[Pages H5426-H5434]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

DRUG IMPORT FAIRNESS ACT OF 1999

Mr. BILBRAY. Mr. Speaker, I move to suspend the rules and pass the
bill (H.R. 3240) to amend the Federal Food, Drug, and Cosmetic Act to
clarify certain responsibilities of the Food and Drug Administration
with respect to the importation of drugs into the United States.
The Clerk read as follows:

H.R. 3240

Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ``Drug Import Fairness Act of
1999''.

SEC. 2. FINDINGS.

The Congress finds as follows:
(1) Pharmacists, patients, and other persons sometimes have
reason to import into the United States drugs that have been
approved by the Food and Drug Administration (``FDA'').
(2) There have been circumstances in which--
(A) a person seeking to import such a drug has received a
notice from FDA that importing the drug violates or may
violate the Federal Food, Drug, and Cosmetic Act; and
(B) the notice failed to inform the person of the reasons
underlying the decision to send the notice.
(3) FDA should not send a warning notice regarding the
importation of a drug without providing to the person
involved a statement of the underlying reasons for the
notice.

SEC. 3. CLARIFICATION OF CERTAIN RESPONSIBILITIES OF FOOD AND
DRUG ADMINISTRATION WITH RESPECT TO IMPORTATION
OF DRUGS INTO UNITED STATES.

Section 801 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 381) is amended by adding at the end the following
subsection:
``(g)(1) With respect to a drug being imported or offered
for import into the United States, the Secretary may not send
a warning notice to a person (including a pharmacist or
wholesale importer) unless the following conditions are met:
``(A) The notice specifies, as applicable to the
importation of the drug, that the Secretary has made a
determination that--
``(i) importation is in violation of section 801(a) because
the drug is or appears to be adulterated, misbranded, or in
violation of section 505;

[[Page H5427]]

``(ii) importation is in violation of section 801(a)
because the drug is forbidden or restricted in sale in the
country in which it was produced or from which it was
exported;
``(iii) importation by any person other than the
manufacturer of the drug is in violation of section 801(d);
or
``(iv) importation is otherwise in violation of Federal
law.
``(B) The notice does not specify any provision described
in subparagraph (A) that is not applicable to the importation
of the drug.
``(C) The notice states the reasons underlying such
determination by the Secretary, including a brief application
to the principal facts involved of the provision of law
described in subparagraph (A) that is the basis of the
determination by the Secretary.
``(2) The term `warning notice', with respect to the
importation of a drug, means a communication from the
Secretary (written or otherwise) notifying a person, or
clearly suggesting to the person, that importing the drug is,
or appears to be, a violation of this Act.''.

The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
California (Mr. Bilbray) and the gentleman from Ohio (Mr. Brown) each
will control 20 minutes.
The Chair recognizes the gentleman from California (Mr. Bilbray).
Mr. BILBRAY. Mr. Speaker, I ask unanimous consent to yield the time
for the purpose of management to the gentleman from Oklahoma (Mr.
Coburn).
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from California?
There was no objection.
Mr. COBURN. Mr. Speaker, I yield 3 minutes to the gentleman from
Minnesota (Mr. Gutknecht).
Mr. GUTKNECHT. Mr. Speaker, I thank the gentleman for yielding me the
time.
Mr. Speaker, I am delighted that we are finally getting a chance to
talk about this bill. We have had a lot of discussion today about the
high cost of prescription drugs. I do not know if this chart was shown
or a chart similar to it, but we have got a lot of charts and a lot of
research has been done by a number of groups around the United States
about the differences between what Americans pay for prescription drugs
and what people around the rest of the world pay for exactly the same
prescription drugs.

{time} 2340

Let me give one example. My father takes a drug called coumadin. If
one buys that drug in the United States, the price is $30, roughly
$30.50 for a 30-day supply. If one buys that same drug made in the same
plant under the same FDA approval in Europe, Switzerland, for example,
you pay $2.85.
Now, Mr. Speaker, we have the North American Free Trade Agreement. We
have passed a number of free trade agreements and somehow we always
wind up on the short end of that stick.
Let me show another example. This is an example of a very commonly-
prescribed drug called prilosec. If one buys it in Minneapolis, the
average price for a 30-day supply is $99.95, but if one buys it in
Winnipeg, Manitoba, if one happens to be vacationing and they have
their prescription, they take it into a pharmaceutical shop and it can
be bought for $50.88, but if one happens to be vacationing down in
Mexico, in Guadalajara, Mexico, the same drug, made in the same plant,
under the same FDA approval, can be bought for $17.50.
Mr. Speaker, this is really about basic fairness. If we are going to
have the North American Free Trade Agreement, American consumers ought
to be able to benefit from this. It is easy for us to blame the big
pharmaceutical supply companies, the big manufacturers, but the truth
of the matter is, one of the real culprits and one of the real reasons
we can see these big differentials is our own Food and Drug
Administration, because when consumers try to order these drugs or
reorder drugs that they have bought at a pharmacy, whether it be in
Guadalajara or Winnipeg or wherever, when they try to reimport, bring
those drugs back in and reorder, they get a very threatening letter
from our own FDA.
The unvarnished truth is, Mr. Speaker, our own FDA is defending this
system. Our own FDA is standing between American consumers and lower
drug prices.
So I have offered a bill. It is a relatively simple bill. Part of the
problem is that right now the burden of proof is on the importer to
prove that it is a legal drug in the United States, and that is very
difficult for a senior citizen living in Minnesota or Montana or
wherever.
What my bill basically says is the burden of proof is now going to be
on the FDA. They must prove that those drugs are, in fact, illegal.
Now, it is not the complete answer but it is a very important first
step. If we can pass this here in the House, if we can get it passed in
the Senate, if we can get it passed by the conference committee, we can
begin the path to opening up our borders and having lower prescription
drug prices for American consumers.
Mr. BROWN of Ohio. Mr. Speaker, I yield myself such time as I may
consume.
Mr. Speaker, I want to thank the gentleman from Minnesota (Mr.
Gutknecht) for bringing attention to the fundamental issue underlying
all of our efforts on prescription drugs. His efforts are admirable.
Prescription drug prices are priced unreasonably, unjustifiably,
outrageously high in the United States. That is the issue. Why are drug
prices two times, three times, four times higher here than in other
industrialized countries? Because the prescription drug industry can
get away with it.
We do not negotiate prices. We do not demand that drug manufacturers
reduce their prices to reflect the taxpayer-funded portion of research
and development. We do not make use of the collective purchasing power
of 39 million Medicare beneficiaries to demand reasonably priced drugs.
Two weeks ago I took a dozen seniors from northeast Ohio across the
border to a Canadian pharmacy in Windsor, Ohio, where they paid one-
half, one-third and in a couple of cases one-sixth of what it would
have cost to purchase their prescriptions in Cleveland or Lorraine or
Medina.
What these seniors were doing out of desperation was engaging in a
practice called parallel importing. Current law prohibits reimportation
of prescription drugs manufactured in the United States. FDA, however,
permits exemptions for individuals who are purchasing a limited supply
of an FDA-approved prescription drug for personal use.
The U.S. is the wealthiest nation in the world. Our tax dollars
finance a significant portion of R&D underlying new prescription drugs.
Our senior citizens should not have to leave the United States to get
the medicines they need. It should never have reached this point.
Why do we tolerate it? We tolerate it because the prescription drug
industry has a huge stake in the status quo and spends lavishly on
television and in this institution to preserve it. They pour money into
political campaigns. They pour money into front groups like Citizens
for a Better Medicare. They pour money into advertising campaigns,
campaigns touting the GOP's prescription drug coverage proposal, which
this Congress in a partisan vote passed today, all of which undercuts
the plan's credibility.
They try to scare Americans into believing that if we do not let drug
manufacturers charge obscenely high prices that medical research and
development will dry up, but drug companies could afford to spend $8.3
billion last year on marketing and advertising. Drug company profits
outpace those of every other industry in this country by more than 5
percentage points.
Last year, Bristol-Myers-Squibb paid their CEO $146 million in salary
and benefits.
The drug industry consistently leads every other industry in return
on investment, in return on assets and return on equity. Thanks to huge
tax breaks, the drug industry's effective tax rate is 65 percent lower
than the average for other U.S. industries. Drug prices can come down
in the United States without stifling research and development.
Unfortunately, it does not matter whether we could take steps to make
prescription drugs more affordable. The only thing that matters is
whether we actually do take those steps, and if the Republicans'
prescription drug coverage plan is any indication GOP leadership is not
going to sneeze without asking the drug industry's permission.
That leaves American consumers who need affordable medicines with
imperfect options like traveling to Canada to fill their prescriptions
or to Mexico in

