[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]
SCIENCE AND MISSION AT RISK: FDA'S SELF-ASSESSMENT
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED TENTH CONGRESS
SECOND SESSION
----------
JANUARY 29, 2008
----------
Serial No. 110-83
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
SCIENCE AND MISSION AT RISK: FDA'S SELF-ASSESSMENT
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED TENTH CONGRESS
SECOND SESSION
__________
JANUARY 29, 2008
__________
Serial No. 110-83
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
U.S. GOVERNMENT PRINTING OFFICE
47-433 PDF WASHINGTON : 2008
----------------------------------------------------------------------
For sale by the Superintendent of Documents, U.S. Government Printing
Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; DC
area (202) 512-1800 Fax: (202) 512-2104 Mail: Stop IDCC,
Washington, DC 20402-0001
COMMITTEE ON ENERGY AND COMMERCE
JOHN D. DINGELL, Michigan, Chairman
HENRY A. WAXMAN, California JOE BARTON, Texas
EDWARD J. MARKEY, Massachusetts Ranking Member
RICK BOUCHER, Virginia RALPH M. HALL, Texas
EDOLPHUS TOWNS, New York FRED UPTON, Michigan
FRANK PALLONE, Jr., New Jersey CLIFF STEARNS, Florida
BART GORDON, Tennessee NATHAN DEAL, Georgia
BOBBY L. RUSH, Illinois ED WHITFIELD, Kentucky
ANNA G. ESHOO, California BARBARA CUBIN, Wyoming
BART STUPAK, Michigan JOHN SHIMKUS, Illinois
ELIOT L. ENGEL, New York HEATHER WILSON, New Mexico
ALBERT R. WYNN, Maryland JOHN B. SHADEGG, Arizona
GENE GREEN, Texas CHARLES W. ``CHIP'' PICKERING,
DIANA DeGETTE, Colorado Mississippi
Vice Chairman VITO FOSSELLA, New York
LOIS CAPPS, California STEVE BUYER, Indiana
MICHAEL F. DOYLE, Pennsylvania GEORGE RADANOVICH, California
JANE HARMAN, California JOSEPH R. PITTS, Pennsylvania
TOM ALLEN, Maine MARY BONO, California
JAN SCHAKOWSKY, Illinois GREG WALDEN, Oregon
HILDA L. SOLIS, California LEE TERRY, Nebraska
CHARLES A. GONZALEZ, Texas MIKE FERGUSON, New Jersey
JAY INSLEE, Washington MIKE ROGERS, Michigan
TAMMY BALDWIN, Wisconsin SUE WILKINS MYRICK, North Carolina
MIKE ROSS, Arkansas JOHN SULLIVAN, Oklahoma
DARLENE HOOLEY, Oregon TIM MURPHY, Pennsylvania
ANTHONY D. WEINER, New York MICHAEL C. BURGESS, Texas
JIM MATHESON, Utah MARSHA BLACKBURN, Tennessee
G.K. BUTTERFIELD, North Carolina
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana
______
Professional Staff
Dennis B. Fitzgibbons, Chief of Staff
Gregg A. Rothschild, Chief Counsel
Sharon E. Davis, Chief Clerk
David L. Cavicke, Minority Staff Director7
Subcommittee on Oversight and Investigations
BART STUPAK, Michigan, Chairman
DIANA DeGETTE, Colorado ED WHITFIELD, Kentucky
CHARLIE MELANCON, Louisiana Ranking Member
Vice Chairman GREG WALDEN, Oregon
HENRY A. WAXMAN, California MIKE FERGUSON, New Jersey
GENE GREEN, Texas TIM MURPHY, Pennsylvania
MIKE DOYLE, Pennsylvania MICHAEL C. BURGESS, Texas
JAN SCHAKOWSKY, Illinois MARSHA BLACKBURN, Tennessee
JAY INSLEE, Washington JOE BARTON, Texas (ex officio)
JOHN D. DINGELL, Michigan (ex officio)
(ii)
C O N T E N T S
----------
Page
Hon. Bart Stupak, a Representative in Congress from the State of
Michigan, opening statement.................................... 1
Hon. John Shimkus, a Representative in Congress from the State of
Illinois, opening statement.................................... 5
Hon. Jay Inslee, a Representative in Congress from the State of
Washington, opening statement.................................. 7
Hon. Joe Barton, a Representative in Congress from the State of
Texas, opening statement....................................... 9
Hon. John D. Dingell, a Representative in Congress from the State
of Michigan, opening statement................................. 10
Hon. Tim Murphy, a Representative in Congress from the State of
Pennsylvania, opening statement................................ 13
Hon. Henry A. Waxman, a Representative in Congress from the State
