[House Hearing, 112 Congress]
[From the U.S. Government Publishing Office]

IMPORT SAFETY: STATUS OF FDA'S SCREENING EFFORTS AT THE BORDER

=======================================================================

HEARING

BEFORE THE

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

OF THE

COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES

ONE HUNDRED TWELFTH CONGRESS

FIRST SESSION

__________

APRIL 13, 2011

__________

Serial No. 112-38

Printed for the use of the Committee on Energy and Commerce

energycommerce.house.gov

U.S. GOVERNMENT PRINTING OFFICE
71-721 WASHINGTON : 2012
-----------------------------------------------------------------------
For sale by the Superintendent of Documents, U.S. Government Printing Office,
http://bookstore.gpo.gov. For more information, contact the GPO Customer Contact Center, U.S. Government Printing Office. Phone 202�09512�091800, or 866�09512�091800 (toll-free). E-mail, gpo@custhelp.com.

COMMITTEE ON ENERGY AND COMMERCE

FRED UPTON, Michigan HENRY A. WAXMAN, California
Chairman Ranking Member
JOE BARTON, Texas JOHN D. DINGELL, Michigan
Chairman Emeritus EDWARD J. MARKEY, Massachusetts
CLIFF STEARNS, Florida EDOLPHUS TOWNS, New York
ED WHITFIELD, Kentucky FRANK PALLONE, Jr., New Jersey
JOHN SHIMKUS, Illinois BOBBY L. RUSH, Illinois
JOSEPH R. PITTS, Pennsylvania ANNA G. ESHOO, California
MARY BONO MACK, California ELIOT L. ENGEL, New York
GREG WALDEN, Oregon GENE GREEN, Texas
LEE TERRY, Nebraska DIANA DeGETTE, Colorado
MIKE ROGERS, Michigan LOIS CAPPS, California
SUE WILKINS MYRICK, North Carolina MICHAEL F. DOYLE, Pennsylvania
Vice Chairman JANICE D. SCHAKOWSKY, Illinois
JOHN SULLIVAN, Oklahoma CHARLES A. GONZALEZ, Texas
TIM MURPHY, Pennsylvania JAY INSLEE, Washington
MICHAEL C. BURGESS, Texas TAMMY BALDWIN, Wisconsin
MARSHA BLACKBURN, Tennessee MIKE ROSS, Arkansas
BRIAN P. BILBRAY, California ANTHONY D. WEINER, New York
CHARLES F. BASS, New Hampshire JIM MATHESON, Utah
PHIL GINGREY, Georgia G.K. BUTTERFIELD, North Carolina
STEVE SCALISE, Louisiana JOHN BARROW, Georgia
ROBERT E. LATTA, Ohio DORIS O. MATSUI, California
CATHY McMORRIS RODGERS, Washington DONNA M. CHRISTENSEN, Virgin
GREGG HARPER, Mississippi Islands
LEONARD LANCE, New Jersey
BILL CASSIDY, Louisiana
BRETT GUTHRIE, Kentucky
PETE OLSON, Texas
DAVID McKINLEY, West Virginia
CORY GARDNER, Colorado
MIKE POMPEO, Kansas
ADAM KINZINGER, Illinois
H. MORGAN GRIFFITH, Virginia

(ii)
Subcommittee on Oversight and Investigations

CLIFF STEARNS, Florida
Chairman
LEE TERRY, Nebraska DIANA DeGETTE, Colorado
JOHN SULLIVAN, Oklahoma Ranking Member
TIM MURPHY, Pennsylvania JANICE D. SCHAKOWSKY, Illinois
MICHAEL C. BURGESS, Texas MIKE ROSS, Arkansas
MARSHA BLACKBURN, Tennessee ANTHONY D. WEINER, New York
SUE WILKINS MYRICK, North Carolina EDWARD J. MARKEY, Massachusetts
BRIAN P. BILBRAY, California GENE GREEN, Texas
PHIL GINGREY, Georgia DONNA M. CHRISTENSEN, Virgin
STEVE SCALISE, Louisiana Islands
CORY GARDNER, Colorado JOHN D. DINGELL, Michigan
H. MORGAN GRIFFITH, Virginia HENRY A. WAXMAN, California (ex
JOE BARTON, Texas officio)
FRED UPTON, Michigan (ex officio)

C O N T E N T S

----------
Page
Hon. Cliff Stearns, a Representative in Congress from the state
of Florida, opening statement.................................. 1
Prepared statement........................................... 3
Hon. Diana DeGette, a Representative in Congress from the state
of Colorado, opening statement................................. 4
Prepared statement........................................... 13
Hon. Henry A. Waxman, a Representative in Congress from the state
of California, opening statement............................... 16
Prepared statement........................................... 17
Hon. John D. Dingell, a Representative in Congress from the state
of Michigan, opening statement................................. 18
Prepared statement........................................... 19
Hon. Fred Upton, a Representative in Congress from the state of
Michigan, prepared statement................................... 60

Witnesses

Margaret A. Hamburg, M.D., Commissioner, Food and Drug
Administration; accompanied by David Elder, Acting Deputy
Assistant Commissioner for Regulatory Affairs for Field
Operations..................................................... 20
Prepared statement........................................... 23
Answers to submitted questions............................... 74

Submitted Material

Testimony from Allan Coukell, Director, Medical Safety Portfolio,
Pew Health Group, The Pew Charitable Trusts, submitted by Ms.
DeGette........................................................ 5
Article entitled, ``The Difficult Fight Against Counterfeit
Drugs--Dr. Sanjay Gupta investigates fake medications on his
first assignment for `60 minutes,''' submitted by Mr. Dingell.. 61
Discussion Draft of Drug Safety Legislation, Section-by-Section
Summary, submitted by Mr. Dingell.............................. 67
Letter of April 15, 2011, from Mr. Dingell to Commissioner
Hamburg, submitted by Mr. Dingell.............................. 73

IMPORT SAFETY: STATUS OF FDA'S SCREENING EFFORTS AT THE BORDER

----------

WEDNESDAY, APRIL 13, 2011

House of Representatives,
Subcommittee on Oversight and Investigations,
Committee on Energy and Commerce,
Washington, DC.
The Subcommittee met, pursuant to call, at 10:34 a.m., in
room 2123 of the Rayburn House Office Building, Hon. Cliff
Stearns (chairman of the subcommittee) presiding.
Members present: Representatives Stearns, Murphy, Burgess,
Blackburn, Myrick, Bilbray, Gingrey, Scalise, Barton, DeGette,
Schakowsky, Christensen, Dingell, and Waxman (ex officio).
Staff present: Allison Busbee, Legislative Clerk; Todd
Harrison, Chief Counsel, Oversight/Investigations; Ruth
Saunders, Detailee, ICE; Alan Slobodin, Deputy Chief Counsel,
Oversight; Sam Spector, Counsel, Oversight; John Stone,
Associate Counsel; Ali Neubauer, Democratic Investigator; Brian
Cohen, Democratic Investigations Staff Director and Senior
Policy Advisor; Stacia Cardille, Democratic Counsel; Rachel
Sher, Democratic Counsel; Eric Flamm, Democratic FDA Detailee;
and Karen Lightfoot, Democratic Senior Policy Advisor and
Communications Director.

OPENING STATEMENT OF HON. CLIFF STEARNS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF FLORIDA

Mr. Stearns. Good morning everybody, and welcome to the
Subcommittee on Oversight and Investigations hearing on Import
Safety and the Status of FDA's Screening Efforts at the Border.
My colleagues, today the Subcommittee on Oversight and
Investigations will examine the status of the Food and Drug
Administration's efforts to ensure that Americans have access
to the safest and highest quality imported food, drugs and
medical products. This subcommittee has a bipartisan tradition
of periodically meeting with and demanding accountability from
the federal officials tasked with screening imported food and
medicines that the American people increasingly rely on for
their health and quality of life. As Commissioner Hamburg
herself noted in February 2010, FDA-regulated products are
currently imported from more than 150 countries, with more than
130,000 importers of record, and more than 300,000 foreign
facilities.
This hearing marks Commissioner Hamburg's first appearance
before our subcommittee since her confirmation. Since assuming
her current position, the commissioner has touted a vision for
FDA to serve as ``a truly global public health agency.'' In her
own words, ``The FDA faces a daunting set of tasks.
Globalization has multiplied the scale of our responsibility
and the challenges that we all face.'' I applaud the
commissioner's expressed support for a number of important FDA
initiatives.
Our concern this morning, however, is less with what has
been promised, and more about what has been achieved in the
interest of the public health. For example, in a February 2010
speech, the commissioner unveiled a new program developed over
the previous decade enabling FDA, for the first time, to
comprehensively and intelligently screen all food, drugs and
medical products that are entering the United States. This
system, known as PREDICT, which is short for Predictive Risk-
Based Evaluation for Dynamic Import Compliance Targeting, is a
cutting-edge, risk-based tool that could help reduce our
vulnerability to poor-quality imported food, and counterfeit or
otherwise prohibited pharmaceuticals.
However, despite promises to begin deploying it nationwide
by late 2009 and have it fully up and running by the spring of
2010, PREDICT has only been deployed in three districts over
the last 14 months. At this rate, it would take FDA over 5
years to deploy PREDICT in the remaining 16 FDA districts. FDA
has informed committee staff that the technical glitches
holding up PREDICT's nationwide deployment have been resolved,
and that FDA anticipates deploying the system to Florida and
Puerto Rico by the end of this month.
If the technical issues have been resolved, why does FDA
continue to deploy PREDICT in such a piecemeal manner? I don't
see any reason not to push more aggressively for its immediate
deployment nationwide. I also expect to have the commissioner
back here before the committee at a future time to comment on
the progress of PREDICT's deployment.
Serious vulnerabilities in our import screening systems do
remain. For example, millions of parcels arrive by
international mail and express couriers' facilities every year.
PREDICT is not deployed at any of these facilities presently,
nor am I aware of any plans for PREDICT to be used in these
settings. FDA must treat each and every one of these parcels
just as it does imported cargo shipments, as potential carriers
of dangerous, tainted foods and adulterated or counterfeit
drugs. FDA cannot claim to be doing all it can to protect the
American people from these threats so long as a major entry
point for goods into the country remains largely unmonitored.
FDA also should not overlook the threats posed by rogue
Internet pharmacies that falsely market their products as
Canadian in origin. A recent 60 Minutes CBS report on
counterfeit drug imports featured a senior FDA official
admitting that his agency lacked the authority to destroy
dangerous shipments and was forced to simply return them to the
sender. This report highlighted a serious and frustrating
problem with our current screening process.
We need to better protect the health and safety of all
Americans. In March 2007, FDA learned that melamine-
contaminated vegetable proteins imported from China and found
in certain pet foods were sickening and killing cats and dogs.
Also, the commissioner noted on 60 Minutes that over 80
Americans died in 2008 as a result of contaminated heparin, a
blood thinner, which had also been imported from China. The
commissioner suggested earlier this year that ``regrettably,
another public health crisis like heparin or melamine seems
inevitable'' unless certain changes are made in our import
screening process. We cannot and must not accept this
inevitability.
PREDICT is the most promising tool we have to enhance our
defenses against such a threat. Let us deploy it nationwide and
without further delay.
So Commissioner, I look forward to discussing with you the
possibilities of legislation or perhaps legislative report
language to help provide more focus and support to the
deployment of PREDICT and other improvements to FDA's import
screening. Let me welcome our witness, Commissioner Hamburg.
[The prepared statement of Mr. Stearns follows:]