[[Page H5428]]

the southern part of the United States. That is what my colleague's
amendment is about and I applaud him for that. It is intended to help
pave the way for seniors to purchase their drugs across the border.
Unfortunately, it does not fulfill that objective. It does not codify a
senior's right to parallel import their prescription medications. The
paperwork burden this amendment could create may force FDA to shift
resources away from intercepting counterfeit or unsafe drugs.
The gentleman from Arkansas (Mr. Berry), the gentlewoman from
Missouri (Mrs. Emerson) and the gentleman from Vermont (Mr. Sanders)
requested the right to offer an amendment during today's deliberations
that would have explicitly enabled seniors to purchase their
prescription drugs from countries where prices are reasonable, without
compromising FDA's ability to protect consumers from counterfeit and
unsafe medicines. The Republican leadership refused to permit
consideration of that amendment.
Once again, the Republicans have created a Catch-22 that protects the
drug industry at the expense of consumers.
Earlier, we were given a choice of voting for a smoke and mirrors
prescription drug plan or voting for no plan at all. Now we are placed
in a position of either, one, voting for an amendment that could
compromise FDA's ability to protect consumers from counterfeit and
unsafe medicines or, two, voting against an amendment that at least
acknowledges the need to address prescription drug price discrimination
and, most importantly, that asserts the right of consumers to fight
back by getting their medicines outside the United States.
Again, I applaud the gentleman from Minnesota (Mr. Gutknecht) for his
good work and for underscoring the need to do something about the drug
industry's discriminatory pricing, but regretfully I must oppose this
particular bill.
Mr. Speaker, I reserve the balance of my time.
Mr. COBURN. Mr. Speaker, I yield myself 30 seconds.
Mr. Speaker, just a couple of points on the points that the gentleman
from Ohio (Mr. Brown) made. We also are not allowed by the rule and by
the powers that be with an ability to limit the direct consumer
advertising that should be a part of this, that consumed $1.9 billion
last year, will consume $3.8 billion this year and will consume $7.6
billion a year from now, all of which has no benefit for the American
consumer except the American consumer is paying for it.

{time} 2350

Mr. Speaker, I yield 2\1/2\ minutes to the gentleman from Florida
(Mr. Miller).
Mr. MILLER of Florida. Mr. Speaker, I thank the gentleman for
yielding time to me.
I congratulate the gentleman from Minnesota (Mr. Gutknecht) for
bringing this issue up. I have been an early cosponsor of his
legislation.
My congressional district in Florida has more seniors than any
district, or as many as any district in the country. It is a beautiful
retirement area in southwest Florida.
At my town meetings, I have had two concerns expressed by seniors.
One is, we need help with our prescription coverage. Our prescription
costs are so much higher today than they were certainly in 1965 when
Medicare came in. We need to do something about it.
This House for the first time in history finally passed legislation.
Let us hope the Senate will act and we will get something to the
President in the next few months. We really need to help the seniors.
The other issue is, why are drugs lower in Canada and elsewhere
around the world? I do not know the answer to that. As the gentleman
from Minnesota (Mr. Gutknecht) showed in his chart, we just look at
prescription after prescription where this is a fraction of the cost in
Europe, whether it is in England, Ireland, France, or if we go to
Mexico, it is lower.
Why? I do not have an answer, but I do know how to solve the problem:
Buy it where it is cheapest. If we can find a cheaper place to buy it,
that is what the marketplace is all about. Let us let the market work.
We should not have the government stand in the way to cause problems.
That is what this FDA is doing, just making it more difficult. There
is no reason why we cannot go buy our drugs from Montreal or London or
Belfast or Bombay or Mexico City. Why not allow the marketplace to
work?
This is just a first step in the right direction. For my
constituents, it is not going to be as convenient to go to Canada as
for those of the gentleman from Minnesota (Mr. Gutknecht) or those of
the gentleman from Vermont (Mr. Sanders) over there, but we should be
able to pick up an 800 number, a fax, or the Internet.
This is a global economy we are in. We have been opening up trade
since I have been in Congress, whether it is the NAFTA bill back in
1993, then we had the GATT, and just a month or so ago we had opening
more trade with China.
Why are not drugs available easily over the Internet? We should make
that possible. Most drugs are manufactured outside the United States,
anyway. The FDA certifies those laboratories where the drugs come from.
It should not be that complicated to solve the problem.
I think our government is just too bureaucratic to solve the problem.
I urge support for this bill, and I hope we can go further beyond this
bill. I congratulate the gentleman from Minnesota (Mr. Gutknecht).
Mr. BROWN of Ohio. Mr. Speaker, I yield 2 minutes to the gentleman
from Arkansas (Mr. Berry), who has been a leader on this and an
absolute warrior against outrageously high prescription drug prices.
(Mr. BERRY asked and was given permission to revise and extend his
remarks.)
Mr. BERRY. Mr. Speaker, I thank the gentleman for yielding time to
me.
Mr. Speaker, I applaud the gentleman from Minnesota (Mr. Gutknecht)
for his effort and his work addressing a very legitimate problem of
Americans getting ripped off by drug manufacturers every time they
visit their local pharmacy.
Undoubtedly, something is needed to rectify the injustice that has
resulted in Americans paying more for FDA-approved products made in
FDA-approved facilities than citizens of any other country in the
world.
I have here two bottles. Both of them are Claritin, made by Schering
Corporation. One of them is sold in North Dakota for $219 for 100
tablets. The same 100 tablets in Canada is $61. It is one of the safest
drugs ever made by man. It is unbelievable how safe this product is.
Yet, the American people get ripped off, pay four times what they ought
to have to pay for this product just because of the laws of the country
that protect the prescription drug manufacturers in this country.
The gentleman from Minnesota (Mr. Gutknecht) has approached this
legislation with noble intentions and placed much effort into passing
it. While I support his efforts, Congress should take a much more
comprehensive approach in dealing with this situation.
Under the Food, Drug, and Cosmetic Act, the burden is on the importer
to demonstrate that an imported drug is safe, effective, and approved
by the FDA. That product was originally made in an FDA-approved
facility. As long as FDA approval information is not required to follow
drugs sold abroad, importation by anyone other than the manufacturer
will be next to impossible.
There is also a great need to revisit a provision in the Food, Drug,
and Cosmetic Act that protects American pharmaceutical companies at the
expense of the consumers. This provision makes it illegal for anyone
other than the manufacturer to reimport into the U.S. prescription
medicine made by an American pharmaceutical manufacturer.
Mr. Speaker, I include for the Record a Dear Colleague letter
concerning H.R. 1885.
The letter referred to is as follows:

Since 1994, Drug Makers Have Imported More foreign-Made Drugs Into The
U.S. Than They Have Exported!

allowing pharmacies and wholesalers the same authority to import safe,
lower-priced, fda approved prescription drugs would save billions of
dollars for patients and american businesses!!!

According to a recent analysis of global prescriptions drug
pricing, the same prescription drugs an American citizen
would spend $1.00 to purchase, would only cost $0.71

[[Page H5429]]

in Germany, $0.68 in Sweden, $0.65 in the United Kingdom,
$0.64 in Canada, $0.57 in France, or $0.51 in Italy.
Economic experts agree that under a market system without
regulatory or trade barriers, significant price differentials
in prescription drugs would not be sustainable. Products
would be bought from the lower-priced, foreign countries and
then resold in the higher-priced country. Economic theory
holds that as this process (known as arbitrage) occurs,
prices in the lower-priced country would rise while prices in
the higher-priced country would fall.
Under FDA regulations and the Food, Drug, and Cosmetic Act,
only the manufacturers of a drug can import it into the
United States. Drug makers have unfairly used this monopoly
control over distribution in the United States to
discriminate against American consumers.
By supporting H.R. 1885, The International Prescription
Drug Parity Act, you can help level the playing field for
American patients as well as businesses who are struggling to
continue providing employees and retirees with quality,
private sector coverage for prescription drugs.
H.R. 1885 amends the Food, Drug, and Cosmetic Act to allow
American pharmacies and wholesalers to competitively purchase
drugs abroad that were manufactured in FDA approved
facilities, which have been safely stored and still meet
FDA's standards, and pass significant savings down to
consumers. Americans will benefit by being able to obtain
needed prescription medicines on a more affordable basis.
Under H.R. 1885, pharmacies and wholesalers importing drugs
would still have to meet the same standards set by FDA, which
allowed $12.8 billion worth of drugs to be imported into the
U.S. by manufacturers in 1997.
Sincerely,
Jo Ann Emerson,
Marion Berry,
Bernie Sanders,
Members of Congress.
(Table attachment).

PHARMACEUTICALS: U.S. SHIPMENTS, DOMESTIC EXPORTS, IMPORTS FOR CONSUMPTION, MERCHANDISE TRADE BALANCE, APPARENT CONSUMPTION, EXPORTS AS A PERCENT OF
SHIPMENTS, AND IMPORTS AS A PERCENT OF CONSUMPTION, 1993-97
[Dollars in millions]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exports as a Imports as a
Apparent percent of percent of
Year Shipments Exports Imports Trade balance consumption shipments consumption
(percent) (percent)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1993.................................... $58,428 $7,222 $6,094 $1,128 $59,556 12.4 10.2
1994.................................... 60,811 7,565 6,966 599 61,410 12.4 11.3
1995.................................... 68,473 7,996 8,583 -587 67,886 11.7 12.6
1996.................................... 75,047 8,889 11,161 -2,272 72,775 11.8 15.3
1997.................................... \1\ 82,550 9,600 \1\ 12,836 -3,236 79,314 11.6 16.2
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Estimated by U.S. International Trade Commission Staff.

Source: U.S. Department of Commerce.

Mr. Speaker, I include for the Record the text of the bipartisan
amendment offered by the gentlewoman from Missouri (Mrs. Emerson),
myself, and the gentleman from Vermont (Mr. Sanders), to the House
Committee on Rules, which failed.
The amendment referred to is as follows:

Add at the end the following title:

TITLE IV--INTERNATIONAL PRICE COMPETITION REGARDING COVERED DRUGS

SEC. 401. FACILITATION OF IMPORTATION OF CERTAIN DRUGS
APPROVED BY FOOD AND DRUG ADMINISTRATION.

(a) In General.--Chapter VIII of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 381 et seq.) is amended--
(1) in section 801(d)--
(A) by striking paragraphs (1) and (2); and
(B) by redesignating paragraphs (3) and (4) as paragraphs
(1) and (2), respectively; and
(2) by inserting after section 801 the following section:

``importation of certain drugs

``Sec. 801A. (a) In General.--After consultation with the
United States Trade Representative (through the Office of
International Relations under section 803), the Secretary
shall promulgate regulations to carry out subsection (c) for
the purpose of facilitating the importation into the United
States of covered drugs (as defined in subsection (f)).
``(b) Compliance With Requirements Regarding Safety and
Effectiveness, Adulteration and Misbranding, and Other
Matters.--With respect to the importation of covered drugs
into the United States pursuant to this section, regulations
under subsection (a) shall include such provisions as the
Secretary determines to be appropriate (such as requiring
tests or documents) to ensure that each of the requirements
of this Act for the importation of drugs is met, including
requirements with respect to--
``(1) the safety and effectiveness of the drugs;
``(2) good manufacturing practices and other provisions
regarding the adulteration of the drugs;
``(3) the misbranding of the drugs; and
``(4) whether the drugs are forbidden or restricted in sale
in the country in which they were produced or from which they
were exported.
``(c) Facilitation of Importation.--If a covered drug is
domestically approved and is manufactured in a State and then
exported, or is domestically approved and is for commercial
distribution manufactured in a foreign establishment
registered under section 510, the manufacturer shall, as a
condition of maintaining the domestic approval of the drug,
comply with the following:
``(1) For each shipment of the drug that is manufactured in
compliance with current good manufacturing practice and other
standards under section 501, the manufacturer shall (without
regard to whether the shipment is intended for importation
into the United States) maintain a record that identifies the
shipment and purchaser of the shipment and states the fact of
such compliance.
``(2) For each such shipment, the manufacturer shall
(without regard to whether the shipment is intended for
importation into the United States) maintain a record that
identifies the shipment and provides the labeling required
for the drug pursuant to section 502 and pursuant to the
application for domestic approval.
``(3) Upon the request of pharmacist, wholesaler, or other
person who intends to import into the United States drugs
from such shipment (and who meets applicable legal
requirements to be an importer of covered drugs), the
manufacturer shall provide to the person a copy of each of
the records maintained under paragraphs (1) and (2) with
respect to the shipment.
``(d) Certain Criteria.--For the purpose of facilitating
the importation into the United States of covered drugs, the
Secretary shall through regulations under subsection (a)
establish the following criteria:
``(1) Criteria regarding the records required in subsection
(c) and the use of the records to demonstrate the domestic
approval of the drugs and compliance of the drugs with
sections 501 and 502.
``(2) Such criteria regarding the labeling of the drugs as
the Secretary determines to be appropriate.
``(3) Criteria regarding the amount of charges that may be
imposed by manufacturers of the drugs for maintaining and
providing the records specified in paragraph (1). Any such
charge may not exceed an amount reasonably calculated to
reimburse the manufacturer involved for the costs of
maintaining and providing the records.
``(4) Criteria regarding the information that may be
required by manufacturers of covered drugs as a condition of
providing the records.
``(5) Criteria regarding entities that may serve as agents
of persons described in subsection (c)(3) or that otherwise
may serve as intermediaries between such persons and
manufacturers of covered drugs.
``(e) Authority to Require Registrations.--
``(1) In general.--In promulgating regulations under
subsection (a), the Secretary may provide that a person may
not import a covered drug into the United States unless--
``(A) the person registers with the Secretary the name and
places of business of the person; and
``(B) in the case of each factory or warehouse in a foreign
country that held the covered drug prior to the drug being
offered for importation into the United States (other than
ones owned or operated by the manufacturer of the drug), the
owner or operator of the factory or warehouse--
``(i) registers with the Secretary the name and places of
business of the owner or operator; and
``(ii) agrees that the factory or warehouse is subject to
inspection in accordance with section 704.
``(2) Exemption for manufacturer.--Paragraph (1) does not
apply with respect to a covered drug that is domestically
approved, manufactured in a State, exported, and then
imported by the manufacturer of the drug.
``(f) Definitions.--For purposes of this section:
``(1) The term `covered drug' means a drug that is
described in section 503(b) or is composed wholly or partly
of insulin.
``(2) The term `domestically approved', with respect to a
drug, means a drug for which an application is approved under
section 505, or as applicable, under section 351 of the
Public Health Service Act. The term `domestic approval', with
respect to a drug, means approval of an application for a
drug under such a section.

[[Page H5430]]

``(3) The term `pharmacist' means a person licensed by a
State to practice pharmacy in the State, including the
dispensing and selling of prescription drugs.
``(4) The term `wholesaler' means a person licensed in the
United States as a wholesaler or distributor of prescription
drugs.''.
(b) Conforming Amendment.--Section 801(d) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 381(d)) is amended in
paragraph (2) (as redesignated by subsection (a)(1) of this
section) by striking ``paragraph (3)'' each place such term
appears and inserting ``paragraph (1)''.
____

Memorandum

To:
From: Christopher J. Sroka, Economic Analyst, Resources,
Science, and Industry Division, Congressional Research
Service.
Subject: Summary of H.R. 1885, the International Prescription
Drug Parity Act.
This memorandum responds to your request for a summary of
the International Prescription Drug Parity Act (H.R. 1885).
H.R. 1885 seeks to amend the Federal Food, Drug, and Cosmetic
Act to facilitate the importation of prescription drugs into
the United States.
It has been widely reported that prescription drug prices
are lower in many foreign countries than in the United
States. Two studies were conducted by the U.S. General
Accounting Office in the early 1990s. One study examined
prices in the U.S. relative to those charged in Canada, while
the second study examined prices in the U.S. vis-a-vis the
United Kingdom. The studies concluded that prices are
typically higher in the U.S. than in Canada or the U.K.
Complementing these empirical studies, there are many
anecdotal accounts of American citizens traveling to Canada
or Mexico to obtain their prescription drugs at a lower
price. Differences between the prices charged in the U.S. and
those charged in other countries have been attributed to
various factors.
In theory, under a market system without regulatory or
trade barriers, significant price differentials in
prescription drugs would not be sustainable. Products would
be bought from the lower-priced, foreign countries and then
resold in the higher-priced country. Economic theory holds
that as this process (known as arbitrage) occurs, prices in
the lower-priced country would rise while prices in the
higher-priced country would fall. Arbitrage would continue
until, after taking into account differences in
transportation costs, a uniform price would prevail in both
countries.
Current federal law and Food and Drug Administration (FDA)
policy prevents arbitrage in prescription drugs. All drugs
sold in the U.S., including imported drugs, must have been
manufactured in an FDA-approved facility. The FDA's policy is
to assume that, unless the importer has proof to the
contrary, imported drugs are not manufactured at FDA-approved
facilities. Obtaining proof that a drug sold abroad was
actually manufactured in an FDA-approved facility can be
burdensome for the importer because the foreign seller of the
drug might not have accurate documentation proving the drug's
origin. Furthermore, the Prescription Drug Marketing Act of
1987 limits the reimportation of prescription drugs.
Reimportation occurs when a drug manufactured in the U.S. is
exported to another country and then imported back into the
U.S. The prescription Drug Marketing Act of 1987 prohibits
reimportation by an entity other than the original
manufacturer of the drug. Thus, even if an importer could
prove that the pharmaceutical it wishes to import was
manufactured in an FDA-approved facility in the U.S., the
reimportation would be illegal.
The intent of the FDA's importation policy and the
Prescription Drug Marketing Act was not to prevent American
consumers from obtaining drugs at lower prices. The purpose
was to ensure the safety of prescription drugs for American
consumers. At the time, the concern was that drugs imported
into the U.S. may have been counterfeit copies of FDA-
approved products. Counterfeit drugs could pose a serious
health threat if they are not manufactured properly. Another
concern was that, even if the drugs were not counterfeit, the
proper storage and handling of legitimate products could not
be guaranteed once they exited the U.S. Furthermore, drugs
manufactured domestically but intended for export may be
labeled for use in the country of destination. Thus, these
drugs, if imported, might not meet the FDA's labeling
requirements. Drugs not labeled in accordance to FDA
regulations might pose additional health threats to American
consumers.
H.R. 1885 seeks to remove the barrier to the importation of
prescription drugs, while at the same time ensuring the
safety of these drugs. The bill would strike the provisions
of the Federal Food, Drug, and Cosmetic Act that were added
by the Drug Marketing Act of 1987. Thus, entities other than
the original manufacturer could reimport pharmaceuticals.
Furthermore, the bill would establish certain record-
keeping requirements for pharmaceutical manufacturers. These
requirements would apply to (1) all drugs manufactured in the
U.S. and intended for export, and (2) all drugs manufactured
in FDA-approved facilities in foreign countries. The record-
keeping requirements would apply regardless of whether the
drugs are intended for final sale in the U.S. Under the bill,
pharmaceutical manufacturers would be required to keep
records proving that each shipment of drugs was manufactured
in an FDA-approved facility. Manufacturers would also be
required to keep a record of the FDA-approved labeling for
each shipment of drugs, regardless of its final destination.
The bill would allow importers to obtain the manufacturing
and labeling records from the pharmaceutical manufacturer. By
obtaining these records, importers might be able to more
easily prove that the drugs they wish to import are safe and
comply with FDA regulations.

