allows the Secretary 
to determine the types of manufacturing changes after which 
distribution of the drug may begin when the supplement is 
submitted. A period for transition from prior requirements is 
defined.

Sec. 13. Streamlining clinical research on drugs

    This section amends section 505(i) of the FFDCA to revise 
the clinical research process in several ways. It provides 
flexibility to reduce the amount of information required by the 
FDA from the drug sponsor before clinical research can begin. 
The section also establishes what information is needed for a 
clinical investigation submission to the FDA, and the terms and 
conditions under which the agency may request additional 
information to protect the health or safety of research 
subjects. New section 505(i)(2) establishes that a clinical 
investigation may begin 30 days after the FDA receives a 
submission containing information about the drug and the 
clinical investigation which includes:
          (A) information about the design of the investigation 
        and adequate reports of basic information, certified by 
        the applicant to be accurate, necessary to assess the 
        drug's safety in a clinical trial; and
          (B) adequate information on the chemistry and 
        manufacturing of the drug, controls available for the 
        drug, and primary data tabulations from animal or human 
        studies.
    New section 505(i)(3) establishes that the Secretary may 
halt the conduct of a clinical research trial at any time by 
issuing a clinical hold, confirmed in writing, prohibiting the 
sponsor from conducting the investigation. The clinical hold 
may be issued based on a determination by the FDA that the drug 
represents an unreasonable risk to the safety of the persons 
who arein the clinical study, taking into account the 
qualifications of the clinical investigators, information about the 
drug, the design of the clinical investigation, the condition for which 
the drug is to be investigated, and the health status of the subjects 
involved. Clinical holds also could be issued for such other reasons as 
the Secretary may establish by regulation, including reasons included 
in regulations that already have been promulgated. The FDA would be 
required to decide in 30 days on a request from the sponsor for the 
removal of a clinical hold, specifying in writing the reasons for 
continuing the hold.

Sec. 14. Data requirements for drugs

    Before a new drug may lawfully be marketed, the sponsor 
must submit a NDA to the FDA, the FDA must review the NDA to 
verify that it demonstrates the safety and effectiveness of the 
drug, and the FDA must then approve the NDA. Under current FDA 
regulations and policy, a NDA consists of hundreds of volumes 
of detailed materials that are painstakingly reviewed by the 
FDA staff. Individual FDA reviewers have substantial discretion 
to impose on sponsors either more detailed or less detailed 
submissions. Some reviewers require that every report of a 
clinical or preclinical study be submitted with individual case 
report forms or other detailed back-up data. Other reviewers 
impose these requirements only for pivotal studies and permit 
data from confirmatory studies to be submitted in abbreviated 
or summary form.
    The FDA and the regulated industry agree that much of the 
data that is submitted with a NDA can be presented in a more 
streamlined and efficient format. The elimination of extra or 
unnecessary data will result in a consistent and uniform 
approach throughout the agency, reduce the cost of NDAs, speed 
up the submission of these applications, reduce wasted time in 
FDA review of applications, and, thus, result in more efficient 
and effective development and review of product applications.
    The Committee intends that studies that are pivotal in 
supporting label claims must be provided to the FDA in 
sufficient detail for agency reviewers to properly evaluate the 
study. Other information should be submitted in abbreviated or 
summary form. Under the legislation, the FDA is required to 
establish guidance for the industry in determining the kinds of 
studies for which abbreviated or summary reports are 
appropriate and the format that those summary reports should 
follow. This will adopt the best practices currently used 
within the agency and provide consistent and efficient policy 
for industry to follow in the future.
    Section 14 requires the Secretary, acting through the 
Commissioner of the FDA, within 1 year of enactment, to issue 
guidance that describes when manufacturers will be permitted to 
submit certain abbreviated study reports instead of traditional 
full reports with their new drug applications (NDAs). The 
guidance must describe when abbreviated reports are appropriate 
and what their format should be.

Sec. 15. Content and review of applications

    This section amends section 505(b) (21 U.S.C. 355(b)) of 
the FFDCA to require the Secretary to issue guidance, for the 
review of applications, relating to promptness, technical 
excellence, lack of bias and conflict of interest, and 
knowledge of regulatory and scientific standards which must 
apply to all individuals who review applications. The Committee 
intends that this guidance should apply to all applications for 
investigational new drug exemptions, new drug approvals, and 
biologics licenses.
    New section 505(b)(4)(B) requires that the Secretary meet 
with sponsor of an investigation or an applicant for approval 
if the sponsor or applicant makes a reasonable request for a 
meeting for the purpose of reaching agreement on the design and 
size of clinical trials. Minutes of such meeting shall be 
prepared by the Secretary and made available to the sponsor or 
applicant upon request. Section 505(b)(4)(C) requires that any 
agreement between the Secretary and the sponsor or applicant 
regarding the parameters of the design and size of clinical 
trails of a new drug shall be made part of the written 
administrative record by the Secretary. This agreement cannot 
be changed after the testing begins, except with the written 
agreement of the sponsor or applicant; or pursuant to a 
decision made by the director of the division in which the drug 
is reviewed, that a substantial scientific issue essential to 
determining the safety or effectiveness of the drug has been 
identified after the testing has begun. In the case when a 
substantial scientific issue has been identified the 
directors's decision shall be in writing, and the Secretary 
shall provide to the sponsor or applicant an opportunity for a 
meeting at which the director documents the scientific issue 
involved.
    New section 505(b)(4)(E) provides that written decision of 
the reviewing division shall be binding upon the field and 
compliance division personnel unless such personnel demonstrate 
to the reviewing division why such decision should be modified. 
Section 505(b)(4)(F) prohibits a delay in an action by a 
reviewing division, based on lack of availability of 
information from field personnel, unless the reviewing division 
determines that a delay is needed to assure safety and 
effectiveness of a product.
    New section 505(j)(3) requires that the Secretary meet with 
an applicant for approval of a generic drug if the applicant 
makes a reasonable request for a meeting to reach agreement on 
the design and size of studies needed for approval of an 
abbreviated new drug application (ANDA). Any agreements 
regarding the parameters of design and size of bioavailability 
and bioequivalence trials of a drug shall be made part of the 
written administrative record. Such agreement shall not be 
changed after the testing begins, except with the written 
agreement of the sponsor or applicant; or pursuant to a 
decision made by the director of the division, that a 
substantial scientific issue essential to the determination of 
the safety or effectiveness of the drug has been identified. 
Such a decision shall be in writing and the Secretary shall 
provide to the sponsor or applicant the opportunity for a 
meeting where the director shall document the scientific issue.
    The written decision of the reviewing division shall be 
binding upon the field or compliance office personnel unless 
such field or compliance personnel demonstrate to the reviewing 
division why such decision should be modified. Further, no 
action by the reviewing division may be delayed by lack of 
availability of the information from the field personnel, 
unless the reviewing division determines that a delay is 
necessary to assure the marketing of a safe and effective drug.
    This section is intended by the Committee to provide for a 
predictable and dependable structure through which the FDA and 
sponsors of applications for marketing of new products can 
communicate effectively regarding requirements that must be met 
to secure marketing clearance or approval. The Committee 
believes that meetings between the appropriate FDA experts and 
their industry counterparts may provide the avenue to 
successful communication that may result in agreements that can 
expedite a manufacturer's understanding of what information, 
data, or investigations may be needed for any particular 
product. The legislation requires that such meetings be held 
upon the reasonable request of a sponsor or applicant, within a 
specified time frame after such request. By ``reasonable 
request,'' the Committee means that the person requesting the 
meeting must be adequately prepared so that the meeting can be 
productive. Specifically, the person requesting the meeting 
must provide to the FDA a detailed description of the person's 
proposal (whether for clinical protocols for other studies), 
and any other available information about the product that will 
assist FDA experts in providing useful advice and guidance.
    The provisions of this section also make clear that the 
FDA, when it has been provided with sufficient information by 
the sponsor or applicant, must respond to meeting requests 
promptly and be prepared to participate in such meetings with a 
view toward reaching the desired conclusion--an agreement 
between that agency and the sponsor or applicant about the 
data, information, or studies needed before marketing approval 
or clearance can be achieved. The Committee intends that when 
FDA officials, including reviewers, provide advice during such 
meetings, and such advice results in an agreement between the 
FDA and the sponsor or applicant, the agreement should be 
communicated in writing by the FDA to the sponsor or applicant, 
and should be made part of the agency's administrative record 
related to the particular application or product.
    Although the Committee believes that such agreements should 
be binding on both parties, the Committee also recognizes that 
changes in medical or scientific information which have a 
direct impact on issues that may have been part of the 
agreement may occur after the agreement has been reached. In 
addition, the Committee recognizes that, despite everyone's 
best efforts to provide all available information at the time 
of the meeting, there may have been information not known to 
the FDA (or to the sponsor or applicant) which has direct 
bearing on a decision or agreement made at the meeting. This is 
why the legislation allows for changes in any such agreements, 
based on the fact that a substantial scientific issue has come 
to light after an agreement has been reached, which has a 
direct bearing on the safety or effectiveness of the product. 
In general, changes also can be made if there is agreement 
between the agency and the sponsor or applicant.

Sec. 16. Scientific advisory panels

    This section amends section 505 for the purpose of 
enhancing the way expert scientific advice and recommendations 
may be provided to the Secretary regarding clinical 
investigation of a drug or the approval for marketing of a drug 
under section 505 of the FFDCA or section 351 of the PHSA.
    The Committee has laid out some important requirements 
regarding advisory committee membership, expertise, and 
operations. The intent of these provisions is not merely to 
create additional administrative requirements for either the 
FDA or its scientific advisors, but to make the advisory 
committee system more responsive to the needs of the FDA, 
sponsors and manufacturers, and patients.
    The bill also provides that a scientific advisory panel 
under this section shall not be subject to the annual 
chartering and annual report requirements of the Federal 
Advisory Committee Act.

Sec. 17. Dispute resolution

    Neither the current law nor existing regulations provides 
an adequate basis for resolving scientific and medical disputes 
that arise in the course of FDA implementation of the law. Such 
disputes are inevitable, considering the breadth of the FDA 
jurisdiction and the depth of FDA authority to regulate 
products subject to its jurisdiction. It is important that 
these matters receive appropriate attention, and be resolved 
efficiently and quickly in order to expedite agency action on 
important matters.
    Current practice, and some regulations, establish at least 
an informal FDA recommendation that any disputed matter be 
appealed through the chain of command to the highest agency 
official responsible for the matter. The Committee agrees that 
this is a reasonable approach. Nonetheless, it must be 
recognized that some matters will not readily be resolved in 
this manner. Where there is a scientific controversy between 
the FDA and a person or company, and it cannot be resolved 
internally, the Secretary shall establish a process by which a 
person or company may request review of the matter by an 
appropriate scientific advisory committee. Any review by an 
advisory committee should take place in a timely manner. This 
process may provide that important scientific issues will 
receive appropriate attention from independent scientists who 
can bring a fresh perspective to assure that the regulated 
industry receives a fair and impartial hearing and that the FDA 
receives sound recommendations and advice.
    This section amends chapter V (21 U.S.C. 351 et seq.) of 
FFDCA by establishing a new section 506, to require that the 
Secretary establish, by regulation, a mechanism for resolving 
scientific disputes between the Secretary and a person who is a 
sponsor, applicant, or manufacturer, and there is no specific 
provision or regulation under the FFDCA that provides a right 
of review of the matter in controversy. In particular, the 
regulations must provide an opportunity for advisory panel 
review of the issue.

Sec. 18. Informal agency statements

    Section 701(h) would require the Secretary to follow 
predictable and consistent procedures in developing, issuing, 
and using guidance documents. The Committee believes providing 
consistent and predictable guidance to sponsors and applicants 
is critical for a rational and efficient process relating to 
the ``processing, content, and evaluation/approval of 
applications and relating to the design, production, 
manufacturing, and testing of regulated products; and (2) 
documents prepared for FDA personnel and/or the public that 
establish policies intended to achieve consistency in the 
agency's regulatory approach and establish inspection and 
enforcement procedure.'' (62 Fed. Reg., 39, 8961 (February 27, 
1997)).
    Subsection (h)(1) requires the Secretary to develop 
guidance documents with public participation and to ensure that 
the documents are made available to the public. These guidance 
documents are not binding on the agency or the public; rather, 
they present the current views of the Secretary on matters 
under the jurisdiction of the FDA. Although these documents do 
not create any rights for, or on, any persons and do not bind 
the Secretary or the public, the Secretary must ensure that 
employees of the FDA do not deviate from such guidance without 
appropriate justification from supervisory personnel. The 
Committee strongly endorses the view that the value of guidance 
documents is to provide consistency and predictability and 
emphasizes the importance of ensuring that the staff of the FDA 
will apply the statute and regulations in a consistent manner.
    Subsection (h)(1)(C) requires the Secretary to ensure 
public participation prior to the implementation of any 
guidance document that sets forth initial interpretations of 
statutes or regulation, changes in interpretation of policy 
that are of more than a minor nature, or presents complex 
scientific issues or highly controversial issues. The Secretary 
can waive this requirement upon a determination that, for 
reasons such as public health, such prior participation is not 
feasible. In those cases, the Secretary shall provide for 
public comment upon implementation of the guidance. The 
Committee intends that the Secretary will waive this 
requirement for prior public participation only in rare and 
extraordinary circumstances where there is a compelling 
rationale.
    Subsection (h)(1)(D) requires, for guidance documents that 
set forth existing practices or minor changes in policy, that 
the Secretary shall provide for public comment upon 
implementation.
    Subsection (h)(2) requires the Secretary to ensure uniform 
nomenclature and uniform internal procedures for approval of 
guidance documents. Subsection (h)(3) requires the FDA to 
maintain electronically and publish periodically in the Federal 
Register a list of guidance documents. Subsection (h)(4) 
requires the Secretary to report to the House Committee on 
Commerce and the Senate Committee on Labor and Human Resources 
by no later than July 1, 2000, on the implementation of these 
practices.

Sec. 19. Positron emission tomography

    Section 19 amends the FFDCA to include the regulation of 
compounded positron emission tomography (PET) drugs. The 
provision defines compounded PET drugs to mean drugs that 
exhibit spontaneous disintegration of unstable nuclei; include 
nonradioactive reagents, nuclide generators, accelerators, 
electronic synthesizers, or associated software used to prepare 
any such drug. The Act is further amended to provide that 
neither a New Drug Application (NDA) nor an Abbreviated New 
Drug Application (ANDA) is required by a licensed practitioner 
to produce a compounded PET product in accordance with United 
States Pharmacopeia (USP) standards. Within 30 days of 
enactment, the Secretary must publish in the Federal Register a 
notice revoking all previously published efforts by the FDA to 
provide industry guidance and regulatory standards for PET 
products.
    The provisions require the Secretary, in 2 years, to 
establish procedures for approving compounded PET products and 
good manufacturing practices for the product, taking account of 
relevant differences between commercial manufacturers and non-
profit organizations and in consultation with patient groups, 
physicians, and others. The Secretary may not require NDAs or 
ANDAs for these products for 4 years (or 2 years after these 
procedures mentioned above are established) The Secretary is 
required to terminate application of certain notices and a 
final rule of April 22, 1997, related to PET products.

Sec. 20. Requirements for radiopharmaceuticals

    Section 20 requires the Secretary, within 180 days of 
enactment, and after consultation with patient advocacy groups, 
associations, physicians licensed to use radiopharmaceuticals, 
and the regulated industry, to issue proposed regulations 
governing the approval of radiopharmaceuticals designed for 
diagnosis and monitoring of diseases and conditions. The 
regulations must provide that the product's safety and 
effectiveness, governed under section 505 of the FFDCA and 
section 351 of the Public Health Service Act, must include (but 
not be limited to) consideration of the product's proposed use 
in the practice of medicine, the product's pharmacological and 
toxicological activity (including any carrier or ligand of the 
radiopharmaceutical), and the product's estimated absorbed 
radiation dose.
    Within 18 months of enactment, the Secretary must issue 
final regulations governing the approval of 
radiopharmaceuticals. This section establishes a ``Special 
Rule'' stating that in the case of a radiopharmaceutical 
intended to be used for diagnostic or monitoring purposes, its 
approved marketing indications may, in appropriate situations, 
refer to manifestations of disease (such as biochemical, 
physiological, anatomic, or pathological processes) common to, 
or present in, one or more disease states. The term 
``radiopharmaceutical'' is defined to mean:
          (A) an article intended for use in the diagnosis or 
        monitoring of a disease or a manifestation of a disease 
        in humans, and which exhibits spontaneous 
        disintegration of unstable nuclei with the emission of 
        nuclear particles or photons; or
          (B) any nonradioactive reagent kit or nuclide 
        generator which is intended to be used in its 
        preparation.

Sec. 21. Modernization of regulation

    Section 21 amends section 351(a) of the Public Health 
Service Act (PHSA) (42 U.S.C. 262(a)) to modify the regulation 
of biological products. This section provides that a biological 
product may not be introduced into interstate commerce unless 
(A) the product has a biologics license; and (B) the package is 
marked with the product's name, the manufacturer's name, 
address, and license number, and the product's expiration date. 
By regulation, the Secretary must establish requirements for 
the approval, suspension, and revocation of biologics licenses. 
A license will be approved based on a demonstration that the 
biological product is safe, pure, and potent, and that the 
facility where the product is manufactured, processed, packed, 
or held meets standards to assure the product's continued 
safety, purity, and potency. Also, the application will be 
approved only on the condition that the licensee agrees to 
permit inspection of its production facility. The Secretary 
must prescribe certain licensing and labeling exemptions for 
products undergoing investigation.
    This section also amends section 351 to prohibit any person 
from falsely labeling or marking or altering any label or mark 
to falsify the label or mark of any package or container of a 
biological product and to eliminate the requirement that 
biologics manufacturers obtain establishment licenses. In 
addition, a biological product is redefined as: ``a virus, 
therapeutic serum, toxin, antitoxin, vaccine, blood, blood 
component or derivative, allergenic product, or analogous 
product, or arsphenamine or derivatives of arsphenamine (or any 
other trivalent organic arsenic compound), applicable to the 
prevention, treatment, or cure of a disease or condition of 
human beings.''
    Section 21(f) establishes a ``Special Rule'' directing the 
Secretary to take steps necessary to minimize differences in 
the review and approval of products required to have both a 
biologic license application under section 351 of the PHSA and 
a new drug application (NDA) under section 505(b)(1) of the 
FFDCA.
    Section 21(g) provides a technical correction to minimize 
any duplication between the Centers for Disease Control and 
Prevention (CDC) and the FDA determinations related to the 
accuracy of test systems. In re-writing Paragraph (3) of 
section 353(d) of the Public Health Service Act, the Committee 
intends to clarify that approval of a test for a home use by 
the FDA is an automatic route to waived status under the 
Clinical Laboratories Improvement Act (CLIA). The Committee is 
aware that the CDC, because of a misunderstanding of the 
statutory language, has denied waived status for at least one 
test approved for home use by prescription. The bill clarifies 
that, when the FDA already has determined that a diagnostic 
product can be used safely and effectively by a layperson at 
home, such a product should not require additional review or 
action by the Secretary to determine whether CLIA requirements 
can be waived for this product. This is the case whether the 
product is available over the counter or by prescription.
    In addition to waiving CLIA requirements for tests approved 
by the FDA for home use, current law also provides that the 
Secretary may determine that other products are simple and have 
an insignificant risk of erroneous results. Subparagraphs (A) 
and (B) provide examples of product types that could satisfy 
this criteria. The bill clarifies, in subparagraph (A) that 
this criteria should focus on test performance ``by the user'' 
and the potential for operator error in performing the test. 
The purpose of CLIA quality control, proficiency testing, and 
personnel requirements is to ensure consistent, reliable, and 
appropriate use of a test system by users of the test. Without 
the clarifying ``by the user,'' interpretations of ``erroneous 
result'' and ``accurate'' could include the inherent clinical 
sensitivity/specificity of a test system, parameters that are 
properly reviewed by the FDA in its process of determining 
whether to approve or clear product for marketing. CLIA 
controls would not meaningfully affect a product's inherent 
sensitivity/specificity profile, and would provide no 
assurances of proper test performance by users. This ``by the 
user'' clarification is intended only to specify the focus of 
subparagraph (A) and is not meant in any way to change the 
acceptable level of user error.

Sec. 22. Pilot and small scale manufacture

    Section 22 amends Section 505(c) (21 U.S.C. 355(c)) of the 
FFDCA to establish that a new human drug manufactured in a 
pilot or small facility may be used to demonstrate the drug's 
safety and effectiveness and to obtain its approval prior to 
scaling up to a larger facility. The Secretary retains the 
authority to determine whether a full scale production facility 
is necessary to ensure the drug's safety and effectiveness. 
Section 512(c) of the FFDCA is similarly amended for animal 
drugs.

Sec. 23. Insulin and antibiotics

    This section repeals sections 506 and 507 of the FFDCA, 
thereby eliminating certain requirements for batch 
certification of insulin and certain antibiotic products. The 
section would also preserve the current provisions for the 
export of insulin and antibiotics.
    The repeal of section 507 also results in applications for 
new antibiotic products being submitted to the FDA under all 
the requirements and benefits of section 505, including the 
granting of market exclusivity to all new drugs under the so-
called Waxman-Hatch provisions. The Committee intends that the 
granting of market exclusivity be limited to products that 
achieve the policy objective of increasing research toward the 
development of new antibiotics. Thus, the granting of market 
exclusivity to new antibiotic drugs is limited to those 
products that are New Chemical Entities and to products for 
which a New Drug Application has not been submitted prior to 
the date of enactment.

Sec. 24. FDA mission and annual report

    Section 24 amends FFDCA Section 903 (21 U.S.C. 393) by 
redesignating subsections (b) and (c) as subsections (c) and 
(d) and adding a new section (b), ``Mission,'' consisting of 
two parts: (1) the FDA shall promote public health by promptly 
and efficiently reviewing clinical research and taking 
appropriate action on the marketing of regulated products in a 
timely manner; and (2) the FDA shall protect the public health 
by ensuring that foods are safe, wholesome, and sanitary; human 
and veterinary drugs are safe and effective; there is a 
reasonable assurance of safety and effectiveness of devices 
intended for human use; cosmetics are safe and properly 
labeled; and the public health and safety are protected from 
electronic product radiation. Further, the FDA shall 
participate with other countries to reduce the burden of 
regulation, to harmonize regulatory requirements, and to 
achieve appropriate reciprocal arrangements.
    Section 24 also requires the Secretary to submit an annual 
report to Congress, at the time of submission of its budget, 
which reviews FDA's performance in meeting its mission and 
assesses the agency's policies to implement its mission. The 
report must address the agency's efforts to meet its own 
performance standards, outcome measurements, and statutory 
deadlines for new product approvals. The report also must 
include a description of agency staffing and resources. In 
addition, the report must describe the FDA's goals, activities, 
and accomplishments in bilateral and multinational meetings 
that address reducing the burden of regulation, harmonizing 
regulations, and seeking reciprocal arrangements.

Sec. 25. Information system

    This provision requires the Secretary to establish and 
maintain an information system to track the status and progress 
of each application or submission (e.g., petition, 
notification, or other form of request) submitted to the FDA.