Prepared statement of Hon. Cliff Stearns

Today, the Subcommittee on Oversight and Investigations
will examine the status of the Food and Drug Administration's
efforts to ensure that Americans have access to the safest and
highest quality imported food, drugs, and medical products.
This subcommittee has a bipartisan tradition of
periodically meeting with and demanding accountability from the
federal officials tasked with screening imported food and
medicines that the American people increasingly rely on for
their health and quality of life. As Commissioner Hamburg
herself noted in February 2010, FDA-regulated products are
currently imported from more than 150 countries, with more than
130,000 importers of record, and from more than 300,000 foreign
facilities.
This hearing marks Commissioner Hamburg's first appearance
before our Subcommittee since her confirmation. Since assuming
her current position, the Commissioner has touted a vision for
FDA to serve as ``a truly global public health agency.'' In her
own words, the ``FDA faces a daunting set of tasks.
Globalization has multiplied the scale of our responsibility,
and the challenges we face.'' I applaud the Commissioner's
expressed support for a number of important FDA initiatives.
Our concern this morning, however, is less with what has been
promised, and more about what has been achieved in the interest
of the public health.
For example, in a February 2010 speech, the Commissioner
unveiled a new program developed over the previous decade,
enabling FDA, for the first time, to comprehensively and
intelligently screen all food, drugs, and medical products
entering the U.S. This system, known as PREDICT, which is short
for ``Predictive Risk-Based Evaluation for Dynamic Import
Compliance Targeting,'' is a cutting-edge, risk-based tool that
could help reduce our vulnerability to poor quality imported
food, and counterfeit or otherwise prohibited pharmaceuticals.
However, despite promises to begin deploying it nationwide
by late-2009 and have it fully up and running by Spring 2010,
PREDICT has only been deployed in three districts over the last
14 months. At this rate, it would take FDA over 5 years to
deploy PREDICT in the remaining 16 FDA districts.
FDA has informed Committee staff that the technical
glitches holding up PREDICT's nationwide deployment have been
resolved, and that FDA anticipates deploying the system to
Florida and Puerto Rico by the end of this month. If the
technical issues have been resolved, why does FDA continue to
deploy PREDICT in such a piecemeal manner. I don't see any
reason not to push more aggressively for its immediate
deployment nationwide. I also expect to have the Commissioner
back here before the Committee at a future time to comment on
the progress of PREDICT's deployment.
Serious vulnerabilities in our import screening systems
remain. For example, millions of parcels arrive by
international mail and express couriers' facilities every year.
PREDICT is not deployed at any of these facilities presently;
nor am I aware of any plans for PREDICT to be used in these
settings. FDA must treat each and every one of these parcels
just as it does imported cargo shipments--as potential carriers
of dangerous, tainted foods and adulterated or counterfeit
drugs. FDA cannot claim to be doing all it can to protect the
American people from these threats so long as such a major
entry-point for goods into the country remains largely
unmonitored.
FDA also should not overlook the threats posed by rogue
Internet pharmacies that falsely market their products as
Canadian in origin. A recent CBS 60 Minutes report on
counterfeit drug imports featured a senior FDA official
admitting that his agency lacked the authority to destroy
dangerous shipments and was forced to simply return them to the
sender. This report highlighted a serious and frustrating
problem with our current screening process.
We need to better protect the health and safety of all
Americans. In March 2007, FDA learned that melamine-
contaminated vegetable proteins imported from China and found
in certain pet foods were sickening and killing cats and dogs.
Also, the Commissioner noted on 60 Minutes that over 80
Americans died in 2008 as a result of contaminated heparin, a
blood thinner, which had also been imported from China. The
Commissioner suggested earlier this year that ``regrettably,
another public health crisis like heparin or melamine seems
inevitable'' unless certain changes are made in our import
screening process. We cannot and must not accept this
inevitability. PREDICT is the most promising tool we have to
enhance our defenses against such a threat. Let's deploy it
nationwide and without further delay.
Commissioner, I look forward to discussing with you the
possibilities of legislation or legislative report language to
help provide more focus and support to the deployment of
PREDICT and other improvements to FDA's import screening.
Let me welcome our witness, Commissioner Hamburg. I will
now yield to Ranking Member DeGette for the purposes of an
opening statement.

# # #

Mr. Stearns. I will now yield to the Ranking Member, Ms.
DeGette from Colorado, for the purposes of an opening
statement.

OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF COLORADO

Ms. DeGette. Thank you very much, Mr. Chairman. I am very
pleased that we are having a hearing today about the safety of
imports regulated by the FDA.
I think that the FDA plays a vital role in protecting the
health and security of Americans, and I know we will have
probably many oversight hearings about this role over the next
couple of years.
Although I am really happy to see Commissioner Hamburg here
before us today, though, Mr. Chairman, I am dismayed that out
of three of the last four hearings, the majority has denied the
minority a witness, and this approach is inconsistent with the
practice of all the other subcommittees on this committee and
this Congress and frankly I think inconsistent with the
practices of this committee in previous Congresses.
In the case of today's hearing, we requested testimony from
Allan Coukell, Director of the Pew Prescription Project. Mr.
Coukell is an expert on issues raised by the influx of imported
drugs and other medical products, and his testimony would have
enhanced our understanding of this matter. So I ask unanimous
consent to put his testimony in the record, Mr. Chairman.
Mr. Stearns. By unanimous consent, so ordered.
[The information follows:]

[GRAPHIC] [TIFF OMITTED] T1721.001

[GRAPHIC] [TIFF OMITTED] T1721.002

[GRAPHIC] [TIFF OMITTED] T1721.003

[GRAPHIC] [TIFF OMITTED] T1721.004

[GRAPHIC] [TIFF OMITTED] T1721.005

[GRAPHIC] [TIFF OMITTED] T1721.006

[GRAPHIC] [TIFF OMITTED] T1721.007

Ms. DeGette. Thank you so much.
Over the past decade, imports of FDA-regulated products
have grown at an astronomical pace. In 2004, the FDA oversaw
the entry of 12 million shipments of products like food,
pharmaceuticals and medical devices. In just 6 years, the
number of imports nearly doubled, reaching 21 million shipments
by 2010, and the number of imports is expected to grow.
Unfortunately, the FDA faces resource constraints that pose
significant challenges to the agency's ability to keep the food
and drug supply safe. For example, the FDA is able to
physically inspect less than 2 percent of imported shipments.
In the face of such challenges, FDA has worked hard to
become more efficient. One example of this is the creation of
the PREDICT database system. This system enables the FDA to
target higher-risk shipments for inspection, enhancing FDA's
ability to ensure the safety of imported food and drugs at
ports of entry into the United States. The system is currently
in use in New York, Los Angeles, Seattle and San Francisco, and
it will soon be implemented nationwide.
So given the increasing number of imports and the resource
constraints facing the FDA, it is difficult to understand why
we would be cutting FDA funding.
In H.R. 1, for example, which was the majority's opening
salvo in the budget debate, the Republicans proposed cutting
FDA's budget by $241 million. The Republicans' fiscal year 2012
budget, recently introduced by Representative Paul Ryan, calls
for massive reductions, rolling back the agency funding to 2008
levels. In FDA's case, this would mean a budget cut of over
$600 million, a nearly 20 percent reduction in the agency's
total budget.
So make no mistake about it: a cut of this size would have
a significant impact on the FDA's ability to keep the food and
drug supply safe. We are going to be voting on this budget this
week, and I am hoping that we can reconsider these devastating
FDA budget cuts. Even once PREDICT is implemented nationwide,
it is not going to substitute for the budget that the FDA needs
to have to undertake its oversight responsibilities.
Mr. Chairman, as you so accurately noted, in the last
Congress we took an important step forward regarding food
safety, passing the bipartisan Food Safety Modernization Act,
which gave the FDA new tools to protect the safety of the
Nation's food supply. Now we have an opportunity to provide the
FDA with the additional resources and authorities it so
desperately needs for pharmaceuticals. Nearly 40 percent of the
pharmaceuticals in this country are imported, and up to 80
percent of the active ingredients in drugs come from foreign
sources.
The Drug Safety Enhancement Act, introduced yesterday by
Mr. Dingell, will hold manufacturers responsible for the safety
of the entire pharmaceutical supply chain, including components
produced in foreign countries, and it will give FDA tools it
needs to enforce these requirements. This is good legislation
that deserves bipartisan support.
Mr. Chairman, there is a lot of ground to cover in today's
hearing, and again, I appreciate Commissioner Hamburg coming
today. I am looking forward to hearing about FDA's efforts on
imports, about the PREDICT database system, about its work
implementing the new food safety law, and its views on the Drug
Safety Enhancement Act. And I hope that we can work together to
explain why budget cuts to the FDA right now are not the way to
go in order to protect our Nation's citizens when it comes to
drugs and food. Thank you.
[The prepared statement of Ms. DeGette follows:]

Prepared statement of Hon. Diana DeGette

Mr. Chairman, I am pleased that we are holding today's
hearing on the safety of imports regulated by the U.S. Food and
Drug Administration. FDA plays a vital role in protecting the
health and security of Americans, and Congress should be
vigilant in examining ways to ensure that FDA is best equipped
to carry out its mission.
I am deeply disappointed, however, that for the third time
in the last month, the majority has denied the minority a
hearing witness. This approach is inconsistent with the
practice in all other Subcommittees regarding minority witness
requests and flies in the face of the bipartisan spirit we
should maintain toward oversight.
In the case of today's hearing, we requested testimony from
Allan Coukell, Director of the Pew Prescription Project. Mr.
Coukell is an expert on issues raised by the influx of imported
drugs and other medical products, and his testimony would have
enhanced the Subcommittee's understanding of this matter. I ask
unanimous consent that Mr. Coukell's written testimony he
prepared be included in the record.
Over the past decade, imports of FDA-regulated products
have grown at an astronomical pace. In 2004, FDA oversaw the
entry of 12 million shipments of products like food,
pharmaceuticals, and medical devices. In just six years, the
number of imports nearly doubled, reaching 21 million shipments
by 2010. And the number of imports is expected to grow.
Unfortunately, FDA faces resource constraints that pose
significant challenges to the Agency's ability to keep the food
and drug supply safe. For example, FDA is able to physically
inspect less than 2% of imported shipments.
In the face of such challenges, FDA has worked hard to
become more efficient. One example of this is the creation of
the PREDICT database system. This system enables FDA to target
higher-risk shipments for inspection, enhancing FDA's ability
to ensure the safety of imported food and drugs at ports of
entry into the United States.
The system is currently in use in New York, Los Angeles,
Seattle, and San Francisco, and it will soon be implemented
nationwide.
Given the increasing number of imports and the resource
constraints facing FDA, it is difficult to understand the
recent efforts by my colleagues on the other side of the aisle
to cut FDA funding.
In H.R. 1, the majority's opening salvo in the budget
debate, Republicans proposed cutting FDA's budget by $241
million. The Republicans' FY 2012 budget, recently introduced
by Rep. Paul Ryan, calls for massive reductions, rolling back
agency funding to 2008 levels. In FDA's case, this would mean a
budget cut of over $600 million, a nearly 20 percent reduction
in the agency's total budget.
Make no mistake--a cut of this size would have a
significant impact on FDA's ability to keep the food and drug
supply safe. The House will be voting on this budget this week,
and I hope that my Republican colleagues will reconsider these
devastating FDA budget cuts.
In the last Congress, we took an important step forward
regarding food safety, passing the bipartisan Food Safety
Modernization Act to give FDA new tools to protect the safety
of the nation's food supply.
We now have a similar opportunity to provide FDA with the
additional resources and authorities it so desperately needs
for pharmaceuticals. Nearly 40% of pharmaceuticals are
imported, and up to 80% of the active pharmaceutical
ingredients in drugs come from foreign sources.
The Drug Safety Enhancement Act, introduced yesterday by
Mr. Dingell, will hold manufacturers responsible for the safety
of their entire pharmaceutical supply chain, including
components produced in foreign countries. And it will give FDA
tools it needs to enforce these requirements. This is good
legislation that deserves bipartisan support.
There is a lot of ground to cover in today's hearing, and I
appreciate Commissioner Hamburg coming today. I'm looking
forward to hearing about FDA's efforts on imports, its work to
implement the new food safety law, and its views on the Drug
Safety Enhancement Act. And I hope Commissioner Hamburg can
help convince my Republican colleagues to reconsider their
proposed cuts to the FDA budget.