Mr. COBURN. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I would like to add to what the gentleman from Arkansas
had to say. Mr. Speaker, $5.9 billion of Claritin were sold last year.
There are four other drugs with similar chemical moieties that have
been approved by the FDA. Guess what, they are all priced the same. Why
is that? Because there is not price competition in the pharmaceutical
industry.
Mr. Speaker, I yield 2 minutes to the gentleman from Michigan (Mr.
Hoekstra).
Mr. HOEKSTRA. Mr. Speaker, I thank my colleague for yielding time to
me. I also applaud my colleague, the gentleman from Minnesota (Mr.
Gutknecht), for introducing this legislation and bringing it to the
floor this evening.
Mr. Speaker, there is no doubt that U.S. consumers are paying a
premium for their prescription drugs. It is wrong. U.S. consumers have
no problem paying for the product that they consume. They have no
problem paying for the research and development costs that the
companies incur. They do not mind paying a fair return to the investor
and the drug companies.
What they do object to is paying the profits and the research and
development costs of our colleagues and our neighbors in Mexico, in
Canada, in other parts of the world. We are subsidizing the consumption
of prescription drugs in Canada, Mexico, and Europe. It is not fair to
the American consumer, it is not fair to our American taxpayer.
What this bill does is it says that if our consumers find these
drugs, prescription drugs, available at a lower price in Canada,
Mexico, or somewhere else, these drugs, prescription drugs, will be
made available to the American consumer. It is the fair thing and it is
the right thing to do.
Mr. BROWN of Ohio. Mr. Speaker, I yield 5 minutes to the gentleman
from Vermont (Mr. Sanders), who has been very involved in fighting for
parallel importation of prescription drugs.
Mr. SANDERS. Mr. Speaker, I very much thank my friend, the gentleman
from Ohio, for yielding time to me.
I want to congratulate my colleague, the gentleman from Minnesota
(Mr. Gutknecht), for introducing what I think is important legislation
which raises some very, very fundamental issues.
I think that tonight's discussion in terms of prescription drugs is
good, and I am delighted to hear it taking place in a nonpartisan way,
progressives, conservatives, who are standing up for the American
consumer.
I believe that I was the first Member of Congress to go across the
border with constituents to purchase prescription drugs. I have made
that trip twice. I made a trip a year ago to Canada. Like everyone else
that we have heard tonight, my experience was that we went across the
border and we were able to save Vermont constituents thousands and
thousands of dollars.
The one particular drug that comes to my mind now is Tamoxifen, which
is widely prescribed for breast cancer. Here we have women fighting for
their lives, they go across the Canadian border and they purchase that
product for one-tenth the price that they were paying in the United
States.
It seems to me, and we have heard it all already, I must tell the
Members, I have concerns about NAFTA and I voted against it; concerns
about that aspect of the global economy.
The bottom line is, as the gentleman from Florida (Mr. Miller) said a
few moments ago, in every single product one can think of, whether it
is a food product, whether it is shoes, whether it is apparel, there
are massive amounts of trade taking place throughout the world. The
question that the American people have to ask is why is it that there
is an exception with prescription drugs.

[[Page H5431]]

Legislation that has been offered by the gentleman from Arkansas (Mr.
Berry) and the gentlewoman from Missouri (Mrs. Emerson) and myself
which now has 85 cosponsors is a very simple piece of legislation. It
is a free trade piece of legislation.
What it says is exactly what the gentleman from Florida (Mr. Miller)
was talking about a moment ago. That is, if one is a prescription drug
distributor, if they are a pharmacist, they should be able to go out
and purchase anyplace in the world that they can FDA-safety-approved
products at the best price that one can purchase it.