of California, opening statement............................... 14
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, opening statement.............................. 15
Hon. Gene Green, a Representative in Congress from the State of
Texas, opening statement....................................... 17
Hon. Marsha Blackburn, a Representative in Congress from the
State of Tennessee, opening statement.......................... 17
Hon. Diana DeGette, a Representative in Congress from the State
of Colorado, opening statement................................. 19
Hon. Jan Schakowski, a Representative in Congress from the State
of Illinois, prepared statement................................ 188
Witnesses
Gail H. Cassell, Ph.D., vice president, Scientific Affairs and
Distinguished Lilly Research Scholar for Infectious Diseases,
Eli Lilly and Company.......................................... 20
Prepared statement........................................... 23
Answers to submitted questions............................... 203
Peter Barton Hutt, senior cousel, Covington & Burling LLP........ 28
Prepared statement........................................... 30
Catherine E. Woteki, Ph.D., global director of scientific
affairs, Mars, Inc............................................. 32
Prepared statement........................................... 34
Garret A. FitzGerald, professor of medicine and professor and
chair of pharmacology, Department of pharmacology, University
of Pennsylvania School of Medicine............................. 35
Prepared statement........................................... 39
Answers to submitted questions............................... 190
Dale Nordenberg, M.D., managing director, Healthcare Industry
Advisory, PriceWaterhouseCoopers............................... 54
Prepared statement........................................... 56
Marcia G. Crosse, Ph.D., Director, Health Care, U.S. Government
Accountability Office.......................................... 82
Prepared statement........................................... 85
Lisa Shames, Director, Food and Agricultural Issues, U.S.
Government Accountability Office............................... 115
Prepared statement........................................... 117
Donna V. Porter, Ph.D., R.D., specialist in food safety and
nutrition, Domestic Social Policy and Nutrition, Domestic
Social Policy Division, Congressional Research Service......... 136
Prepared statement........................................... 138
Andrew C. von Eschenbach, M.D., Commissioner, Food and Drug
Administration................................................. 150
Prepared statement........................................... 153
Answers to submitted questions............................... 192
Submitted Material
Subcommittee exhibit binder...................................... 211
``Appendix B, The State of Science at the Food and Drug
Administration,'' submitted by Peter Barton Hutt............... 417
SCIENCE AND MISSION AT RISK: FDA'S SELF-ASSESSMENT
----------
TUESDAY, JANUARY 29, 2008
House of Representatives,
Subcommittee on Oversight and Investigations,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10:00 a.m., in
room 2123 of the Rayburn House Office Building, Hon. Bart
Stupak (chairman) presiding.
Members present: Representatives Stupak, DeGette, Melancon,
Waxman, Green, Schakowsky, Inslee, Dingell (ex officio),
Shimkus, Walden, Murphy, Burgess, Blackburn and Barton (ex
officio).
Staff present: Chris Knauer, Keith Barstow, Scott
Schloegel, John Sopko, Angela Davis, Kyle Chapman, Alan
Slobodin, Peter Spencer, and Whitney Drew.
OPENING STATEMENT OF HON. BART STUPAK, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MICHIGAN
Mr. Stupak. This meeting will come to order.
Today we have a hearing entitled ``Science and Mission At
Risk: FDA's Self-Assessment.'' Each member will be recognized
for a 5-minute opening statement. I will begin.