Mr. Stearns. I thank the gentlelady. I am just a little
puzzled because I thought the National Journal just reported
that the FDA got a $107 million increase, so maybe our figures
are different, and I would also say to the gentlelady, the Hon.
Hamburg is really the Administration's witness. Probably the
Republicans could argue that----
Ms. DeGette. You know, if the gentleman would yield?
Mr. Stearns. I would be glad to yield. I mean, we could
almost request our witness because she is really more or less
your witness, and as you and I discussed earlier that we want
to concentrate on this PREDICT model, and she is the only one
that can do it, and we just wanted one panel, and she is the
top person. I yield to you. Go ahead.
Ms. DeGette. This was the same thing, Mr. Chairman, that
you told me the last time you denied the minority a witness
when you called the Administration in to testify, so I talked
to our chairman emeritus, Mr. Dingell, about this, and I said,
you know, when we were in the majority and we called an
Administration in when the Administration was of the other
party, did we allow the minority a witness, and he said yes. If
someone calls a witness, it doesn't matter if they are a
Democrat or Republican. The fact is, the minority retains the
ability to call witnesses. In the case of the hearing today,
the witness we would have wanted to call would have actually
helped us understand this PREDICT system.
Mr. Stearns. OK. I think the Hon. Dr. Hamburg seems very
competent and capable of handling this all by herself.
With that, I will recognize Chairman Emeritus Mr. Barton
from Texas for 2 minutes.
Mr. Barton. Thank you. Well, I want to congratulate you and
Ms. DeGette. You at least got an Administration person to come.
We have a hearing upstairs where apparently everybody at EPA is
on vacation. So I want to give you two credit. You have our
distinguished commissioner, and I am absolutely certain that
she is going to be able to handle any questions either group of
us posed to her.
We do welcome you, Madam Commissioner. You have a very
difficult job, and we are always glad to hear your input.
This is an important issue. It is not on the front pages
right now, which is a good thing. In the last 3 to 4 years, we
have had several food poisoning situations that have made the
front pages, so it is good to hold a hearing in a non-crisis
situation.
We all know how much of our food is being imported, how
much of our medical devices, how many of our pharmaceutical
finished products and precursor ingredients, so how the FDA
regulates and inspects these products is extremely important.
This is an area where there has been bipartisan support in the
past. Chairman Dingell, Chairman Waxman, myself, Chairman Upton
have all in the past 6 years worked together to improve our
food system and improve the screening process.
I am going to be very interested in your comments on the
PREDICT model. I know that is being used now in four locations
or four regions. I would like to know why perhaps we can't go
ahead and implement it nationwide.
So Mr. Chairman and Madam Ranking Member, this is a good
hearing. Hopefully it will be bipartisan in nature, and we will
put the facts before the American people. With that, I yield
back.
Mr. Stearns. I thank the gentleman and recognize the
gentleman from Texas, Dr. Burgess, for 2 minutes.
Mr. Burgess. I thank the chairman for the recognition, and
I will just mention to the gentlelady from Colorado, the
Ranking Member of the committee, that I will support her
efforts to have a full and open hearing on the heparin issue. I
tried to do that when I was ranking member of the minority and
then-Chairman Waxman refused those entreaties. I was fortunate
enough to get a briefing by Dr. Hamburg in my office but
nothing substitutes for a full and open hearing so the American
people can actually hear what is going on.
Now, the Food and Drug Administration is truly at a
crossroads of the issues that really impact our country today
and will shape tomorrow from the food on our tables today to
the cures, the drugs and devices that our Nation's doctors will
offer the patients of America. The ability of tomorrow's
doctors to alleviate human suffering is going to be something
on a scale that none us have ever seen before if they can get
through the FDA, and your agency, Commissioner, is obviously at
the forefront of those battles.
This committee with its oversight of Food and Drug is
responsible for maintaining an active dialog with you on the
full breadth of your jurisdiction to ensure that you have the
tools that you need but you are using them in a way that is
beneficial for the country at large. Primarily this hearing
today will focus on food safety, and I have been concerned
about that for years. In 2007, I introduced legislation that
would give the Secretary of Health and Human Services the power
to refuse admission to a food that was strongly associated with
a suspected foodborne illness. We all remember the Lou Dobbs'
reports from a couple of years ago when contaminated tomatoes
were quarantined in Texas, Georgia and Florida and it turned
out these were peppers coming across the border. It was found
on a Friday afternoon and nothing could be done until Monday
because, after all, it was a weekend. We have to be able to
stop that stuff when we find it. When there is a known source
of contaminated food, you should be able to act without wasting
time.
Now, we all knew this hearing that coming into this year
that another salmonella outbreak was going to happen. We passed
a food safety law last year. We have increased the FDA budget.
So I am interested in, do you have the tools you need with the
new legislation that you have, the budgetary allowance that you
have had. Now, Dr. Sharfstein came in and said you needed no
more money for drugs and devices, so I am assuming you have put
a lot into food safety, and we do want to know what is going to
be different this April, this May, this June than previous
years when this inevitable salmonella outbreak occurs.
I thank the chairman for the recognition. I will yield back
my time.
Mr. Stearns. The gentleman yields back. The gentleman from
California, Mr. Bilbray, is recognized for 1 minute.
Mr. Bilbray. Thank you, Mr. Chairman.
Mr. Chairman, I come from a State where you can't talk
about health without talking about holistic issues too and the
interrelationship between components, that nothing in health is
isolated. One of the things that is quite obvious that we are
not going to specifically address today but I think that we all
have to be aware of, that the reality of what is happening with
the development of drugs and the production of drugs in this
country, this issue of importation is going to grow
dynamically. Literally right now, you have companies that are
leaving this country in droves and going overseas to not only
produce the drugs but also the research and development, and I
just think this committee needs to be aware that this issue may
be increasingly substantially basically because we are seeing
the next generation of innovation and drug development
literally leaving the country, and sadly, the fact is, is that
things like drug manufacturing and research doesn't take a lot
of time to leave the country and evaporate as much as, let us
say, auto manufacturing. We are seeing that going. So this
issue is going to grow.
The one place where it is going to probably be reduced by
this crisis is the reimportation, and that is something we need
to talk very openly and frankly about, the assumption that
something claims to being reimported so it is not reviewed,
there is no oversight. As somebody who was born and raised
along the border and seeing what happens across the largest
port of entry in the world, the Tijuana-San Diego port of
entry, this is obviously something that is very near and dear
not just to my constituents but to my family, and I think that
we need to address those issues and really talk about them
extensively.
But I just think that as we look at this, we have got to be
aware of the crisis coming down the pike and address that with
this. Thank you very much, Mr. Chairman.
Mr. Stearns. I thank the gentleman. The gentleman from
California, Mr. Waxman, the ranking member, is recognized for 3
minutes.

OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA

Mr. Waxman. Mr. Chairman, this is the fourth oversight
hearing, and three out of the four, we have been denied
minority witnesses. I want to join Ms. DeGette in complaining
about it. Representatives of this Administration are not
minority witnesses. They represent the other branch of
government, and we are going to have a serious talk about this.
This isn't the way this committee has operated when the
Republicans controlled or when the Democrats controlled the
committee in the past.
FDA's ability to protect the American public is an
important topic for oversight, and our witness would have added
to that understanding of this hearing. FDA is responsible for
ensuring the safety of food, drugs and medical devices, and if
FDA does not do its job, lives are at stake.
In the official hearing memo for today's meeting on the
safety of imports, the right questions were posed: What are
FDA's solutions for enhancing the screening of imported food,
drugs and medical devices? What is FDA doing to improve its IT
infrastructure for risk-based screening? How can FDA better
ensure the safety of imported products?
But there is an enormous disconnect between these questions
and what is happening in Congress this very week. GAO told us
that improving the safety of our food and drugs requires that
we provide FDA with more funding and resources, yet we are
doing the exact opposite.
Just last week, Representative Paul Ryan introduced the
Republican budget for fiscal year 2012. The House will soon be
voting on this proposal. There is not a lot of detail but there
is enough to know what it would mean for FDA. Republicans
propose to roll back discretionary funding for all federal
agencies to fiscal year 2008 levels.
In the case of the FDA, the agency budget would be reduced
by $600 million, a budget cut of almost 20 percent. This
Republican budget would require a dramatic reduction in FDA's
funding to keep the food and drug supply safe. The result would
be the reverse of what the American people want: fewer
inspections and more adulterated and dangerous food and drugs.
Mr. Chairman, there is a word now, I think part of the
American language, called chutzpah. It means you have got a lot
of nerve, I think the Republicans have a lot of nerve to haul
the FDA commissioner up here and grill her about why FDA is not
doing more to keep the food and drug supply safe while
simultaneously passing a budget that takes away the resources
she needs to do her job. It is chutzpah as well for the
Republicans on this subcommittee to complain that FDA is not
doing enough about food safety when the majority of the members
on this committee voted against the Food Safety Modernization
Act, which was the first expansion of FDA's food safety
authorities in 70 years.
Commissioner Hamburg, we appreciate your being here. You
are not here at the request of the minority. It would be
ridiculous to have this hearing without you.
Mr. Chairman, I want to yield the rest of my time, 2
minutes, to Mr. Dingell, who has been instrumental in the food
safety and drug and medical device safety questions and it is
important that we hear from him.
[The prepared statement of Mr. Waxman follows:]

Prepared statement of Hon. Henry A. Waxman

FDA's ability to protect the American public is an
important topic for oversight. The agency is responsible for
ensuring the safety of food, drugs, and medical devices, and if
FDA does not do its job, lives are at stake.
In the official hearing memo for today's hearing on the
safety of imports, the right questions are posed. What are
FDA's solutions for enhancing the screening of imported food,
drugs, and medical devices? What is FDA doing to improve its IT
infrastructure for risk-based screening? How can FDA better
ensure the safety of imported products?
But there is an enormous disconnect between these questions
and what is happening in Congress this week. GAO report after
GAO report tells us that improving the safety of our food and
drugs requires that we provide FDA with more funding and
resources. Yet we are doing exactly the opposite.
Just last week, Rep. Paul Ryan introduced the Republican
budget for Fiscal Year 2012. The House will soon be voting on
this proposal. While there's not a lot of detail in the budget,
there is enough to know what it would mean for FDA: Republicans
propose to roll back discretionary funding for all federal
agencies to FY 2008 levels.
What would this mean? In the case of FDA, it would mean
that the agency budget would be reduced by $600 million--a
budget cut of almost 20%. This Republican budget would require
a dramatic reduction in FDA's funding to keep the food and drug
supply safe.
The result would be the reverse of what the American people
want: fewer inspections and more adulterated and dangerous food
and drugs.
Mr. Chairman, when I read the Republican budget and then
look at the topic of today's hearings, I'm reminded of an old
Yiddish term: chutzpah. Roughly translated, it means someone
who's got a lot of nerve.
It takes chutzpah to haul the FDA Commissioner up here and
grill her about why FDA is not doing more to keep the food and
drug supply safe . while simultaneously passing a budget that
takes away the resources she needs to do her job.
And it takes chutzpah for Republicans on this Subcommittee
to complain that FDA is not doing enough about food safety when
the majority of them voted against the Food Safety
Modernization Act, the first expansion of FDA's food safety
authorities in 70 years.
Commissioner Hamburg, I appreciate you coming today. I am
looking forward to your testimony, and I look forward to
working with you to ensure that FDA has the tools and the
budget to continue doing its job.

Mr. Stearns. The gentleman is recognized for 2 minutes.
Mr. Waxman. And I am pleased you are allowing him to give
an opening statement.

OPENING STATEMENT OF HON. JOHN D. DINGELL, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MICHIGAN

Mr. Dingell. Mr. Chairman, I thank you. I thank my good
friend from California for yielding me this time. I commend you
for having this hearing because it is a great opportunity for
us. I think for us to spend time caviling over whether a
witness is a Democratic or a Republican witness is a prodigious
waste of time. This committee has a fine history of having
worked together to put out good legislation and includes the
food safety legislation in the last Congress, also the
wonderful legislation we put together over the question of
Consumer Product Safety Commission and giving it the authority.
Americans suffer from unsafe pharmaceuticals coming into
this country. They have neither the personnel nor the money to
do the job that we need to do to catch these things coming in.
They function under inadequate law which does not enable us to
seize the products coming into this country and to destroy them
and rather they are turned around and sent out and come back in
through another port. Americans are dying of this. They are
being denied proper prescription pharmaceuticals in order to
address the problems that they confront in terms of dealing
with major problems like cancer, heart disease, hypertension
and other things that are killing Americans.
Yesterday I introduced with my colleagues, Ranking Members
Waxman, Pallone and DeGette, H.R. 1483, the Drug Safety
Enhancement Act. This legislation would require manufacturers
to implement improved quality and safety standards including
stronger supply-chain management, a matter often the concern of
my Republican colleagues. It would require manufacturers to
notify FDA of counterfeits or safety concerns and to list drugs
and components by the country of origin to enable us to track
the movement of these pharmaceuticals as they move through
commerce. It would strengthen importers' and custom brokers'
oversight. It would arm FDA with administrative detention to
structure mandatory recall authorities, subpoena power and
clear extraterritorial jurisdiction. It would strengthen
criminal and civil penalties for crime deterrents, and it would
increase foreign manufacturing inspections to be on a par with
those that are suffered by American manufacturers. It would
also create new funding mechanisms for FDA inspectional
activities so that globalization is not going to burden
American taxpayers.
I have an excellent article about the safety problems that
we confront together with an analysis of the legislation, H.R.
1483. I ask unanimous consent that those be inserted into the
record.
Mr. Stearns. By unanimous consent, so ordered.
[The information appears at the conclusion of the hearing.]
Mr. Dingell. And I commend you for this, Mr. Chairman. You
are leading an effort which I believe can bring great good to
our people.
[The prepared statement of Mr. Dingell follows:]

Prepared statement from Hon. John D. Dingell

Mr. Chairman, I thank you for holding today's hearing.
For too long, Americans have suffered from unsafe
pharmaceuticals coming into this country from foreign
manufacturers and counterfeit drug operations. The Heparin
crisis was a wake up call that the FDA needs greater authority
to stop unsafe pharmaceuticals and pharmaceutical ingredients
from crossing our borders.
Just yesterday I introduced with my colleagues Ranking
Members Waxman, Pallone and DeGette, H.R. 1483, the Drug Safety
Enhancement Act. This legislation would give FDA much-needed
authorities and resources to address the safety gaps in our
drug supply system.
This legislation would:
Require manufacturers to implement improved
quality and safety standards, including stronger supply chain
management;
Require manufacturers to notify FDA of
counterfeits or safety concerns and to list drugs and drug
components country of origin;
Strengthen importers and customs brokers
oversight;
Arm FDA with administrative detention,
destruction, and mandatory recall authorities, subpoena power,
and clear extraterritorial jurisdiction;
Strengthen criminal and civil penalties for crime
deterrence;
Increase FDA foreign manufacturing inspections to
be on par with domestic facilities; and,
Create new funding mechanisms for FDA inspectional
activities, so globalization doesn't burden US taxpayers.
This last point is an important one. At the same time this
Committee and Congress is asking the FDA to do more, the new
Majority is cutting their funding.
The FDA serves as the watchdog for what food, drugs,
devices and cosmetics are coming across our borders and they
need a steady, reliable stream of funding to carry out their
duties. Further, we need to address gaps in authorities that
are leaving consumers vulnerable to shoddy practices overseas.
I sincerely hope my colleagues on both sides of the aisle
will work with me to provide FDA with the authority it needs to
improve the safety of imports coming across our border.