{time} 0000

And if the case is that one can go to Canada, the reason that
Tamoxifen and all the other products are sold less expensively in
Canada is that the pharmacists purchase the product for significantly
lower amounts of money. Why is it that an American pharmacist has to
pay 10 times more for a product than a Canadian or Mexican pharmacist?
Mr. Speaker, it seems that people who believe in the competitive,
free enterprise system should support legislation which says that a
prescription drug distributor, so long as the product that comes into
the country is safe and that is easily done, that that businessperson
has a right to purchase that product at the lowest price he or she can
so that it can be sold to the American people at a lower price, so that
we end the disgrace that that chart was showing us that Americans are
paying by far more than the people of any other country for the same
exact prescription drug.
Mr. Speaker, I think this particular piece of legislation is a small
step forward, but it may open the door for further discussion. I hope
tonight, and I mean this very sincerely, that in a nonpartisan way we
can go forward. I think we are in basic agreement. The only rational
objection that anyone can throw us is the fear of adulteration from
abroad and so forth. That is easily addressed. If we can bring into
this country pork and beef and lettuce and tomatoes from farms and
ranches all over this continent, my God, we can regulate the
importation of prescription drugs which are made in a relatively few
factories.
I think that we are onto something big tonight, and I think if we
continue to work together in developing the concept of reimportation,
we can substantially lower the cost of prescription drugs in this
country 30, 40, or 50 percent and not see the American consumer the
laughing stock of the world by paying two, three, five times more for
products than other people throughout this world.
So I see this discussion as a very, very important step forward. I
congratulate the gentleman from Minnesota (Mr. Gutknecht) for bringing
this piece of legislation to the floor; and I hope that after tomorrow,
we will continue to meet and go forward and represent the American
consumers and finally stand up to the pharmaceutical industry which is
ripping our people off.
Mr. COBURN. Mr. Speaker, I yield 2\1/2\ minutes to the gentlewoman
from Idaho (Mrs. Chenoweth-Hage).
Mrs. CHENOWETH-HAGE. Mr. Speaker, I thank the gentleman from Oklahoma
for yielding me this time. It is very interesting, but since 1996, drug
costs have increased by over 50 percent. But in yesterday's Wall Street
Journal, the Wall Street Journal reported that the average cost of a
prescription rose almost 10 percent in 1999.
Now, for those aged 70 and up, costs for prescriptions rose by 15
percent. Tell me, our senior citizens who are on fixed incomes, where
are they going to get the extra 15 percent? From their heating bill?
From their food? From the cost of their air conditioner? Where? And yet
the drug companies are making massive profits off of the American
consumer.
Prilosec here for instance, $109 here. But in Mexico, it is $17.64
for the same prescription. Something is dreadfully wrong.
The Canadian Government yesterday released a study showing that the
Canadian consumers pay 56 percent less than Americans for patented
medications.
Now, our drug companies are well supported by the American taxpayer.
According to a 1993 report by the Office of Technology, in addition to
general research and training support, there are 13 programs
specifically targeted to fund pharmaceutical research and development.
That same report noted, of all U.S. industries, innovation within the
pharmaceutical industry is the most dependent upon academic research
and the Federal funds that support it. Translate that to the taxpayers'
dollars that already support it.
In fact, in 1997, Merck and Pfizer devoted only 11.2 percent of their
revenue to research and development. Pfizer and Merck devoted 11.2
percent to research and development, while marketing costs consumed 30
percent. And that includes all the television ads that we are seeing
now. So generally across the board for the drug companies, research and
development is about 20 percent, marketing about 20 to 30 percent; but
manufacturing is 5 to 25 percent. That is the level that other
countries draw when they negotiate these contracts with American drug
manufacturers.
Mr. Speaker, I highly support the bill offered by the gentleman from
Minnesota.
Mr. BROWN of Ohio. Mr. Speaker, I yield 4 minutes to the gentleman
from Michigan (Mr. Dingell), who tried so hard to offer an alternative
plan today, and was not allowed, on the prescription drug bill.
Mr. DINGELL. Mr. Speaker, I thank the distinguished gentleman from
Ohio (Mr. Brown) for making this time available to me.
I would love to support this bill. I think it is a wonderful thing. I
am looking at the picture down there which tells how outrageously high
drug prices are in this country. I commend the author of the
legislation, and I hope that in some way this is helpful.
Mr. Speaker, I wish that we had considered these matters with a
greater degree of care at a little earlier time when we were
considering the legislation which related to what we are going to do to
American citizens who are senior citizens who are desperately in need
of fairer and more appropriate prices for prescription pharmaceuticals.
I think it is a great shame that this body did want to have a rule
which permitted the proper consideration of a perfectly germane
amendment which would have been offered by the gentleman from Arkansas
(Mr. Berry), the gentleman from Vermont (Mr. Sanders), and the
gentlewoman from Missouri (Mrs. Emerson) on the other side of the
aisle. I think that we would then have come up with an end package
which would have afforded us a great deal more hope that, in fact, we
were doing good for the American people in seeing to it that they got
prescription pharmaceuticals at more fair and more competitive prices.
But, unfortunately, this curious rule has precluded us from
considering a perfectly germane amendment which would have done that.
We now find ourselves in the regrettable position of confronting the
possibility that the easing of the law with regard to food and drug and
cosmetics, which is going to be done here under this legislation, will
in fact reduce the safety of the American consuming public.
I would like my colleagues to know that this Congress has worked very
carefully to see to it that the American people got the greatest
protection with regard to prescription pharmaceuticals. We did it by
putting the burden upon the importers, putting the burden upon the
manufacturers, so that at every stage the burden was on him who would
release into the marketplace substances which have enormous capacity
for doing good, but which also have intolerable and enormous capacity
to do great hurt to the consuming public: to kill, to maim, to hurt, to
blind, to poison, and, indeed, to sicken.
The practical result of this legislation the way it is done is going
to be to facilitate the entry into this country of pharmaceutical
products over which the Food and Drug Administration is going to lose
much of its power to protect the American consuming public. And, in
fact, the practical result of this legislation is going to be to
increase the risk to the American public in order to afford competition
for what we all know are, in fact, excessively highly priced
prescription pharmaceuticals.
What we are doing here, and what history is going to tell us we have
done, is that we have increased the risk

[[Page H5432]]

but afforded a very small increase in benefits in terms of competition
and that the risk that we are increasing is going to be very, very
large and that we are going to find that there will be some splendid
scandal on the hands of those of us who vote for this legislation
tonight.
Mr. Speaker, the result of that is going to be that we are going to
be compelled at some time in the not-distant future, after we have seen
what is going to occur under this legislation, to come back and address
something which could have been handled better if the rule had
permitted the consideration of the amendment which the gentleman from
Arkansas (Mr. Berry), the gentleman from Vermont (Mr. Sanders), and the
gentlewoman from Missouri (Mrs. Emerson) would have offered to the
people of this country and upon which we might have done a better job
of legislating in the overall public interest.
Mr. Speaker, I regret what we are doing. We will be sorry.
Mr. Speaker, I rise in opposition to H.R. 3240, because, although it
seems benign, it would hurt the enforcement of laws ensuring the safety
and efficacy of imported drugs.
The Prescription Drug Marketing Act came into being after an
investigation that revealed serious irregularities with respect to
adulterated and counterfeit drugs from abroad. Recent investigations of
Internet Web sites indicate there is still cause for concern.
Significant quantities of prescription drugs from every source around
the globe are entering this country on a daily basis through the U.S.
mail. In fact, just last year the U.S. Customs agency had a more than
400 percent increase in the amount of pharmaceutical drugs they found
being sent into this country from abroad. In many cases, these drugs
arrive in unmarked plastic bags, with no indications of what they are,
where they came from, or even how they should be taken. Are they real?
Who knows? Are they adulterated? Who knows? Can they cause harm? Who
knows? What we do know is that there was a problem with certain drug
sources when we first looked into this matter more than decade ago, and
there continues to be a problem today.
I do want to acknowledge the beneficial aspects of the bill before
us. Lack of access to medically necessary prescription drugs is a real
problem faced by millions of Americans. I command my colleague, Mr.
Gutknecht, and all who will support him today, for recognizing that the
price Americans pay for drugs is too high. But, first and foremost, the
PDMA is a public health and safety law. We should therefore tread
carefully before changing it. I am greatly concerned that the bill
before us has not been the subject of hearings, or a thorough
examination about why the Food and Drug Administration (FDA) sends
warning letters to consumers that may be engaged in potentially risky
behavior. This bill may make it very difficult for the FDA, as a
practical matter, to provide thousands of consumers with a warning
regarding what may be potentially risky behavior. I speak not only
about the person that drives across to border to Mexico, but also to
the numerous individuals now purchasing their drugs from one of
hundreds of Internet sites that now exist.
I am open to a careful review and revision of PDMA for the purpose of
creating a paradigm for drug importation that is safe for our consumers
while facilitating access to the international market prices at which
many commonly prescribed prescription drugs are available. But this
bill, and this process, do not have my support.