Since the Federal Food, Drug and Cosmetic Act was first
enacted in 1938, the FDA's role in protecting American
consumers has expanded considerably. The FDA is now responsible
for ensuring the safety of medical devices, human food, animal
feed additives, new human and animal drugs, human biological
products, the list goes on. Today, no new pharmaceutical
product or medical technology can be used in the United States
without the FDA first determining that it is safe and effective
for its intended use. By some estimates, the agency now
regulates more than $1 trillion in consumer products or close
to 25 cents of every U.S. dollar spent. Unfortunately, as this
committee under both Republican and Democratic leadership has
documented, FDA's resources have become wholly inadequate,
given the agency's expansive mission. Accordingly, the agency's
ability to protect American families from unsafe food, drugs,
medical devices and other products has radically deteriorated.
Last year's slew of tainted consumer goods and related recalls
were the proverbial canary in the coalmine, illustrating the
strain under which the FDA now functions.
To his credit, in 2006 FDA Commission Andrew von Eschenbach
requested the FDA's Science Board, which is his primary
advisory group, which is made up of a special subcommittee, to
assess whether science and technology at the agency is capable
of supporting existing and future regulatory operations. The
subcommittee had extensive input from 30 world-class external
advisors representing industry, academia and other government
agencies. These experts were selected based on their extensive
knowledge of cutting-edge research, budget, science and
management operations. Their assessments were compiled in a
report entitled ``FDA Science and Mission at Risk, Report of
the Subcommittee on Science and Technology.'' All 33 advisors
and subcommittee members signed off on the findings of this
report and was presented to the FDA last month and unanimously
accepted by the Science Advisory Board.
Today we have the honor and privilege to hear directly from
the chair of the Science Board subcommittee as well as from a
number of its expert advisors. They will raise a number of
concerns regarding FDA's current capability. More directly,
they will raise their concern that the FDA's overall mission of
protecting public health is at risk. The report's findings are
shocking and extensive. Some key concerns include the
following.
The FDA cannot fulfill its mission because its scientific
base has eroded and its scientific organization structure is
weak. It does not have the capacity to ensure the safety of the
Nation's food supply furthermore. The FDA's ability to provide
basic inspections, conduct key rulemaking and carry out
enforcement actions are severely eroded as is its ability to
respond to food-related outbreaks in a timely manner. During
the past 35 years the decrease in FDA funding has forced the
agency to impose a 78 percent reduction in food inspections.
The FDA cannot fulfill many of its core regulatory functions
because its IT infrastructure is obsolete, unstable and
inefficient. The agency faces substantial employee recruitment
and retention challenges. The agency has insufficient access to
clinical data needed for various core missions and thus cannot
effectively regulate products based on new science, and this
list goes on and on.
Alone, each one of these issues would be a daunting task to
resolve. Taken together, they suggest much of the FDA's core
regulatory mission is at risk. When coupled with the recent
findings by the Government Accountability Office (GAO)
regarding the agency's effort to inspect food, foreign-made
drugs and medical devices, the situation is truly alarming. As
pointed out in the GAO report, American lives are now at risk.
The findings of this report, however, should come as little
surprise to members of this subcommittee. The work we conducted
last year provides ample evidence that FDA is increasingly
struggling to perform its most rudimentary regulatory mission.
For example, the subcommittee held four hearings last year
related to how FDA protects Americans against substandard
foods. These were prompted because of incidents involving
tainted human and pet food and other commodities. FDA's failed
regulation of domestic food producers, its ill-conceived plan
to close laboratories and reorganize field staff and its
inability to ensure the safety of imported foods from China and
other foreign markets painted a bleak picture of FDA's ability
to protect the Nation's food supply.
In addition to our food safety investigations, the
subcommittee examined FDA's foreign drug inspection program.
The investigation found FDA's IT system for managing drug
imports and related inspections was antiquated and disturbingly
incapable of providing timely and basic data. Because of
resource constraints on field inspectors and related travel,
FDA could only inspect about 7 percent of all foreign
establishments in any given year. Experts told the subcommittee
that foreign drug firms should be inspected at least once every
few years but at that rate it would take the FDA 13 years to
inspect each foreign establishment for one time.