Sec. 26. Education and training

    This section requires the Secretary to conduct training and 
education programs for FDA employees related to the regulatory 
responsibilities and policies established by this Act 
(including scientific and administrative process training 
programs and programs related to integrity issues).

Sec. 27. Centers for education and research on drugs

    This section amends chapter IX of the FFDCA to create new 
section 908, ``Demonstration Program Regarding Centers For 
Education and Research On Drugs, Devices, And Biological 
Products,'' which would require the Secretary to establish a 
demonstration program to make at least one grant for the 
establishment and operation of one center that would conduct 
clinical and laboratory research to increase awareness of new 
uses and unforeseen risks of new uses of drugs. The clinical 
information gained in the project would be provided to health 
care practitioners, pharmacy benefit managers, health 
maintenance or managed health careorganizations, and health 
care insurers or government agencies. The purpose of the research also 
would be to improve health care quality while reducing costs through 
the prevention of adverse effects of these products such as unnecessary 
hospitalizations. Research would also be conducted on the comparative 
effectiveness and safety of drugs. The grant has one limitation: it 
cannot be used to assist the Secretary in the review of new drugs. 
Applications for grants must contain all agreements, assurances, and 
information that would be needed to carry out program activities. The 
grant application must undergo appropriate technical and scientific 
peer review. The bill authorizes $2 million in Fiscal Year 1998 and $3 
million in Fiscal Year 1999 to be spent on this demonstration program.

Sec. 28. Harmonization

    Section 28 requires the Secretary to participate in 
meetings with foreign governments to reduce the burden of 
regulation and harmonize regulatory requirements if the 
Secretary finds that harmonization would further consumer 
protections consistent with the purposes of this Act. The 
Secretary must report to the House Committee on Commerce and 
the Senate Committee on Labor and Human Resources at least 60 
days before executing a bilateral or multilateral agreement.

Sec. 29. Environmental impact review

    Section 29 amends Chapter VII of the FFDCA, as amended, 
adding new section 761 dealing with environmental impact 
reviews. An environmental impact statement prepared in 
accordance with regulations published under part 25 of 21 
C.F.R. in connection with an action carried out under this Act 
will be considered to meet the requirements under section 
102(2)(C) of the National Environmental Policy Act.

Sec. 30. National uniformity

    Section 30 amends Chapter VII (21 U.S.C. 371 et seq.) of 
the FFDCA, as amended by section 29 of the bill, by adding a 
new subchapter H entitled ``National Uniformity for 
Nonprescription Drugs for Human Use and Preemption for Labeling 
or Packaging of Cosmetics.'' New section 771(a) provides that, 
with certain exceptions, no State or political subdivision of a 
State may establish or continue in effect any requirement: (1) 
that relates to the regulation of a drug intended for human use 
that is not subject to the requirements of section 503(b)(1); 
and (2) that is different from, or in addition to, a 
requirement of this Act, the Poison Prevention Packaging Act of 
1970, or the Fair Packaging and Labeling Act. This section 
``grandfathers'' California's Proposition 65.
    However, upon application by a State or political 
subdivision, the Secretary may, by regulation, after notice and 
opportunity for written and oral views, exempt a State 
requirement that protects an important public interest that 
would otherwise be unprotected; would not cause any drug to be 
in violation of any applicable requirement or prohibition under 
Federal law; and would not unduly burden interstate commerce. 
This provision does not apply to any requirement that relates 
to the practice of pharmacy or any requirement that a drug be 
dispensed only upon the prescription of a practitioner licensed 
by law to administer the drug. Furthermore, with regard to 
scope, this provision shall include any requirement relating to 
public information or any public communication relating to a 
warning for a drug or cosmetic. And, nothing in this section 
shall be construed to modify or otherwise affect any action or 
the liability of any person under the product liability law of 
any State.
    With respect to drugs that are not the subject of an 
application approved under section 505 or 507 or a final 
regulation established by the Secretary, this section applies 
only to State requirements that relate to the same subject as, 
but are different from, or in addition to, or that is otherwise 
not identical with a regulation or other requirement under 
Federal law. Nothing in this section prevents any State from 
enforcing, under relevant civil or other enforcement authority, 
a requirement that is identical to a requirement of this Act.
    Section 772 applies to uniformity for labeling or packaging 
of cosmetics and is intended to apply to any State requirement, 
whether imposed by statute, regulation, common law, or 
otherwise. The Committee believes that uniformity of Federal 
and State requirements is important for cosmetics, which are 
manufactured and distributed in national markets.
    Under section 772, with stated exceptions, a state 
requirement applicable to an aspect or aspects of the packaging 
or labeling of a cosmetic or class of cosmetics is preempted 
for such cosmetics or class of cosmetic, if there is a federal 
requirement related to that aspect or aspects of the cosmetic, 
and the state requirement is not identical with the federal 
requirement. A requirement may be a ``requirement for labeling 
or packaging of a cosmetic'' even if it also applies to other 
kinds of products. A requirement that is ``specifically 
applicable'' to a particular cosmetic or class of cosmetics is 
one that applies to a cosmetic or class of cosmetics, whether 
or not it also applies to other kinds of products.
    Under the concept of the ``same aspect'' if the FDA has 
required disclosure of a particular risk on the label of a 
cosmetic and has specified the text of the disclosure or 
criteria that it must meet, a state would be preempted from 
applying to that cosmetic a disclosure or other requirement 
that relates to the same risk that differs from the FDA 
requirement in any aspect, including the form or location of 
the disclosure.

Sec. 31. FDA study of mercury compounds in drugs and food

    Section 31(a) requires that within 2 years, the FDA compile 
a list of drugs and foods that contain intentionally introduced 
mercury compounds and provide a quantitative and qualitative 
analysis of these mercury compounds. Section 31(b) also 
requires the FDA to study the effect on humans of the use of 
mercury compounds in nasal sprays. Section 31(c) requires that 
the FDA or, under a contract, the Institute of Medicine, 
conduct a study on the effect on humans of the use of 
elemental, organic, or inorganic mercury when offered for sale 
as a drug or dietary supplement. The study will evaluate the 
scope of mercury use as a drug or dietary supplement and 
evaluate the adverse effects on health of children and other 
sensitive populations resulting from exposure to, or ingestion 
or inhalation of, mercury when so used. In conducting the 
study, the FDA shall consult with the Administrator of the 
Environmental Protection Agency, the Chair of the Consumer 
Product Safety Commission, and the Administrator of the Agency 
for Toxic Substances and Disease Registry. The conduct of this 
study is subject to available appropriations.

Sec. 32. Notification of discontinuance of a life saving product

    Section 32 amends Chapter VII (21 U.S.C. 371 et seq.), as 
amended by section 30, by adding a new subchapter I entitled 
``Notification of the Discontinuance of a Life Saving 
Product.'' This section provides that a manufacturer that is 
the sole manufacturer of a drug or device that is life 
supporting, life sustaining, or intended for use in the 
prevention of a debilitating disease or condition, and for 
which an application has been approved under section 505(b), 
505(j), or 515(d), shall notify the Secretary of a 
discontinuance of the manufacture of the drug or device at 
least 6-months prior to the date of the discontinuance.
    On the application of the manufacturer, this 6 month period 
for notification may be reduced by the Secretary if good cause 
exists for the reduction of the period such as the following 
situations: (1) a public health problem may result from 
continuation of the manufacturing for the 6-month period; (2) a 
biomaterial shortage prevents the continuation of the 
manufacturing for the 6-month period; (3) a liability problem 
may exist for the manufacturer if the manufacturing is 
continued for the 6-month period; (4) continuation of the 
manufacturing for the 6-month period may cause substantial 
economic hardship for the manufacturer; (5) the manufacturer 
has filed for bankruptcy; or (6) the Secretary determines that 
there would be no adverse impact from the discontinuance of a 
drug or device.
    The Secretary shall distribute information on the 
discontinuance of the drugs and devices to appropriate 
physician and patient groups to the maximum extent practicable.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3 of rule XIII of the Rules of the 
House of Representatives, changes in existing law made by the 
bill, as reported, are shown as follows (existing law proposed 
to be omitted is enclosed in black brackets, new matter is 
printed in italic, existing law in which no change is proposed 
is shown in roman):

                  FEDERAL FOOD, DRUG, AND COSMETIC ACT

          * * * * * * *

                        CHAPTER II--DEFINITIONS

          * * * * * * *
  Sec. 201. For the purposes of this Act--
  (a) * * *
          * * * * * * *
  (aa) The term ``abbreviated drug application'' means an 
application submitted under section 505(j) [or 507] for the 
approval of a drug that relies on the approved application of 
another drug with the same active ingredient to establish 
safety and efficacy, and--
          (1) * * *
          * * * * * * *
  (dd) For purposes of sections 306 and 307, the term ``drug 
product'' means a drug subject to regulation under section 505, 
[507,] 512, or 802 of this Act or under section 351 of the 
Public Health Service Act.
          * * * * * * *
  (ff) The term ``dietary supplement''--
          (1) * * *
          * * * * * * *
          (3) does--
                  (A) include an article that is approved as a 
                new drug under section 505[, certified as an 
                antibiotic under section 507,] or licensed as a 
                biologic under section 351 of the Public Health 
                Service Act (42 U.S.C. 262) and was, prior to 
                such approval, certification, or license, 
                marketed as a dietary supplement or as a food 
                unless the Secretary has issued a regulation, 
                after notice and comment, finding that the 
                article, when used as or in a dietary 
                supplement under the conditions of use and 
                dosages set forth in the labeling for such 
                dietary supplement, is unlawful under section 
                402(f); and
          * * * * * * *
  (ii) The term ``compounded positron emission tomography 
drug''--
          (1) means a drug that--
                  (A) exhibits spontaneous disintegration of 
                unstable nuclei by the emission of positrons 
                and is used for the purpose of providing dual 
                photon positron emission tomographic diagnostic 
                images; and
                  (B) has been compounded by or on the order of 
                a practitioner who is licensed by a State to 
                compound or order compounding for a drug 
                described in subparagraph (A), and is 
                compounded in accordance with that State's law, 
                for a patient or for research, teaching, or 
                quality control; and
          (2) includes any nonradioactive reagent, reagent kit, 
        ingredient, nuclide generator, accelerator, target 
        material, electronic synthesizer, or other apparatus or 
        computer program to be used in the preparation of such 
        a drug.

               CHAPTER III--PROHIBITED ACTS AND PENALTIES

                            prohibited acts

  Sec. 301. The following acts and the causing thereof are 
hereby prohibited:
  (a) * * *
          * * * * * * *
  (e) The refusal to permit access to or copying of any record 
as required by section 412, 504, or 703; or the failure to 
establish or maintain any record, or make any report, required 
under section 412, 504, 505 (i) or (k), [507(d) or (g),] 
512(a)(4)(C), 512 (j), (l) or (m), 515(f), or 519 or the 
refusal to permit access to or verification or copying of any 
such required record.
          * * * * * * *
  (i)(1) Forging, counterfeiting, simulating, or falsely 
representing, or without proper authority using any mark, 
stamp, tag, label, or other identification device authorized or 
required by regulations promulgated under the provisions of 
section 404[, 506, 507,] or 721.
          * * * * * * *
  (j) The using by any person to his own advantage, or 
revealing, other than to the Secretary or officers or employees 
of the Department, or to the courts when relevant in any 
judicial proceeding under this Act, any information acquired 
under authority of section 404, 409, 412, 505, [506, 507,] 510, 
512, 513, 514, 515, 516, 518, 519, 520, 704, 708, or 721 
concerning any method or process which as a trade secret is 
entitled to protection; or the violating of section 408(i)(2) 
or any regulation issued under that section. This paragraph 
does not authorize the withholding of information from either 
House of Congress or from, to the extent of matter within its 
jurisdiction, any committee or subcommittee of such committee 
or any joint committee of Congress or any subcommittee of such 
joint committee.
          * * * * * * *
  (x) The dissemination of information in violation of section 
745.
          * * * * * * *

        debarment, temporary denial of approval, and suspension

  Sec. 306. (a) * * *
          * * * * * * *
  (d) Termination of Debarment.--
          (1) * * *
          * * * * * * *
          (4) Special termination.--
                  (A) * * *
                  (B) Corporations.--Upon an application 
                submitted under subparagraph (A), the Secretary 
                may take the action described in subparagraph 
                (D) if the Secretary, after an informal 
                hearing, finds that--
                          (i) * * *
                          (ii) all individuals who were 
                        involved in the commission of the 
                        offense or who knew or should have 
                        known of the offense have been removed 
                        from employment involving the 
                        development or approval of any drug 
                        subject to section 505 [or 507],
          * * * * * * *

                      CHAPTER V--DRUGS AND DEVICES

                    Subchapter A--Drugs and Devices

                     adulterated drugs and devices

  Sec. 501. A drug or device shall be deemed to be 
adulterated--
  (a)(1) If it consists in whole or in part of any filthy, 
putrid, or decomposed substance; or (2)(A) if it has been 
prepared, packed, or held under insanitary conditions whereby 
it may have been contaminated with filth, or whereby it may 
have been rendered injurious to health; or (B) if it is a drug 
and the methods used in, or the facilities or controls used 
for, its manufacture, processing, packing, or holding do not 
conform to or are not operated or administered in conformity 
with current good manufacturing practice to assure that such 
drug meets the requirements of this Act as to safety and has 
the identity and strength, and meets the quality and purity 
characteristics, which it purports or is represented to 
possess[; or (3)]; or (C) if it is a compounded positron 
emission tomography drug and the methods used in, or the 
facilities and controls used for, its compounding, processing, 
packing, or holding do not conform to or are not operated or 
administered in conformity with the positron emission 
tomography compounding standards and the official monographs of 
the United States Pharmacopeia to assure that such drug meets 
the requirements of this Act as to safety and has the identity 
and strength, and meets the quality and purity characteristics, 
that it purports or is represented to possess; or (3) if its 
container is composed, in whole or in part, of any poisonous or 
deleterious substance which may render the contents injurious 
to health; or (4) if (A) it bears or contains, for purposes of 
coloring only, a color additive which is unsafewithin the 
meaning of section 721(a), or (B) it is a color additive the intended 
use of which in or on drugs or devices is for purposes of coloring only 
and is unsafe within the meaning of section 721(a); or (5) if it is a 
new animal drug which is unsafe within the meaning of section 512; or 
(6) if it is an animal feed bearing or containing a new animal drug, 
and such animal feed is unsafe within the meaning of section 512.
          * * * * * * *

                      misbranded drugs and devices

  Sec. 502. A drug or device shall be deemed to be misbranded--
  (a) If its labeling is false or misleading in any particular. 
Health care economic information provided to a formulary 
committee, or other similar entity, in the course of the 
committee or the entity carrying out its responsibilities for 
the selection of drugs for managed care or other similar 
organizations, shall not be considered to be false or 
misleading if the health care economic information directly 
relates to an indication approved under section 505 or 507 or 
section 351(a) of the Public Health Service Act (42 U.S.C. 
262(a)) for such drug and is based on competent and reliable 
scientific evidence. The requirements set forth in section 
505(a), 507, or section 351(a) of the Public Health Service Act 
(42 U.S.C. 262(a)) shall not apply to health care economic 
information provided to such a committee or entity in 
accordance with this paragraph. Information that is relevant to 
the substantiation of the health care economic information 
presented pursuant to this paragraph shall be made available to 
the Secretary upon request. In this paragraph, the term 
``health care economic information'' means any analysis that 
identifies, measures, or compares the economic consequences, 
including the costs of the represented health outcomes, of the 
use of a drug to the use of another drug, to another health 
care intervention, or to no intervention.
          * * * * * * *
  (e)[(1) If it is a drug, unless (A) its label bears, to the 
exclusion of any other nonproprietary name (except the 
applicable systematic chemical name or the chemical formula), 
(i) the established name (as defined in subparagraph (3)) of 
the drug, if such there be, and (ii) in case it is fabricated 
from two or more ingredients, the established name and quantity 
of each active ingredient, including the quantity, kind, and 
proportion of any alcohol, and also including whether active or 
not, the established name and quantity or proportion of any 
bromides, ether, chloroform, acetanilide, acetophenetidin, 
amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, 
arsenic, digitalis, digitalis glucosides, mercury, ouabain, 
strophanthin, strychnine, thyroid, or any derivative or 
preparation of any such substances, contained therein. 
Provided, That the requirement for stating the quantity of the 
active ingredients, other than the quantity of those 
specifically named in this paragraph, shall apply only to 
prescription drugs; and (B) for any prescription drug the 
established name of such drug or ingredient, as the case may 
be, on such label (and on any labeling on which a name for such 
drug or ingredient is used) is printed prominently and in type 
at least half as large as that used thereon for any proprietary 
name or designation for such drug or ingredient: and Provided, 
That to the extent that compliance with the requirements of 
clause (A)(ii) or clause (B) of this subparagraph is 
impracticable, exemptions shall be established by regulations 
promulgated by the Secretary.] (1)(A) If it is a drug, unless 
its label bears, to the exclusion of any other nonproprietary 
name (except the applicable systematic chemical name or the 
chemical formula)--
          (i) the established name (as defined in subparagraph 
        (3)) of the drug, if there is such a name;
          (ii) the established name and quantity or, if deemed 
        appropriate by the Secretary, the proportion of each 
        active ingredient, including the quantity, kind, and 
        proportion of any alcohol, and also including whether 
        active or not the established name and quantity or if 
        deemed appropriate by the Secretary, the proportion of 
        any bromides, ether, chloroform, acetanilide, 
        acetophenetidin, amidopyrine, antipyrine, atropine, 
        hyoscine, hyoscyamine, arsenic, digitalis, digitalis 
        glucosides, mercury, ouabain, strophanthin, strychnine, 
        thyroid, or any derivative or preparation of any such 
        substances, contained therein, except that the 
        requirement for stating the quantity of the active 
        ingredients, other than the quantity of those 
        specifically named in this subclause, shall not apply 
        to nonprescription drugs not intended for human use; 
        and
          (iii) the established name of each inactive 
        ingredient listed in alphabetical order on the outside 
        container of the retail package and, if deemed 
        appropriate by the Secretary, on the immediate 
        container, as prescribed in regulation promulgated by 
        the Secretary, but nothing in this clause shall be 
        deemed to require that any trade secret be divulged, 
        except that the requirements of this subclause with 
        respect to alphabetical order shall apply only to 
        nonprescription drugs that are not also cosmetics and 
        this subclause shall not apply to nonprescription drugs 
        not intended for human use.
  (B) For any prescription drug the established name of such 
drug or ingredient, as the case may be, on such label (and on 
any labeling on which a name for such drug or ingredient is 
used) shall be printed prominently and in type at least half as 
large as that used thereon for any proprietary name or 
designation for such drug or ingredient, except that to the 
extent that compliance with the requirements of clause (A)(ii) 
or (iii) or this subparagraph is impracticable, exemptions 
shall be established by regulations promulgated by the 
Secretary.
          * * * * * * *
  [(k) If it is, or purports to be, or is represented as a drug 
composed wholly or partly of insulin, unless (1) it is from a 
batch with respect to which a certificate or release has been 
issued pursuant to section 506, and (2) such certificate or 
release is in effect with respect to such drug.
  [(l) If it is, or purports to be, or is represented as a drug 
(except a drug for use in animals other than man) composed 
wholly or partly of any kind of penicillin, streptomycin, 
chlortetracycline, chloramphenicol, bacitracin, or any other 
antibiotic drug, or any derivative thereof, unless (1) it is 
from a batch with respect to which a certificate or release has 
been issued pursuant to section 507, and (2) such certificate 
or release is in effect with respect to such drug: Provided, 
That this paragraph shall not apply to any drug or class of 
drugs exempted by regulations promulgated under section 507 (c) 
or (d).]
          * * * * * * *

exemptions and consideration for certain drugs, devices, and biological 
                                products

  Sec. 503. (a) * * *
          * * * * * * *
  (g)(1) * * *
          * * * * * * *
  (4) As used in this subsection:
          (A) The term ``biological product'' has the meaning 
        given the term in section [351(a)] 351(i) of the Public 
        Health Service Act (42 U.S.C. [262(a)] 262(i)).
          (B) The term ``market clearance'' includes--
                  (i) * * *
          * * * * * * *
                  (iii) approval of a [product or establishment 
                license under subsection (a) or (d)] biologics 
                license application under subsection (a) of 
                section 351 of the Public Health Service Act 
                (42 U.S.C. 262).
          * * * * * * *