{time} 0010

Mr. COBURN. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I would just like to make note of the fact that the
wonderful Food and Drug Administration bureaucracy that we have seen
built over the last 40 years, the average price to get a drug through
that organization is $450 million, of which only $50 million is
allocated for safety, $400 million for efficacy for a Food and Drug
Administration to tell somebody where to put a bathroom in a plant, and
bureaucratic overregulation.
So when we talk about how effective it is, it is important to know
what portion of the costs are really on safety and that portion which
is not associated with safety.
Mr. Speaker, I yield 3 minutes to the gentleman from Montana (Mr.
Hill).
Mr. HILL of Montana. Mr. Speaker, I thank the gentleman from Oklahoma
for yielding me the time, and I thank the gentleman from Minnesota (Mr.
Gutknecht) for bringing this measure before the House. I am proud to be
a sponsor of the bill and to stand here to support it.
We just spent I think about 12 hours debating Medicare reform and
prescription drugs. Regardless of where my colleagues were on the final
vote, I think that everybody in this House should be happy with the
fact that the Congress has finally got on record that it is going to do
something to try to help senior citizens with prescription drugs. I
know that everybody here is hopeful that we can get a bill that the
Senate can pass and the President can sign to do that.
But we have a big problem in this country, and that is the soaring
cost of pharmaceutical drugs. The General Accounting Office estimated
the bill we just passed will reduce the price of prescription drugs to
seniors by 25 percent, perhaps as much as 39 percent. But I am
concerned whether that will become a reality as a consequence of that
bill. Drugs are going up at the rate of four times the rate of
inflation. Last year, almost 10 percent, the price of pharmaceutical
drugs went up.
The irony is that, in my State of Montana, people can go right across
the border, and they can buy these same prescription drugs for 56
percent less in Canada. The reason is that the FDA, in essence, has
created a barrier so that Montanans cannot purchase drugs. They cannot
purchase their pharmacy needs in Canada.
Now, the irony of all this is that we have the North American Free
Trade Agreement. We have below-cost, cheap cattle pouring across the
border in Montana, over a million of them last year. We have below-cost
wheat pouring across the Montana border taking away our markets. Cheap
cattle and cheap grain come across the border, no problem at all.
As a matter of fact, I do not know if the Members of the House
realize it, but cattle, swinging carcases, come into this country from
Canada, and they have a USDA stamp on them that says that they are
inspected and graded by the U.S. Department of Agriculture even though
they are not because the NAFTA agreement says that they can do that.
Now, Montanans would like to have a little benefit from NAFTA. They
would like to buy their medicines from Canada as well. The irony is
that ag producers who are being forced to sell their products below
cost are saying, buck it up. You cannot compete in this marketplace.
Yet, the FDA has, in essence, protected, created a protected market
for one of the wealthiest industries in this country, in the world, in
the pharmacy companies here in this country.
So what the Gutknecht bill basically says is, no, we are not going to
do that anymore. We are going to try to induce competition by allowing
people to buy their medications elsewhere.
The gentleman from Vermont (Mr. Sanders) is absolutely correct. This
does not just apply to retail. The bill of the gentleman from Minnesota
(Mr. Gutknecht) basically applies only to retail trade and
pharmaceutical drugs. It ought to apply to the wholesale as well so
that our local pharmacists can buy from any distributor anywhere in the
world.
Now, the gentleman from Michigan (Mr. Dingell) raised a concern about
the safety issue. But what we have to realize is that these are the
exact same formulations that are licensed in the United States. They
are produced in exactly the same plants as they are that come into the
United States. They are in the same package.
I urge my colleagues to support this bill and also support the bill
of the gentleman from Vermont (Mr. Sanders).
Mr. BROWN of Ohio. Mr. Speaker, how much time is remaining on each
side?
The SPEAKER pro tempore (Mr. Pease). The gentleman from Ohio (Mr.
Brown) has 4\1/2\ minutes remaining. The gentleman from Oklahoma (Mr.
Coburn) has 6 minutes remaining.
Mr. BROWN of Ohio. Mr. Speaker, I reserve the balance of my time.
Mr. COBURN. Mr. Speaker, I yield myself 2\1/2\ minutes.
Mr. Speakers, one of the ironic things about today's debate is the
debate was about whose prescription drug bill would do the problem. We
had a debate about the wrong problem. The problem is the lack of price
competition in the pharmaceutical industry. For if prices were not
rising, seniors would not be screaming, and we would not be addressing
this issue at all, putting the risk of the Medicare program

[[Page H5433]]