Today GAO will report similar findings relating to FDA's
ability to inspect foreign medical device manufacturers. One of
the key findings of the Science Advisory Board report is that,
and I quote, ``In contrast to previous reviews warned crisis
would arise if funding issues were not addressed. Recent events
and our findings indicate that some of those crises are now
realities and American lives are at risk.'' These observations
are troubling and they fit a pattern. FDA is increasingly being
asked to do more and more with less and less and many of the
agency's tools and resources are stretched to the breaking
point and incapable of supporting the agency's mission.
I would like to thank the witnesses who will be testifying
today. Your work has assisted the committee greatly and we look
forward to your continued help and leadership. The committee
takes the reports and your findings very, very seriously. The
deterioration of the FDA's ability to protect the American
people did not happen overnight. This deterioration is like a
cancer that has developed over many years under the watch of
both Republican and Democratic administrations. This
deterioration is also not something that will be changed
overnight, but there are many recommendations in the Science
Advisory Board report that can be addressed immediately.
The FDA and Congress have an opportunity for great
leadership. It is my sincere hope that Commissioner von
Eschenbach will commit to us that he will not just accept the
startling findings and the positive recommendations made by the
Science Advisory Board but that he will develop and implement
the Science Advisory Board and GAO recommendations to put the
agency back on track as the world's premiere agency to
safeguard food and drugs.
The Commissioner should know that Congress is not willing
to throw more money at the problem. We will require a realistic
plan with vision and measurable results to ensure the promises
made are commitments kept. The Commissioner has taken the first
step in developing a plan by asking for this report. He has
also shown a willingness to listen and learn from our hearings.
Just last week he announced that he will implement one of our
key recommendations from last fall's hearing on drug imports.
The FDA plans to open offices in foreign countries such as
China and India where so much of our food and drugs now come
from. This is an important small step. With required follow-
through and oversight it can be a positive step. I look forward
to working with the Commissioner on how he can forge ahead to
give the FDA the tools necessary to protect the American
public. Our Nation deserves nothing less.
[The prepared statement of Mr. Stupak follows:]
Statement of Hon. Bart Stupak
Since the Federal Food, Drug, and Cosmetic Act was first
enacted in 1938, FDA's role in protecting the American consumer
has expanded considerably. FDA is now responsible for ensuring
the safety of medical devices, human food, animal feed
additives, new human and animal drugs, human biological
products, and the list goes on. Today, no new pharmaceutical
product or medical technology can be used in the U.S. without
FDA first determining that it is safe and effective for its
intended use. By some estimates, the agency now regulates more
than $1 trillion in consumer products or close to 25 cents of
every U.S. consumer dollar spent.
Unfortunately, as this Committee under both Republican and
Democratic leadership has documented, FDA's resources have
become woefully inadequate given the agency's expansive
mission. Accordingly, the agency's ability to protect American
families from unsafe foods, drugs, medical devices, and other
products has radically deteriorated. Last year's slew of
tainted consumer goods and related recalls was the proverbial
canary-in-the-coal-mine illustrating the strain under which the
FDA now functions.
To his credit, in December 2006, FDA Commissioner Andrew
von Eschenbach requested that the FDA Science Board-which is
his primary advisory group-form a special subcommittee to
assess whether "science and technology" at the agency is
capable of supporting existing and future regulatory
operations.
The subcommittee had extensive input from 30 world class
external advisors representing industry, academia, and other
government agencies. These experts were selected based on their
extensive knowledge of cutting-edge research, budget, science,
and management operations. Their assessments were compiled in a
report entitled, "FDA Science and Mission at Risk: Report of
the Subcommittee on Science and Technology." All 33 advisors
and subcommittee members signed off on the findings of this
report, which was presented to FDA last month and unanimously
accepted by the Science Advisory Board.