                               new drugs

  Sec. 505. (a) * * *
  (b)(1) Any person may file with the Secretary an application 
with respect to any drug subject to the provisions of 
subsection (a). Such persons shall submit to the Secretary as a 
part of the application (A) full reports of investigations 
which have been made to show whether or not such drug is safe 
for use and whether such drug is effective in use; (B) a full 
list of the articles used as components of such drug; (C) a 
full statement of the composition of such drug; (D) a full 
description of the methods used in, and the facilities and 
controls used for, the manufacture, processing, and packing of 
such drug; (E) such samples of such drug and of the articles 
used as components thereof as the Secretary may require; and 
(F) specimens of the labeling proposed to be used for such 
drug. The applicant shall file with the application the patent 
number and the expiration date of any patent which claims the 
drug for which the applicant submitted the application or which 
claims a method of using such drug and with respect to which a 
claim of patent infringement could reasonably be asserted if a 
person not licensed by the owner engaged in the manufacture 
use, or sale of the drug. If an application is filed under this 
subsection for a drug and a patent which claims such drug or a 
method of using such drug is issued after the filing date but 
before approval of the application, the applicant shall amend 
the application to include the information required by the 
preceding sentence. Upon approval of the application, the 
Secretary shall publish information submitted under the two 
preceding sentences. The Secretary shall, in consultation with 
the Director of the National Institutes of Health, review and 
develop guidance, as appropriate, on the inclusion of women and 
minorities in clinical trials required by clause (A).
          * * * * * * *
  (4)(A) The Secretary shall issue guidance for the review of 
applications submitted under paragraph (1) relating to 
promptness, technical excellence, lack of bias and conflict of 
interest, and knowledge of regulatory and scientific standards 
which shall apply equally to all individuals who review such 
applications.
  (B) The Secretary shall meet with a sponsor of an 
investigation or an applicant for approval under this section 
or section 351 of the Public Health Service Act if the sponsor 
or applicant makes a reasonable request for a meeting, for the 
purpose of reaching agreement on the design and size of 
clinical trials. Minutes of any such meeting shall be prepared 
by the Secretary and made available to the sponsor or applicant 
upon request.
  (C) Agreement regarding the parameters of the design and size 
of clinical trials of a new drug that are reached between the 
Secretary and a sponsor or applicant shall be reduced to 
writing and made part of the administrative record by the 
Secretary. Such agreement shall not be changed after the 
testing begins, except--
          (i) with the written agreement of the sponsor or 
        applicant; or
          (ii) pursuant to a decision, made in accordance with 
        subparagraph (D) by the director of the division in 
        which the drug is reviewed, that a substantial 
        scientific issue essential to determining the safety or 
        effectiveness of the drug has been identified after the 
        testing has begun.
  (D) A decision under subparagraph (C)(ii) by the director 
shall be in writing and the Secretary shall provide to the 
sponsor or applicant an opportunity for a meeting at which the 
director and the sponsor or applicant will be present and at 
which the director documents the scientific issue involved.
  (E) The written decisions of the reviewing division shall be 
binding upon, and may not directly or indirectly be changed by, 
the field or compliance division personnel unless such field or 
compliance division personnel demonstrate to the reviewing 
division why such decision should be modified. For purposes of 
this paragraph, the reviewing division is the division 
responsible for the review of an application for approval of a 
drug (including all scientific and medical matters, chemistry, 
manufacturing, and controls).
  (F) No action by the reviewing division may be delayed 
because of the unavailability of information from or action by 
field personnel unless the reviewing division determines that a 
delay is necessary to assure the marketing of a safe and 
effective drug.
  (c)(1) * * *
          * * * * * * *
  (4) A drug manufactured in a pilot or other small facility 
may be used to demonstrate the safety and effectiveness of the 
drug and to obtain approval prior to scaling up to a larger 
facility, unless the Secretary makes a determination that a 
full scale production facility is necessary to ensure the 
safety or effectiveness of the drug.
  (d) If the Secretary finds, after due notice to the applicant 
in accordance with subsection (c) and giving him an opportunity 
for a hearing, in accordance with said subsection, that (1) the 
investigations, reports of which are required to be submitted 
to the Secretary pursuant to subsection (b), do not include 
adequate tests by all methods reasonably applicable to show 
whether or not such drug is safe for use under the conditions 
prescribed, recommended, or suggested in the proposed labeling 
thereof; (2) the results of such tests show that such drug is 
unsafe for use under such conditions or do not show that such 
drug is safe for use under such conditions; (3) the methods 
used in, and the facilities and controls used for, the 
manufacture, processing, and packing of such drug are 
inadequate to preserve its identity, strength, quality, and 
purity; (4) upon the basis of the information submitted to him 
as part of the application, or upon the basis of any other 
information before him with respect to such drug, he has 
insufficient information to determine whether such drug is safe 
for use under such conditions; or (5) evaluated on the basis of 
the information submitted to him as part of the application and 
any other information before him with respect to such drug, 
there is a lack of substantial evidence that the drug will have 
the effect it purports or is represented to have under the 
conditions of use prescribed, recommended, or suggested in the 
proposed labeling thereof; or (6) the application failed to 
contain the patent information prescribed by subsection (b); or 
(7) based on a fair evaluation of all material facts, such 
labeling is false or misleading in any particular; he shall 
issue an order refusing to approve the application. If, after 
such notice and opportunity for hearing, the Secretary finds 
that clauses (1) through (6) do not apply, he shall issue an 
order approving the application. As used in this subsection and 
subsection (e), the term ``substantial evidence'' means 
evidence consisting of adequate and well-controlled 
investigations, including clinical investigations, by experts 
qualified by scientific training and experience to evaluate the 
effectiveness of the drug involved, on the basis of which it 
could fairly and responsibly be concluded by such experts that 
the drug will have the effect it purports or is represented to 
have under the conditions of use prescribed, recommended, or 
suggested in the labeling or proposed labeling thereof. If the 
Secretary determines, based on relevant science, that data from 
one adequate and well-controlled clinical investigation and 
confirmatory evidence (obtained prior to or after such 
investigation) are sufficient to establish effectiveness, the 
Secretary may consider such data and evidence to constitute 
substantial evidence for purposes of the preceding sentence.
          * * * * * * *
  (i)(1) The Secretary shall promulgate regulations for 
exempting from the operation of the foregoing subsections of 
this section drugs intended solely for investigational use by 
experts qualified by scientific training and experience to 
investigate the safety and effectiveness of drugs. Such 
regulations may, within the discretion of the Secretary, among 
other conditions relating to the protection of the public 
health, provide for conditioning such exemption upon--
          [(1)] (A) the submission to the Secretary, before any 
        clinical testing of a new drug is undertaken, of 
        reports, by the manufacturer or the sponsor of the 
        investigation of such drug, or preclinical tests 
        (including tests on animals) of such drug adequate to 
        justify the proposed clinical testing;
          [(2)] (B) the manufacturer or the sponsor of the 
        investigation of a new drug proposed to be distributed 
        to investigators for clinical testing obtaining a 
        signed agreement from each of such investigators that 
        patients to whom the drug is administered will be under 
        his personal supervision, or under the supervision of 
        investigators responsible to him, and that he will not 
        supply such drug to any other investigator, or to 
        clinics, for administration to human beings; and
          [(3)] (C) the establishment and maintenance of such 
        records, and the making of such reports to the 
        Secretary, by the manufacturer or the sponsor of the 
        investigation of such drug, of data (including but not 
        limited to analytical reports by investigators) 
        obtained as the result of such investigational use of 
        such drug, as the Secretary finds will enable him to 
        evaluate the safety and effectiveness of such drug in 
        the event of the filing of an application pursuant to 
        subsection (b).
[Such regulations shall provide that such exemption shall be 
conditioned upon the manufacturer, or the sponsor of the 
investigation, requiring that experts using such drugs for 
investigational purposes certify to such manufacturer or 
sponsor that they will inform any human beings to whom such 
drugs, or any controls used in connection therewith, are being 
administered, or their representatives, that such drugs are 
being used for investigational purposes and will obtain the 
consent of such human beings or their representatives, except 
where they deem it not feasible or, in their professional 
judgment, contrary to the best interests of such human beings. 
Nothing in this subsection shall be construed to require any 
clinical investigator to submit directly to the Secretary 
reports on the investigational use of drugs.]
  (2) Subject to paragraph (3), a clinical investigation of a 
new drug may begin 30 days after the Secretary has received 
from the manufacturer or sponsor of the investigation a 
submission containing such information about the drug and the 
clinical investigation, including --
          (A) information on design of the investigation and 
        adequate reports of basic information, certified by the 
        applicant to be accurate reports, necessary to assess 
        the safety of the drug for use in clinical 
        investigation; and
          (B) adequate information on the chemistry and 
        manufacturing of the drug, controls available for the 
        drug, and primary data tabulations from animal or human 
        studies.
  (3)(A) At any time, the Secretary may prohibit the sponsor of 
an investigation from conducting the investigation (referred to 
in this paragraph as a ``clinical hold'') if the Secretary 
makes a determination described in subparagraph (B). The 
Secretary shall specify the basis for the clinical hold, 
including the specific information available to the Secretary 
which served as the basis for such clinical hold, and confirm 
such determination in writing.
  (B) For purposes of subparagraph (A), a determination 
described in this subparagraph with respect to a clinical hold 
is that--
          (i) the drug involved represents an unreasonable risk 
        to the safety of the persons who are the subject of the 
        clinical investigation, taking into account the 
        qualifications of the clinical investigators, 
        information about the drug, the design of the clinical 
        investigation, the condition for which the drug is to 
        be investigated, and the health status of the subjects 
        involved; or
          (ii) the clinical hold should be issued for such 
        other reasons as the Secretary may by regulation 
        establish (including reasons established by regulation 
        before the date of the enactment of the Prescription 
        Drug User Fee Reauthorization and Drug Regulatory 
        Modernization Act of 1997).
Such regulations shall provide that such exemption shall be 
conditioned upon the manufacturer, or the sponsor of the 
investigation, requiring that experts using such drugs for 
investigational purposes certify to such manufacturer or 
sponsor that they will inform any human beings to whom such 
drugs, or any controls used in connection therewith, are being 
administered, or their representatives, that such drugs are 
being used for investigational purposes and will obtain the 
consent of such human beings or their representatives, except 
where they deem it not feasible or, in their professional 
judgment, contrary to the best interests of such human beings. 
Nothing in this subsection shall be construed to require any 
clinical investigator to submit directly to the Secretary 
reports on the investigational use of drugs.
  (C) Any request to the Secretary from the sponsor of an 
investigation that a clinical hold be removed shall receive a 
decision, in writing and specifying the reasons therefor, 
within 30 days after receipt of such request. Any such request 
shall include sufficient information to support the removal of 
such clinical hold.
  (j)(1) * * *
  (2)(A) An abbreviated application for a new drug shall 
contain--
          (i) information to show that the conditions of use 
        prescribed, recommended, or suggested in the labeling 
        proposed for the new drug have been previously approved 
        for a drug listed under paragraph [(6)] (7) 
        (hereinafter in this subsection referred to as a 
        ``listed drug'');
          * * * * * * *
  (3)(A) The Secretary shall issue guidance for the review of 
applications submitted under paragraph (1) relating to 
promptness, technical excellence, lack of bias and conflict of 
interest, and knowledge of regulatory and scientific standards 
which shall apply equally to all individuals who review such 
applications.
  (B) The Secretary shall meet with an applicant for approval 
of a drug under this subsection if the applicant makes a 
reasonable request for a meeting for the purpose of reaching 
agreement on the design and size of studies needed for approval 
of such application. Minutes of any such meeting shall be 
prepared by the Secretary and made available to the sponsor or 
applicant.
  (C) Agreements regarding the parameters of design and size of 
bioavailability and bioequivalence trials of a drug under this 
subsection that are reached between the Secretary and a sponsor 
or applicant shall be reduced to writing and made part of the 
administrativerecord by the Secretary. Such agreement shall not 
be changed after the testing begins, except--
          (i) with the written agreement of the sponsor or 
        applicant; or
          (ii) pursuant to a decision, made in accordance with 
        subparagraph (D) by the director of the division in 
        which the drug is reviewed, that a substantial 
        scientific issue essential to determining the safety or 
        effectiveness of the drug has been identified after the 
        testing has begun.
  (D) A decision under subparagraph (C)(ii) by the director 
shall be in writing and the Secretary shall provide to the 
sponsor or applicant an opportunity for a meeting at which the 
director and the sponsor or applicant will be present and at 
which the director documents the scientific issue involved.
  (E) The written decisions of the reviewing division shall be 
binding upon, and may not directly or indirectly be changed by, 
the field or compliance office personnel unless such field or 
compliance office personnel demonstrate to the reviewing 
division why such decision should be modified. For purposes of 
this paragraph, the reviewing division is the division 
responsible for the review of an application under this 
subsection (including scientific matters, chemistry, 
manufacturing, and controls).
  (F) No action by the reviewing division may at any time be 
delayed because of the unavailability of information from or 
action by field personnel unless the reviewing division 
determines that a delay is necessary to assure the marketing of 
a safe and effective drug.
  [(3)] (4) Subject to paragraph [(4)] (5), the Secretary shall 
approve an application for a drug unless the Secretary finds--
          (A) * * *
          * * * * * * *
          (I) the approval under subsection (c) of the listed 
        drug referred to in the application under this 
        subsection has been withdrawn or suspended for grounds 
        described in the first sentence of subsection (e), the 
        Secretary has published a notice of opportunity for 
        hearing to withdraw approval of the listed drug under 
        subsection (c) for grounds described in the first 
        sentence of subsection (e), the approval under this 
        subsection of the listed drug referred to in the 
        application under this subsection has been withdrawn or 
        suspended under paragraph [(5)] (6), or the Secretary 
        has determined that the listed drug has been withdrawn 
        from sale for safety or effectiveness reasons;
          * * * * * * *
  [(4)] (5)(A) Within one hundred and eighty days of the 
initial receipt of an application under paragraph (2) or within 
such additional period as may be agreed upon by the Secretary 
and the applicant, the Secretary shall approve or disapprove 
the application.
          * * * * * * *
  [(5)] (6) If a drug approved under this subsection refers in 
its approved application to a drug the approval of which was 
withdrawn or suspended for grounds described in the first 
sentence of subsection (e) or was withdrawn or suspended under 
this paragraph or which, as determined by the Secretary, has 
been withdrawn from sale for safety or effectiveness reasons, 
the approval of the drug under this subsection shall be 
withdrawn or suspended--
          (A) * * *
          * * * * * * *
  [(6)] (7)(A)(i) Within sixty days of the date of the 
enactment of this subsection, the Secretary shall publish and 
make available to the public--
          (I) * * *
          * * * * * * *
  (C) If the approval of a drug was withdrawn or suspended for 
grounds described in the first sentence of subsection (e) or 
was withdrawn or suspended under paragraph [(5)] (6) or if the 
Secretary determines that a drug has been withdrawn from sale 
for safety or effectiveness reasons, it may not be published in 
the list under subparagraph (A) or, if the withdrawal or 
suspension occurred after its publication in such list, it 
shall be immediately removed from such list--
          (i) for the same period as the withdrawal or 
        suspension under subsection (e) or paragraph [(5)] (6), 
        or
          * * * * * * *
  [(7)] (8) For purposes of this subsection:
          (A) The term ``bioavailability'' means the rate and 
        extent to which the active ingredient or therapeutic 
        ingredient is absorbed from a drug and becomes 
        available at the site of drug action.
          * * * * * * *
  [(8)] (9) The Secretary shall, with respect to each 
application submitted under this subsection, maintain a record 
of--
          (A) * * *
          * * * * * * *
  (n)(1) For the purpose of providing expert scientific advice 
and recommendations to the Secretary regarding a clinical 
investigation of a drug or the approval for marketing of a drug 
under section 505 or section 351 of the Public Health Service 
Act, the Secretary shall establish panels of experts or use 
panels of experts established before the date of the enactment 
of this subsection, or both.
  (2) The Secretary may delegate the appointment and oversight 
authority granted under section 904 to a director of a center 
or successor entity within the Food and Drug Administration.
  (3) The Secretary shall make appointments to each panel 
established under paragraph (1) so that each panel shall 
consist of--
          (A) members who are qualified by training and 
        experience to evaluate the safety and effectiveness of 
        the drugs to be referred to the panel and who, to the 
        extent feasible, possess skill and experience in the 
        development, manufacture, or utilization of such drugs;
          (B) members with diverse expertise in such fields as 
        clinical and administrative medicine, pharmacy, 
        pharmacology, pharmacoeconomics, biological and 
        physical sciences, and other related professions;
          (C) a representative of consumer interests and a 
        representative of interests of the drug manufacturing 
        industry not directly affected by the matter to be 
        brought before the panel; and
          (D) 2 or more members who are specialists or have 
        other expertise in the particular disease or condition 
        for which the drug under review is proposed to be 
        indicated.
Scientific, trade, and consumer organizations shall be afforded 
an opportunity to nominate individuals for appointment to the 
panels. No individual who is in the regular full-time employ of 
the United States and engaged in the administration of this Act 
may be a voting member of any panel. The Secretary shall 
designate one of the members of each panel to serve as chairman 
thereof.
  (4) Each member of a panel shall publicly disclose all 
conflicts of interest that member may have with the work to be 
undertaken by the panel. No member of a panel may vote on any 
matter where the member or the immediate family of such member 
could gain financially from the advice given to the Secretary. 
The Secretary may grant a waiver of any conflict of interest 
upon public disclosure of such conflict of interest if such 
waiver is necessary to afford the panel essential expertise, 
except that the Secretary may not grant a waiver for a member 
of a panel when the member's own scientific work is involved.
  (5) The Secretary shall provide education and training to 
each new panel member before such member participates in a 
panel's activities, including education regarding requirements 
under this Act and related regulations of the Secretary, and 
the administrative processes and procedures related to panel 
meetings.
  (6) Panel members (other than officers or employees of the 
United States), while attending meetings or conferences of a 
panel or otherwise engaged in its business, shall be entitled 
to receive compensation for each day so engaged, including 
traveltime, at rates to be fixed by the Secretary, but not to 
exceed the daily equivalent of the rate in effect for positions 
classified above grade GS-15 of the General Schedule. While 
serving away from their homes or regular places of business, 
panel members may be allowed travel expenses (including per 
diem in lieu of subsistence) as authorized by section 5703 of 
title 5, United States Code, for persons in the Government 
service employed intermittently.
  (7) The Secretary shall ensure that scientific advisory 
panels meet regularly and at appropriate intervals so that any 
matter to be reviewed by such panel can be presented to the 
panel not more than 60 days after the matter is ready for such 
review. Meetings of the panel may be held using electronic 
communication to convene the meeting.
  (8) Within 60 days after a scientific advisory panel makes 
recommendations on any matter under its review, the Food and 
Drug Administration official responsible for the matter shall 
review the conclusions and recommendations of the panel, and 
notify the affected persons of the final decision on the 
matter, or of the reasons that no such decision has been 
reached. Each such final decision shall be documented including 
the rationale for the decision.
  (9) A scientific advisory panel under this subsection shall 
not be subject to the annual chartering and annual report 
requirements of the Federal Advisory Committee Act.


                       pediatric studies of drugs


  Sec. 505A. (a) Market Exclusivity for New Drugs.--If, prior 
to approval of an application that is submitted under section 
505(b)(1), the Secretary determines that information relating 
to the use of a drug in the pediatric population may produce 
health benefits in that population, the Secretary makes a 
written request for pediatric studies (which shall include a 
timeframe for completing such studies), and such studies are 
completed within any such timeframe and the reports thereof 
submitted in accordance with subsection (d)(2) or accepted in 
accordance with subsection (d)(3)--
          (1)(A) the period during which an application may not 
        be submitted under subsections (c)(3)(D)(ii) and 
        (j)(4)(D)(ii) of section 505 shall be five years and 
        six months rather than five years, and the references 
        in subsections (c)(3)(D)(ii) and (j)(4)(D)(ii) of 
        section 505 to four years, to forty-eight months, and 
        to seven and one-half years shall be deemed to be four 
        and one-half years, fifty-four months, and eight years, 
        respectively; or
          (B) the period of market exclusivity under 
        subsections (c)(3)(D)(iii) and (iv) and (j)(4)(D)(iii) 
        and (iv) of section 505 shall be three years and six 
        months rather than three years; and
          (2)(A) if the drug is the subject of--
                  (i) a listed patent for which a certification 
                has been submitted under subsections 
                (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of section 
                505 and for which pediatric studies were 
                submitted prior to the expiration of the patent 
                (including any patent extensions); or
                  (ii) a listed patent for which a 
                certification has been submitted under 
                subsections (b)(2)(A)(iii) or 
                (j)(2)(A)(vii)(III) of section 505,
        the period during which an application may not be 
        approved under section 505(c)(3) or section 
        505(j)(4)(B) shall be extended by a period of six 
        months after the date the patent expires (including any 
        patent extensions); or
          (B) if the drug is the subject of a listed patent for 
        which a certification has been submitted under 
        subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of 
        section 505, and in the patent infringement litigation 
        resulting from the certification the court determines 
        that the patent is valid and would be infringed, the 
        period during which an application may not be approved 
        under section 505(c)(3) or section 505(j)(4)(B) shall 
        be extended by a period of six months after the date 
        the patent expires (including any patent extensions).
  (b) Secretary To Develop List of Drugs for Which Additional 
Pediatric Information May Be Beneficial.--Not later than 180 
days after the date of enactment of this section, the 
Secretary, after consultation with experts in pediatric 
research shall develop, prioritize, and publish an initial list 
of approved drugs for which additional pediatric information 
may produce health benefits in the pediatric population. The 
Secretary shall annually update the list.
  (c) Market Exclusivity for Already-Marketed Drugs.--If the 
Secretary makes a written request to the holder of an approved 
application under section 505(b)(1) for pediatric studies 
(which shall include a timeframe for completing such studies) 
concerning a drug identified in the list described in 
subsection (b), the holder agrees to the request, the studies 
are completed within any such timeframe and the reports thereof 
are submitted in accordance with subsection (d)(2) or accepted 
in accordance with subsection (d)(3)--
          (1)(A) the period during which an application may not 
        be submitted under subsection (c)(3)(D)(ii) or 
        (j)(4)(D)(ii) of section 505 shall be five years and 
        six months rather than five years, and the references 
        in subsections (c)(3)(D)(ii) and (j)(4)(D)(ii) of 
        section 505 to four years, to forty-eight months, and 
        to seven and one-half years shall be deemed to be four 
        and one-half years, fifty-four months, and eight years, 
        respectively; or
          (B) the period of market exclusivity under 
        subsections (c)(3)(D)(iii) and (iv) and (j)(4)(D)(iii) 
        and (iv) of section 505 shall be three years and six 
        months rather than three years; and
          (2)(A) if the drug is the subject of--
                  (i) a listed patent for which a certification 
                has been submitted under subsection 
                (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of section 
                505 and for which pediatric studies were 
                submitted prior to the expiration of the patent 
                (including any patent extensions); or
                  (ii) a listed patent for which a 
                certification has been submitted under 
                subsection (b)(2)(A)(iii) or 
                (j)(2)(A)(vii)(III) of section 505,
        the period during which an application may not be 
        approved under section 505(c)(3) or section 
        505(j)(4)(B) shall be extended by a period of six 
        months after the date the patent expires (including any 
        patent extensions); or
          (B) if the drug is the subject of a listed patent for 
        which a certification has been submitted under 
        subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of 
        section 505, and in the patent infringement litigation 
        resulting from the certification the court determines 
        that the patent is valid and would be infringed, the 
        period during which an application may not be approved 
        under section 505(c)(3) or section 505(j)(4)(B) shall 
        be extended by a period of six months after the date 
        the patent expires (including any patent extensions).
  (d) Conduct of Pediatric Studies.--
          (1) Agreement for studies.--The Secretary may, 
        pursuant to a written request for studies, after 
        consultation with--
                  (A) the sponsor of an application for an 
                investigational new drug under section 505(i);
                  (B) the sponsor of an application for a drug 
                under section 505(b)(1); or
                  (C) the holder of an approved application for 
                a drug under section 505(b)(1),
        agree with the sponsor or holder for the conduct of 
        pediatric studies for such drug.
          (2) Written protocols to meet the studies 
        requirement.--If the sponsor or holder and the 
        Secretary agree upon written protocols for the studies, 
        the studies requirement of subsection (a) or (c) is 
        satisfied upon the completion of the studies and 
        submission of the reports thereof in accordance with 
        the original written request and the written agreement 
        referred to in paragraph (1). Not later than 60 days 
        after the submission of the report of the studies, the 
        Secretary shall determine if such studies were or were 
        not conducted in accordance with the original written 
        request and the written agreement and reported in 
        accordance with the requirements of the Secretary for 
        filing and so notify the sponsor or holder.
          (3) Other methods to meet the studies requirement.--
        If the sponsor or holder and the Secretary have not 
        agreed in writing on the protocols for the studies, the 
        studies requirement of subsection (a) or (c) is 
        satisfied when such studies have been completed and the 
        reports accepted by the Secretary. Not later than 90 
        days after the submission of the reports of the 
        studies, the Secretary shall accept or reject such 
        reports and so notify the sponsor or holder. The 
        Secretary's only responsibility in accepting or 
        rejecting the reports shall be to determine, within the 
        90 days, whether the studies fairly respond to the 
        written request, whether such studies have been 
        conducted in accordance with commonly accepted 
        scientific principles and protocols, and whether such 
        studies have been reported in accordance with the 
        requirements of the Secretary for filing.
  (e) Delay of Effective Date for Certain Applications; Period 
of Market Exclusivity.--If the Secretary determines that the 
acceptance or approval of an application under section 
505(b)(2) or 505(j) for a drug may occur after submission of 
reports of pediatric studies under this section, which were 
submitted prior to the expiration of the patent (including any 
patent extension) or market exclusivity protection, but before 
the Secretary has determined whether the requirements of 
subsection (d) have been satisfied, the Secretary shall delay 
the acceptance or approval under section 505(b)(2) or 505(j), 
respectively, until the determination under subsection (d) is 
made, but such delay shall not exceed 90 days. In the event 
that requirements of this section are satisfied, the applicable 
period of market exclusivity referred to in subsection (a) or 
(c) shall be deemed to have been running during the period of 
delay.
  (f) Notice of Determinations on Studies Requirement.--The 
Secretary shall publish a notice of any determination that the 
requirements of subsection (d) have been met and that 
submissions and approvals under section 505(b)(2) or (j) for a 
drug will be subject to the provisions of this section.
  (g) Definitions.--As used in this section, the term 
``pediatric studies'' or ``studies'' means at least one 
clinical investigation (that, at the Secretary's discretion, 
may include pharmacokinetic studies) in pediatric age groups in 
which a drug is anticipated to be used.
  (h) Limitation.--The holder of an approved application for a 
new drug that has already received six months of market 
exclusivity under subsection (a) or (c) may, if otherwise 
eligible, obtain six months of market exclusivity under 
subsection (c)(1)(B) for a supplemental application, except 
that the holder is not eligible for exclusivity under 
subsection (c)(2).
  (i) Relationship to Regulations.--Notwithstanding any other 
provision of law, if any pediatric study is required pursuant 
to regulations promulgated by the Secretary, such study shall 
be deemed to satisfy the requirement for market exclusivity 
pursuant to this section.
  (j) Sunset.--No period of market exclusivity shall be granted 
under this section based on studies commenced after January 1, 
2002. The Secretary shall conduct a study and report to 
Congress not later than January 1, 2001, based on the 
experience under the program. The study and report shall 
examine all relevant issues, including--
          (1) the effectiveness of the program in improving 
        information about important pediatric uses for approved 
        drugs;
          (2) the adequacy of the incentive provided under this 
        section;
          (3) the economic impact of the program on taxpayers 
        and consumers, including the impact of the lack of 
        lower cost generic drugs on lower income patients; and
          (4) any suggestions for modification that the 
        Secretary deems appropriate.