and its viability in the future on the line.
It is interesting to note that we have a President that is screaming
for a prescription drug bill, and his own Justice Department will not
even answer letters requesting an investigation into the antitrust
activities of the pharmaceutical industry.
It is interesting to note that politics has reigned supreme in the
debate about pharmaceutical and Medicare drug benefit when, in fact, we
can accomplish a limitation on advertising, we can accomplish setting
in force of motion of the very administrative agencies that are already
in place to assure the American people that we do not have monopolies
and we do not have price gouging and we do not have price fixing.
It is to be noted that the FTC has already received two consent
decrees from two large pharmaceuticals manufacturers, one of which was
paying $60 million a year to another pharmaceutical company not to
bring a drug to market, consequently costing American consumers for
$250 million for that drug alone. That drug was a calcium channel
blocker known as diltiazen.
Another one, Hytrin, used for prostatic hypertrophy and hypertension,
same thing, $15 million a month paid to another pharmaceutical company
so they will not bring a drug to market.
We have collusion, and we have lack of competition. Until we address
that, we will not be good stewards of the Medicare program. We will not
be good stewards, whatever drug benefit we offer.
The other point that I would make, as we have done in every other
area of Medicare, because we have not been good stewards, we are going
to cost shift. We are going to lower the prices. Under the Democrat
plan or the Republican plan, the prices for Medicare seniors will go
down. But that price, if we do not work on the industry, will cost
shift to the private sector.
So we are going to raise taxes on everybody else, their cost of
health care, to supplant the lack of the proper benefits in Medicare.
Mr. Speaker, I reserve the balance of my time.
Mr. BROWN of Ohio. Mr. Speaker, I yield 4\1/4\ minutes to the
gentleman from Pennsylvania (Mr. Klink) who has worked hard for a
prescription drug benefit for Medicare beneficiaries.
Mr. KLINK. Mr. Speaker, I would start off by thanking the gentleman
from Ohio for yielding me the time, even though the hour is late, and I
would like to compliment the gentleman from Minnesota (Mr. Gutknecht)
for his bill.
However, I must rise in opposition to H.R. 3240 because, while it
seems harmless, and I laud the goal in the end of making sure that we
can get the most fair price for drugs for all of our senior citizens,
in fact for all of our citizens, this bill may seem harmless, but it
could very seriously undercut the Food and Drug Administration's
ability to warn the public that they are importing something that may
not, in fact, be real.
The gentleman from Montana (Mr. Hill) I will tell him I wished I had
the same surety that he does that these drugs were made in the same
factory. We have seen with a lot of the investigations that we have
done that, in fact, we have seen adulterated products. We have seen
products that are not what they purport to be.
My colleagues may not realize it, but the Internet has become the new
frontier for international drug purchases. Anyone with a computer and a
mouse can click on a site, and one does not even need prescriptions,
one does not need a doctor's okay, one just gets the drugs, and who
knows where they are shipped from.
One recent investigation that we had in the Committee on Commerce of
Internet pharmaceutical sales shows that buying drugs on-line can
really be the on-line equivalent of trick-or-treating on Halloween in a
very dangerous neighborhood. The drugs are often shipped in unmarked
packages. There are no indications of strength or quality, no way of
knowing what the products are, no way of knowing where they came from,
no way of knowing who handled them, where they were stored or even what
is in them.
We have seen reports in the news of arrests that were made for
smuggling in fake Viagra. We have seen accounts of arrests being made
for selling fake Xenical that was made only from starch and a small
amount of an antiasthmatic drug. We have seen reports of fake
ampicillin and AZT made from starch and anti-mold powder.
How prevalent are these bogus drugs? Well, the fact of the matter is
we do not know. That is the frightening thing about all of this. Much
of our investigation has focused on what the Federal Government is
doing to protect consumers from unknowingly being harmed by something
they import from one of these rogue sites.
Now, we have got to remember the Prescription Drug Marketing Act,
which regulates the import of pharmaceutical products, was enacted in
response to a lot of problems people had when they unknowingly imported
drugs that were being adulterated or counterfeit drugs from abroad.
The gentleman, who had spoken earlier about the importation of food,
one of the problems that he and I have both had with NAFTA and with
GATT and with some of these other agreements is that we know that food
has been brought into this country that was bad.

{time} 0020

We have seen strawberries in Michigan that have caused kids to get
very sick. We have seen meat products that have come in that have
caused people to get sick. We have seen vegetables and fruits that come
in with DDT and other kinds of things sprayed on them that we could not
get away with here. So we know that the safety of food has been a
problem, and the safety of drugs has been a problem too.
I want to get where the author of this bill is trying to get, but I
do not think this is the way to get there. We want to help the FDA be
better. They are not perfect. The reality is that this piece of
legislation, with virtual conveyor belts at every international airport
coming in, with these drugs being shipped by the Internet, if it were
just Canada, we could deal with that, because their system is very
similar to ours. The problem is we are talking about Africa and Asia
and South America and central America and all of these islands nations.
These drugs are being set up and manufactured all over the place, and
some are real, some are not. We do not know what we are getting into.
What the gentleman is doing here, we are putting unrealistic burdens
on an FDA that we have found out in the Committee on Commerce that they
cannot deal with the problem as it is now. They do not have enough
people to deal with what is coming in now. And the communications
between the FDA and Customs is horrible, and the public is at risk
already.
We cannot make it more at risk. We all want to get senior citizens
access to cheaper drugs. I have concerns about the potential unintended
regulatory consequences of this bill. If this bill dealt only with
imports from countries like Canada, we would not have a problem. I
think we need to amend the Prescription Drug Marketing Act. I wish we
that we had had hearings on this bill. I wish we had had a chance to
talk more about it. I am not prepared tonight to gamble with the safety
and efficacy of the drugs coming into this country.
Mr. BROWN of Ohio. Mr. Speaker, I have no further requests for time,
and I yield back the balance of my time.
Mr. COBURN. Could I inquire of the Chair the time remaining.
The CHAIRMAN. The gentleman from Oklahoma (Mr. Coburn) has 3\1/2\
minutes remaining.
Mr. COBURN. Mr. Speaker, I yield 3\1/2\ minutes to the gentleman from
Minnesota (Mr. Gutknecht).
Mr. GUTKNECHT. Mr. Speaker, first of all, I want to clarify
something. Section 3 of our bill says including a pharmacist or
wholesale importer. We want our local pharmacies to be able to set up
correspondent relationships.
In terms of the whole issue of people getting bad drugs, I mean, the
truth of the matter is, this is happening now; and the reason is
because of these huge differentials. We have tried now for 2 years to
work with the FDA to come up with a plan so that we can bring down
these barriers to local pharmacists and HMOs.
Let me give an example. One of the HMOs in Minneapolis, they did a
study on their own, and if they could buy their drugs from Winnipeg, if
they could realize half of the savings that

[[Page H5434]]

they recognized in this study, they could save their subscribers $30
million a year. Now, they are already negotiating better deals with
their drugs than the average consumer, certainly the average senior
citizen can. So what we are talking about is opening up markets.
We want to work with the FDA, but for 2 years the FDA has basically
refused to return our phone calls. Mr. Speaker, there is a crisis out
there; but the crisis is price. I am not here tonight to beat up on the
pharmaceutical companies. The truth of the matter is they are going to
charge as much as they can. I mean, shame on the pharmaceutical
companies, yes, for what they are charging; but shame on the FDA for
letting them get away with it, and shame on us for not doing something
about it.
Now, this bill is not perfect, and I understand that we should be
going further; but I think that is as far as we can get this year, or
at least in the next several weeks. As we go forward, perhaps in the
Senate, perhaps in conference committee, sometime perhaps before we get
it to the President's desk, maybe we can strengthen it this year. And
if the FDA does not respond appropriately, I guarantee I will be back
next year and we will be fighting for even stronger legislation.
Because this idea that American consumers should pay $30.25 for
Coumadin when consumers in Switzerland pay $2.85 for the same drug,
that is simply wrong. And shame on us if we let that continue.
The time has come to send a very clear message to our own FDA that we
are not going to allow them to stand between American consumers in the
day and age of NAFTA, in the day and age of the Internet, and in the
day and age of the information age. The game is over. We are not going
to allow them to stand between American consumers, and particularly
American seniors, and lower drug prices. The game is over.
This is the night when we begin the journey to bring lower prices to
American consumers. When we allow markets to work, we will see lower
prices for American consumers, and especially for American seniors.
The SPEAKER pro tempore (Mr. Pease). The question is on the motion
offered by the gentleman from California (Mr. Bilbray) that the House
suspend the rules and pass the bill, H.R. 3240.
The question was taken; and (two-thirds having voted in favor
thereof) the rules were suspended and the bill was passed.
A motion to reconsider was laid on the table.

____________________