Today, we have the honor and privilege to hear directly
from the Chair of the Science Board's Subcommittee as well as
from a number of its expert advisors. They will raise a number
of concerns regarding FDA's current capability. More directly,
they will raise their concern that the FDA's overall mission of
protecting the public's health is at risk. The report's
findings are shocking and extensive. Some key concerns include
the following:
The FDA cannot fulfill its mission because its
scientific base has eroded and its scientific organizational
structure is weak;
The FDA does not have the capacity to ensure the
safety of the Nation's food supply;
The FDA's ability to provide basic inspections,
conduct key rulemakings, and carry out enforcement actions are
severely eroded, as is its ability to respond to food-related
outbreaks in a timely manner;
During the past 35 years, the decrease in FDA
funding has forced the agency to impose a 78 percent reduction
in food inspections;
The FDA cannot fulfill many of its core
regulatory functions because its IT infrastructure is obsolete,
unstable, and inefficient;
The agency faces substantial employee recruitment
and retention challenges;
The agency has insufficient access to critical
data needed for various core missions and thus cannot
effectively regulate products based on new science;
And the list goes on.
Alone, each of these issues would be a daunting task to
resolve. Taken together, they suggest much of FDA's core
regulatory mission is at risk. When coupled with the recent
findings by the Government Accountability Office (GAO)
regarding the agency's effort to inspect food, foreign-made
drugs, and medical devices, the situation is truly alarming. As
pointed out in the GAOreport, "American lives are now at risk."
The findings of this report, however, should come as little
surprise to Members of this Subcommittee. The work we conducted
last year provides ample evidence that FDA is increasingly
struggling to perform its most rudimentary regulatory missions.
For example, the Subcommittee held four hearings related to
how FDA protects Americans against substandard foods. These
were prompted because of incidents involving tainted human and
pet food and other commodities. FDA's failed regulation of
domestic food producers, its ill-conceived plan to close
laboratories and reorganize field staff, and its inability to
ensure the safety of imported foods from China and other
foreign markets, painted a bleak picture of FDA's ability to
protect the Nation's food supply.
In addition to our food safety investigations, the
Subcommittee examined FDA's foreign drug inspection program.
That investigation found FDA's IT system for managing drug
imports and related inspections was antiquated and disturbingly
incapable of providing timely and basic data.
Because of resource constraints on field inspectors and
related travel, FDA could only inspect about 7 percent of all
foreign establishments in any given year. Experts told the
Subcommittee that foreign drug firms should be inspected at
least once every few years, but at that rate it would take FDA
13 years to inspect each foreign establishment a single time.
Today, GAO will report similar findings relating to FDA's
ability to inspect foreign medical device manufacturers.
One of the key findings in the Science Advisory Board's
report is that "In contrast to previous reviews that warned
crises would arise if funding issues were not addressed, recent
events and our findings indicate that some of those crises are
now realities and American lives are at risk." These
observations are troubling and they fit a pattern: FDA is
increasingly being asked to do more and more with less and less
and many of the agency's tools and resources are stretched to
the breaking point and incapable of supporting the agency's
mission.
I would like to thank the witnesses who will be testifying
today. Your work has assisted this Committee greatly, and we
look forward to your continued help and leadership. The
Committee takes the report's findings very seriously.
The deterioration of the FDA's ability to protect the
American people did not happen over night. This deterioration
is a cancer that has developed over many years, under the watch
of both Republican and Democratic Administrations. This
deterioration is also not something that will be changed over
night, but there are many recommendations in the Science
Advisory Board's report that can be addressed immediately.
The FDA - and Congress - have an opportunity for great
leadership. It is my sincere hope that Commissioner von
Eschenbach will commit to us that he will not just accept the
startling findings and the positive recommendations made by the
Science Advisory Board, but he will develop and implement the
Science Board and GAO's recommendations to put the agency back
on track as the world's premier agency to safeguard food and
drugs. The Commissioner should know, that Congress is not
willing to just throw more money at the problem. We will
require a realistic plan with vision and measurable results to
ensure the promises made are commitments kept.
The Commissioner has taken the first step in developing a
plan by asking for this report. He has also shown a willingness
to listen and learn from our hearings. Just last week he
announced that he will implement one of our key recommendations
from last fall's hearing on drug imports. The FDA plans to open
offices in foreign countries such as China and India, where so
much of our food and drugs now come from. This is an important
small step - with required follow through - and oversight.