               [certification of drugs containing insulin

  [Sec. 506. (a) The Secretary, pursuant to regulations 
promulgated by him, shall provide for the certification of 
batches of drugs composed wholly or partly of insulin. A batch 
of any such drug shall be certified if such drug has such 
characteristics of identity and such batch has such 
characteristics of strength, quality, and purity, as the 
Secretary prescribes in such regulations as necessary to 
adequately insure safety and efficacy of use, but shall not 
otherwise be certified. Prior to the effective date of such 
regulations the Secretary, in lieu of certification, shall 
issue a release for any batch which, in his judgment, may be 
released without risk as to the safety and efficacy of its use. 
Such release shall prescribe the date of its expiration and 
other conditions under which it shall cease to be effective as 
to such batch and as to portions thereof.
  [(b) Regulations providing for such certification shall 
contain such provisions as are necessary to carry out the 
purposes of this section, including provisions prescribing (1) 
standards of identity and of strength, quality, and purity; (2) 
tests and methods of assay to determine compliance with such 
standards; (3) effective periods for certificates, and other 
conditions under which they shall cease to be effective as to 
certified batches and as to portions thereof; (4) 
administration and procedure; and (5) such fees, specified in 
such regulations, as are necessary to provide, equip, and 
maintain an adequate certification service. Such regulations 
shall prescribe no standard of identity or of strength, 
quality, or purity for any drug different from the standard of 
identity, strength, quality, or purity set forth for such drug 
in an official compendium.
  [(c) Such regulations, insofar as they prescribe tests or 
methods of assay to determine strength, quality, or purity of 
any drug, different from the tests or methods of assay set 
forth for such drug in an official compendium, shall be 
prescribed, after notice and opportunity for revision of such 
compendium, in the manner provided in the second sentence of 
section 501(b). The provisions of subsections (e), (f), and (g) 
of section 701 shall be applicable to such portion of any 
regulation as prescribes any such different test or method, but 
shall not be applicable to any other portion of any such 
regulation.

                     [certification of antibiotics

  [Sec. 507. (a) The Secretary, pursuant to regulations 
promulgated by him, shall provide for the certification of 
batches of drugs (except drugs for use in animals other than 
man) composed wholly or partly of any kind of penicillin, 
streptomycin, chlortetracycline, chloramphenicol, bacitracin, 
or any other antibiotic drug, or any derivative thereof. A 
batch of any such drug shall be certified if such drug has such 
characteristics of identity and such batch has such 
characteristics of strength, quality, and purity, as the 
Secretary prescribes in such regulations as necessary to 
adequately insure safety and efficacy of use, but shall not 
otherwise be certified. Prior to the effective date of such 
regulations the Secretary, in lieu of certification, shall 
issue a release for any batch which, in his judgment, may be 
released without risk as to the safety and efficacy of its use. 
Such release shall prescribe the date of its expiration and 
other conditions under which it shall cease to be effective as 
to such batch and as to portions thereof. For purposes of this 
section and of section 502(l), the term ``antibiotic drug'' 
means any drug intended for use by man containing any quantity 
of any chemical substance which is produced by a micro-organism 
and which has the capacity to inhibit or destroy micro-
organisms in dilute solution (including the chemically 
synthesized equivalent of any such substance).
  [(b) Regulations providing for such certifications shall 
contain such provisions as are necessary to carry out the 
purposes of this section, including provisions prescribing (1) 
standards of identity and of strength, quality, and purity; (2) 
tests and methods of assay to determine compliance with such 
standards; (3) effective periods for certificates, and other 
conditions under which they shall cease to be effective as to 
certified batches and as to portions thereof; (4) 
administration and procedure; and (5) such fees, specified in 
such regulations, as are necessary to provide, equip, and 
maintain an adequate certification service. Such regulations 
shall prescribe only such tests and methods of assay as will 
provide for certification or rejection within the shortest time 
consistent with the purposes of this section.
  [(c) Whenever in the judgment of the Administrator, the 
requirements of this section and of section 502(l) with respect 
to any drug or class of drugs are not necessary to insure 
safety and efficacy of use, the Administrator shall promulgate 
regulations exempting such drug or class of drugs from such 
requirements. In deciding whether an antibiotic drug, or class 
of antibiotic drugs, is to be exempted from the requirement of 
certification the Secretary shall give consideration, among 
other relevant factors, to--
          [(1) whether such drug or class of drugs is 
        manufactured by a person who has, or hereafter shall 
        have, produced fifty consecutive batches of such drug 
        or class of drugs in compliance with the regulations 
        for the certification thereof within a period of not 
        more than eighteen calendar months, upon the 
        application by such person to the Secretary; or
          [(2) whether such drug or class of drugs is 
        manufactured by any person who has otherwise 
        demonstrated such consistency in the production of such 
        drug or class of drugs, in compliance with the 
        regulations for the certification thereof, as in the 
        judgment of the Secretary is adequate to insure the 
        safety and efficacy of use thereof.
When an antibiotic drug or a drug manufacturer has been 
exempted from the requirement of certification, the 
manufacturer may still obtain certification of a batch or 
batches of that drug if he applies for and meets the 
requirements for certification. Nothing in this Act shall be 
deemed to prevent a manufacturer or distributor of an 
antibiotic drug from making a truthful statement in labeling or 
advertising of the product as to whether it has been certified 
or exempted from the requirement of certification.
  [(d) The Administrator shall promulgate regulations exempting 
from any requirement of this section and of section 502(l), (1) 
drugs which are to be stored, processed, labeled, or repacked 
at establishments other than those where manufactured, on 
condition that such drugs comply with all such requirements 
upon removal from such establishments; (2) drugs which conform 
to applicable standards of identity, strength, quality, and 
purity prescribed by these regulations and are intended for use 
in manufacturing other drugs; and (3) drugs which are intended 
solely for investigational use by experts qualified by 
scientific training and experience to investigate the safety 
and efficacy of drugs. Such regulations may, within the 
discretion of the Secretary, among other conditions relating to 
the protection of the public health, provide for conditioning 
the exemption under clause (3) upon--
          [(1) the submission to the Secretary, before any 
        clinical testing of a new drug is undertaken, of 
        reports, by the manufacturer or the sponsor of the 
        investigation of such drug, of preclinical tests 
        (including tests on animals) of such drug adequate to 
        justify the proposed clinical testing;
          [(2) the manufacturer or the sponsor of the 
        investigation of a new drug proposed to be distributed 
        to investigators for clinical testing obtaining a 
        signed agreement from each of such investigators that 
        patients to whom the drug is administered will be under 
        his personal supervision, or under the supervision of 
        investigators responsible to him, and that he will not 
        supply such drug to any other investigator, or to 
        clinics, for administration to human beings; and
          [(3) the establishment and maintenance of such 
        records, and the making of such reports to the 
        Secretary, by the manufacturer or the sponsor of the 
        investigation of such drug, of data (including but not 
        limited to analytical reports by investigators) 
        obtained as the result of such investigational use of 
        such drug, as the Secretary finds will enable him to 
        evaluate the safety and effectiveness of such drug in 
        the event of the filing of an application for 
        certification or release pursuant to subsection (a).
Such regulations shall provide that such exemption shall be 
conditioned upon the manufacturer, or the sponsor of the 
investigation,requiring that experts using such drugs for 
investigational purposes certify to such manufacturer or sponsor that 
they will inform any human beings to whom such drugs, or any controls 
used in connection therewith, are being administered, or their 
representatives, that such drugs are being used for investigational 
purposes and will obtain the consent of such human beings or their 
representatives, except where they deem it not feasible or, in their 
professional judgment, contrary to the best interests of such human 
beings. Nothing in this subsection shall be construed to require any 
clinical investigator to submit directly to the Secretary reports on 
the investigational use of drugs.
  [(e) No drug which is subject to this section shall be deemed 
to be subject to any provision of section 505 except a new drug 
exempted from the requirements of this section and of section 
502(l) pursuant to regulations promulgated by the Secretary. 
For purposes of section 505, the initial request for 
certification, as thereafter duly amended, pursuant to this 
section, of a new drug so exempted shall be considered a part 
of the application filed pursuant to section 505(b) with 
respect to the person filing such request and to such drug as 
of the date of the exemption. Compliance of any drug subject to 
section 502(l) or this section with section 501(b) and 502(g) 
shall be determined by the application of the standards of 
strength, quality, and purity, the tests and methods of assay, 
and the requirements of packaging, and labeling, respectively, 
prescribed by regulations promulgated under this section.
  [(f) Any interested person may file with the Administrator a 
petition proposing the issuance, amendment, or repeal of any 
regulation contemplated by this section. The petition shall set 
forth the proposal in general terms and shall state reasonable 
grounds therefor. The Administrator shall give public notice of 
the proposal and an opportunity for all interested persons to 
present their views thereon, orally or in writing, and as soon 
as practicable thereafter shall make public his action upon 
such proposal. At any time prior to the thirtieth day after 
such action is made public any interested person may file 
objections to such action, specifying with particularity the 
changes desired, stating reasonable grounds therefor, and 
requesting a public hearing upon such objections. The 
Administrator shall thereupon, after due notice, hold such 
public hearing. As soon as practicable after completion of the 
hearing, the Administrator shall by order make public his 
action on such objections. The Administrator shall base his 
order only on substantial evidence of record at the hearing and 
shall set forth as part of the order detailed findings of fact 
on which the order is based. The order shall be subject to the 
provision of section 701 (f) and (g).
  [(g)(1) Every person engaged in manufacturing, compounding, 
or processing any drug within the purview of this section with 
respect to which a certificate or release has been issued 
pursuant to this section shall establish and maintain such 
records, and make such reports to the Secretary, of data 
relating to clinical experience and other data or information, 
received or otherwise obtained by such person with respect to 
such drug, as the Secretary may by general regulation, or by 
order with respect to such certification or release, prescribe 
on the basis of a finding that such records and reports are 
necessary in order to enable the Secretary to make, or to 
facilitate, a determination as to whether such certification or 
release should be rescinded or whether any regulation issued 
under this section should be amended or repealed. Regulations 
and orders issued under this subsection and under clause (3) of 
subsection (d) shall have due regard for the professional 
ethics of the medical profession and the interests of patients 
and shall provide, where the Secretary deems it to be 
appropriate, for the examination, upon request, by the persons 
to whom such regulations or orders are applicable, of similar 
information received or otherwise obtained by the Secretary.
  [(2) Every person required under this section to maintain 
records, and every person having charge or custody thereof, 
shall, upon request of an officer or employee designated by the 
Secretary, permit such officer or employee at all reasonable 
times to have access to and copy and verify such records.
  [(h) In the case of a drug for which, on the day immediately 
preceding the effective date of this subsection, a prior 
approval of an application under section 505 had not been 
withdrawn under section 505(e), the initial issuance of 
regulations providing for certification or exemption of such 
drug under this section shall, with respect to the conditions 
of use prescribed, recommended, or suggested in the labeling 
covered by such application, not be conditioned upon an 
affirmative finding of the efficacy of such drug. Any 
subsequent amendment or repeal of such regulations so as no 
longer to provide for such certification or exemption on the 
ground of a lack of efficacy of such drug for use under such 
conditions of use may be effected only on or after that 
effective date of clause (3) of the first sentence of section 
505(e) which would be applicable to such drug under such 
conditions of use if such drug were subject to section 505(e), 
and then only if (1) such amendment or repeal is made in 
accordance with the procedure specified in subsection (f) of 
this section (except that such amendment or repeal may be 
initiated either by a proposal of the Secretary or by a 
petition of any interested person) and (2) the Secretary finds, 
on the basis of new information with respect to such drug 
evaluated together with the information before him when the 
application under section 505 became effective or was approved, 
that there is a lack of substantial evidence (as defined in 
section 505(d)) that the drug has the effect it purports or is 
represented to have under such conditions of use.]


                           dispute resolution


  Sec. 506. If, regarding an obligation under this Act, there 
is a scientific controversy between the Secretary and a person 
who is a sponsor, applicant, or manufacturer and no specific 
provision of this Act or regulation promulgated under this Act 
provides a right of review of the matter in controversy, the 
Secretary shall, by regulation, establish a procedure under 
which such sponsor, applicant, or manufacturer may request a 
review of such controversy by an appropriate scientific 
advisory panel under section 505(n). Such review shall take 
place in a timely manner. The Secretary shall promulgate such 
regulations within 180 days of the date of the enactment of the 
Prescription Drug User Fee Reauthorization and Medical Device 
Regulatory Modernization Act of 1997.
          * * * * * * *

             registration of producers of drugs and devices

  Sec. 510. (a) * * *
          * * * * * * *
  (j)(1) Every person who registers with the Secretary under 
subsection (b), (c), or (d) shall, at the time of registration 
under any such subsection, file with the Secretary a list of 
all drugs and a list of all devices and a brief statement of 
the basis for believing that each device included in the list 
is a device rather than a drug (with each drug and device in 
each list listed by its established name (as defined in section 
502(e)) and by any proprietary name) which are being 
manufactured, prepared, propagated, compounded, or processed by 
him for commercial distribution and which he has not included 
in any list of drugs or devices filed by him with the Secretary 
under this paragraph or paragraph (2) before such time of 
registration. Such list shall be prepared in such form and 
manner as the Secretary may prescribe and shall be accompanied 
by--
          (A) in the case of a drug contained in the applicable 
        list and subject to section 505[, 506, 507,] or 512, or 
        a device intended for human use contained in the 
        applicable list with respect to which a performance 
        standard has been established under section 514 or 
        which is subject to section 515, a reference to the 
        authority for the marketing of such drug or device and 
        a copy of all labeling for such drug or device;
          * * * * * * *
          (D) if the registrant filing a list has determined 
        that a particular drug product or device contained in 
        such list is not subject to section 505[, 506, 507,] or 
        512, or the particular device contained in such list is 
        not subject to a performance standard established under 
        section 514 or to section 515 or is not a restricted 
        device, a brief statement of the basis upon which the 
        registrant made such determination if the Secretary 
        requests such a statement with respect to that 
        particular drug product or device.
          * * * * * * *

                            new animal drugs

  Sec. 512. (a) * * *
          * * * * * * *
  (c)(1) * * *
          * * * * * * *
  (4) A drug manufactured in a pilot or other small facility 
may be used to demonstrate the safety and effectiveness of the 
drug and to obtain approval prior to scaling up to a larger 
facility, unless the Secretary makes a determination that a 
full scale production facility is necessary to ensure the 
safety or effectiveness of the drug.
          * * * * * * *

general provisions respecting control of devices intended for human use

                              General Rule

  Sec. 520. (a) * * *
          * * * * * * *

    Transitional Provisions for Devices Considered as New Drugs [or 
                           Antibiotic Drugs]

  (l)(1) * * *
          * * * * * * *
  [(4) Any device intended for human use which on the enactment 
date was subject to the requirements of section 507 shall be 
subject to such requirements as follows:
          [(A) In the case of such a device which is classified 
        into class I, such requirements shall apply to such 
        device until the effective date of the regulation 
        classifying the device into such class.
          [(B) In the case of such a device which is classified 
        into class II, such requirements shall apply to such 
        device until the effective date of a performance 
        standard applicable to the device under section 514.
          [(C) In the case of such a device which is classified 
        into class III, such requirements shall apply to such 
        device until the date on which the device is required 
        to have in effect an approved application under section 
        515.]
          * * * * * * *

          Subchapter B--Drugs for Rare Diseases or Conditions

   recommendations for investigations of drugs for rare diseases or 
                               conditions

  Sec. 525. (a) The sponsor of a drug for a disease or 
condition which is rare in the States may request the Secretary 
to provide written recommendations for the nonclinical and 
clinical investigations which must be conducted with the drug 
before--
          (1) it may be approved for such disease or condition 
        under section 505, or
          [(2) if the drug is an antibiotic, it may be 
        certified for such disease or condition under section 
        507, or]
          [(3)] (2) if the drug is a biological product, it may 
        be licensed for such disease or condition under section 
        351 of the Public Health Service Act.
If the Secretary has reason to believe that a drug for which a 
request is made under this section is a drug for a disease or 
condition which is rare in the States, the Secretary shall 
provide the person making the request written recommendations 
for the nonclinicaland clinical investigations which the 
Secretary believes, on the basis of information available to the 
Secretary at the time of the request under this section, would be 
necessary for approval of such drug for such disease or condition under 
section 505[, certification of such drug for such disease or condition 
under section 507,] or licensing of such drug for such disease or 
condition under section 351 of the Public Health Service Act.
          * * * * * * *

          designation of drugs for rare diseases or conditions

  Sec. 526. (a)(1) The manufacturer or the sponsor of a drug 
may request the Secretary to designate the drug as a drug for a 
rare disease or condition. A request for designation of a drug 
shall be made before the submission of an application under 
section 505(b) for the drug, [the submission of an application 
for certification of the drug under section 507,] or the 
submission of an application for licensing of the drug under 
section 351 of the Public Health Service Act. If the Secretary 
finds that a drug for which a request is submitted under this 
subsection is being or will be investigated for a rare disease 
or condition and--
          (A) if an application for such drug is approved under 
        section 505, or
          [(B) if a certification for such drug is issued under 
        section 507, or]
          [(C)] (B) if a license for such drug is issued under 
        section 351 of the Public Health Service Act,
the approval, certification, or license would be for use for 
such disease or condition, the Secretary shall designate the 
drug as a drug for such disease or condition. A request for a 
designation of a drug under this subsection shall contain the 
consent of the applicant to notice being given by the Secretary 
under subsection (b) respecting the designation of the drug.
          * * * * * * *
  (b) A designation of a drug under subsection (a) shall be 
subject to the condition that--
          (1) if an application was approved for the drug under 
        section 505(b)[, a certificate was issued for the drug 
        under section 507,] or a license was issued for the 
        drug under section 351 of the Public Health Service 
        Act, the manufacturer of the drug will notify the 
        Secretary of any discontinuance of the production of 
        the drug at least one year before discontinuance, and
          (2) if an application has not been approved for the 
        drug under section 505(b)[, a certificate has not been 
        issued for the drug under section 507,] or a license 
        has not been issued for the drug under section 351 of 
        the Public Health Service Act and if preclinical 
        investigations or investigations under section 505(i) 
        are being conducted with the drug, the manufacturer or 
        sponsor of the drug will notify the Secretary of any 
        decision to discontinue active pursuit of approval of 
        an application under section 505(b)[, approval of an 
        application for certification under section 507,] or 
        approval of a license under section 351 of the Public 
        Health Service Act.
          * * * * * * *

          protection for drugs for rare diseases or conditions

  Sec. 527. (a) Except as provided in subsection (b), if the 
Secretary--
          (1) approves an application filed pursuant to section 
        505, or
          [(2) issues a certification under section 507, or]
          [(3)] (2) issues a license under section 351 of the 
        Public Health Service Act
for a drug designated under section 526 for a rare disease or 
condition, the Secretary may not approve another application 
under section 505[, issue another certification under section 
507,] or issue another license under section 351 of the Public 
Health Service Act for such drug for such disease or condition 
for a person who is not the holder of such approved 
application, of such certification, or of such license until 
the expiration of seven years from the date of the approval of 
the approved application, the issuance of the certification, or 
the issuance of the license. Section 505(c)(2) does not apply 
to the refusal to approve an application under the preceding 
sentence.
  (b) If an application filed pursuant to section 505 is 
approved for a drug designated under section 526 for a rare 
disease or condition[, if a certification is issued under 
section 507 for such a drug, or] if a license is issued under 
section 351 of the Public Health Service Act for such a drug, 
the Secretary may, during the seven-year period beginning on 
the date of the application approval, [of the issuance of the 
certification under section 507,] or of the issuance of the 
license, approve another application under section 505, [issue 
another certification under section 507, or] issue a license 
under section 351 of the Public Health Service Act, for such 
drug for such disease or condition for a person who is not the 
holder of such approved application, of such certification, or 
of such license if--
          (1) * * *
          * * * * * * *

           Subchapter D--Unapproved Therapies and Diagnostics

SEC. 551. EXPANDED ACCESS TO UNAPPROVED THERAPIES AND DIAGNOSTICS.