Mr. Stearns. And I thank the chairman emeritus and his long
serving as the former chairman of this committee. I would point
out--I asked staff based on what Ms. DeGette and Mr. Waxman
indicated--that last year under Democrat majority, they had a
hearing with only the FDA commissioner on May 6, 2010. So I
think at this point----
Mr. Waxman. Mr. Chairman, will you yield to me? This is kid
stuff.
Mr. Stearns. Well, no----
Mr. Waxman. I don't know if you requested a witness or not.
If we request a witness who we think adds to it, it is going to
be 5 minutes more out of your life to hear from that witness.
Mr. Stearns. All right.
Mr. Waxman. I think it is very narrow and mean-spirited to
try to deny us an opportunity to hear witnesses that we think
could add to the hearing.
Mr. Stearns. Well, I appreciate your sentiments. I just
don't agree with you.
OK. With that, we are very pleased----
Mr. Waxman. We will invoke rules that require it if that is
the way the chairman wishes to deal with it.
Mr. Stearns. We welcome our witness today, the Hon.
Margaret A. Hamburg, medical doctor, Commissioner of the Food
and Drug Administration. If you don't mind, just turn your
microphone on and move the microphone a little closer to you
and that will be very helpful. I have to swear you in.
[Witness sworn.]
Mr. Stearns. We welcome your opening statement.

TESTIMONY OF MARGARET A. HAMBURG, M.D., COMMISSIONER OF FOOD
AND DRUGS; ACCOMPANIED BY DAVID ELDER, ACTING DEPUTY ASSISTANT
COMMISSIONER FOR REGULATORY AFFAIRS FOR FIELD OPERATIONS

Dr. Hamburg. Thank you very much, and good morning,
Chairman Stearns, Ranking Member DeGette, members of the
subcommittee. I am Dr. Margaret Hamburg, Commissioner of Food
and Drugs, and joining me here is David Elder, Acting Deputy
Assistant Commissioner for Regulatory Affairs for Field
Operations. He has been with the agency for 23 years, 15 of
which he spent in the field.
I appreciate the opportunity to be here with you to discuss
our approach to import safety and the Predictive Risk-Based
Evaluation for Dynamic Import Compliance Targeting application,
or PREDICT, and its role in our efforts to protect our Nation's
supply of food and medical products in an increasingly
globalized market.
When President Franklin Delano Roosevelt established the
modern FDA back in 1938, the percentage of food and medical
products imported into the United States was minimal. Today,
the landscape, as you have already been discussing, is
dramatically changed. FDA-regulated products are currently
imported from more than 150 countries. This year, we expect
that nearly 24 million shipments of FDA-regulated products will
arrive at U.S. ports of entry. It is estimated that between 15
to 20 percent of all food now consumed in the United States
originates outside our borders. Further, up to 40 percent of
the drugs Americans take and up to 80 percent of the active
pharmaceutical ingredients in those drugs come from foreign
sources.
We face great challenges in ensuring that products are high
quality and travel safely throughout their complex supply
chain. As members of this committee well know, our concerns are
not purely hypothetical. The consequences of adulterated
medical products throughout the world have already been noted,
and they have been tragic. Pet food adulterated with the
industrial chemical melamine in 2007 sickened several thousand
pets here in the United States, and that same contaminant was
added to infant formula in China, fatally poisoning about six
babies and making 300,000 others gravely ill in that country.
And members of this committee are well aware of the 2008
heparin contamination crisis in which adulterated heparin was
associated with several deaths and cases of serious illness.
To address these threats and others, we need a paradigm
shift in our approach to import safety where the border is no
longer our primary line of defense. We must partner with
industry and our global counterparts to push responsibility for
safety and quality further up the supply chain and to monitor
the integrity of that supply chain throughout. That is why FDA
is developing a global strategy and action plan, more fully
detailed in my written testimony, which will allow us to more
effectively oversee the safety of all products that reach U.S.
consumers in the future. While we cannot simply be guardians at
the gate, border screening, surveillance and intervention must
remain an important part of our comprehensive import safety
program.
The task is enormous. In fiscal year 2010, FDA received a
total of 21.2 million lines of FDA-regulated commodities
imported from over 150 countries. FDA is currently managing 264
active import alerts, which flag potentially high-risk imports
representing 3,100 types of products from over 11,000
manufacturers in 150 different countries or areas.
To help make our imports screening more efficient, FDA has
developed the PREDICT application, a sophisticated information
technology system which provides FDA staff on the front lines
with more information regarding the many risks associated with
products entering our borders and allows them to target for
examination those shipments at greatest risk. PREDICT has been
launched in Los Angeles, New York, Seattle and San Francisco,
covering about 40 percent of all imports at the present time.
Some technical difficulties, as noted, delayed our national
rollout. However, I am pleased to report that we have addressed
those issues and are back on track. This month, PREDICT will be
implemented in our Florida and San Juan districts, expanding
coverage to almost 50 percent of all imports. If successful, it
will then be rolled out across the country.
PREDICT is an exciting and important innovation that
harnesses advances in information science to enable us to do
our job better and to improve our service to the Nation. But as
I mentioned earlier, it is just one step in our efforts to
fully secure the supply chain.
Congress has provided the agency with critical tools to
assure the safety of imported food. New regulatory authorities
for drugs similarly may help ensure that we can hold industry
accountable for the security and integrity of their supply
chains and the quality control systems they use to produce
drugs for the American people. Those may include authorities in
the areas of corporate responsibility, enforcement and
information sharing, which are detailed more fully in my
testimony.
Thank you for the opportunity to testify this morning, and
I look forward to answering your questions.
[The prepared statement of Dr. Hamburg follows:]