I look forward to working with the Commissioner on how we
can forge ahead to give the FDA the tools necessary to protect
the American public. Our Nation deserves nothing less.
----------
Mr. Stupak. I would next turn to my friend, the ranking
member, Mr. Shimkus from Illinois, for an opening statement,
please.
OPENING STATEMENT OF HON. JOHN SHIMKUS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF ILLINOIS
Mr. Shimkus. Thank you, Mr. Chairman.
Today's hearing will focus on the findings and
recommendations by the special subcommittee of the Food and
Drug Administration's Science Advisory Board, which sought to
review the state of science at the FDA, and I appreciate your
attendance and your work.
As we will hear this morning from some of the report's
distinguished authors, the ability of the agency to carry out
its various missions to protect the public health has severely
deteriorated over the past 2 decades. This has occurred because
more has been asked and required of the agency over the years
without the requisite resources provided to do the job. As we
will hear, the report does not paint a pretty picture. This
report makes the case for strengthening the FDA in very
sobering language. We will hear about obsolete information
networks, failures of planning, the draining of science talent,
loss of key managers, and that Congress has enacted more than
100 statutes with little added funding. These findings are
troubling but not surprising.
We know from this subcommittee's own investigation that
there are serious shortcomings in FDA's ability to manage and
confront 21st century challenges in food and drug safety. In
the hearing today, I believe we should be careful as we react
to the testimony to focus on what we need to understand. If we
are serious about making progress on resources, we will need
strong bipartisan support. Such support was behind the budget
increases for the Centers for Disease Control and the National
Institutes of Health. We should resist taking shots at the
Administration or the Commissioner. The FDA's problems are
longstanding and can be traced to both political parties.
It would be very tempting to pile on the negative findings
so much that we create an image in the public's mind of an
agency that cannot be fixed. That burning down the village to
save it approach won't work. The more we do that, the harder it
will be to make a case down the road that more resources here
and more scientists there can actually fix the problem. Our job
will be to build evidence for areas where we can make a
bipartisan case and we should focus on that objective.
There are a few areas I am hopeful we can examine today.
First, I understand the Science Board report provided an
outline for a strategy to restore FDA capabilities in a number
of areas. I would like a clear understanding of some of those
structural fixes that had been proposed and how these will
contribute to the agency's mission, and where possible, I would
like to know what would be the absolute top priorities. I would
like to understand how the board's strategy dovetails with the
Commissioner's own strategy for focusing the agency on current
and future risk. How will the two work together and what
measures or indicators can we expect that will help us see how
important gaps can be filled?
Second, we have to be wary of the bureaucratic imperative
to expand into areas beyond the agency's basic mission.
Bureaucracies such as the FDA tend to want to expand their turf
through more regulation and litigation. Thus, some additional
resources wind up diverted for expanding turf, not enhancing
basic mission capacity. We have to be very candid about the
fact that many problems that this subcommittee has identified
raise questions about management of resources and
decisionmaking at the agency.
As we consider the Science Board's recommendations, we have
to reconcile those with our own work. We have to explore how we
can develop confidence that money expended will be expended
efficiently on the most pressing and essential needs. I would
like to hear from the GAO about improving the management
culture at the FDA.
The subcommittee needs to complete its own diagnosis of the
FDA's problems. For example, we know Congress responds to the
FDA's needs when the case can be made. After September 11, the
Secretary of HHS, Tommy Thompson, made his case to Congress and
the Administration for more resources, some 600 FDA inspectors,
and we responded. We know now that those inspectors have fallen
off the books. How did this happen and why did it happen?