  (a) Emergency Situations.--The Secretary may, under 
appropriate conditions determined by the Secretary, authorize 
the shipment of investigational drugs (as defined in 
regulations prescribed by the Secretary) for the diagnosis or 
treatment of a serious disease or condition in emergency 
situations.
  (b) Individual Patient Access to Investigational Products 
Intended for Serious Diseases.--Any person, acting through a 
physician licensed in accordance with State law, may request 
from a manufacturer or distributor, and any manufacturer or 
distributor may provide to such physician after compliance with 
the provisions of this subsection, an investigational drug (as 
defined in regulations prescribed by the Secretary) for the 
diagnosis or treatment of a serious disease or condition if--
          (1) the licensed physician determines that the person 
        has no comparable or satisfactory alternative therapy 
        available to diagnose or treat the disease or condition 
        involved, and that the risk to the person from the 
        investigational drug is not greater than the risk from 
        the disease or condition;
          (2) the Secretary determines that there is sufficient 
        evidence of safety and effectiveness to support the use 
        of the investigational drug in the case described in 
        paragraph (1);
          (3) the Secretary determines that provision of the 
        investigational drug will not interfere with the 
        initiation, conduct, or completion of clinical 
        investigations to support marketing approval; and
          (4) the sponsor, or clinical investigator, of the 
        investigational drug submits to the Secretary a 
        clinical protocol consistent with the provisions of 
        section 505(i) and any regulations promulgated under 
        section 505(i) describing the use of investigational 
        drugs in a single patient or a small group of patients.
  (c) Treatment INDs.--Upon submission by a sponsor or a 
physician of a protocol intended to provide widespread access 
to an investigational drug for eligible patients, the Secretary 
shall permit such investigational drug to be made available for 
expanded access under a treatment investigational new drug 
application if the Secretary determines that--
          (1) under the treatment investigational new drug 
        application, the investigational drug is intended for 
        use in the diagnosis or treatment of a serious or 
        immediately life-threatening disease or condition;
          (2) there is no comparable or satisfactory 
        alternative therapy available to diagnose or treat that 
        stage of disease or condition in the population of 
        patients to which the investigational drug is intended 
        to be administered;
          (3)(A) the investigational drug is under 
        investigation in a controlled clinical trial for the 
        use described in paragraph (1) under an effective 
        investigational new drug application; or
          (B) all clinical trials necessary for approval of 
        that use of the investigational drug have been 
        completed;
          (4) the sponsor of the controlled clinical trials is 
        actively pursuing marketing approval of the 
        investigational drug for the use described in paragraph 
        (1) with due diligence;
          (5) the provision of the investigational drug will 
        not interfere with the enrollment of patients in 
        ongoing clinical investigations under section 505(i);
          (6) in the case of serious diseases, there is 
        sufficient evidence of safety and effectiveness to 
        support the use described in paragraph (1); and
          (7) in the case of immediately life-threatening 
        diseases, the available scientific evidence, taken as a 
        whole, provides a reasonable basis to conclude that the 
        product may be effective for its intended use and would 
        not expose patients to an unreasonable and significant 
        risk of illness or injury.
A protocol submitted under this subsection shall be subject to 
the provisions of section 505(i) and regulations promulgated 
under section 505(i). The Secretary may inform national, State, 
and local medical associations and societies, voluntary health 
associations, and other appropriate persons about the 
availability of an investigational drug under expanded access 
protocols submitted under this subsection. The information 
provided by the Secretary, in accordance with the preceding 
sentence, shall be of the same type of information that is 
required by section 402(j)(3) of the Public Health Service Act.
  (d) Termination.--The Secretary may, at any time, with 
respect to a sponsor, physician, manufacturer, or distributor 
described in this section, terminate expanded access provided 
under this section for an investigational drug if the 
requirements under this section are no longer met.
          * * * * * * *

                     CHAPTER VII--GENERAL AUTHORITY

            Subchapter A--General Administrative Provisions

                        regulations and hearings

  Sec. 701. (a) * * *
          * * * * * * *
  (h)(1)(A) The Secretary shall develop guidance documents with 
public participation and ensure that the existence of such 
documents and the documents themselves are made available to 
the public both in written form and through electronic means. 
Such documents shall not create or confer any rights for or on 
any person, although they present the views of the Secretary on 
matters under the jurisdiction of the Food and Drug 
Administration.
  (B) Although guidance documents shall not be binding on the 
Secretary, the Secretary shall ensure that employees of the 
Food and Drug Administration do not deviate from such guidances 
without appropriate justification and supervisory concurrence.
  (C) For guidance documents that set forth initial 
interpretations of statute or regulation, changes in 
interpretation or policy that are of more than a minor nature, 
complex scientific issues, or highly controversial issues, the 
Secretary shall ensure public participation prior to 
implementation of any guidance documents, unless the Secretary 
determines that for reasons of the public health need, such 
prior public participation is not feasible. In such cases, the 
Secretary shall provide for public comment upon implementation, 
and take such comment into account.
  (D) For guidance documents that set forth existing practices 
or minor changes in policy, the Secretary shall provide for 
public comment upon implementation.
  (2) In developing guidance documents, the Secretary shall 
ensure uniform nomenclature and uniform internal procedures for 
approval of such documents. The Secretary shall ensure that 
guidance documents and revisions of such documents are properly 
dated and indicate the nonbinding nature of the documents.
  (3) The Secretary, through the Food and Drug Administration, 
shall maintain electronically and publish periodically in the 
Federal Register a list of guidance documents. Such list shall 
be updated quarterly. All such documents shall be made 
available to the public.
  (4) The Secretary shall report to the Committee on Commerce 
of the House of Representatives and the Committee on Labor and 
Human Resources of the Senate no later than July 1, 2000, on 
the implementation of these practices.
          * * * * * * *

                           factory inspection

  Sec. 704. (a)(1) For purposes of enforcement of this Act, 
officers or employees duly designated by the Secretary, upon 
presenting appropriate credentials and a written notice to the 
owner, operator, or agent in charge, are authorized (A) to 
enter, at reasonable times, any factory, warehouse, or 
establishment in which food, drugs, devices, or cosmetics are 
manufactured, processed, packed, or held, for introduction into 
interstate commerce or after such introduction, or to enter any 
vehicle, being used to transport or hold such food, drugs, 
devices, or cosmetics in interstate commerce; and (B) to 
inspect, at reasonable times and within reasonable limits and 
in a reasonable manner, such factory, warehouse, establishment, 
or vehicle and all pertinent equipment, finished and unfinished 
materials, containers, and labeling therein. In the case of any 
factory, warehouse, establishment, or consulting laboratory in 
which [prescription drugs] prescription drugs, nonprescription 
drugs intended for human use, or restricted devices are 
manufactured, processed, packed, or held, inspection shall 
extend to all things therein (including records, files, papers, 
processes, controls, and facilities) bearing on whether 
[prescription drugs] prescription drugs, nonprescription drugs 
intended for human use, or restricted devices which are 
adulterated or misbranded within the meaning of this Act, or 
which may not be manufactured, introduced into interstate 
commerce, or sold, or offered for sale by reason of any 
provision of this Act, have been or are being manufactured, 
processed, packed, transported, or held in any such place, or 
otherwise bearing on violation of this Act. No inspection 
authorized by the preceding sentence or by paragraph (3) shall 
extend to financial data, sales data other than shipment data, 
pricing data, personnel data (other than data as to 
qualifications of technical and professional personnel 
performing functions subject to this Act), and research data 
(other than data relating to new drugs, antibiotic drugs, and 
devices and subject to reporting and inspection under 
regulations lawfully issued pursuant to section 505 (i) or 
(k)[, section 507 (d) or (g)], section 519, or 520(g), and data 
relating to other drugs or devices which in the case of a new 
drug would be subject to reporting or inspection under lawful 
regulations issued pursuant to section 505(j)). A separate 
notice shall be given for each such inspection, but a notice 
shall not be required for each entry made during the period 
covered by the inspection. Each such inspection shall be 
commenced and completed with reasonable promptness.
          * * * * * * *

                           Subchapter C--Fees

          * * * * * * *

                     PART 2--FEES RELATING TO DRUGS

SEC. 735. DEFINITIONS.

  For purposes of this subchapter:
          (1) The term ``human drug application'' means an 
        application for--
                  (A) approval of a new drug submitted under 
                section 505(b)(1),
                  (B) approval of a new drug submitted under 
                section 505(b)(2) after September 30, 1992, 
                which requests approval of--
                          (i) a molecular entity which is an 
                        active ingredient (including any salt 
                        or ester of an active ingredient), or
                          (ii) an indication for a use,
                that had not been approved under an application 
                submitted under section 505(b), or
                  [(C) initial certification or initial 
                approval of an antibiotic drug under section 
                507, or]
                  [(D)] (C) licensure of a biological product 
                under section 351 of the Public Health Service 
                Act.
        Such term does not include a supplement to such an 
        application, does not include an application with 
        respect to whole blood or a blood component for 
        transfusion, does not include an application with 
        respect to a bovine blood product for topical 
        application licensed before September 1, 1992, an 
        allergenic extract product, or an in vitro diagnostic 
        biologic product licensed under section 351 of the 
        Public Health [Service Act, and] Service Act, does not 
        include an application with respect to a large volume 
        parenteral drug product approved before [September 1, 
        1992.] September 1, 1992, does not include an 
        application for a licensure of a biological product for 
        further manufacturing use only, and does not include an 
        application or supplement submitted by a State or 
        Federal Government entity for a drug that is not 
        distributed commercially. Such term does include an 
        application for licensure, as described in subparagraph 
        (D), of a large volume biological product intended for 
        single dose injection for intravenous use or infusion.
          * * * * * * *
          (3) The term ``prescription drug product'' means a 
        specific strength or potency of a drug in final dosage 
        form--
                  (A) for which a human drug application has 
                been approved, and
                  (B) which may be dispensed only under 
                prescription pursuant to section 503(b).
        Such term does not include whole blood or a blood 
        component for transfusion, does not include a bovine 
        blood product for topical application licensed before 
        September 1, 1992, an allergenic extract product, or an 
        in vitro diagnostic biologic product licensed under 
        section 351 of the Public Health [Service Act, and] 
        Service Act, does not include a large volume parenteral 
        drug product approved before [September 1, 1992.] 
        September 1, 1992, does not include a biological 
        product that is licensed for further manufacturing use 
        only, and does not include a drug that is not 
        distributed commercially and is the subject of an 
        application or supplement submitted by a State or 
        Federal Government entity. Such term does include a 
        large volume biological product intended for single 
        dose injection for intravenous use or infusion.
          (4) The term ``final dosage form'' means, with 
        respect to a prescription drug product, a finished 
        dosage form which is approved for administration to a 
        patient [without] without substantial further 
        manufacturing.
          [(5) The term ``prescription drug establishment'' 
        means a foreign or domestic place of business which 
        is--
                  [(A) at one general physical location 
                consisting of one or more buildings all of 
                which are within 5 miles of each other, at 
                which one or more prescription drug products 
                are manufactured in final dosage form, and
                  [(B) under the management of a person that is 
                listed as the applicant in a human drug 
                application for a prescription drug product 
                with respect to at least one such product.
        For purposes of this paragraph, the term 
        ``manufactured'' does not include packaging.]
          (5) The term ``prescription drug establishment'' 
        means a foreign or domestic place of business which is 
        at one general physical location consisting of one or 
        more buildings all of which are within 5 miles of each 
        other and at which one or more prescription drug 
        products are manufactured in final dosage form.
          * * * * * * *
          (7) The term ``costs of resources allocated for the 
        process for the review of human drug applications'' 
        means the expenses incurred in connection with the 
        process for the review of human drug applications for--
                  (A) officers and employees of the Food and 
                Drug Administration, [employees under contract 
                with the Food and Drug Administration who work 
                in facilities owned or leased for the Food and 
                Drug Administration,] contractors of the Food 
                and Drug Administration, advisory committees, 
                and costs related to such officers, employees, 
                [and committees,] and committees and to 
                contracts with such contractors,
          * * * * * * *
          (8) The term ``adjustment factor'' applicable to a 
        fiscal year is the lower of--
                  (A) the Consumer Price Index for all urban 
                consumers (all items; United States city 
                average) for [August of] April of the preceding 
                fiscal year divided by such Index for [August 
                1992] April 1997, or
                  (B) the total of discretionary budget 
                authority provided for programs in the domestic 
                category for the immediately preceding fiscal 
                year (as reported in the Office of Management 
                and Budget sequestration preview report, if 
                available, required under section 254(d) of the 
                Balanced Budget and Emergency Deficit Control 
                Act of 1985) divided by such budget authority 
                for fiscal year [1992] 1997 (as reported in the 
                Office of Management and Budget final 
                sequestration report submitted after the end of 
                the 102d Congress, 2d Session).
        [The terms ``budget authority'' and ``category'' in 
        subparagraph (B) are as defined in the Balanced Budget 
        and Emergency Deficit Control Act of 1985, as in effect 
        as of September 1, 1992.]
          (9) The term ``affiliate'' means a business entity 
        that has a relationship with a second business entity 
        if, directly or indirectly--
                  (A) one business entity controls, or has the 
                power to control, the other business entity; or
                  (B) a third party controls, or has power to 
                control, both of the business entities.

SEC. 736. AUTHORITY TO ASSESS AND USE DRUG FEES.

  (a) Types of Fees.--[Beginning in fiscal year 1993] Beginning 
in fiscal year 1998, the Secretary shall assess and collect 
fees in accordance with this section as follows:
          (1) Human drug application and supplement fee.--
                  (A) * * *
                  [(B) Payment schedule.--
                          [(i) First payment.--50 percent of 
                        the fee required by subparagraph (A) 
                        shall be due upon submission of the 
                        application or supplement.
                          [(ii) Final payment.--The remaining 
                        50 percent of the fee required by 
                        subparagraph (A) shall be due upon--
                                  [(I) the expiration of 30 
                                days from the date the 
                                Secretary sends to the 
                                applicant a letter designated 
                                by the Secretary as an action 
                                letter described in section 
                                735(6)(B), or
                                  [(II) the withdrawal of the 
                                application or supplement after 
                                it is filed unless the 
                                Secretary waives the fee or a 
                                portion of the fee because no 
                                substantial work was performed 
                                on such application or 
                                supplement after it was filed.
                        The designation under subclause (I) or 
                        the waiver under subclause (II) shall 
                        be solely in the discretion of the 
                        Secretary and shall not be reviewable.]
                  (B) Payment.--The fee required by 
                subparagraph (A) shall be due upon submission 
                of the application or supplement.
          * * * * * * *
                  (D) Refund of fee if application [not 
                accepted] refused for filing.--The Secretary 
                shall refund [50] 75 percent of the fee paid 
                under [subparagraph (B)(i)] subparagraph (B) 
                for any application or supplement which is [not 
                accepted] refused for filing.
                  (E) Exception for designated orphan drug or 
                indication.--A human drug application for a 
                prescription drug product that has been 
                designated as a drug for a rare disease or 
                condition pursuant to section 526 shall not be 
                subject to a fee under subparagraph (A), unless 
                the human drug application includes indications 
                for other than rare diseases or conditions. A 
                supplement proposing to include a new 
                indication for a rare disease or condition in a 
                human drug application shall not be subject to 
                a fee under subparagraph (A), if the drug has 
                been designated pursuant to section 526 as a 
                drug for a rare disease or condition with 
                regard to the indication proposed in such 
                supplement.
                  (F) Exception for supplements for pediatric 
                indications.--A supplement to a human drug 
                application for an indication for use in 
                pediatric populations shall not be assessed a 
                fee under subparagraph (A).
                  (G) Refund of fee if application withdrawn.--
                If an application or supplement is withdrawn 
                after the application or supplement is filed, 
                the Secretary may waive and refund the fee or a 
                portion of the fee if no substantial work was 
                performed on the application or supplement 
                after the application or supplement was filed. 
                The Secretary shall have the sole discretion to 
                waive and refund a fee or a portion of the fee 
                under this subparagraph. A determination by the 
                Secretary concerning a waiver or refund under 
                this paragraph shall not be reviewable.
          [(2) Prescription drug establishment fee.--Each 
        person that--
                  [(A) owns a prescription drug establishment, 
                at which is manufactured at least 1 
                prescription drug product which is not the, or 
                not the same as a, product approved under an 
                application filed under section 505(b)(2) or 
                505(j), and
                  [(B) after September 1, 1992, had pending 
                before the Secretary a human drug application 
                or supplement,
        shall be subject to the annual fee established in 
        subsection (b) for each such establishment, payable on 
        or before January 31 of each year.]
          (2) Prescription drug establishment fee.--
                  (A) In general.--Except as provided in 
                subparagraph (B), each person that is named as 
                the applicant in a human drug application, and 
                after September 1, 1992, had pending before the 
                Secretary a human drug application or 
                supplement, shall be assessed an annual fee 
                established in subsection (b) for each 
                prescription drug establishment listed in its 
                approved human drug application as an 
                establishment that manufactures the 
                prescription drug product named in the 
                application. The annual establishment fee shall 
                be assessed in each fiscal year in which the 
                prescription drug product named in the 
                application is assessed a fee under paragraph 
                (3) unless the prescription drug establishment 
                listed in the application does not engage in 
                themanufacture of the prescription drug product 
during the fiscal year. The establishment fee shall be payable on or 
before January 31 of each year. Each such establishment shall be 
assessed only one fee per establishment, notwithstanding the number of 
prescription drug products manufactured at the establishment. In the 
event an establishment is listed in a human drug application by more 
than 1 applicant, the establishment fee for the fiscal year shall be 
divided equally and assessed among the applicants whose prescription 
drug products are manufactured by the establishment during the fiscal 
year and assessed product fees under paragraph (3).
                  (B) Exception.--If, during the fiscal year, 
                an applicant initiates or causes to be 
                initiated the manufacture of a prescription 
                drug product at an establishment listed in its 
                human drug application--
                          (i) that did not manufacture the 
                        product in the previous fiscal year; 
                        and
                          (ii) for which the full establishment 
                        fee has been assessed in the fiscal 
                        year at a time before manufacture of 
                        the prescription drug product was 
                        begun;
                the applicant will not be assessed a share of 
                the establishment fee for the fiscal year in 
                which the manufacture of the product began.
          (3) Prescription drug product fee.--
                  (A) In general.--Except as provided in 
                subparagraph (B), each person--
                          (i) who is named as the applicant in 
                        a human drug application for a 
                        prescription drug product which [is 
                        listed] has been submitted for listing 
                        under section 510, and
                          (ii) who, after September 1, 1992, 
                        had pending before the Secretary a 
                        human drug application or supplement,
                shall pay for each such prescription drug 
                product the annual fee established in 
                subsection (b). [Such fee shall be payable at 
                the time of the first such listing of such 
                product in each calendar year. Such fee shall 
                be paid only once each year for each listed 
                prescription drug product irrespective of the 
                number of times such product is listed under 
                section 510.] Such fee shall be payable for the 
                fiscal year in which the product is first 
                submitted for listing under section 510, or for 
                relisting under section 510 if the product has 
                been withdrawn from listing and relisted. After 
                such fee is paid for that fiscal year, such fee 
                shall be payable on or before January 31 of 
                each year. Such fee shall be paid only once for 
                each product for a fiscal year in which the fee 
                is payable.
                  (B) Exception.--The listing of a prescription 
                drug product under section 510 shall not 
                require the person who listed such product to 
                pay the fee prescribed by subparagraph (A) if 
                such product is the same product as a product 
                approved under an application filed under 
                section 505(b)(2) or [505(j).] 505(j), under an 
                abbreviated application filed under section 
                507, or under an abbreviated new drug 
                application pursuant to regulations in effect 
                prior to the implementation of the Drug Price 
                Competition and Patent Term Restoration Act of 
                1984.
  [(b) Fee Amounts.--
          [(1) Schedule.--Except as provided in paragraph (2) 
        and subsections (c), (d), (f), and (g), the fees 
        required under subsection (a) shall be paid in 
        accordance with the following schedule:
      

----------------------------------------------------------------------------------------------------------------
                                                   [Fiscal    Fiscal Year  Fiscal Year  Fiscal Year  Fiscal Year
                                                  Year 1993       1994         1995         1996         1997   
----------------------------------------------------------------------------------------------------------------
Drug application fee:                                                                                           
  Subsection (a)(1)(A)(i) fee..................     $100,000     $150,000     $208,000     $217,000     $233,000
  Subsection (a)(1)(A)(ii) fee.................      $50,000      $75,000     $104,000     $108,000     $116,000
  Fee revenue..................................  $12,000,000  $18,000,000  $25,000,000  $26,000,000  $28,000,000
                                                ----------------------------------------------------------------
Annual establishment fee:                                                                                       
  Fee per estab- lishment......................      $60,000      $88,000     $126,000     $131,000     $138,000
  Fee revenue..................................  $12,000,000  $18,000,000  $25,000,000  $26,000,000  $28,000,000
                                                ----------------------------------------------------------------
Annual product fee:                                                                                             
  Fee per product..............................       $6,000       $9,000      $12,500      $13,000      $14,000
  Fee revenue..................................  $12,000,000  $18,000,000  $25,000,000  $26,000,000  $28,000,000
                                                ----------------------------------------------------------------
Total fee revenues.............................  $36,000,000  $54,000,000  $75,000,000  $78,000,000  $84,000,000
---------------------------------------------------------