[GRAPHIC] [TIFF OMITTED] T1721.021

[GRAPHIC] [TIFF OMITTED] T1721.022

[GRAPHIC] [TIFF OMITTED] T1721.023

[GRAPHIC] [TIFF OMITTED] T1721.024

[GRAPHIC] [TIFF OMITTED] T1721.025

[GRAPHIC] [TIFF OMITTED] T1721.026

[GRAPHIC] [TIFF OMITTED] T1721.027

[GRAPHIC] [TIFF OMITTED] T1721.028

[GRAPHIC] [TIFF OMITTED] T1721.029

[GRAPHIC] [TIFF OMITTED] T1721.030

[GRAPHIC] [TIFF OMITTED] T1721.031

[GRAPHIC] [TIFF OMITTED] T1721.032

[GRAPHIC] [TIFF OMITTED] T1721.033

[GRAPHIC] [TIFF OMITTED] T1721.034

Mr. Stearns. Thank you, Commissioner Hamburg.
We have a clip we are going to show on the screen here,
which is from a speech you gave in January discussing the FDA's
new global challenges. If we can, play the clip and maybe just
drop the lights a little bit.
[Video shown.]
Mr. Stearns. That statement indicates that you believe the
current threat is pretty serious and you have spoken repeatedly
about the challenges we face in assuring the safety and quality
of imported products in a global age. You mentioned that in
your opening statement, and I think we can conclude that import
safety is one of your top priorities, and you have promoted
PREDICT as an important tool to leverage FDA's resources in
responding to this global challenge.
As you mentioned in your testimony, you formally unveiled
PREDICT in February 2010 in a speech and you stated that you
hoped to have it up and running nationwide by the end of the
spring of 2010, as we recollect. The question is, what did you
do to try and accelerate the implementation of the process
considering you had indicated that you thought it would be up
and running by the spring of 2010.
Dr. Hamburg. Well, as noted, PREDICT is a very important
tool that will enable greater efficiencies in who we target
resources, and it is very exciting to see it now in action in
four of our districts and covering about 40 percent of all
imports at the present time. As we rolled it out, from the very
beginning it was determined that it should be done in a
systematic stepwise way because very often with computer system
implementations that involve extremely large databases, there
are issues that emerge in the process. So we began in one
location with a limited focus, expanded the focus and then
began to roll it out.
In the course of that, unfortunately, some issues did
emerge and we actually at a certain point decided to stop with
the actual use of PREDICT in the field while we brought in
experts and put together a team which examined that.
Mr. Stearns. So really, in a sense, rather than trying to
accelerate the implementation process, you really stopped it
then.
Dr. Hamburg. Well, what we did was when the problems
emerged----
Mr. Stearns. I mean, isn't that true?
Dr. Hamburg [continuing]. In its implementation, we stopped
it in order to identify what those problems were rather than
keeping a system----
Mr. Stearns. Let me get a little more specific for you.
After PREDICT was deployed in the New York district in the
spring of 2010, there appeared to have been a 5- to 6-month
delay while a government contractor wrote a white paper on a
performance assessment of PREDICT. Given that import safety is
one of your top priorities, is this delay of the deployment
acceptable considering how important it is? And you said
earlier in your speech that this has to be enforced.
Dr. Hamburg. Mr. Chairman, I understand your concern about
an unfortunate delay that occurred in the process. However,
this system is very, very important. It is critical that it
work effectively and efficiently. We had identified problems
with its implementation. We stopped the full rollout while we
brought in outside experts and our internal experts to identify
the source of the problem. The effort that you mentioned was an
effort to identify the----
Mr. Stearns. Can I say this morning that all the technical
problems have been solved?
Dr. Hamburg. We believe that we identified the underlying
problem that led to the----
Mr. Stearns. So the answer is yes?
Dr. Hamburg [continuing]. Inefficiencies in the system.
Mr. Stearns. The answer is yes, that you think all the
technical problems have been taken care of?
Dr. Hamburg. It seems to be now functioning very well in
the sites where it is present.
Mr. Stearns. Can you, based upon that, make a prediction
this morning that PREDICT will be fully implemented nationwide
by the end of the year?
Dr. Hamburg. That is our absolute goal but if there are
problems in the implementation, we will of course examine those
and correct them, but we are moving forward. We see no barriers
to the further implementation of PREDICT in the two additional
sites at the end of this month and extending it to 100 percent
implementation by the end of the year.
Mr. Stearns. In your opinion, wouldn't PREDICT benefit from
a program focused oversight structure with executive-level
involvement?
Dr. Hamburg. I am sorry. Would it benefit from an
oversight----
Mr. Stearns. Yes, a more focused approach with more
executive-level involvement. Instead of having these technical
white papers, can't you just have your staff focus down on this
and bring in the executives to make decisions?
Dr. Hamburg. You know, I feel that we have been
implementing this in a very responsible way with a clear
program plan with internal and external experts overseeing the
project. When problems emerge, we have taken the appropriate
actions to remediate them. We now have the system up and
running in the desired way providing benefits.
Mr. Stearns. Well, do you think you need congressional
support? Should we pass legislation specifically authorizing
this program and working with the Appropriations Committee to
include report language? Would that help you at all, or do you
think that is not necessary?
Dr. Hamburg. The continuing support of Congress for our
efforts to support import safety is extremely welcome. I don't
think we need targeted legislation or activities for the
PREDICT program. As I said, I believe that it is moving forward
in an appropriate and valuable way and that it was our
responsibility as problems emerged to identify the source of
those underlying problems, fix them and make sure that the
program in place in fact was fully functional and able to do
the tasks that we are asking it to do and it is proving to be
of great value as we screen products today.
Mr. Stearns. My time is expired. The gentlelady from
Colorado is recognized for 5 minutes.
Ms. DeGette. Thank you, Mr. Chairman.
So Dr. Hamburg, let me get this straight. It was about 14
months ago, February of last year, that the FDA announced this
PREDICT program, right?
Dr. Hamburg. In the speech that you saw the segment of we
formally announced that this PREDICT was----
Ms. DeGette. About 14 months ago, correct?
Dr. Hamburg [continuing]. Going to start to unfold.
Ms. DeGette. And then you started implementing it and you
found some problems and so you had to correct those problems as
the implementation went forward, correct?
Dr. Hamburg. That is correct.
Ms. DeGette. And if you had just tried to implement the
whole thing within 2 months, it is your view that it may not
have worked because it had some problems, right?
Dr. Hamburg. It would not have worked.
Ms. DeGette. Now, as of today, 14 months later, it is about
40 percent implemented, correct? You need to use words. It is
about 40 percent implemented?
Dr. Hamburg. It is implemented in four sites that cover 40
percent of the imports.
Ms. DeGette. And so is it the FDA's view that the major
problems in the PREDICT problem have now been solved by these
efforts over the last 14 months?
Dr. Hamburg. It is our belief that through the systematic
scale-up and the examination of problems as they emerge that we
have been able to correct the underlying problem in code, which
actually wasn't in PREDICT, it was in an interface with
PREDICT.
Ms. DeGette. I see. OK.
Dr. Hamburg. And that now the system, you know, is working
in the sites that it is in place and we see no barriers at the
present time to the full implementation in a timely manner.
Ms. DeGette. And the FDA believes in this program and wants
to implement it as quickly as possible as well as us, right?
Dr. Hamburg. Absolutely.
Ms. DeGette. So, you know, I join with Mr. Stearns in
saying, you know, whatever we can do to help you implement
this, we think that it is important and it should be done as
soon as possible but it should also be done right.
But here is my next question. You said in your testimony,
PREDICT isn't the only thing we need to do. Why is that?
Dr. Hamburg. Because the volume of imports coming in at the
borders and the number of sites of importation are so huge that
the ability to really do the hands-on inspection, even with a
screening tool like PREDICT, limits us in our reach. We want to
reach back further, closer to where the products are actually
produced and manufactured and try to build in assurances of
safety and quality from the very beginning and throughout the
supply chain, so working more closely with industry in terms of
the standards that are expected, working with sister regulatory
authorities in countries around the world so we have this
harmonization of standards, sharing information with others.
Ms. DeGette. OK. And so let me ask you, because we passed
the Food Safety Modernization Act last year. Do you think that
the FDA needs new authorities to begin to do what you are
talking about and to protect the safety of the drug supply?
Dr. Hamburg. I think the Food Safety Modernization Act has
clearly given us additional authorities and a new framework for
addressing food safety in this context. I think we do need to
very carefully examine the opportunities on the drug side as
well. We know that there are huge challenges and as was noted,
they are growing. We do need additional authorities to be able
to do our job and of course we need resources as well.
Mr. DeGette. Yes. One thing that I worked a lot on in this
food safety bill that is also in the Drug Safety Enhancement
Act is mandatory recall authority for the FDA for drugs. Do you
believe this authority is necessary?
Dr. Hamburg. I do believe that authority is necessary.
Ms. DeGette. And why is that?
Dr. Hamburg. So that we can move swiftly when there is an
imminent threat to the health of the public, to take action to
make sure that a product with risks does not get out to
consumers, is pulled back from shelves when it is out there. It
is very vitally important, and our current authorities require
us to either act through the authorities of States to embargo
or pull back these products or to seek the support of the
courts in taking these actions.
Ms. DeGette. You know, this is one thing when I worked on
mandatory recall for the food safety, my constituents were
shocked because they thought the FDA already had that
authority, and I bet that is true with drugs too. I bet people
just think the FDA has that authority with drugs.
One last question. One of the controversial areas in this
new bill that we introduced calls for new registration fees on
importers. I am wondering if you can talk about what the FDA
opinion is on these registration fees.
Dr. Hamburg. Well, I think it is very, very important that
we recognize that the magnitude of the problem is huge and
growing and outstrips available resources. Clearly, we need to
bring appropriate resources to bear. Clearly, this is the
responsibility that the American people care about as well as
industry, and I think it is appropriate that these programs be
supported with industry contributions as well, and the ability
to work with industry to achieve common goals in reducing these
threats to health and safety will be, I think, enhanced in this
kind of an approach.
Ms. DeGette. Thank you very much. Thank you, Mr. Chairman.
Mr. Stearns. I thank the gentlelady. Dr. Burgess is
recognized for 5 minutes.
Mr. Burgess. Thank you, Mr. Chairman.
Well, they can be enhanced in that kind of approach only if
we understand the problem that we had and how to deal with the
problem. That of course brings me back to the heparin question,
and you were kind enough to come and brief me last year in the
last Congress. If I could, let me just recapitulate a couple of
the things that we talked about that day. I would like to have
them part of the committee's record. Can you provide to the
committee a list of the people with whom you met in China, the
Chinese officials with whom you met?
Dr. Hamburg. A list of officials with whom I met while I
was visiting China?
Mr. Burgess. Yes.
Dr. Hamburg. I could.
Mr. Burgess. Because you met with several.
Dr. Hamburg. For the record. I mean, I can't produce that
right now.
Mr. Burgess. Correct, and I understand that. That is why I
was asking you if you could produce it for us. And did the
subject of the adulterated heparin come up when you met with
the Chinese officials?
Dr. Hamburg. It did. I raised it with them to express our--
--
Mr. Burgess. They didn't bring it up spontaneously? You had
to raise it?
Dr. Hamburg. I believe that I raised it.
Mr. Burgess. OK. And what did they commit to you as far as
action to investigate and uncover what happened?
Dr. Hamburg. What was indicated to me was that they felt
that there was not anything to be gained at this point by
trying to continue the investigations of the underlying cause
and instigators of the heparin contamination but they did
recommit to working with us to ensure that this specific
problem and similar problems will not occur going forward, and
we do have a memorandum of understanding with the Chinese
government with respect to some of the critical public health
measures that need to be in place and are in place to help
protect----
Mr. Burgess. See, that whole approach is problematic to me
because now we have, with all good intentions, drug safety
legislation being introduced but we don't really understand
what happened and how we are going to control it, and that then
makes for legislative difficulties. But the heparin question is
so fundamentally different from the melamine. Melamine, it can
be argued, was the equivalent of a dishonest grocery putting
his thumb on the scale when he weighed your produce, but the
heparin, this was a molecule that was developed specifically to
defeat the mass spect that was used by the manufacturer to
document that in fact what they had extracted from the live
specimen was the desired active pharmaceutical ingredient. So
hypersulfated and chondroitin sulfate would exactly reside
within the peak that normal heparin would provide one the mass
spect, and only when it was done with an ultra-sensitive
machine could you separate out and see, oh, there is actually
two compounds here instead of one, and that compound was
patented under the Chinese system. So why was it created and
what possible use could it have had in a commercial application
and how in the world did it find its way in to contaminate the
pharmaceutical supply chain? I mean, these are some pretty
critical questions that need to be answered, and to just say
well, going forward we are going to be sure things are done
right, I am sorry, maybe the heparin will be done right but
what was the intent here? Was it simply a dishonest retailer or
was there something more nefarious afoot? And we just simply
don't know.
So now you have the chairman emeritus and the ranking
member writing legislation which in all likelihood I could
support in principle but we don't know what we are trying to
fix. We don't know how it happened in the first place. That is
why we need your help. You were in China. You met with these
officials. We need your help to understand how we do in fact
prevent this happening in the future. Would you not agree with
that?
Dr. Hamburg. I agree that this is a very serious concern
and I agree that the heparin contamination was a very
sophisticated example of a broader phenomenon in fact, which
you note, the economic adulteration of products, and I think it
speaks to the urgency of our really strengthening the
activities to ensure import safety, the importance of
additional resources and authorities, the importance of
stronger authorities to enable us to do investigations when
there are problems outside of our----
Mr. Burgess. Right. It almost requires that we think like
the criminal because after melamine, you know, melamine, shame
on us, but heparin, why didn't we see it coming.
Let me just ask you a question though because it is so
important that I get this in too. We have a hearing with device
manufacturers. We hear from drug manufacturers. There is a lot
of complaints that the process that people have to go through
with FDA to get drugs and devices approved is in fact at this
point unknowable and it makes the investment community nervous
and in fact it makes the investment dollars dry up, or worse
yet, go overseas so these drugs and devices are developed in
other markets rather than the United States so it is an
outsourcing, it is an offshoring problem as well. What are you
doing within the agency to ensure that those pathways can in
fact be known before someone starts--so that you can actually
tell people what they will need to provide and then not change
the rules of the game as they go through it?
Dr. Hamburg. You raise a really important issue, you know,
for our Nation in terms of supporting innovation, critical
industries, economic and global competitiveness, and FDA
clearly has an important role to play. We are looking very
carefully at our regulatory pathways and how we can be more
transparent and predictable, also looking at how we can bring
the best possible science to bear so that we have better
knowledge and tools and approaches to make the regulatory
pathways more effective and efficient. We are working in
partnership with academic scientists and industry scientists
and government scientists to really try to strengthen the
underlying science because some of the problem with the
regulatory pathway is in fact scientific uncertainty about how
do you take a good idea and make it into a real-world product,
and of course, a bit outside of the FDA's bailiwick is the
important question of what are the economic incentives to help
ensure investments in important candidate products that hold
real promise.
Mr. Burgess. I think we both have to agree that the
timeline is a strong economic disincentive. I heard from a
physician who developed a product as he watched his son being
circumcised and decided there had to be a better way to do some
of these things. His son is going to college and it is still
tied up in the FDA.
Thank you. I yield back.
Mr. Stearns. The gentleman's time is expired. The gentleman
from Michigan, Mr. Dingell, is recognized for 5 minutes.
Mr. Dingell. Mr. Chairman, I thank you.
Commissioner, I want to focus on the adulterated drugs that
are crossing our borders. Some have said it is as much as $75
million a year. I think it is rather more. And recent scares
like heparin and other matters show how much needs to be done
to monitor imported drugs and pharmaceuticals. Now, having said
that, in recent reports by CBS News, more than 36 million
Americans have unknowingly purchased drugs on counterfeit-drug
Web sites. Often these purchases are being dropped in the mail
where they may not be tested either by Customs or Border
Patrol. It is my understanding that under current law, if FDA
recognizes counterfeit or adulterated drugs, FDA cannot detain
or destroy products on site without going through a lengthy
process providing notice and an opportunity for hearing so that
FDA often ships these drugs back to the sender. Is that
correct?
Dr. Hamburg. That is correct.
Mr. Dingell. So under current law, it is possible for a
drug operation that is counterfeiting or adulterating drugs to
put it in a package that was rejected by the FDA at one mail
facility and to simply resend it through a different mail
facility or again through the same fiscal year? Yes or no.
Dr. Hamburg. Unfortunately, yes.
Mr. Dingell. I believe I am correct in believing that if
FDA had the authority to destroy drugs believed to be
adulterated, misbranded or counterfeit that this would help to
keep counterfeit drugs from reentering our country through
alternative mail facilities or other facilities. Yes or no.
Dr. Hamburg. That is correct.
Mr. Dingell. Now, section 201 of the Drug Safety
Enhancement Act, which I introduced yesterday with my
colleagues, Mr. Waxman, Mr. Pallone and Ms. DeGette, would give
FDA's officers or employees the authority to order destruction.
Section 202 of the bill would authorize the destruction of any
drug valued at $2,000 or less or that the Secretary deems to be
a significant adverse health risk. Anything valued at more than
$2,000 could not be destroyed until notice and opportunity for
hearing occurred. Do you believe having this authority would
discourage counterfeit drug operations from shipping their
products into the United States? Yes or no.
Dr. Hamburg. Yes.
Mr. Dingell. Now, we know that these counterfeit and
adulterated drug operations are a lucrative business. These
operations make money out of the pockets of consumers who may
not know that their prescriptions are either unsafe or
ineffective. I believe that we must impose severe penalties at
least equivalent to similar violations relating to different
kinds of products so as to discourage their continued
operation. The legislation introduced yesterday proposes
strengthening civil and criminal penalties for any person who
knowingly distributes unsafe pharmaceuticals. Do you believe
that criminal and civil penalties discourage the counterfeit
and adulterated drug operations? Yes or no.
Dr. Hamburg. Yes, I believe they would.
Mr. Dingell. Now, Commissioner, the Drug Safety Enhancement
Act would also require FDA to inspect every establishment,
foreign and domestic, at least once every 2 years following
registration. You at FDA have been continuously and chronically
underfunded. Personnel from FDA have said publicly that FDA's
resources do not keep pace with the volume of products coming
into the United States. The majority proposed the 2012 budget
cut $600 million from FDA in spite of the fact there are new
safety authorities for food safety that you are required to
implement. Would you agree that a fee system could help provide
a stable funding source for drug safety activities? Yes or no.
Dr. Hamburg. I believe we need additional resources to do
the task before us.
Mr. Dingell. Would you support such a fee system,
Commissioner?
Dr. Hamburg. Pardon me?
Mr. Dingell. Would you support a fee system?
Dr. Hamburg. Yes, I would.
Mr. Dingell. Now, can you give us an appreciation of how
many people you have in charge of dealing with imports of
pharmaceuticals? You don't have to tell us this morning. Submit
that for the record. Would you also submit to us how much that
costs and would you submit to us how many people you need to do
this work and how much that would cost, please?
Dr. Hamburg. I would be delighted to put that together and
submit it for the record.
Mr. Dingell. I believe we need to know that. Now, this
committee going back as far as when I was chairman of Oversight
used to have people in to discuss these matters and we never
got around to doing anything about it. Last year, we passed by
overwhelming vote, it came unanimously out of this committee,
if my memory serves me correctly, the food safety bill. Is that
working well?
Dr. Hamburg. We are still very early in the implementation
but it is a huge contribution and historic shift really in how
we are able to address food safety issues giving us a new----
Mr. Dingell. It gives you lots of new and added
authorities?
Dr. Hamburg. It does.