Finally, we should also recognize that we have a great
opportunity to focus both on the management and structural
reforms as well as resources needed. We are fortunate to have
Commissioner von Eschenbach here today. He has demonstrated by
this report, other actions and even his presence today that he
is seeking a way to move this agency into the 21st century. We
should support him in this effort, and the challenge today will
be to work with each of the panelists to start building the
bipartisan case we need to move forward, and I guess in ending,
in one year the Commissioner has been here four times and in
three of those testimonies he sat through the hearing prior to
his testifying. He will do so today. He is in the audience. We
appreciate that. That doesn't include the individual staff
meetings like yesterday that you have committed to. I do think
that does represent goodwill and hopefully we can work together
to move forward.
Thank you, Mr. Chairman.
Mr. Stupak. Thank you, Mr. Shimkus.
Mr. Inslee for an opening statement, sir.
OPENING STATEMENT OF HON. JAY INSLEE, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF WASHINGTON
Mr. Inslee. Thank you. I want to thank Mr. Stupak for
having these hearings, and I want to focus on the problem of
medical scams, and this is a problem one would have thought
that we had under control in this country after centuries of
flimflam artists using people's desperation to their profit.
But I was looking at a Seattle Times series about the explosion
of the medical scam industry in the United States and it does
appear to be not just an aberration but a multinational
industry that we are totally not controlling in the United
States, and I was flabbergasted to read the stories of what is
going on out there using fancy flashing light electronic gizmos
to make people think they are being cured and in fact they are
being abused by these medical scam artists and it is not a
small thing.
Just to tell you how tragic it can be, I will just tell the
story of one lady named Joan Burgraff, a 58-year-old woman in
Tulsa who was having pain and had lost her husband to cancer.
She was upset with the medical community, or at least didn't
think the medical community could help her. She started to
develop pain in her joints so she went to a clinic by a person
who had been trained in Seattle using a device called the EPFX
and they took this woman in and they strapped her to a chair
and put all kinds of official looking electronics on her and
plugged into a little box with a bunch of flashing lights and
allegedly diagnosed her condition, and the operator later said
that the way it worked is, you put the machine in zap mode and
they zapped her for some period of time, telling her that they
were taking care of her problem. Months and months went by.
Finally she became worse and worse, developed terrible,
terrible situations, blacking out, tremendous pain. Her son
finally convinced her to go to a hospital. They had to transfer
her by helicopter to get her to the hospital at that point. And
as the story, as you can tell, ended, she had undiagnosed
leukemia and died shortly thereafter. Now, we don't know what
her course would have been but we do know that it was inhuman
to expose this woman to some multi-colored light device that
robbed her of any real hope that she really may have had, and I
really can't think of a viler thing to do than to use people's
desperation, which is going on over and over again in this
country. That is the story in Tulsa.
A story closer to home, a woman named Karen MacBeth, who is
59, had cancer, terrible pain, looking for some alternative,
went to a ``clinic'' in Port Orchard, Washington, using a
machine called the EPFX machine. Same thing happened to her.
She spent $17,000 out of her life savings. She was told that
the treatment could cure cancer. She believed that. Later on
the machine turned out to be something that would basically
generate random electronic flashing pulses but no relationship
to anybody's health, and she later died, having had no
effective medical treatment that was delayed because of this
scam.
Now, I will point out that from this excellent work by the
Seattle Times, we find out this is something that is going on
all over the country. There is one company with a fellow
American who is now avoiding an indictment who is in Budapest
that is operating these scams in 22 different countries around
the world. This is like a major international corporation, and
the fact that the United States of America can't shut it down
is really sad. It is kind of pathetic, really, that we know
that this is going on on a routine, consistent, repeated basis
across this country and we can't shut these people down.
So we need to know how we address these mega scams'
multinational efforts, how we really look at this honor system
which is allowing people to get these machines in being treated
as ``biofeedback'' machines and then they are told to the
patient that they cure everything from cancer to osteoporosis
to you name it, how we are going to get over this problem of
using independent review boards, because some of these machines
I have talked about, they have gone through a loophole using
``independent review boards'' to treat them as clinical trials
while they are really just perpetuating these scams, and how
finally we are going to get targeted resources and IT systems
into the FDA so that they can finally find out what is even out
in the marketplace, and I hope these hearings will be helpful
to really get to the bottom of this. It is just incredible that
this is going on in the United States and we have got to put a
stop to it. Thank you.