          [(2) Small business exception.--Any business which 
        has fewer than 500 employees, including employees of 
        affiliates, and which does not have a prescription drug 
        product introduced or delivered for introduction into 
        interstate commerce shall pay one-half the amount of 
        the fee for human drug applications it submits and 
        shall pay the entire amount of the fee for supplements 
        it submits. Such a business shall not be required to 
        pay any portion of any fee required under subsection 
        (a)(1)(A) until 1 year after the date of the submission 
        of the application involved. For purposes of this 
        paragraph, one business is an affiliate of another 
        business when, directly or indirectly, one business 
        controls, or has the power to control, the other 
        business or a third party controls, or has the power to 
        control, both businesses.]
  (b) Fee Amounts.--Except as provided in subsections (c), (d), 
(f), and (g), the fees required under subsection (a) shall be 
determined and assessed as follows:
          (1) Application and supplement fees.--
                  (A) Full fees.--The application fee under 
                subsection (a)(1)(A)(i) shall be $250,704 in 
                fiscal year 1998, $256,338 in each of fiscal 
                years 1999 and 2000, $267,606 in fiscal year 
                2001, and $258,451 in fiscal year 2002.
                  (B) Other fees.--The fee under subsection 
                (a)(1)(A)(ii) shall be $125,352 in fiscal year 
                1998, $128,169 in each of fiscal years 1999 and 
                2000, $133,803 in fiscal year 2001, and 
                $129,226 in fiscal year 2002.
          (2) Fee revenues for establishment fees.--The total 
        fee revenues to be collected in establishment fees 
        under subsection (a)(2) shall be $35,600,000 in fiscal 
        year 1998, $36,400,000 in each of fiscal years 1999 and 
        2000, $38,000,000 in fiscal year 2001, and $36,700,000 
        in fiscal year 2002.
          (3) Total fee revenues for product fees.--The total 
        fee revenues to be collected in product fees under 
        subsection (a)(3) in a fiscal year shall be equal to 
        the total fee revenues collected in establishment fees 
        under subsection (a)(2) in that fiscal year.
  (c) [Increases and] Adjustments.--
          [(1) Revenue increase.--The total fee revenues 
        established by the schedule in subsection (b)(1) shall 
        be increased by the Secretary] (1) Inflation 
        adjustment.--The fees and total fee revenues 
        established in subsection (b) shall be adjusted by the 
        Secretary by notice, published in the Federal Register, 
        for a fiscal year to reflect the greater of--
                  (A) the total percentage [increase] change 
                that occurred during the preceding fiscal year 
                in the Consumer Price Index for all urban 
                consumers (all items; U.S. city average), or
                  (B) the total percentage [increase] change 
                for such fiscal year in basic pay under the 
                General Schedule in accordance with section 
                5332 of title 5, United States Code, as 
                adjusted by any locality-based comparability 
                payment pursuant to section 5304 of such title 
                for Federal employees stationed in the District 
                of Columbia.
        The adjustment made each fiscal year by this subsection 
        will be added on a compounded basis to the sum of all 
        adjustments made each fiscal year after fiscal year 
        1997 under this subsection.
          (2) Annual fee adjustment.--Subject to the amount 
        appropriated for a fiscal year under subsection (g), 
        the Secretary shall, within 60 days after the end of 
        each fiscal year beginning after [October 1, 1992, 
        adjust the fees established by the schedule in 
        subsection (b)(1) for the following fiscal year to 
        achieve the total fee revenues, as may be increased 
        under paragraph (1). Such fees shall be adjusted under 
        this paragraph to maintain the proportions established 
        in such schedule.] September 30, 1997, adjust the 
        establishment and product fees described in subsection 
        (b) for the fiscal year in which the adjustment occurs 
        so that the revenues collected from each of the 
        categories of fees described in paragraphs (2) and (3) 
        of subsection (b) shall be set to be equal to the 
        revenues collected from the category of application and 
        supplement fees described in paragraph (1) of 
        subsection (b).
          (3) Limit.--The total amount of fees charged, as 
        adjusted under [paragraph (2)] this subsection, for a 
        fiscal year may not exceed the total costs for such 
        fiscal year for the resources allocated for the process 
        for the review of human drug applications.
  (d) Fee Waiver or Reduction.--[The Secretary shall grant a 
waiver from or a reduction of 1 or more fees under subsection 
(a) where the Secretary finds that--]
          (1) In general.--The Secretary shall grant a waiver 
        from or a reduction of one or more fees assessed under 
        subsection (a) where the Secretary finds that--
                  [(1)] (A) such waiver or reduction is 
                necessary to protect the public health,
                  [(2)] (B) the assessment of the fee would 
                present a significant barrier to innovation 
                because of limited resources available to such 
                person or other circumstances,
                  [(3)] (C) the fees to be paid by such person 
                will exceed the anticipated present and future 
                costs incurred by the Secretary in conducting 
                the process for the review of human drug 
                applications for such person[, or],
                  [(4)] (D) assessment of the fee for an 
                application or a supplement filed under section 
                505(b)(1) pertaining to a drug containing an 
                active ingredient would be inequitable because 
                an application for a product containing the 
                same active ingredient filed by another person 
                under section 505(b)(2) could not be assessed 
                fees under subsection (a)(1)[.], or
                  (E) the applicant is a small business 
                submitting its first human drug application to 
                the Secretary for review.
[In making the finding in paragraph (3), the Secretary may use 
standard costs.]
          (2) Use of standard costs.--In making the finding in 
        paragraph (1)(C), the Secretary may use standard costs.
          (3) Rules relating to small businesses.--
                  (A) Definition.--In paragraph (1)(E), the 
                term ``small business'' means an entity that 
                has fewer than 500 employees, including 
                employees of affiliates.
                  (B) Waiver of application fee.--The Secretary 
                shall waive under paragraph (1)(E) the 
                application fee for the first human drug 
                application that a small business or its 
                affiliate submits to the Secretary for review. 
                After a small business or its affiliate is 
                granted such a waiver, the small business or 
                its affiliate shall pay--
                          (i) application fees for all 
                        subsequent human drug applications 
                        submitted to the Secretary for review 
                        in the same manner as an entity that 
                        does not qualify as a small business; 
                        and
                          (ii) all supplement fees for all 
                        supplements to human drug applications 
                        submitted to the Secretary for review 
                        in the same manner as an entity that 
                        does not qualify as a small business.
          * * * * * * *
  (f) Assessment of Fees.--
          (1) Limitation.--Fees may not be assessed under 
        subsection (a) for a fiscal year beginning after fiscal 
        year [1993] 1997 unless appropriations for salaries and 
        expenses of the Food and Drug Administration for such 
        fiscal year (excluding the amount of fees appropriated 
        for such fiscal year) are equal to or greater than the 
        amount of appropriations for the salaries and expenses 
        of the Food and Drug Administration for the [fiscal 
        year 1992] fiscal year 1997 (excluding the amount of 
        fees appropriated for such fiscal year) multiplied by 
        the adjustment factor applicable to the fiscal year 
        involved.
          * * * * * * *
  (g) Crediting and Availability of Fees.--
          (1) In general.--Fees collected for a fiscal year 
        pursuant to subsection (a) shall be credited to the 
        appropriation account for salaries and expenses of the 
        Food and Drug Administration and shall be available in 
        accordance with appropriation Acts until expended 
        without fiscal year limitation. Such sums as may be 
        necessary may be transferred from the Food and Drug 
        Administration salaries and expenses appropriation 
        account without fiscal year limitation to such 
        appropriation account for salaries and expenses with 
        such fiscal year limitation. The sums transferred shall 
        be available solely for the process for the review of 
        human drug applications within the meaning of section 
        735(6).
          (2) Collections and appropriation acts.--The fees 
        authorized by this section--
                  (A) shall be collected in each fiscal year in 
                an amount equal to the amount specified in 
                appropriation [Acts] Acts, or otherwise made 
                available for obligation, for such fiscal year, 
                and
                  (B) shall only be collected and available to 
                defray increases in the costs of the resources 
                allocated for the process for the review of 
                human drug applications (including increases in 
                such costs for an additional number of full-
                time equivalent positions in the Department of 
                Health and Human Services to be engaged in such 
                process) [over such costs for fiscal year 1992] 
                over such costs, excluding costs paid from fees 
                collected under this section, for fiscal year 
                1997 multiplied by the adjustment factor.
          [(3) Authorization of appropriations.--There are 
        authorized to be appropriated for fees under this 
        section--
                  [(A) $36,000,000 for fiscal year 1993,
                  [(B) $54,000,000 for fiscal year 1994,
                  [(C) $75,000,000 for fiscal year 1995,
                  [(D) $78,000,000 for fiscal year 1996, and
                  [(E) $84,000,000 for fiscal year 1997,
        as adjusted to reflect increases in the total fee 
        revenues made under subsection (c)(1).]
          (3) Authorization of appropriations.--There is 
        authorized to be appropriated for fees under this 
        section--
                  (A) $106,800,000 for fiscal year 1998;
                  (B) $109,200,000 for fiscal year 1999;
                  (C) $109,200,000 for fiscal year 2000;
                  (D) $114,000,000 for fiscal year 2001; and
                  (E) $110,100,000 for fiscal year 2002,
        as adjusted to reflect adjustments in the total fee 
        revenues made under this section and changes in the 
        total amounts collected by application, supplement, 
        establishment, and product fees.
          (4) Offset.--Any amount of fees collected for a 
        fiscal year which exceeds the amount of fees specified 
        in appropriation Acts for such fiscal year shall be 
        credited to the appropriation account of the Food and 
        Drug Administration as provided in paragraph (1), and 
        shall be subtracted from the amount of fees that would 
        otherwise be authorized to be collected under 
        appropriation Acts for a subsequent fiscal year.
          * * * * * * *
  (i) Written Requests for Waivers, Reductions, and Refunds.--
To qualify for consideration for a waiver or reduction under 
subsection (d), or for a refund of any fee collected in 
accordance with subsection (a), a person shall submit to the 
Secretary a written request for such waiver, reduction, or 
refund not later than 180 days after such fee is due.
  [(i)] (j) Construction.--This section may not be construed to 
require that the number of full-time equivalent positions in 
the Department of Health and Human Services, for officers, 
employers, and advisory committees not engaged in the process 
of the review of human drug applications, be reduced to offset 
the number of officers, employees, and advisory committees so 
engaged.

                   Subchapter D--Fast Track Products

SEC. 741. FAST TRACK PRODUCTS.

  (a) Designation of Drug as a Fast Track Product.--
          (1) In general.--The Secretary shall facilitate the 
        development and expedite the review of new drugs that 
        are intended for the treatment of serious or life-
        threatening conditions and that demonstrate the 
        potential to address unmet medical needs for such 
        conditions. In this section, such products shall be 
        known as ``fast track products''.
          (2) Request for designation.--The sponsor of a drug 
        may request the Secretary to designate the drug as a 
        fast track product. A request for the designation may 
        be made concurrently with, or at any time after, 
        submission of an application for the investigation of 
        the drug under section 505(i) or section 351(a)(4) of 
        the Public Health Service Act.
          (3) Designation.--Within 30 calendar days after the 
        receipt of a request under paragraph (2), the Secretary 
        shall determine whether the drug that is the subject of 
        the request meets the criteria described in paragraph 
        (1). If the Secretary finds that the drug meets the 
        criteria, the Secretary shall designate the drug as a 
        fast track product and shall take such actions as are 
        appropriate to expedite the development and review of 
        the application for approval of such product.
  (b) Approval of Application for a Fast Track Product.--
          (1) In general.--The Secretary may approve an 
        application for approval of a fast track product under 
        section 505(b) or section 351 of the Public Health 
        Service Act (21 U.S.C. 262) upon a determination that 
        the product has an effect on a clinical endpoint or a 
        surrogate endpoint that is reasonably likely to predict 
        clinical benefit.
          (2) Limitation.--Approval of a fast track product 
        under this subsection may be subject to the 
        requirements--
                  (A) that the sponsor conduct appropriate 
                post-approval studies to validate the surrogate 
                endpoint or otherwise confirm the effect on the 
                clinical endpoint; and
                  (B) that the sponsor submit copies of all 
                promotional materials related to the fast track 
                product during the preapproval review period 
                and, following approval and for such period 
                thereafter as the Secretary deems appropriate, 
                at least 30 days prior to dissemination of the 
                materials.
          (3) Expedited withdrawal of approval.--The Secretary 
        may withdraw approval of a fast track product using 
        expedited procedures (as prescribed by the Secretary in 
        regulations which shall include an opportunity for an 
        informal hearing), if--
                  (A) the sponsor fails to conduct any required 
                post-approval study of the fast track drug with 
                due diligence;
                  (B) a post-approval study of the fast track 
                product fails to verify clinical benefit of the 
                product;
                  (C) other evidence demonstrates that the fast 
                track product is not safe or effective under 
                the conditions of use; or
                  (D) the sponsor disseminates false or 
                misleading promotional materials with respect 
                to the product.
  (c) Review of Incomplete Applications for Approval of a Fast 
Track Product.--
          (1) In general.--If the Secretary determines, after 
        preliminary evaluation of clinical data submitted by 
        the sponsor, that a fast track product may be effective 
        the Secretary shall evaluate for filing, and may 
        commence review of portions of, an application for the 
        approval of the product before the sponsor submits a 
        complete application. The Secretary shall commence such 
        review only if the applicant (A) provides a schedule 
        for submission of information necessary to make the 
        application complete, and (B) pays any fee that may be 
        required under section 736.
          (2) Exception.--Any time period for review of human 
        drug applications that has been agreed to by the 
        Secretary and that has been set forth in goals 
        identified in letters of the Secretary (relating to the 
        use of fees collected under section 736 to expedite the 
        drug development process and the review of human drug 
        applications) shall not apply to an application 
        submitted under paragraph (1) until the date on which 
        the application is complete.
  (d) Awareness Efforts.--The Secretary shall--
          (1) develop and disseminate to physicians, patient 
        organizations, pharmaceutical and biotechnology 
        companies, and other appropriate persons a description 
        of the provisions applicable to fast track products 
        established under this section; and
          (2) establish a program to encourage the development 
        of surrogate endpoints that are reasonably likely to 
        predict clinical benefit for serious or life-
        threatening conditions for which there exist 
        significant unmet medical needs.

         Subchapter E--Dissemination of Treatment Information 

SEC. 745. REQUIREMENTS FOR DISSEMINATION OF TREATMENT INFORMATION ON 
                    DRUGS.

  (a) In General.--Notwithstanding sections 301(d), 502(f), and 
505 and section 351 of the Public Health Service Act (42 U.S.C. 
262), a manufacturer may disseminate to--
          (1) a health care practitioner,
          (2) a pharmacy benefit manager,
          (3) a health insurance issuer,
          (4) a group health plan, or
          (5) a Federal or State governmental agency,
written information concerning the safety, effectiveness, or 
benefit of a use not described in the approved labeling of a 
drug if the manufacturer meets the requirements of subsection 
(b).
  (b) Specific Requirements.--A manufacturer may disseminate 
information about a new use of a drug under subsection (a) only 
if--
          (1) there is in effect for such drug an application 
        filed under section 505(b) or a biologics license 
        issued under section 351 of the Public Health Service 
        Act;
          (2) the information meets the requirements of section 
        746;
          (3) the information to be disseminated is not derived 
        from clinical research conducted by another 
        manufacturer or if it was derived from research 
        conducted by another manufacturer, the manufacturer 
        disseminating the information has the permission of 
        such other manufacturer to make the dissemination;
          (4) the manufacturer has, 60 days before such 
        dissemination, submitted to the Secretary--
                  (A) a copy of the information disseminated; 
                and
                  (B) any clinical trial information the 
                manufacturer has relating to the safety or 
                effectiveness of the new use, any reports of 
                clinical experience pertinent to the safety of 
                the new use, and a summary of such information;
          (5) the manufacturer has complied with the 
        requirements of section 748 (relating to certification 
        that the manufacturer will submit a supplemental 
        application with respect to such use);
          (6) the manufacturer agrees to include along with the 
        information disseminated under this subsection--
                  (A) a prominently displayed statement that 
                discloses--
                          (i) that the information concerns a 
                        use of a drug that has not been 
                        approved by the Food and Drug 
                        Administration;
                          (ii) if applicable, that the 
                        information is being disseminated at 
                        the expense of the manufacturer;
                          (iii) if applicable, the name of any 
                        authors of the information who are 
                        employees of, consultants to, or have 
                        received compensation from, the 
                        manufacturer, or who have a significant 
                        financial interest in the manufacturer;
                          (iv) the official labeling for the 
                        drug and all updates with respect to 
                        the labeling;
                          (v) if applicable, a statement that 
                        there are products or treatments that 
                        have been approved for the use that is 
                        the subject of the information being 
                        disseminated pursuant to subsection 
                        (a)(1); and
                          (vi) the identification of any person 
                        that has provided funding for the 
                        conduct of a study relating to the new 
                        use of a drug for which such 
                        information is being disseminated; and
                  (B) a bibliography of other articles from a 
                scientific reference publication or scientific 
                or medical journal that have been previously 
                published about the such use of the drug 
                covered by the information disseminated (unless 
                the information already includes such 
                bibliography).
  (c) Additional information.--If the Secretary determines, 
after providing notice of such determination and an opportunity 
for a meeting with respect to such determination, that the 
information submitted by a manufacturer under subsection 
(b)(3)(B), with respect to the use of a drug for which the 
manufacturer is disseminating information, fails to provide 
data, analyses, or other written matter that is objective and 
balanced, the Secretary may require the manufacturer to 
disseminate--
          (1) additional objective and scientifically sound 
        information that pertains to the safety or 
        effectiveness of the use and is necessary to provide 
        objectivity and balance, including any information that 
        the manufacturer has submitted to the Secretary or, 
        where appropriate, a summary of such information or any 
        other information that the Secretary has authority to 
        make available to the public; and
          (2) an objective statement of the Secretary, based on 
        data or other scientifically sound information 
        available to the Secretary, that bears on the safety or 
        effectiveness of the new use of the drug.

SEC. 746. INFORMATION AUTHORIZED TO BE DISSEMINATED.

  (a) Authorized information.--A manufacturer may disseminate 
the information on the new use of a drug under section 745 only 
if the information--
          (1) is in the form of an unabridged--
                  (A) reprint or copy of an article, peer-
                reviewed by experts qualified by scientific 
                training or experience to evaluate the safety 
                or effectiveness of the drug, which was 
                published in a scientific or medical journal 
                (as defined in section 750(6)), which is about 
                a clinical investigation with respect to the 
                drug, and which would be considered to be 
                scientifically sound by such experts; or
                  (B) reference publication, described in 
                subsection (b), that includes information about 
                a clinical investigation with respect to the 
                drug that would be considered to be 
                scientifically sound by experts qualified by 
                scientific training or experience to evaluate 
                the safety or effectiveness of the drug that is 
                the subject of such a clinical investigation; 
                and
          (2) is not false or misleading and would not pose a 
        significant risk to the public health.
  (b) Reference Publication.--A reference publication referred 
to in subsection (a)(1)(B) is a publication that--
          (1) has not been written, edited, excerpted, or 
        published specifically for, or at the request of, a 
        manufacturer of a drug;
          (2) has not been edited or significantly influenced 
        by a such a manufacturer;
          (3) is not solely distributed through such a 
        manufacturer but is generally available in bookstores 
        or other distribution channels where medical textbooks 
        are sold;
          (4) does not focus on any particular drug of a 
        manufacturer that disseminates information under 
        section 745 and does not have a primary focus on new 
        uses of drugs that are marketed or under investigation 
        by a manufacturer supporting the dissemination of 
        information; and
          (5) presents materials that are not false or 
        misleading.

SEC. 747. ESTABLISHMENT OF LIST OF ARTICLES AND PUBLICATIONS 
                    DISSEMINATED AND LIST OF PROVIDERS THAT RECEIVED 
                    ARTICLES AND REFERENCE PUBLICATIONS.

  (a) In General.--A manufacturer may disseminate information 
under section 745 only if the manufacturer prepares and submits 
to the Secretary biannually--
          (1) a list containing the titles of the articles and 
        reference publications relating to the new use of drugs 
        that were disseminated by the manufacturer to a person 
        described in section 745(a) for the 6-month period 
        preceding the date on which the manufacturer submits 
        the list to the Secretary; and
          (2) a list that identifies the categories of 
        providers (as described in section 745(a)) that 
        received the articles and reference publications for 
        the 6-month period described in paragraph (1).
  (b) Records.--A manufacturer that disseminates information 
under section 745 shall keep records that may be used by the 
manufacturer when, pursuant to section 749, such manufacturer 
is required to take corrective action and shall be made 
available to the Secretary, upon request, for purposes of 
ensuring or taking corrective action pursuant to such section. 
Such records, at the Secretary's discretion, may identify the 
recipient of information provided pursuant to section 745 or 
the categories of such recipients.

SEC. 748. REQUIREMENT REGARDING SUBMISSION OF SUPPLEMENTAL APPLICATION 
                    FOR NEW USE; EXEMPTION FROM REQUIREMENT.

  (a) In General.--A manufacturer may disseminate information 
under section 745 on a new use only if--
          (1) the manufacturer meets the condition described in 
        subsection (b) or in subsection (c); or
          (2) there is in effect for the manufacturer an 
        exemption under subsection (d) from the requirement of 
        paragraph (1).
  (b) Supplemental Application; Condition in Case of Completed 
Studies.--For purposes of subsection (a)(1), a manufacturer may 
disseminate information on a new use if the manufacturer has 
submitted to the Secretary an application containing a 
certification that--
          (1) the studies needed for the submission of a 
        supplemental application for the new use have been 
        completed; and
          (2) the supplemental application will be submitted to 
        the Secretary not later than 6 months after the date of 
        the initial dissemination of information under section 
        745.
  (c) Supplemental Application; Condition in Case of Planned 
Studies.--
          (1) In general.--For purposes of subsection (a)(1), a 
        manufacturer may disseminate information on a new use 
        if--
                  (A) the manufacturer has submitted to the 
                Secretary an application containing--
                          (i) a proposed protocol and schedule 
                        for conducting the studies needed for 
                        the submission of a supplemental 
                        application for the new use; and
                          (ii) a certification that the 
                        supplemental application will be 
                        submitted to the Secretary not later 
                        than 36 months after the date of the 
                        initial dissemination of information 
                        under section 745 (or, as applicable, 
                        not later than such date as the 
                        Secretary may specify pursuant to an 
                        extension under this paragraph or 
                        paragraph (3)); and
                  (B) the Secretary has determined that the 
                proposed protocol is adequate and that the 
                schedule for completing such studies is 
                reasonable.
        The Secretary may grant a longer period of time for a 
        manufacturer to submit a supplemental application if 
        the Secretary determines that the studies needed to 
        submit such an application cannot be completed and 
        submitted within 36 months.
          (2) Progress reports on studies.--A manufacturer that 
        submits to the Secretary an application under paragraph 
        (1) shall submit to the Secretary periodic reports 
        describing the status of the studies involved.
          (3) Extension of time regarding planned studies.--The 
        period of 36 months authorized in paragraph (1)(A)(ii) 
        for the completion of studies may be extended by the 
        Secretary if the manufacturer involved submits to the 
        Secretary a written request for the extension and the 
        Secretary determines that the manufacturer has acted 
        with due diligence to conduct the studies in a timely 
        manner. Such extension may not provide more than 24 
        additional months.
  (d) Exemption From Requirement of Supplemental Application.--
          (1) In general.--For purposes of subsection (a)(2), a 
        manufacturer may disseminate information on a new use 
        if--
                  (A) the manufacturer has submitted to the 
                Secretary an application for an exemption from 
                meeting the requirement of subsection (a)(1); 
                and
                  (B)(i) the Secretary has approved the 
                application in accordance with paragraph (2); 
                or
                  (ii) the application is deemed under 
                paragraph (3)(A) to have been approved (unless 
                such approval is terminated pursuant to 
                paragraph (3)(B)).
          (2) Conditions for approval.--The Secretary may 
        approve an application under paragraph (1) for an 
        exemption only if the Secretary determines that--
                  (A) it would be economically prohibitive with 
                respect to such drug for the manufacturer to 
                incur the costs necessary for the submission of 
                a supplemental application for reasons, as 
                defined by the Secretary, such as the lack of 
                availability under law of any period during 
                which the manufacturer would have exclusive 
                marketing rights with respect to the new use 
                involved or that the population expected to 
                benefit from approval of the supplemental 
                application is small; or
                  (B) it would be unethical to conduct the 
                studies necessary for the supplemental 
                application for a reason such as the new use 
                involved is the standard of medical care for a 
                health condition.
          (3) Time for consideration of application; deemed 
        approval.--
                  (A) In general.--The Secretary shall approve 
                or deny an application under paragraph (1) for 
                an exemption not later than 60 days after the 
                receipt of the application. If the Secretary 
                does not comply with the preceding sentence, 
                the application is deemed to be approved.
                  (B) Termination of deemed approval.--If 
                pursuant to a deemed approval under 
                subparagraph (A) a manufacturer disseminates 
                written information under section 745 on a new 
                use, the Secretary may at any time terminate 
                such approval and under section 749(b)(3) order 
                the manufacturer to cease disseminating the 
                information.
  (e) Requirements Regarding Applications.--Applications under 
this section shall be submitted in the form and manner 
prescribed by the Secretary.
  (f) Transition Rule.--For purposes of this section, in any 
case in which a manufacturer has submitted to the Secretary a 
supplemental application for which action by the Secretary is 
pending as of the date of the enactment of the Prescription 
Drug User Fee Reauthorization and Drug and Biological Products 
Regulatory Modernization Act of 1997, the application is deemed 
to be a supplemental application submitted under subsection 
(b).