Mr. Dingell. And you recognize many of those authorities in
the pharmaceutical safety bill introduced yesterday, do you
not?
Dr. Hamburg. I think we would like to see parallel
authorities in the drug area in many key arenas.
Mr. Dingell. Mr. Chairman, I thank you for your courtesy to
me. I hope that we will be able to use this hearing as a
mechanism to move forward towards safety of our people from bad
pharmaceuticals as we have done with regard to bad food safety,
and I would hope my colleagues would work with me in a
bipartisan fashion towards this end. Thank you, Mr. Chairman.
Mr. Stearns. I thank the gentleman. Dr. Gingrey is
recognized for 5 minutes.
Mr. Gingrey. Mr. Chairman, thank you.
Mr. Hamburg, thank you for being here today and for your
leadership at the helm of the FDA. I greatly appreciate your
efforts and focus on efforts to encourage the FDA to adapt and
improve its functions including the use of the PREDICT software
at our borders and ports of entry, and we appreciate that.
Going to the PREDICT model, one that is flexible and able to
meet new and emerging threats to our borders and ports, in many
respects I see the FDA reform in much the same light and I
think from your previous statements here, I know you do as
well.
Federal initiatives to develop new drugs and diagnostics,
whether in the antibiotic space or elsewhere, can be greatly
supported by an FDA that is flexible, adaptable to new
technologies, and understanding of the human body and genome is
critical. How important of a role do you think that the
regulatory science--you referenced that earlier--how important
of a role do you think regulatory science can be to support the
FDA in its work in the coming years and decades?
Dr. Hamburg. You know, I think it is enormously important,
and I truly appreciate your question. It is an important area
of science. It is the knowledge and the tools that are needed
to really effectively and efficiently evaluate a product for
safety, efficacy, quality and performance, and there have been
huge advances in science and technology that can be brought to
bear on the regulatory process as well as on the drug
development and medical product development process to make it
more streamlined and more modern, and will give us tools so
that we can really shorten the timeframe for the regulatory
process in key ways using innovative clinical trial models,
using biomarkers to help us identify early concerns like
toxicity----
Mr. Gingrey. Dr. Hamburg, thank you, and I think you know I
am currently working on some proposals in support of regulatory
science and I am hoping that I can get your commitment that you
will sit down and work with me and my staff in support of this
worthy goal.
Dr. Hamburg. I am extremely eager to work with you on that.
Mr. Gingrey. I really appreciate that. Thank you, Dr.
Hamburg.
You expressed support for developing a track and trace and
authentication system to help combat the counterfeit drugs. Can
you update us on FDA's efforts in this area and give me your
thoughts on the scope of drug counterfeiting and diversion in
the United States? What else can we as a Congress do?
Dr. Hamburg. Well, with respect to the big picture, we know
that counterfeit drugs represent a very large and growing
problem. It is most--the burden is most pronounced in the
developing world where in some countries 30 to 50 percent of
drugs for serious diseases being used in fact are not what they
purport to be. It is a smaller problem in this country in large
part because we have a very strong regulatory framework and we
work very closely with counterpart agencies to minimize the
problem but with the growing complexity of supply chains and
globalization and the fact that we know that especially in the
absence of strong civil and criminal penalties that
counterfeiting is an increasingly attractive area for some bad
guys, I am sad to say. We cannot be complacent and we need to
make sure that we have the programs and policies that----
Mr. Gingrey. Well, before the hearing started, I had spoke
with you briefly about the 60 Minutes clip that I am sure a lot
of folks on both sides of the aisle saw recently, and the
magnitude of the problem is downright scary, and certainly this
is a timely hearing.
Real quickly in the last minute that I have, the events and
controversy related to the approval and subsequent price
increase of a drug manufactured by KV Pharmaceuticals for the
prevention of premature birth--premature labor and possibly
premature birth. While not directly tied to import screening,
it does involve FDA's mission to ensure the safety and efficacy
of our Nation's drug supply, and it was initially thought that
pharmacies would be precluded from compounding versions of this
product which they had been doing for some time and selling for
much less than the product marketed by KV, and because of the
controversy that ensued, KV ultimately significantly lowered
the price and FDA announced that it would not initiate
enforcement against the compounding pharmacies. I have a couple
of questions in regard to that issue. Are you aware of any
safety concerns with patients taking a compounded version of
this drug versus the Makena product?
Dr. Hamburg. As far as I know, we have not had reports of
adverse events associated with compounding of this particular
product.
Mr. Gingrey. And then the last thing, and I realize I am a
little bit over time, are any ingredients for the compounded
version imported as far as you know?
Dr. Hamburg. You know, I would have to get back to you. I
honestly don't know the answer to that question.
Mr. Gingrey. And then real quickly, Mr. Chairman, I just
wanted to ask you, Dr. Hamburg, in regard to Dr. Burgess's line
of questioning about the heparin. Have we then abandoned the
heparin investigation? Is that pretty much over and done with?
Dr. Hamburg. In terms of the investigation of who actually
instigated this economic adulteration of the heparin product,
the investigations have come up dry and there are not active
new leads. I think the other side of it that is important for
you all to understand, for the American people to understand,
is that we do have a very large number of steps in place and
safeguards to protect against the importation of contaminated
heparin if there were those who chose to try to begin again
with this contamination of this important product.
Mr. Gingrey. Dr. Hamburg, thank you. Mr. Chairman, thank
you for your indulgence. I appreciate it.
Mr. Stearns. The gentlelady from Illinois, Ms. Schakowsky,
is recognized for 5 minutes.
Ms. Schakowsky. Thank you, Mr. Chairman.
Thank you, Dr. Hamburg. The job that you have taken is so
expansive from baby food to medical devices in between, and I
know that imports of FDA-regulated products have dramatically
increased over the last 7 years. In 2004, FDA oversaw 11.8
million shipments of products like food and pharmaceuticals and
medical devices, but by 2010, the importation of FDA-regulated
products had nearly doubled, totaling in 2010, 21.1 million
shipments. That is a lot. And so I wanted to ask you about the
resources that you really have to deal with that.
The President's budget for 2012 asks for a significant
increase in the FDA's budget, approximately 33 percent, which
actually includes the new user fees that Mr. Dingell had
mentioning, bringing it to a total of $4.3 billion, but the
Republican budget as presented by Paul Ryan we understand would
likely roll back FDA funding to the fiscal year 2008 funding
levels, which means the agency would be cut by about $600
million. So what I am concerned about, and my first question
is, what effect would a funding cut on have the ability as
specifically as possible to be able to do its job? How would
that affect ordinary consumers and what would you have to do?
Dr. Hamburg. Well, the magnitude of the cut you described,
you know, would be enormously difficult for our agency to
absorb without taking serious cuts in critical programs to the
health and safety of the American people with respect to our
ability to inspect and support the safety of the food supply,
our ability to ensure the safety of the drug supply, our
ability to approve new and promising medical products for the
American people, our ability to protect the safety of the blood
supply and other critical FDA-regulated products that people
depend on every day, and it would certainly make it very, very
hard for us to move forward to more fully and effectively
address the challenges of import safety.
Ms. Schakowsky. And what then would be your priorities were
the increases to go through, if the Congress were in fact to
give you more money? For example, would we be able to--as Dr.
Burgess mentioned, would there be any possibility of speeding
up the permits for new pharmaceuticals or new products?
Dr. Hamburg. We are trying to target additional resources
and additional energy in the area of supporting innovation and
really modernizing our regulatory pathways. Dr. Gingrey
mentioned the importance of regulatory science, and investments
there are making a difference in really moving our systems
forward. But a lot of what matters in moving a product swiftly
and surely through the regulatory pathway involves having the
staff resources to work with the sponsor companies to lay out
the expectations for what kinds of data and evidence they need
to put forward to support the approval of their product and to
work with them as they are collecting that data, analyzing that
data and presenting it to us.
So if we have deep cuts, we will not be able to achieve
some of what we know makes a difference in terms of the review
teams and what needs to be done. We won't be able to apply
advances in science and technology to modernize our regulatory
pathways. And, we won't be able to do the important work every
day both to ensure the safety and quality of the manufacturing
and production of drugs and the important work to make sure
that once those drugs are approved and they are being used by
people in the real world, we continue to monitor for the safety
and the efficacy of those drugs so that the American people can
actually trust and depend on these important products.
Ms. Schakowsky. Thank you very much.
Mr. Stearns. I thank the gentlelady. Ms. Myrick is
recognized for 5 minutes.
Mrs. Myrick. Thank you, Mr. Chairman, and thank you both
for being here, and we do appreciate the work. I know you have
got a very difficult job.
As was previously mentioned, Dr. Hamburg, you and Mr. Elder
were interviewed on that 60 Minutes special regarding the
threat of counterfeit imported drugs to the U.S. pharmaceutical
supply. Would you mind if we just play the clip so everybody
could see?
Dr. Hamburg. OK.
[Video shown.]
Mrs. Myrick. It is really frightening, I think, to all of
us because we share your concern, and I know you have already
answered the questions that you don't have the authority, etc.,
but in 2009 and 2010, the U.S. Customs and Border Protection
seized approximately 2,000 parcels of pharmaceuticals coming
through the mail. Do you have any way of knowing how many of
those were screened by the FDA that were destroyed or returned
to the sender? Do you have way to track any of that?
Dr. Hamburg. The way the system works is that the products
come into the mail facility. Customs and Border Protection
screens. Those that look like they contain drugs or medical
products get then targeted to the FDA. We work closely with
CBP, of course. And then we undertake the examination of a
subset of those products that have been targeted to us through
Customs and Border Protection, and unfortunately, we cannot
screen all of those products because of limited resources, and
we do lack the authority when we find violative products to
actually detain and destroy them.
Mrs. Myrick. And when they are returned to the sender, I
mean, that is kind of the majority of the work that you do. In
other words, you can't destroy them so you have to return them
to the sender. Is that correct?
Dr. Hamburg. We have a couple of options. We can hold the
product and seek support from the courts to destroy them.
Mrs. Myrick. I know it would be helpful to you if you had
some authority from us to be able to----
Dr. Hamburg. Absolutely. It would make much more sense in
terms of addressing important public health problems and
efficient use of resources.
Mrs. Myrick. This is a separate question. I hear a lot from
patients and doctors in my area. They have really big concerns
about the FDA's risk-benefit analysis. FDA threatens to remove
certain drugs and devices from the market that have relatively
low risk compared to a patient's risk of death without access
to the drugs or devices, and in some cases we are talking about
terminal illnesses, and patients are often willing in that case
to take a little extra risk because it means they can live
longer. So how does the FDA take these patients into account
when it comes to approval and sometimes withdrawing the
approval, and can the approach that you use be improved in any
way, in your opinion?
Dr. Hamburg. Well, it is such an important part of how we
think about and use drugs in this country. We obviously do look
at the risks and benefits in the context of a given disease and
what other treatments are available, and people are willing to
accept many more risks if they have a fatal disease and they
have no other option.
Mrs. Myrick. So you do take that into account?
Dr. Hamburg. Yes. We are in the middle of a process of
really trying to make this all more transparent and really
systematic and lay out the criteria for weighing risks and
benefits in different contexts both in terms of the
understanding that our own staff have about how to think about
it and the training but also so that medical product sponsors
and the public including patients can understand this as well,
and we are doing this in an open way, getting input as we try
to shape this model.
Mrs. Myrick. I really appreciate it, because it is
heartbreaking when you sit with somebody who is using a drug
and it has successfully prolonged their life and they are
living a normal life and then the drug is pulled or it can't be
used for that particular disease. So it presents a big
challenge, and it just breaks your heart. So I appreciate your
looking at it. Thank you.
Mr. Chairman, I yield back.
Mr. Stearns. The gentlelady yields back. The gentlelady
from the Virgin Islands is recognized for 5 minutes.
Mr. Christensen. Thank you, Mr. Chairman, and welcome, Dr.
Hamburg. I regret that I have been in and out, and I may be
repeating some of the questions, but I think it is important
for us to understand the implementation of PREDICT, so I have
some questions about the PREDICT database and realizing that it
is a new tool that was created to enhance FDA's risk-based
screening efforts at ports of entry and recognizing, of course,
that FDA can't inspect every import shipment. The system
enables the agency to target shipments that are more likely to
violate FDA regulations.
So as I understand it, now PREDICT is fully operational for
all FDA-regulated products in Los Angeles, New York, Seattle
and San Francisco. Did you say San Juan as well?
Dr. Hamburg. Not yet in San Juan. It is being implemented
in a staged way and so components even aren't as fully fleshed
out as they will be over time but the major components are
fully operational and covering 40 percent of imports out of
those four districts.
Mr. Christensen. Thank you. And I know that the chairman
asked several questions about the delay, and you said that
there were problems, and if you have already specifically
stated what those problems are, I apologize, but why
specifically, what were the problems that caused the delay in
the full deployment of PREDICT?
Dr. Hamburg. Well, as we started to implement the system,
it was operating much more slowly than people expected. It was
much more cumbersome. And so questions were asked about why
that would be. It was initially thought that it was an
infrastructure problem that we were overlying a very large data
management set of tasks onto our existing infrastructure. That
was systematically looked at. It actually turned out that the
problem was really most focused on a piece of software that
interfaced with the PREDICT system that was slowing it down
because it was doing a series of initializations underlying the
entry process and that was corrected and it is now working in a
very efficient way and we are seeing measurable improvements in
our ability to quickly move low-risk products through and
target high-risk products.
Mr. Christensen. And then you convened a high-level group
of FDA officials to identify and fix the problem. Just to
clarify, did the problems that you identified with PREDICT
cause any risk to the public health or food or drug safety at
any time?
Dr. Hamburg. I really appreciate that question because I
should emphasize that even when we were having problems with
PREDICT, we still had underlying systems that were supporting
our screening, and while not as robust and rich as PREDICT,
they were still able to provide the core set of public health
responsibilities that go with our import screening activities.
Mr. Christensen. Thank you. You know, I think it is
important not to make a mountain out of a molehill here. The
FDA is implementing a brand-new IT system to help keep the food
and drug supply safe, and it seems to me the agency is doing
exactly the right thing in the right way. No IT system is
implemented without problems. But the key is that when you
found the problems, you acted rapidly to identify and fix them
and to make sure that the public health was not harmed. So we
are looking forward to the full implementation.
Let us see if I can get another question. I would like to
ask you about courier fees because millions of shipments of
FDA-regulated products enter the U.S. through express courier
facilities like FedEx and UPS every year, and the President in
his budget for 2012 proposes a new international courier fee
that would be assessed. The President's budget requests a new
international courier fee not to exceed $5.3 million. What
activities would that fee support?
Dr. Hamburg. It would enable us to do the kind of review
and, when necessary, examination of products coming in through
that mechanism. It is a growing component of imported products.
It is one that operates on a 24/7 time frame. Because of our
limited resources, we haven't been able to target the courier
services in the way that would most benefit them and so
actually this is something that I think they are very eager to
work with us on in order to support greater deployment of FDA
personnel.
Mr. Christensen. So you don't expect that this fee would
cause hardships for the couriers and importers, do you?
Dr. Hamburg. I think it will benefit them because they very
much are committed to very rapid transit of the materials that
they are importing and this will enable FDA to be able to
support their business model in terms of transit of products
that are safe and low risk.
Mr. Christensen. Thank you.
Thank you, Mr. Chairman.
Mr. Stearns. I thank the gentlelady. The gentleman from
California, Mr. Bilbray, is recognized for 5 minutes.
Mr. Bilbray. Thank you.
Mr. Hamburg, I appreciate your being here. In the last 2
years prior to the new majority being here, how has your budget
been impacted by the new Administration proportionally from the
previous Administration? Has the budget been severely reduced
or has it been enhanced to some degree, or what is the deal?
Dr. Hamburg. Well, actually, beginning in the last
Administration we began to see some significant increases in
our budget though over the last few years we had had increases
in our budget that have been very, very welcome. We do have----
Mr. Bilbray. Do you have any idea what kind of percentages
you have seen in the last 24 months?
Dr. Hamburg. In the last 24 months?
Mr. Bilbray. Since you have been there.
Dr. Hamburg. Well, we have had--in the last year, it was--
you know, it is a little hard to----
Mr. Bilbray. But it has been a healthy increase?
Dr. Hamburg. We have had significant increases in the last
couple of years.
Mr. Bilbray. OK. I appreciate that. I want to get back to
this issue that we have got China demanding that research be
done in China for drug development for anything sold there, so
we are going to see a shift there. We will see a shift in the
emphasis why manufacturing should go to China with this basic
extortion game going there. You have got Europe that is really
reducing their review of drugs and devices to a point way below
basically it looks like much more efficient. They are getting
more efficient going out. So we have got this potential of this
big increase of imports coming in as we are watching our
manufacturing capabilities be exported. Are you reflecting
that? Are you planning on that increase in your inspection at
the borders that looks which everybody in the industry is
saying is basically an indication we are seeing across the
board?
Dr. Hamburg. Let me first address some misperceptions.
There is a sense that we are much slower than Europe, our
counterparts there, in reviewing drugs and devices. In the drug
area, in fact, we went back and looked over the last couple of
years and the majority of new molecular entities, new drugs
that both of us approved were approved first in the United
States. In fact, if you look at priority drugs, the number is
actually higher.
Mr. Bilbray. I would like to see that because the
applications were made here first many times and they were
basically moved on others because of the perception but the
fact is that from the data we have, from the data I have
received basically reflects the fact that even though you had
major increases--and I think this is an issue about what do we
do with the money, you know, we are looking at a 28 percent
slowdown of the review of drug processing by FDA at a time your
budget was expanding. So there are a lot of these institutional
changes that we have to address, and just sending money across
over doesn't necessarily guarantee the job is going to be done
efficiently or--you know, not efficiently but basically the
mindset of the bureaucracy does affect timeline and
performance, does it not?
Dr. Hamburg. Let me just assure you, we take very seriously
the timeliness of our reviews, and through the user-fee program
we actually negotiate with industry about timelines for
performance.
Mr. Bilbray. Doctor, let me just say, we have got industry
people that we are going to have to testify about your
operation behind closed screens because they are that scared of
the process. But in all fairness, at a time when you had major
expansion of resources to get the job done, the numbers that we
have got before our committee is that 28 percent longer period
for drugs, a 43 percent extension of time for devices. That
means that just by giving you more money doesn't mean the
system is going to run more efficiently.
Dr. Hamburg. I don't know those numbers, and we would be
delighted to sit down with you and go over the numbers, but I
think the bottom line is that we need to do better, we can do
better. We are working with industry----
Mr. Bilbray. Related to this issue, that means we have a
vested interest in safety to try to make the system more
efficient here as it relates to not just safety and efficiency
but also the timeline because that timeline affects the
decision of do you produce it in the United States or do you go
overseas and then we buy our own inefficiency here, our lack of
reform here in processing, we create a crisis for ourselves to