SEC. 749. CORRECTIVE ACTIONS; CESSATION OF DISSEMINATION.

  (a) Postdissemination Data Regarding Safety and 
effectiveness.--
          (1) Corrective actions.--With respect to data 
        received by the Secretary after the dissemination of 
        information under section 745 by a manufacturer has 
        begun (whether received pursuant to paragraph (2) or 
        otherwise), if the Secretary determines that the data 
        indicate that the new use involved may not be effective 
        or may present a significant risk to public health, the 
        Secretary shall, in consultation with the manufacturer, 
        take such action regarding the dissemination of the 
        information as the Secretary determines to be 
        appropriate for the protection of the public health, 
        which may include ordering that the manufacturer cease 
        the dissemination of the information.
          (2) Responsibilities of manufacturers to submit 
        data.--After a manufacturer disseminates information 
        pursuant to section 745, the manufacturer shall submit 
        to the Secretary a notification of any additional 
        knowledge of the manufacturer on clinical research or 
        other data that relate to the safety or effectiveness 
        of the new use involved. If the manufacturer is in 
        possession of the data, the notification shall include 
        the data. The Secretary shall by regulation establish 
        the scope of the responsibilities of manufacturers 
        under this paragraph, including such limits on the 
        responsibilities as the Secretary determines to be 
        appropriate.
  (b) Cessation of Dissemination.--
          (1) Failure of manufacturer to comply with 
        requirements.--The Secretary may order a manufacturer 
        to cease the dissemination of information pursuant to 
        section 745 if the Secretary determines that the 
        information being disseminated does not comply with the 
        requirements established in this subchapter. Such an 
        order may be issued only after the Secretary has 
        provided notice to the manufacturer of the intent of 
        the Secretary to issue the order and has provided an 
        opportunity for a meeting with respect to such intent 
        unless paragraph (2)(B) applies. If the failure of the 
        manufacturer constitutes a minor violation of this 
        subchapter, the Secretary shall delay issuing the order 
        and provide to the manufacturer an opportunity to 
        correct the violation.
          (2) Supplemental applications.--The Secretary may 
        order a manufacturer to cease the dissemination of 
        information pursuant to section 745 if the Secretary 
        determines that--
                  (A) in the case of a manufacturer to which 
                section 748(b) applies, the Secretary 
                determines that the supplemental application 
                received under such section does not contain 
                adequate information for approval of the new 
                use with respect to which the application was 
                submitted; or
                  (B) in the case of a manufacturer to which 
                section 748(c) applies, the Secretary 
                determines, after an informal hearing, that the 
                manufacturer is not acting with due diligence 
                to complete the studies involved.
          (3) Termination of deemed approval of exemption 
        regarding supplemental applications.--If under section 
        748(d)(3) the Secretary terminates a deemed approval of 
        an exemption, the Secretary may order the manufacturer 
        involved to cease disseminating the information. A 
        manufacturer shall comply with an order under the 
        preceding sentence not later than 60 days after the 
        receipt of the order.
  (c) Corrective Actions by Manufacturers.--
          (1) In general.--In any case in which under this 
        section the Secretary orders a manufacturer to cease 
        disseminating information, the Secretary may order the 
        manufacturer to take action to correct the information 
        that has been disseminated, except as provided in 
        paragraph (2).
          (2) Termination of deemed approval of exemption 
        regarding supplemental applications.--In the case of an 
        order under subsection (b)(3) to cease disseminating 
        information, the Secretary may not order the 
        manufacturer involved to take action to correct the 
        information that has been disseminated unless the 
        Secretary determines that the new use described in the 
        information would pose a significant risk to the public 
        health.

SEC. 750. DEFINITIONS.

  For purposes of this subchapter:
          (1) The term ``health care practitioner'' means a 
        physician, or other individual who is a provider of 
        health care, who is licensed under the law of a State 
        to prescribe drugs.
          (2) The terms ``health insurance issuer'' and ``group 
        health plan'' have the meaning given such terms under 
        section 2791 of the Public Health Service Act.
          (3) The term ``manufacturer'' means a person who 
        manufactures a drug, or who is licensed by such person 
        to distribute or market the drug.
          (4) The term ``new use'', with respect to a drug, 
        means a use that is not included in the approved 
        labeling of the drug.
          (5) The term ``pharmacy benefit manager'' means an 
        organization that--
                  (A) manages pharmaceutical costs through--
                          (i) pharmacy benefit administration, 
                        including claims processing 
                        adjudication, pharmacy networks, mail 
                        service, and data reporting;
                          (ii) formulary management and 
                        contracting, including evaluating drugs 
                        for formulary status, negotiations of 
                        contracts with manufacturers, and 
                        disbursement of rebates; and
                          (iii) utilization management, 
                        including communicating and enforcing 
                        therapy guidelines and drug use 
                        principles to physicians, pharmacists, 
                        and patients; and
                  (B) serves 2 principal types of customers 
                which are--
                          (i) employers, both private- and 
                        public-sector, who use either self-
                        funded health benefits through a third 
                        party administrator's insurance carrier 
                        or use traditional indemnity coverage, 
                        using providers from a preferred 
                        provider network or in a fee-for-
                        service capacity; and
                          (ii) health maintenance 
                        organizations.
          (6) The term ``scientific or medical journal'' means 
        a scientific or medical publication--
                  (A) that is published by an organization--
                          (i) that has an editorial board;
                          (ii) that utilizes experts, who have 
                        demonstrated expertise in the subject 
                        of an article under review by the 
                        organization and who are independent of 
                        the organization, to review and 
                        objectively select, reject, or provide 
                        comments about proposed articles; and
                          (iii) that has a publicly stated 
                        policy, to which the organization 
                        adheres, of full disclosure of any 
                        conflict of interest or biases for all 
                        authors or contributors involved with 
                        the journal or organization;
                  (B) whose articles are peer-reviewed and 
                published in accordance with the regular peer-
                review procedures of the organization;
                  (C) that is generally recognized to be of 
                national scope and reputation;
                  (D) that is indexed in the Index Medicus of 
                the National Library of Medicine of the 
                National Institutes of Health; and
                  (E) that is not in the form of a special 
                supplement that has been funded in whole or in 
                part by 1 or more manufacturers.

SEC. 751. RULES OF CONSTRUCTION.

  (a) Unsolicited Request.--Nothing in section 745 shall be 
construed as prohibiting a manufacturer from disseminating 
information in response to an unsolicited request from a health 
care practitioner.
  (b) Dissemination of Information on Drugs Not Evidence of 
Intended Use.--Notwithstanding subsection (a), (f), or (o) of 
section 502, or any other provision of law, the dissemination 
of information relating to a new use of a drug, in accordance 
with section 745, shall not be construed by the Secretary as 
evidence of a new intended use of the drug that is different 
from the intended use of the drug set forth in the official 
labeling of the drug. Such dissemination shall not be 
considered by the Secretary as labeling, adulteration, or 
misbranding of the drug.
  (c) Patent Protection.--Nothing in section 745 shall affect 
patent rights in any manner.
  (d) Authorization for Dissemination of Articles and Fees for 
Reprints of Articles.--Nothing in section 745 shall be 
construed as prohibiting an entity that publishes a scientific 
journal (as defined in section 750(6)) from requiring 
authorization from the entity to disseminate an article 
published by such entity or charging fees for the purchase of 
reprints of published articles from such entity.

                  Subchapter F--Manufacturing Changes

SEC. 755. MANUFACTURING CHANGES.

  (a) In General.--With respect to a drug for which there is in 
effect an approved application under section 505 or 512 or a 
license under section 351 of the Public Health Service Act, a 
change from the manufacturing process approved pursuant to such 
application or license may be made, and the drug as made with 
the change may be distributed, if--
          (1) the holder of the approved application or license 
        (referred to in this section as a ``holder'') has 
        validated the effects of the change in accordance with 
        subsection (b); and
          (2)(A) in the case of a major manufacturing change, 
        the holder has complied with the requirements of 
        subsection (c); or
          (B) in the case of a change that is not a major 
        manufacturing change, the holder complies with the 
        applicable requirements of subsection (d).
  (b) Validation of Effects of Changes.--For purposes of 
subsection (a)(1), a drug made with a manufacturing change 
(whether a major manufacturing change or otherwise) may be 
distributed only if, before distribution of the drug as so 
made, the holder involved validates the effects of the change 
on the identity, strength, quality, purity, and potency of the 
drug as the identity, strength, quality, purity, and potency 
may relate to the safety, bioequivalence, bioavailability, or 
effectiveness of the drug.
  (c) Major Manufacturing Changes.--
          (1) Requirement of supplemental application.--For 
        purposes of subsection (a)(2)(A), a drug made with a 
        major manufacturing change may be distributed only if, 
        before the distribution of the drug as so made, the 
        holder involved submits to the Secretary a supplemental 
        application for such change and the Secretary approves 
        the application. The application shall contain such 
        information as the Secretary determines to be 
        appropriate, and shall include the information 
        developed under subsection (b) by the holder in 
        validating the effects of the change.
          (2) Changes qualifying as major changes.--For 
        purposes of subsection (a)(2)(A), a major manufacturing 
        change is a manufacturing change that--
                  (A) is determined by the Secretary to have 
                substantial potential to adversely affect the 
                identity, strength, quality, purity, or potency 
                of the drug as they may relate to the safety, 
                bioequivalence, bioavailability, or 
                effectiveness of a drug; and
                  (B)(i) is made in the qualitative or 
                quantitative formulation of the drug involved 
                or in the specifications in the approved 
                application or license referred to in 
                subsection (a) for the drug (unless exempted by 
                the Secretary from the requirements of this 
                subsection);
                  (ii) is determined by the Secretary by 
                regulation or guidance to require completion of 
                an appropriate clinical study demonstrating 
                equivalence of the drug to the drug as 
                manufactured without the change; or
                  (iii) is determined by the Secretary by 
                regulation or guidance to have a substantial 
                potential to adversely affect the safety or 
                effectiveness of the drug.
  (d) Other Manufacturing Changes.--
          (1) In general.--For purposes of subsection 
        (a)(2)(B), the Secretary may regulate drugs made with 
        manufacturing changes that are not major manufacturing 
        changes as follows:
                  (A) The Secretary may authorize holders to 
                distribute such drugs without prior approval by 
                the Secretary.
                  (B) The Secretary may require that, prior to 
                the distribution of such drugs, holders submit 
                to the Secretary supplemental applications for 
                such changes.
                  (C) The Secretary may establish categories of 
                such changes and designate categories to which 
                subparagraph (A) applies and categories to 
                which subparagraph (B) applies.
          (2) Changes not requiring supplemental application.--
                  (A) Submission of report.--A holder making a 
                manufacturing change to which paragraph (1)(A) 
                applies shall submit to the Secretary a report 
                on the change, which shall contain such 
                information as the Secretary determines to be 
                appropriate, and which shall include the 
                information developed under subsection (b) by 
                the holder in validating the effects of the 
                change. The report shall be submitted by such 
                date as the Secretary may specify.
                  (B) Authority regarding annual reports.--In 
                the case of a holder that during a single year 
                makes more than one manufacturing change to 
                which paragraph (1)(A) applies, the Secretary 
                may in carrying out subparagraph (A) authorize 
                the holder to comply with such subparagraph by 
                submitting a single report for the year that 
                provides the information required in such 
                subparagraph for all the changes made by the 
                holder during the year.
          (3) Changes requiring supplemental application.--
                  (A) Submission of supplemental application.--
                The supplemental application required under 
                paragraph (1)(B) for a manufacturing change 
                shall contain such information as the Secretary 
                determines to be appropriate, which shall 
                include the information developed under 
                subsection (b) by the holder in validating the 
                effects of the change.
                  (B) Authority for distribution.--In the case 
                of a manufacturing change to which paragraph 
                (1)(B) applies:
                          (i) The holder involved may commence 
                        distribution of the drug involved 30 
                        days after the Secretary receives the 
                        supplemental application under such 
                        paragraph, unless the Secretary 
                        notifies the holder within such 30-day 
                        period that prior approval of the 
                        application is required before 
                        distribution may be commenced.
                          (ii) The Secretary may designate a 
                        category of such changes for the 
                        purpose of providing that, in the case 
                        of a change that is in such category, 
                        the holder involved may commence 
                        distribution of the drug involved upon 
                        the receipt by the Secretary of a 
                        supplemental application for the 
                        change.
                          (iii) If the Secretary disapproves 
                        the supplemental application, the 
                        Secretary may order the manufacturer to 
                        cease the distribution of the drugs 
                        that have been made with the 
                        manufacturing change.

               Subchapter G--Environmental Impact Review

SEC. 761. ENVIRONMENTAL IMPACT REVIEW.

  Notwithstanding any other provision of law, an environmental 
impact statement prepared in accordance with the regulations 
published at part 25 of 21 C.F.R. (as in effect on August 31, 
1997) in connection with an action carried out under (or a 
recommendation or report relating to) this Act, shall be 
considered to meet the requirements for a detailed statement 
under section 102(2)(C) of the National Environmental Policy 
Act.

 Subchapter H--National Uniformity for Nonprescription Drugs for Human 
       Use and Preemption for Labeling or Packaging of Cosmetics

SEC. 771. NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS FOR HUMAN USE.

  (a) In General.--Except as provided in subsection (b), 
(c)(1), (d), (e), or (f), no State or political subdivision of 
a State may establish or continue in effect any requirement--
          (1) that relates to the regulation of a drug intended 
        for human use that is not subject to the requirements 
        of section 503(b)(1); and
          (2) that is different from or in addition to, or that 
        is otherwise not identical with, a requirement under 
        this Act, the Poison Prevention Packaging Act of 1970 
        (15 U.S.C. 1471 et seq.), or the Fair Packaging and 
        Labeling Act (15 U.S.C. 1451 et seq.).
  (b) Exemption.--Upon application of a State or political 
subdivision thereof, the Secretary may by regulation, after 
notice and opportunity for written and oral presentation of 
views, exempt from subsection (a), under such conditions as may 
be prescribed in such regulation, a State or political 
subdivision requirement that--
          (1) protects an important public interest that would 
        otherwise be unprotected;
          (2) would not cause any drug to be in violation of 
        any applicable requirement or prohibition under Federal 
        law; and
          (3) would not unduly burden interstate commerce.
  (c) Scope.--
          (1) In general.--This section shall not apply to--
                  (A) any State or political subdivision 
                requirement that relates to the practice of 
                pharmacy; or
                  (B) any State or political subdivision 
                requirement that a drug be dispensed only upon 
                the prescription of a practitioner licensed by 
                law to administer such drug.
          (2) Safety or effectiveness.--For purposes of 
        subsection (a), a requirement that relates to the 
        regulation of a drug shall be deemed to include any 
        requirement relating to public information or any other 
        form of public communication relating to a warning of 
        any kind for a drug.
  (d) Exceptions.--
          (1) In general.--In the case of a drug described in 
        subsection (a)(1) that is not the subject of an 
        application approved under section 505 or 507 or a 
        final regulation promulgated by the Secretary 
        establishing conditions under which the drug is 
        generally recognized as safe and effective and not 
        misbranded, subsection (a) shall apply only with 
        respect to a requirement of a State or political 
        subdivision of a State that relates to the same subject 
        as, but is different from or in addition to, or that is 
        otherwise not identical with--
                  (A) a regulation in effect with respect to 
                the drug pursuant to a statute described in 
                subsection (a)(2); or
                  (B) any other requirement in effect with 
                respect to the drug pursuant to an amendment to 
                such a statute made on or after the date of 
                enactment of this section.
          (2) State initiatives.--This section shall not apply 
        to a State public initiative enacted prior to the date 
        of enactment of this section.
  (e) No Effect on Product Liability Law.--Nothing in this 
section shall be construed to modify or otherwise affect any 
action or the liability of any person under the product 
liability law of any State.
  (f) State Enforcement Authority.--Nothing in this section 
shall prevent a State or political subdivision thereof from 
enforcing, under any relevant civil or other enforcement 
authority, a requirement that is identical to a requirement of 
this Act.

SEC. 772. PREEMPTION FOR LABELING OR PACKAGING OF COSMETICS.

  (a) In General.--Except as provided in subsection (b), (d), 
or (e), a State or political subdivision of a State shall not 
impose or continue in effect any requirement for labeling or 
packaging of a cosmetic that is different from or in addition 
to, or that is otherwise not identical with a requirement that 
is specifically applicable to a particular cosmetic or class of 
cosmetics under this Act, the Poison Prevention Packaging Act 
of 1970 (15 U.S.C. 1471 et seq.), or the Fair Packaging and 
Labeling Act (15 U.S.C. 1451 et seq.).
  (b) Exemption.--Upon application of a State or political 
subdivision thereof, the Secretary may by regulation after 
notice and opportunity for written and oral presentation of 
views, exempt from subsection (a), under such conditions as may 
be prescribed in such regulation, a State or political 
subdivision requirement for labeling and packaging that--
          (1) protects an important public interest that would 
        otherwise be unprotected;
          (2) would not cause a cosmetic to be in violation of 
        any applicable requirements or prohibition under 
        Federal law; and
          (3) would not unduly burden interstate commerce.
  (c) Scope.--For purposes of subsection (a), a reference to a 
State requirement that relates to the packaging or labeling of 
a cosmetic means any specific requirement relating to the same 
aspect of such cosmetic as a requirement specifically 
applicable to that particular cosmetic or class of cosmetics 
under this Act for packaging or labeling, including any State 
requirement relating to public information or any other form of 
public communication.
  (d) No Effect on Product Liability Law.--Nothing in this 
section shall be construed to modify or otherwise affect any 
action or the liability of any person under the product 
liability law of any State.
  (e) State Initiative.--This section shall not apply to a 
State requirement adopted by a State public initiative or 
referendum enacted prior to September 1, 1997.

   Subchapter I--Notification of the Discontinuance of a Life Saving 
                                Product

SEC. 781. DISCONTINUANCE OF A LIFE SAVING PRODUCT.

  (a) In General.--A manufacturer that is the sole manufacturer 
of a drug or device--
          (1) that is--
                  (A) life supporting;
                  (B) life sustaining; or
                  (C) intended for use in the prevention of a 
                debilitating disease or condition; and
          (2) for which an application has been approved under 
        section 505(b), 505(j), or 515(d),
shall notify the Secretary of a discontinuance of the 
manufacture of the drug or device at least 6 months prior to 
the date of the discontinuance.
  (b) Reduction in Notification Period.--On application of a 
manufacturer, the Secretary may reduce the notification period 
required under subsection (a) for the manufacturer if good 
cause exists for the reduction, such as a situation in which--
          (1) a public health problem may result from 
        continuation of the manufacturing for the 6-month 
        period;
          (2) a biomaterials shortage prevents the continuation 
        of the manufacturing for the 6-month period;
          (3) a liability problem may exist for the 
        manufacturer if the manufacturing is continued for the 
        6-month period;
          (4) continuation of the manufacturing for the 6-month 
        period may cause substantial economic hardship for the 
        manufacturer;
          (5) the manufacturer has filed for bankruptcy under 
        chapter 7 or 11 of title 11, United States Code; or
          (6) the Secretary determines that there would be no 
        adverse impact from the discontinuance of a drug or 
        device.
  (c) Distribution.--To the maximum extent practicable, the 
Secretary shall distribute information on the discontinuation 
of the drugs and devices described in subsection (a) to 
appropriate physician and patient organizations.

                   CHAPTER VIII--IMPORTS AND EXPORTS

                          imports and exports

  Sec. 801. (a) * * *
          * * * * * * *
  (d)(1) Except as provided in paragraph (2), no drug subject 
to section 503(b) or composed wholly or partly of insulin which 
is manufactured in a State and exported may be imported into 
the United States unless the drug is imported by the 
manufacturer of the drug.
          * * * * * * *

                 exports of certain unapproved products

  Sec. 802. (a) * * *
          * * * * * * *
  (i) Insulin and antibiotics may be exported without regard to 
the requirements in this section if the insulin and antibiotics 
meet the requirements of section 801(e)(1).

                   office of international relations

  Sec. 803. (a) * * *
          * * * * * * *
  (c) The Secretary shall participate in meetings with 
representatives of other countries to discuss methods and 
approaches to reduce the burden of regulation and harmonize 
regulatory requirements if the Secretary determines that such 
harmonization continues consumer protections consistent with 
the purposes of this Act. The Secretary shall report to the 
Committee on Commerce of the House of Representatives and the 
Committee on Labor and Human Resources of the Senate at least 
60 days before executing any bilateral or multilateral 
agreement under subsection (b).

                       CHAPTER IX--MISCELLANEOUS

          * * * * * * *

SEC. 903. FOOD AND DRUG ADMINISTRATION.

  (a) * * *
  (b) Mission.--The Food and Drug Administration shall promote 
the public health by promptly and efficiently reviewing 
clinical research and taking appropriate action on the 
marketing of regulated products in a timely manner, and with 
respect to such products shall protect the public health by 
ensuring that--
          (1) foods are safe, wholesome, sanitary, and properly 
        labeled;
          (2) human and veterinary drugs are safe and 
        effective;
          (3) there is reasonable assurance of safety and 
        effectiveness of devices intended for human use;
          (4) cosmetics are safe and properly labeled; and
          (5) public health and safety are protected from 
        electronic product radiation.
The Food and Drug Administration shall participate with other 
countries to reduce the burden of regulation, harmonize 
regulatory requirements, and achieve appropriate reciprocal 
arrangements.
  [(b)] (c) Commissioner.--
          (1) * * *
          * * * * * * *
  [(c)] (d) Technical and Scientific Review Groups.--The 
Secretary through the Commissioner of Food and Drugs may, 
without regard to the provisions of title 5, United States 
Code, governing appointments in the competitive service and 
without regard to the provisions of chapter 51 and subchapter 
III of chapter 53 of such title relating to classification and 
General Schedule pay rates, establish such technical and 
scientific review groups as are needed to carry out the 
functions of the Administration, including functions under the 
Federal Food, Drug, and Cosmetic Act, and appoint and pay the 
members of such groups, except that officers and employees of 
the United States shall not receive additional compensation for 
service as members of such groups.
  (e) Annual Report.--The Secretary shall, simultaneously with 
the submission each year of the budget for the Food and Drug 
Administration, submit to the Committee on Commerce of the 
House of Representatives and the Committee on Labor and Human 
Resources of the Senate an annual report which shall--
          (1) review the performance of the Food and Drug 
        Administration in meeting its mission and the 
        development of Food and Drug Administration policies to 
        implement such mission;
          (2) review the performance of the Food and Drug 
        Administration in meeting its own performance 
        standards, including its own outcome measurements, and 
        statutory deadlines for the approval of products or for 
        other purposes contained in this Act;
          (3) describe the staffing and resources of the Food 
        and Drug Administration; and
          (4)(A) list each bilateral and multinational meeting 
        held by the Food and Drug Administration to address 
        methods and approaches to reduce the burden of 
        regulation, to harmonize regulation, and to seek 
        appropriate reciprocal arrangements, (B) describe the 
        goals, activities, and accomplishments of the Food and 
        Drug Administration in such meetings, and (C) list 
        issues that the Food and Drug Administration is 
        considering or has presented for each such meeting.
          * * * * * * *

SEC. 906. INFORMATION SYSTEM.