have to review that much more coming in to address this issue.
And I hope we have that kind of commitment by your agency
showing that slowing down the process is not just an issue that
makes it safe for the bureaucracy, it something that makes it
more risky for everybody because it may have unintended
consequences such as causing us to have to now import more
drugs and have to be reviewing those.
Dr. Hamburg. Well, I understand your concerns and we are
very committed. We do take the performance timelines very
seriously and we are meeting the majority of our goals. I am
also systematically reaching out, listening to industry and
their concerns. I just met yesterday most of the day with a
group representing both device and pharmaceutical industry
representatives or former representatives to hear more about
some of these specific concerns and how we can identify areas
to work on together to streamline the process, to help support
the need to move critical products into the marketplace.
Mr. Bilbray. OK. I would just like to ask one last
question. Were you consulted about the potential of the device
tax that was placed in the bill last year, the potential that
device tax being an incentive to bootleg devices into this
country?
Dr. Hamburg. I was not.
Mr. Bilbray. OK. Do you have a position on that device tax
and its impact?
Dr. Hamburg. You know, it is a complex issue and it is not
within our jurisdiction.
Mr. Bilbray. I appreciate that.
Mr. Chairman, I think before we do things like device
taxes, we should be asking regulators about how it is going to
impact their job. These things are all related, like I said. It
is holistic. You can't do one without impacting the other. And
I yield back.
Mr. Stearns. The gentleman's time is expired. I think we
will go a second round here. As the Chairman, I have the
prerogative to start but I am going to let Dr. Burgess, who has
to leave, if he will start on our side. So Dr. Burgess, you are
recognized for 5 minutes.
Mr. Burgess. Thank you, Mr. Chairman. And just on Mr.
Bilbray's point about the devices, I can hardly go anywhere and
speak to any group without someone pulling me aside so I am
heartened by the fact that you are hearing some of these same
things but also his point that people are afraid to come
forward. When I have someone come and tell me their particular
tale of woe about what they have developed and where they are
in the process, and I say would you be willing to come to the
committee and talk about this, and they say no, you know, I
don't want to jeopardize whatever chance I might have now with
the FDA, I wouldn't want to put myself out there and jeopardize
it. That is an unfortunate place for us to be.
And Mr. Bilbray is also correct, the device tax essentially
zapped the research and development budget for many of these
small startup companies. Also, in addition to your agency's
regulations, we also have the comparative effectiveness, PCORI,
the Patient-Centered Outcomes and Research Institute, that was
funded in the Patient Protection and Affordable Care Act. All
of these things now interplay with the bringing of new drugs
and devices to market. Witness the controversy that has existed
over Provenge and Avastin since the first of the year. We have
certainly heard a lot about Provenge for prostate cancer and
the period of time that it provides for survival, it is not
cost-effective to provide it to prostate-cancer patients but I
think there was recently a relaxation of that ruling, breast
cancer with Avastin, some of the same considerations.
I also hear people ask me why can we not talk about
surrogate endpoints. It was very effective in developing the
drugs that are now useful for treating HIV/AIDS, if
survivability is the only endpoint that can be used and we are
not certain how reduction of viral load will affect that
survivability. In the early days of that, having a surrogate
endpoint actually allowed those products to move forward with a
great deal more facility and provide relief to a segment of the
population that previously had been denied relief.
So these are not just abstract issues that we are talking
about. They are very real issues. And again, I know that
because I can't go anywhere in the country without someone
telling me that, you know, I was delayed 4 years with this
anti-cancer drug, I am saving 2,500 people a year now so I have
to assume 10,000 died while I was put on hold by a regulatory
agency. I mean, that is pretty severe when we put it in those
types of numbers. So I am encouraged that you are considering
this, but please also understand that we don't even have the
freedom to brings these folks to committee and ask them
questions because they are fearful of retaliation from the FDA.
Surely you have heard that before.
Dr. Hamburg. You know, I can assure you that we make our
decisions based on the best available data, not on, you know,
other information. They do not need to worry about retaliation.
I think what we need to focus on together, though, is to make
sure that our regulatory pathways are as well defined and as
predictable as possible for sponsors who are bringing new
candidate products before us. We need to make sure that we are
able to work with them closely so that there is clear
understanding of what is expected of them and why we need to
make sure that we are bringing the best possible science to
bear in terms of making sure that the data that is being
collected in support of a product is the right data and that,
you know, things you just mentioned about surrogate endpoints,
we do use surrogate endpoints, but we need to be undertaking a
massive effort working with scientists and industry and
government to really develop more much more innovative clinical
trial models that will enable o us to get the robust scientific
answers we need but with shorter times, lower costs and fewer
patients and other areas where we can apply better science to
both the drug and medical product development and the review.
Mr. Burgess. And we can't move the goalpost, which again,
is a frequent criticism that I am hearing.
Let me just ask you question. I was talking about heparin
in the first round of questioning and the molecule,
hypersulfated chondroitin sulfate. Am I correct that that was
actually patented under a Chinese patent?
Dr. Hamburg. I don't know the answer to that.
Mr. Burgess. What is the purpose in developing a molecule
like that? Does it have a use in industry?
Dr. Hamburg. I don't know the answer to that. I would be
happy to get our experts at the agency to provide you with
additional information.
Mr. Burgess. Well, it might be something that is useful to
know. Again, we are talking about the committee developing
legislation to prevent these products from coming into the
country. We kind of need to know what was involved and why even
develop such a product if it wasn't to cheat somebody who is
buying heparin.
Thank you. I will yield back, Mr. Chairman.
Mr. Stearns. The gentlelady from Colorado is recognized in
the second round for 5 minutes.
Ms. DeGette. Thank you very much, Mr. Chairman.
Mr. Hamburg, how many drug approval applications do you
know offhand does the FDA get in a year? Do you know offhand?
Dr. Hamburg. Let me see if one of my other experts knows. I
don't know offhand but that is easy information for us to
actually get.
Ms. DeGette. Well, the reason I am asking the question is
because I know that the FDA is working on trying to streamline
the approval process but at the same time making sure that the
process for each new drug is thorough, correct?
Dr. Hamburg. Right.
Ms. DeGette. If we have a large budget cut to the FDA in
next year's budget, is that going to help or hurt our ability
to expedite the drug approval process?
Dr. Hamburg. Well, unfortunately, it will clearly hinder
our ability, and we are talking about very large numbers,
especially if you look at the drug and the device side. And as
we have been talking about already, the ability to really
support sponsors in their efforts to bring products before us
does require--is a resource-intensive, staff-intensive activity
to be able to provide the best possible and the most timely
review.
Ms. DeGette. You know, you can streamline processes, and I
assume you are doing that, but at some point it does take the
resources to pay for the staff to review the applications and
to do what needs to be done. Is that right?
Dr. Hamburg. That is correct.
Ms. DeGette. A second question I have is, this discussion
that a lot of folks have been having in this hearing about the
approval process resulting in a slow and more cumbersome
process than in the EU, and I hear this a lot and I have read
it a lot in the media. I am wondering, I don't think you got to
fully explain what the FDA found when they looked at this claim
that the EU is much more fast and efficient and does a better
job. I am wondering if you can just finish your answer to that
question.
Dr. Hamburg. OK. You know, we did take a very serious look
at the exact numbers because we were hearing more and more
questions raised in this area, and what we found was very
striking. I may get the numbers slightly wrong because I didn't
review them before coming to this hearing. I was more focused
on the import safety issues. But I believe that between 2006
and 2010, there were about 53 or 54 new molecular entities that
were approved by both the EU and the U.S. and that we were in
fact significantly more rapid in approving those drugs in well
over 50 percent, I think it was 43 or so of those products. If
you actually look at cancer drugs, and the time frame that we
looked at that was a little different, I think it was 2003 to
2010, but there were 23 new cancer drugs that were approved by
both entities and we were first in approving those.
So, there clearly is a misperception that we are slower
than our counterparts in the European Union, and for the
priority drugs we were almost twice as fast in approving these
drugs.
Ms. DeGette. Was this a study that you did?
Dr. Hamburg. It was a systematic review. I mean, I fear I
probably should not have even tried to give numbers----
Ms. DeGette. If you could supplement your testimony with
that today, that would be great.
Dr. Hamburg. OK.
Ms. DeGette. And I just have a couple more questions. One
is, we have been talking about this terrible adulterated
heparin so I guess my view would be, under this Drug Safety
Enhancement Act which Mr. Dingell and some of us introduced
yesterday, would that give the FDA new authorities to address
issues like intentional economic adulteration like in the
heparin situation?
Dr. Hamburg. I think it could very well give us important
authorities that would make a difference, additional
authorities to really pursue investigations in places outside
of our borders when there are public health concerns, our
ability to share information with counterpart regulatory
authorities so that we can get a richer understanding of
potential or emerging threats. Those would certainly make a
difference, and I think that enhanced civil and criminal
penalties could reduce the attractiveness of pursuing some of
these kinds of nefarious activities as well.
Ms. DeGette. Thank you, Mr. Chairman.
Dr. Hamburg. Thank you.
Mr. Stearns. Mr. Hamburg, I am just sort of curious about
these 150 countries that export food and drugs to us. If you
don't mind, if you could send us a list of those countries,
that would be helpful.
Dr. Hamburg. OK.
Mr. Stearns. Going to your Web site, I noticed that just
for this year alone it lists countries that there have been
alerts on. For example, Bangladesh had 10 alerts, Cambodia had
one. Indonesia, there are 27 alerts. The Ivory Coast,
considering what is going on there, had three, Nicaragua had
nine, Thailand had 47 and Zimbabwe had one. Do you have the
authority to stop all imports when there is, shall we say,
turmoil, war, a revolution, civil war that is going on over
there? Do you stop imports from those countries considering the
potential danger?
Dr. Hamburg. Well, our import alerts are based on public
health risks but certainly they are targeted to events in the
world.
Mr. Stearns. Do you have the authority to stop, for
example, imports from Thailand where there is unrest and they
had 47 alerts? Isn't that enough to say you are going to stop
imports altogether?
Dr. Hamburg. Well, I think an important and timely example
is----
Mr. Stearns. Do you have the authority to do that?
Dr. Hamburg. We do an import alert based on----
Mr. Stearns. Just yes or no.
Dr. Hamburg [continuing]. A public health threat.
Mr. Stearns. I would just like to know, yes or no, do you
have the authority to stop--for example, the Ivory Coast had
three alerts this year. Do you have the authority to stop all
imports from Ivory Coast?
Dr. Hamburg. No, we would have to be able to show that
there was reason to believe that a product or set of products
was violative.
Mr. Stearns. But if you had three alerts in Ivory Coast and
27 in Indonesia, isn't that enough to suddenly stop imports--
especially if there is a civil war?
Dr. Hamburg. I know that for particular products where
there are concerns----
Mr. Stearns. So you don't have the authority? You have to
identify the risk in detail before you do that. Otherwise you
don't have the authority.
Dr. Hamburg. Right. We don't do blanket restrictions based
on circumstances within a country.
Mr. Stearns. OK. Mr. Bilbray had talked a little bit about
the budget, and I mentioned it earlier, that your budget went
up by $107 million. Did you know that?
Dr. Hamburg. We have, as I said, had, you know, very
significant increases in our budget in the last couple of
years. It has made a difference. I think it is important to
recognize, though, that we have been underresourced for
literally decades.
Mr. Stearns. But you understand the budget has gone up for
this fiscal year?
Dr. Hamburg. I do, and I have been appreciative of that.
Mr. Stearns. But as I understand it, when you were talking
to Mr. Bilbray, you weren't sure by what percentage the budget
had gone up and you weren't really clear what your budget
number was. Is that correct, that you weren't quite clear on
that?
Dr. Hamburg. You know, this has been an unusual budget
period. He was asking me what the budget increase was in the
last, did he say 24 months?
Mr. Stearns. Yes.
Dr. Hamburg. But, you know, we certainly do have that
information.
Mr. Stearns. So you don't really know your budget numbers
at this point. You don't know that they have gone up. Is that
correct?
Dr. Hamburg. Well, we are still looking forward to learning
our budget numbers for this year.
Mr. Stearns. OK. We have a chart here that has come from
you folks, the Fiscal Year 2010 ORA Field workplan. I just want
to show you this, and staff has given it to you. If you go down
to the fifth line, I know President Obama has talked about food
safety being one of his top priorities, and he has indicated
that it is very important for the Administration, yet when you
look at imported foods in general on this line and the work
plan for FTEs, which I understand to be full-time equivalents,
which are not people but are just block-outs. It appears to me
that in 2009 to 2010, 2009 was the Bush Administration and 2010
was the Obama Administration, it actually has gone down in
terms of the work power that has actually been expended on
imported foods. Is that correct? It is a little surprising
considering the priorities which you have talked about, to
think that the man-hours in this area have gone down, and I
just want you to explain, why have they gone down?
Dr. Hamburg. I am going to let my colleague, Mr. Elder,
respond. This is a very specific question of a line. It is less
than one full-time equivalent person.
Mr. Stearns. But at the same time----
Dr. Hamburg. But I will let him----
Mr. Stearns. You know, the imports have increased--but the
point is, with the increase of the imports, and the fact that
your manpower has gone down on this is just a little puzzling.
Yes, Mr. Elder, you are welcome to take the mic. Is it
turned on?
Mr. Elder. I believe it is, Mr. Chairman. Thank you. The
highlighted decrease involves one particular program within our
overall foods program. It is what we call program assignment
code 03819 A and B. It is import foods in general. It does
reflect a 0.7 FTE decrease from the previous year. It is not
the only program, however, in which we cover imported foods.
You can see that imported seafood products were raised by 7
FTEs in the fiscal year. There was an overall increase of 61
FTEs----
Mr. Stearns. But Mr. Elder, you would agree that that is
the biggest program you have. When you look at all the other
figures, it is multiples of all the other programs. So I think
you are sort of discounting a program, which is the top
program, and to see the top program actually in man-hours go
down in terms of the FDA's work plan is quite startling.
Dr. Hamburg. I think that Mr. Elder was indicating, though,
that this is just one component of our overall import safety
program for foods and that that program has actually expanded.
Mr. Stearns. But wouldn't you agree, Dr. Hamburg, that all
these things should have a positive, they should not have a
negative?
Dr. Hamburg. Well, I think we want to make sure that we are
deploying our resources in the most responsible and efficient
way possible. I don't----
Mr. Stearns. But I would think imported foods is one of
your highest priorities.
Dr. Hamburg. But I think we also need to look at the
overall program and how individuals are being deployed, and
this does not mean that the overall food import program has
decreased. In fact, it has increased in terms of----
Mr. Stearns. Well, I would say that your workplan does not
show an increase, rather, it shows a decrease.
My time is expired. The gentleman from Michigan is
recognized for 5 minutes.
Mr. Dingell. Mr. Chairman, I thank you for your courtesy.
Mr. Hamburg, you have in response to a question from Ms.
DeGette said that review times in United States and Europe vary
and that FDA is faster in reviewing drugs. We have also been
hearing that Europe is 2 years faster in clearing devices than
our FDA. Is that statement true, and if so, why?
Dr. Hamburg. You know, first of all, it is not a
competition and we obviously have different regulatory
frameworks, but when you look at the numbers in both drugs and
devices, the lag times are not what have been put forward. In
fact, in the drug area, as I said, in key areas we clearly have
approved critical products more swiftly. The device system in
Europe is quite different than that here but we are not----
Mr. Dingell. It is a difference in what is done over there
as opposed to----
Dr. Hamburg. They have a very different approach to device
review, and it is also----
Mr. Dingell. Would you submit to us a statement as to why
that is so, please, for the record?
Dr. Hamburg. We would be happy to, the numbers that are
available about comparative times.
Mr. Dingell. Thank you, Doctor. I want to get now to some
other things. I would like to come back to the new authorities
given FDA in the Food Safety Modernization Act and how they are
going to make the food supply and imported food safer. Is that
statute working and do you have the authorities now you need?
Do you need new authorities or do you need more money?
Dr. Hamburg. We are obviously very early in the
implementation of this historic piece of legislation, but we
are making good progress. And we can see that it will very
significantly strengthen our ability to protect the safety of
the food supply to be able to really shift to a preventive
approach and to work in greater partnership with our State and
local partners, with foreign governments and with industry.
Clearly, in terms of being able to implement all of the
requirements, and there are many in that Food Safety
Modernization Act, you know, we again face the resource
limitation issue and we are hoping to be able to work Congress
on----
Mr. Dingell. Let me interrupt you. I remember, Doctor, that
when one of your predecessors, Frank Young, for whom I had
great respect and still do, used to call me up and say John, we
are going to move this situation forward, we are doing a real
fine job and we have a great new plan and we are going to do
this without new money. And I said Frank, that is a lot of
hooey. And a couple days later he would call me up and say
well, John, we just can't do it because we don't have the money
for this, and this brings us back to the question of
registration fees.
The House bill as it came out of this committee had
registration fees in it with the support of the industry, which
still supports that idea. It was taken out in the Senate. So
user fees in that regard both with regard to food and with
regard to pharmaceuticals would ease your financial stresses
and strains, would it not?
Dr. Hamburg. We clearly cannot fully implement this bill
without additional resources.
Mr. Dingell. The other thing I remember that is very
troublesome to me is, we had a movie before this subcommittee
one time when I was the chairman and it showed a bunch of stuff
coming into this country, mostly pharmaceuticals and things of
that kind, and most of these pharmaceuticals were unsafe,
misbranded, counterfeit, and some of them, believe it or not,
were controlled substances, and they were just coming in
through the mails. Everybody was sort of waving them as they
went by. And I see you confronting the same problem, and I
would be willing to bet if somebody were to put movies down
there at some of the points where these things are imported, we
would find the same situation is going on. Now, this situation
happened to relate to the center at Miami where they would come
in, and so I think that something here has to be done.
Mr. Chairman, I just want you to know that I appreciate
your holding this hearing. It my hope that we can work in a
bipartisan fashion with us all working together as we have done
in the past. It makes great good sense. It is something that
the public needs. Americans are being killed either by bad
stuff coming into this country that poisons them or makes them
sick or they are being killed by being denied workable and
worthwhile treatments and pharmaceuticals because people are
sending in things like chalk and sugar as part of the medicines
that we are receiving.
So I want to commend you and thank you for the hearing and
hope that as we go forward that we will be able to use this
hearing as the beginning of an honest effort to work together
to do something that we can do by working together, and I think
it is a lot better than quibbling about whether we have got
Democratic or Republican witnesses because that is not really
important. I will be happy to take credit for the presence of
Dr. Hamburg, and I am sure you would too, and not to quibble
about whether she is a Republican or a Democratic witness.
So I commend you, Mr. Chairman, for your leadership in this
matter and I thank you for your recognizing me, and I again
appreciate the opportunity to start moving on something that is
in the public interest.
Mr. Stearns. I thank the distinguished chairman emeritus of
the Energy and Commerce Committee and I appreciate his past
leadership and his spirit of bipartisanship, that he continues
to reach out. I think it is a good example for all of us to
remember in this process.
Mr. Hamburg, I want to thank you very much for your
forbearance and patience for this hearing.
All members have 10 days in which to submit any extraneous
material they would like to, and with that, the subcommittee is
adjourned.
[Whereupon, at 12:26 p.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]