  The Secretary shall establish and maintain an information 
system to track the status and progress of each application or 
submission (including a petition, notification, or other 
similar form of request) submitted to the Food and Drug 
Administration requesting agency action.

SEC. 907. EDUCATION.

  The Secretary shall conduct training and education programs 
for the employees of the Food and Drug Administration relating 
to the regulatory responsibilities and policies established by 
this Act, including programs for scientific training and 
training in administrative process and procedure and integrity 
issues.

SEC. 908. DEMONSTRATION PROGRAM REGARDING CENTERS FOR EDUCATION AND 
                    RESEARCH ON DRUGS.

  (a) In General.--The Secretary, acting through the 
Commissioner of Food and Drugs, shall establish a demonstration 
program for the purpose of making one or more grants for the 
establishment and operation of one or more centers to carry out 
the activities specified in subsection (b).
  (b) Required Activities.--The activities referred to in 
subsection (a) are the following:
          (1) The conduct of state-of-the-art clinical and 
        laboratory research for the following purposes:
                  (A) To increase awareness of new uses of 
                drugs and the unforeseen risks of new uses of 
                drugs.
                  (B) To provide objective clinical information 
                to the following entities:
                          (i) Health care practitioners or 
                        other providers of health care goods or 
                        services.
                          (ii) Pharmacy benefit managers.
                          (iii) Health maintenance 
                        organizations or other managed health 
                        care organizations.
                          (iv) Health care insurers or 
                        governmental agencies.
                  (C) To improve the quality of health care 
                while reducing the cost of health care through 
                the prevention of adverse effects of drugs and 
                the consequences of such effects, such as 
                unnecessary hospitalizations.
          (2) The conduct of research on the comparative 
        effectiveness and safety of drugs.
          (3) Such other activities as the Secretary determines 
        to be appropriate, except that the grant may not be 
        expended to assist the Secretary in the review of new 
        drugs.
  (c) Application for Grant.--A grant under subsection (a) may 
be made only if an application for the grant is submitted to 
the Secretary and the application is in such form, is made in 
such manner, and contains such agreements, assurances, and 
information as the Secretary determines to be necessary to 
carry out this section.
  (d) Peer Review.--A grant under subsection (a) may be made 
only if the application for the grant has undergone appropriate 
technical and scientific peer review.
  (e) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated $2,000,000 for fiscal year 1998, and $3,000,000 
for fiscal year 1999.
                              ----------                              


                       PUBLIC HEALTH SERVICE ACT

          * * * * * * *

     TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE

          * * * * * * *

    Part F--Licensing--Biological Products and Clinical Laboratories

                     Subpart 1--Biological Products

                   regulation of biological products

  Sec. 351. [(a) No person shall sell, barter, or exchange, or 
offer for sale, barter, or exchange in the District of 
Columbia, or send, carry, or bring for sale, barter, or 
exchange from any State or possession into any other State or 
possession or into any foreign country, or from any foreign 
country into any State or possession, any virus, therapeutic 
serum, toxin, antitoxin, vaccine, blood, blood component or 
derivative, allergenic product, or analogous product, or 
arsphenamine or its derivatives (or any other trivalent organic 
arsenic compound), applicable to the prevention, treatment, or 
cure of diseases or injuries of man, unless (1) such virus, 
serum, toxin, antitoxin, vaccine, blood, blood component or 
derivative, allergenic product, or other product has been 
propagated or manufactured and prepared at an establishment 
holding an unsuspended and unrevoked license, issued by the 
Secretary as hereinafter authorized, to propagate or 
manufacture, and prepare such virus, serum, toxin, antitoxin, 
vaccine, blood, blood component or derivative, allergenic 
product, or other product for sale in the District of Columbia, 
or for sending, bringing, or carrying from place to place 
aforesaid; and (2) each package of such virus, serum, toxin, 
antitoxin, vaccine, blood, blood component or derivative, 
allergenic product, or other product is plainly marked with the 
proper name of the article contained therein, the name, 
address, and license number of the manufacturer, and the date 
beyond which the contents cannot be expected beyond reasonable 
doubt to yield their specific results. The suspension or 
revocation of any license shall not prevent the sale, barter, 
or exchange of any virus, serum, toxin, antitoxin, vaccine, 
blood, blood component or derivative, allergenic product, or 
other product aforesaid which has been sold and delivered by 
the licensee prior to such suspension or revocation, unless the 
owner or custodian of such virus, serum, toxin, antitoxin, 
vaccine, blood, blood component or derivative, allergenic 
product, or other product aforesaid has been notified by the 
Secretary not to sell, barter, or exchange the same.
  [(b) No person shall falsely label or mark any package or 
container or any virus, serum, toxin, antitoxin, vaccine, 
blood, blood component or derivative, allergenic product, or 
other product aforesaid; nor alter any label or mark on any 
package or container of any virus, serum, toxin, antitoxin, 
vaccine, blood, blood component or derivative, allergenic 
product, or other product aforesaid so as to falsify such label 
or mark.]
  (a)(1) No person shall introduce or deliver for introduction 
into interstate commerce any biological product unless--
          (A) a biologics license is in effect for the 
        biological product; and
          (B) each package of the biological product is plainly 
        marked with--
                  (i) the proper name of the biological product 
                contained in the package;
                  (ii) the name, address, and applicable 
                license number of the manufacturer of the 
                biological product; and
                  (iii) the expiration date of the biological 
                product.
  (2)(A) The Secretary shall establish, by regulation, 
requirements for the approval, suspension, and revocation of 
biologics licenses.
  (B) The Secretary shall approve a biologics license 
application--
          (i) on the basis of a demonstration that--
                  (I) the biological product that is the 
                subject of the application is safe, pure, and 
                potent; and
                  (II) the facility in which the biological 
                product is manufactured, processed, packed, or 
                held meets standards designed to assure that 
                the biological product continues to be safe, 
                pure, and potent; and
          (ii) if the applicant (or other appropriate person) 
        consents to the inspection of the facility that is the 
        subject of the application, in accordance with 
        subsection (c).
  (3) The Secretary shall prescribe requirements under which a 
biological product undergoing investigation shall be exempt 
from the requirements of paragraph (1).
  (b) No person shall falsely label or mark any package or 
container of any biological product or alter any label or mark 
on the package or container of the biological product so as to 
falsify the label or mark.
  (c) Any officer, agent, or employee of the Department of 
Health and Human Services, authorized by the Secretary for the 
purpose, may during all reasonable hours enter and inspect any 
establishment for the propagation or manufacture and 
preparation of any [virus, serum, toxin, antitoxin, vaccine, 
blood, blood component or derivative, allergenic product, or 
other product aforesaid for sale, barter, or exchange in the 
District of Columbia, or to be sent, carried, or brought from 
any State or possession into any other State or possession or 
into any foreign country, or from any foreign country into any 
State or possession.] biological product.
  [(d)(1) Licenses for the maintenance of establishments for 
the propagation or manufacture and preparation of products 
described in subsection (a) of this section may be issued only 
upon a showing that the establishment and the products for 
which a license is desired meet standards, designed to insure 
the continued safety, purity, and potency of such products, 
prescribed in regulations, and licenses for new products may be 
issued only upon a showing that they meet such standards. All 
such licenses shall be issued, suspended, and revoked as 
prescribed by regulations and all licenses issued for the 
maintenance of establishment for the propagation or manufacture 
and preparation, in any foreign country, of any such products 
for sale, barter, or exchange in any State or possession shall 
be issued upon condition that the licensees will permit the 
inspection of their establishments in accordance with 
subsection (c) of this section.]
    [(2)(A) Upon] (d)(1) Upon a determination that a batch, 
lot, or other quantity of a product licensed under this section 
presents an imminent or substantial hazard to the public 
health, the Secretary shall issue an order immediately ordering 
the recall of such batch, lot, or other quantity of such 
product. An order under this paragraph shall be issued in 
accordance with section 554 of title 5, United States Code.
    [(B)] (2) Any violation of [subparagraph (A)] paragraph (1) 
shall subject the violator to a civil penalty of up to $100,000 
per day of violation. The amount of a civil penalty under [this 
subparagraph] this paragraph shall, effective December 1 of 
each year beginning 1 year after the effective date of [this 
subparagraph] this paragraph, be increased by the percent 
change in the Consumer Price Index for the base quarter of such 
year over the Consumer Price Index for the base quarter of the 
preceding year, adjusted to the nearest \1/10\ of 1 percent. 
For purposes of [this subparagraph] this paragraph, the term 
``base quarter'', as used with respect to a year, means the 
calendar quarter ending on September 30 of such year and the 
price index for a base quarter is the arithmetical mean of such 
index for the 3 months comprising such quarter.
          * * * * * * *
  (i) In this section, the term ``biological product'' means a 
virus, therapeutic serum, toxin, antitoxin, vaccine, blood, 
blood component or derivative, allergenic product, or analogous 
product, or arsphenamine or derivative of arsphenamine (or any 
other trivalent organic arsenic compound), applicable to the 
prevention, treatment, or cure of a disease or condition of 
human beings.
          * * * * * * *

                    Subpart 2--Clinical Laboratories

                     certification of laboratories

  Sec. 353. (a) * * *
          * * * * * * *
  (d) Requirements for Certificates.--
          (1) * * *
          * * * * * * *
          [(3) Examinations and procedures.--The examinations 
        and procedures identified in paragraph (2) are simple 
        laboratory examinations and procedures which, as 
        determined by the Secretary, have an insignificant risk 
        of an erroneous result, including those which--
                  [(A) have been approved by the Food and Drug 
                Administration for home use,
                  [(B) employ methodologies that are so simple 
                and accurate as to render the likelihood of 
                erroneous results negligible, or
                  [(C) the Secretary has determined pose no 
                reasonable risk of harm to the patient if 
                performed incorrectly.]
          (3) Examinations and procedures.--The examinations 
        and procedures identified in paragraph (2) are 
        laboratory examinations and procedures which have been 
        approved by the Food and Drug Administration for home 
        use or which, as determined by the Secretary, are 
        simple laboratory examinations and procedures which 
        have an insignificant risk of an erroneous result, 
        including those which--
                  (A) employ methodologies that are so simple 
                and accurate as to render the likelihood of 
                erroneous results by the user negligible, or
                  (B) the Secretary has determined pose no 
                reasonable risk of harm to the patient if 
                performed incorrectly.
          * * * * * * *

                 TITLE IV--NATIONAL RESEARCH INSTITUTES

                 Part A--National Institutes of Health

          * * * * * * *

              appointment and authority of director of nih

  Sec. 402. (a) * * *
          * * * * * * *
  (j)(1) The Secretary, acting through the Director of the 
National Institutes of Health, shall establish, maintain, and 
operate a program with respect to information on research 
relating to the treatment, detection, and prevention of serious 
or life-threatening diseases and conditions. The program shall, 
with respect to the agencies of the Department of Health and 
Human Services, be integrated and coordinated, and, to the 
extent practicable, coordinated with other data banks 
containing similar information.
  (2)(A) After consultation with the Commissioner of Food and 
Drugs, the directors of the appropriate agencies of the 
National Institutes of Health (including the National Library 
of Medicine), and the Director of the Centers for Disease 
Control and Prevention, the Secretary shall, in carrying out 
paragraph (1), establish a data bank of information on clinical 
trials for drugs for serious or life-threatening diseases and 
conditions.
  (B) In carrying out subparagraph (A), the Secretary shall 
collect, catalog, store, and disseminate the information 
described in such subparagraph. The Secretary shall disseminate 
such information through information systems, which shall 
include toll-free telephone communications, available to 
individuals with serious or life-threatening diseases and 
conditions, to other members of the public, to health care 
providers, and to researchers.
  (3) The data bank shall include the following:
          (A) A registry of clinical trials (whether federally 
        or privately funded) of experimental treatments for 
        serious or life-threatening diseases and conditions 
        under regulations promulgated pursuant to sections 505 
        of the Federal Food, Drug, and Cosmetic Act that 
        provides a description of the purpose of each 
        experimental drug, either with the consent of the 
        protocol sponsor, or when a trial to test effectiveness 
        begins. Information provided shall consist of 
        eligibility criteria, a description of the location of 
        trial sites, and a point of contact for those wanting 
        to enroll in the trial, and shall be in a form that can 
        be readily understood by members of the public. Such 
        information must be forwarded to the data bank by the 
        sponsor of the trial not later than 21 days after 
        trials to test clinical effectiveness have begun.
          (B) Information pertaining to experimental treatments 
        for serious or life-threatening diseases and conditions 
        that may be available--
                  (i) under a treatment investigational new 
                drug application that has been submitted to the 
                Food and Drug Administration under section 
                551(c) of the Federal Food, Drug, and Cosmetic 
                Act; or
                  (ii) as a Group C cancer drug (as defined by 
                the National Cancer Institute).
        The data bank may also include information pertaining 
        to the results of clinical trials of such treatments, 
        with the consent of the sponsor, including information 
        concerning potential toxicities or adverse effects 
        associated with the use or administration of such 
        experimental treatments.
  (4) The data bank shall not include information relating to 
an investigation if the sponsor has provided a detailed 
certification to the Secretary that disclosure of such 
information would substantially interfere with the timely 
enrollment of subjects in the investigation, unless the 
Secretary, after the receipt of the certification, provides the 
sponsor with a detailed written determination that such 
disclosure would not substantially interfere with such 
enrollment.
  (5) For the purpose of carrying out this subsection, there 
are authorized to be appropriated such sums as may be 
necessary. Fees collected under section 736 of the Federal 
Food, Drug, and Cosmetic Act shall not be used in carrying out 
this subsection.
  [(j)] (k)(1) The Director of NIH may establish a program to 
provide day care services for the employees of the National 
Institutes of Health similar to those services provided by 
other Federal agencies (including the availability of day care 
service on a 24-hour-a-day basis).
          * * * * * * *
  [(k)] (l) The Director of NIH shall carry out the program 
established in part F of title XII (relating to interagency 
research on trauma).
          * * * * * * *
                              ----------                              


              SECTION 8126 OF TITLE 38, UNITED STATES CODE

Sec. 8126. Limitation on prices of drugs procured by Department and 
                    certain other Federal agencies

  (a) * * *
          * * * * * * *
  (h) In this section:
          (1) * * *
                  (D) Section 8126(h)(2) of title 38, United 
                States Code, is amended by inserting ``or'' at 
                the end of subparagraph (B), by striking ``; 
                or'' at the end of subparagraph (C) and 
                inserting a period, and by striking 
                subparagraph (D).
          (2) The term ``covered drug'' means--
                  (A) * * *
                  (B) a drug described in section 
                1927(k)(7)(A)(iv) of the Social Security Act, 
                or that would be described in such section but 
                for the application of the first sentence of 
                section 1927(k)(3) of such Act; or
                  (C) any biological product identified under 
                section 600.3 of title 21, Code of Federal 
                Regulations[; or].
                  [(D) insulin certified under section 506 of 
                the Federal Food, Drug, and Cosmetic Act.]
          * * * * * * *
                              ----------                              


                    SECTION 5 OF THE ORPHAN DRUG ACT

  grants and contracts for development of drugs for rare diseases and 
                               conditions

  Sec. 5. (a) * * *
  (b) For purposes of subsection (a):
          (1) The term ``qualified testing'' means--
                  (A) human clinical testing--
                          (i) * * *
                          (ii) which occurs after the date such 
                        drug is designated under section 526 of 
                        such Act and before the date on which 
                        an application with respect to such 
                        drug is submitted under section 505(b) 
                        [or 507] of such Act or under section 
                        351 of the Public Health Service Act; 
                        and
                  (B) preclinical testing involving a drug for 
                a rare disease or condition which occurs after 
                the date such drug is designated under section 
                526 of such Act and before the date on which an 
                application with respect to such drug is 
                submitted under section 505(b) [or 507] of such 
                Act or under section 351 of the Public Health 
                Service Act.
          * * * * * * *
                              ----------                              


            SECTION 45C OF THE INTERNAL REVENUE CODE OF 1986

Sec. 45C. Clinical testing expenses for certain drugs for rare diseases 
                    or conditions

  (a) General Rule.--For purposes of section 38, the credit 
determined under this section for the taxable year is an amount 
equal to 50 percent of the qualified clinical testing expenses 
for the taxable year.
  (b) Qualified Clinical Testing Expenses.--For purposes of 
this section--
          (1) * * *
          (2) Clinical testing.--
                  (A) In general.--The term ``clinical 
                testing'' means any human clinical testing--
                          (i) * * *
                          (ii) which occurs--
                                  (I) after the date such drug 
                                is designated under section 526 
                                of such Act, and
                                  (II) before the date on which 
                                an application with respect to 
                                such drug is approved under 
                                section 505(b) [or 507] of such 
                                Act or, if the drug is a 
                                biological product, before the 
                                date on which a license for 
                                such drug is issued under 
                                section 351 of the Public 
                                Health Service Act, and
          * * * * * * *
                              ----------                              


              SECTION 156 OF TITLE 35, UNITED STATES CODE

Sec. 156. Extension of patent term

  (a) * * *
          * * * * * * *
  (f) For purposes of this section:
          (1) * * *
          * * * * * * *
          (4)(A) * * *
          (B) Any reference to section 503, 505, [507,] 512, or 
        515 is a reference to section 503, 505, [507,] 512, or 
        515 of the Federal Food, Drug, and Cosmetic Act.
          * * * * * * *

               ADDITIONAL VIEWS OF HON. EDWARD J. MARKEY

    The United States has the safest foods and drugs in the 
world because American consumers and patients demand that the 
Food and Drug Administration be given full authority to reign 
in the renegades and require food and drug manufacturers to 
maintain the highest possible safety and effectiveness 
standards before allowing products to come to market. We must 
be vigilant in our defense of those high standards, and of a 
strong FDA.
    The drug bill will reauthorize the Prescription Drug User 
Fee Act, a program universally regarded as a success. Since the 
inception of PDUFA, the FDA has made the review and approval 
process for new drug applications an efficient and expeditious 
exercise. The bill will permit the Secretary to require 
companies to perform studies on the benefits of new drugs in 
pediatric populations. And the bill will expedite the study, 
approval and access to ``fast track'' drugs, investigational 
therapies and clinical trials for serious or life-threatening 
diseases. In the areas of food and devices, some of the reforms 
will result in increased streamlining and less unwanted and 
unneeded bureaucracy.
    But, we are also being asked to take the bad with the good. 
The drug bill contains a dangerous and precedent-setting 
provision regarding dissemination of information. The ``Off-
label'' provision could be better described as the ``under the 
table'' provision, allowing companies to market a product for 
unsupported uses that could seriously send thousands of 
consumers ``off the cliff.'' In putting profits over patient 
care, this bill opens the door for aggressive promotion of 
unproven uses of drugs, while giving companies three to five 
years to produce scientific evidence that these off-label uses 
are safe and effective. Much has been said recently about the 
Fen-Phen tragedy--clearly this drug combination was 
overprescribed and undermonitored, putting thousands of 
Americans, mainly women, at risk of heart-valve irregularities 
and pulmonary hypertension--and these prescriptions were 
written without an aggressive off-label marketing campaign.
    I realize that the bill as written applies to journal and 
text articles, that the FDA may review this material, and that 
the provision sunsets in 7 years--but there is no excuse for 
approving an ill-considered and dangerous off-label experiment 
on the grounds that it is only temporary. The sun could set on 
the health of thousands of consumers long before it sets on 
this provision.
    I am hopeful that stronger consumer and patient protections 
in the ``off-label'' section of this bill are included before 
the final version of H.R. 1411 comes to the House floor.

                                                  Edward J. Markey.

                 ADDITIONAL VIEWS OF HON. BOBBY L. RUSH

          inclusion of women and minorities in clinical trials

    During the markup of H.R. 1411, The Drug and Biological 
Products Modernization Act of 1997, I offered an amendment to 
the bill to ensure that women and members of minority and 
ethnic groups would be adequately represented in clinical 
trials of new drugs that are submitted to the Food and Drug 
Administration [FDA] for approval. This amendment specifically 
directs the Secretary of Health and Human Services to consult 
with the National Institute of Health (NIH) to review and 
develop guidelines on the inclusion of women and minorities in 
clinical trials.
    This important amendment was unanimously adopted by the 
Committee by voice vote.
    This amendment is long overdue. Medical research in the 
last 15 years points to the rapid development of a new field--
pharmogenetics. We are quickly learning that women and members 
of racial and ethnic groups may respond differently to certain 
drugs than white males. Dr. Richard Levy has highlighted these 
key findings in his 1993 study ``Ethnic and Racial Differences 
in Response to Medicine.''
    In passing H.R. 1411, the Committee engaged in a vigorous 
debate about the respective roles of government and the 
industry. We have heard a lot about how we must not sacrifice 
the public health and consumer safety by allowing faster 
approval of new drugs. In the same spirit, we must not lose 
sight of equity issues.
    We know too much not to pass this amendment. Historically, 
women and members of minority groups have faced barriers to 
participation in many areas of American life--higher education, 
business, and government. Congress has recognized these 
inequities and enacted legislation and federal programs that 
target participation of these groups in our economic and 
political life.
    My amendment calls for development of guidance by FDA. It 
does not ask the FDA to require industry to demonstrate that 
they have adequately included women and minorities in clinical 
drug trials. However, in 1993, Congress, passed the National 
Institutes of Health [NIH] Revitalization Act. The Act requires 
the NIH include women and members of minority groups as 
subjects in each clinical research project supported by NIH. It 
has been argued that the FDA does not conduct studies and, 
therefore, should not have to adopt the same requirements. 
Nevertheless, the agency has a responsibility to make sure that 
new drugs they do approve have been adequately tested on the 
populations they are intend to help. If, for example, we know 
that African-American males suffer higher rates of hypertension 
than white males, then companies seeking approval for these 
drugs should be required to demonstrate that they have been 
adequately tested on African-American men.
    The FDA has indicated a desire to move in this direction. 
The Agency has issued guidelines on the inclusion of women in 
clinical trials. However, there is no similar guidance on 
inclusion of minorities. If FDA recognizes the differential 
impact of drugs on certain groups, then the agency must assume 
responsibility for assuring that they have access to this 
information from the industry. This inevitably means that 
clinical trials must be designed and carried out with 
participation of persons from different age groups, genders, 
and racial subgroups.
    There appears to be evidence that an increasing number of 
drug manufacturers do test new drugs on more ethnic and racial 
minority groups. A study reported by the Pharmaceutical 
Manufacturers Association in 1991 showed that a majority of 
drug companies include racial minorities (67 percent) and women 
(76 percent) in their clinical trials. This represents 
progress. However, FDA must take the next step to make sure 
that women and/or members of minority groups are sufficiently 
represented, based on what we know about the incidence of 
particular diseases among these groups.
    My amendment was offered with the intent of urging the 
Administration to seriously move in this direction. As we move 
into the 21st century and become a more culturally diverse 
society, the FDA and the industry should begin to work toward 
developing a process to ensure that clinical drug trials 
reflect this diversity. This public policy is vital to 
guaranteeing that all Americans, regardless of their 
background, have access to the most lifesaving therapies.

                                                     Bobby L. Rush.