Prepared statement of Hon. Fred Upton

Few subjects have a more direct impact on public health and
the safety of the American people than our topic today, and I
applaud the Chairman for convening this hearing.
The Food and Drug Administration has the daunting task of
screening the millions of shipments, packages, and parcels that
traverse our borders by air, ship, truck, and by land--
responsible for preventing the entry of food, pharmaceuticals,
and other medical products that violate our laws or pose a
threat to the public health. This effort has not been made any
easier by the growing number of imports we are seeing every
year, as well as the increasing globalization of the supply
chain.
For this reason, FDA must use its resources intelligently,
and in a manner geared to most effectively target higher-risk
shipments for further inspections while expediting the passage
of low-risk products. Today, FDA has the tools and technologies
to enhance its risk-based review of imported food and medicines
without obstructing the free flow of commerce into our country.
However, I am concerned FDA may not presently be bringing
all of its resources to bear in fulfilling its crucial gate-
keeping responsibilities. I believe the Commissioner is serious
about attaining her vision of an FDA that better assures the
safety and quality of imported goods. I agree with the
Commissioner that it is simply not possible, regardless of the
amount of resources devoted, to inspect our way to safety.
Therefore, I believe that FDA should get to work immediately on
deploying all of the high-tech, intelligent, risk-based tools
at its disposal. The American people deserve nothing less.
----------

[GRAPHIC] [TIFF OMITTED] T1721.008

[GRAPHIC] [TIFF OMITTED] T1721.009

[GRAPHIC] [TIFF OMITTED] T1721.010

[GRAPHIC] [TIFF OMITTED] T1721.011

[GRAPHIC] [TIFF OMITTED] T1721.012

[GRAPHIC] [TIFF OMITTED] T1721.013

[GRAPHIC] [TIFF OMITTED] T1721.014

[GRAPHIC] [TIFF OMITTED] T1721.015

[GRAPHIC] [TIFF OMITTED] T1721.016

[GRAPHIC] [TIFF OMITTED] T1721.017

[GRAPHIC] [TIFF OMITTED] T1721.018

[GRAPHIC] [TIFF OMITTED] T1721.019

[GRAPHIC] [TIFF OMITTED] T1721.020

[GRAPHIC] [TIFF OMITTED] T1721.035

[GRAPHIC] [TIFF OMITTED] T1721.036

[GRAPHIC] [TIFF OMITTED] T1721.037

[GRAPHIC] [TIFF OMITTED] T1721.038

[GRAPHIC] [TIFF OMITTED] T1721.039

[GRAPHIC] [TIFF OMITTED] T1721.040

[GRAPHIC] [TIFF OMITTED] T1721.041

[GRAPHIC] [TIFF OMITTED] T1721.042

[GRAPHIC] [TIFF OMITTED] T1721.043

[GRAPHIC] [TIFF OMITTED] T1721.044

[GRAPHIC] [TIFF OMITTED] T1721.045

[GRAPHIC] [TIFF OMITTED] T1721.046

[GRAPHIC] [TIFF OMITTED] T1721.047

[GRAPHIC] [TIFF OMITTED] T1721.048

[GRAPHIC] [TIFF OMITTED] T1721.049

[GRAPHIC] [TIFF OMITTED] T1721.050

[GRAPHIC] [TIFF OMITTED] T1721.051

[GRAPHIC] [TIFF OMITTED] T1721.052

[GRAPHIC] [TIFF OMITTED] T1721.053

[GRAPHIC] [TIFF OMITTED] T1721.054

[GRAPHIC] [TIFF OMITTED] T1721.055

[GRAPHIC] [TIFF OMITTED] T1721.056

[GRAPHIC] [TIFF OMITTED] T1721.057

[GRAPHIC] [TIFF OMITTED] T1721.058