Mr. Stupak. I thank the gentleman for his time. You are
talking about the EPFX machines and they are being used also in
Michigan. You are correct in that there is a nine-count warrant
against the so-called inventor of these machines for a scam,
and the FDA did bring that charge against him. The gentleman
has fled to Budapest, Hungary, and the committee is looking at
it at your urging, an area we will take a look at. If we have a
warrant for the individual that creates the machines, why do we
still allow them in the country? It is still beyond me. It is
something we will look at.
Mr. Barton for opening statement, please.
OPENING STATEMENT OF HON. JOE BARTON, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TEXAS
Mr. Barton. Thank you, Mr. Chairman.
As most of us know, we are having a hearing in the Health
Subcommittee right now about SCHIP, which I have been asking
for for almost a year, so I am going to have to go up there
some too so I am not being disrespectful to this hearing, but I
will come back and shuttle back and forth.
Obviously today we are having an important hearing on the
future of the FDA. We are going to take a look at the latest
study about FDA and its science mission, mission at risk. It
was prepared by the Science Advisory Board, Subcommittee on
Science and Technology. I don't think it is a big news flash
that the report found that the scientific capacity of the FDA
is eroding as a result of lack of funding. We have got hearings
in this committee as far back as 1955 that says the same thing.
From the 1955 hearing, the quote was, ``Adequate accomplishment
on this recommendation will not be possible until much larger
funds and facilities are made available to the FDA.'' That is
over 50 years ago.
What is troubling about the latest report is the
pessimistic tone almost across the entire report. There doesn't
appear to be much positive anywhere, and obviously we can
provide more funding. This committee has shown in a bipartisan
fashion that we can do that. We just in the last Congress
reauthorized and increased the authorization for the National
Institutes of Health. It is one of my signature accomplishments
as chairman. We are still trying to get the appropriators to
follow through on what the authorizing committee has done but
if there is a need and there is bipartisan will, we can get
some of this stuff done. We shouldn't use this report to beat
up on President Bush or Dr. von Eschenbach, who is out in the
audience. Today is either the fourth or the fifth time that he
has appeared in person before this subcommittee in the last
year. I can't recall another FDA commissioner who has been that
accessible in a personal way to the subcommittee and the full
committee. We know that the problems at the FDA are
longstanding. It is my opinion that they are not of a political
nature. They are more of a process and just a structural
nature. If we are going to get more resources for the FDA, we
are going to have to work together and I am sure that Mr.
Stupak and Mr. Dingell want to do that.
We also know that when the Congress does provide more funds
to an agency like the FDA, sometimes the money just disappears.
It just goes into bureaucracy and we never see it again. For
example, 6 years ago after 9/11 and the anthrax attacks, Health
and Human Services Secretary Tommy Thompson came before the
committee and the Congress and asked for more than 600 new FDA
inspectors at the border. We gave him the money, he got the
inspectors. Five years later the inspectors are gone. What
happened? As the FDA continues to struggle to meet its
responsibilities in this 21st century, we need to make sure
that their struggles are not simply a result of a bureaucracy
that takes money and swallows it up and we never see it again.
I am very pleased that we are going to have a panel of
experts before us today. I am sure that they are going to be
frank and I am sure that they are going to give us honest
answers about what they think is really the problem. As I have
said, I am also pleased that Commissioner von Eschenbach is
here. He is going to have a long day today. The usual practice
is for a presidential appointee to go first and then to clear
out. Dr. von Eschenbach is going to sit here and listen to the
experts so that when he appears before us this afternoon, he
will have had the comfort of hearing what the folks before him
had to say.
So Mr. Chairman, I am glad that we are having the hearing.
I am going to be going back and forth but obviously we want an
FDA that is up to snuff on the science mission so that it can
do all of its missions also. Thank you.
Mr. Stupak. Thank you, Mr. Barton. I would also note that
there is a Telecommunications and Internet Subcommittee hearing
also going on today so Mr. Dingell has three different hearings
going at once. It keeps us all busy, and I know members will
pay attention to their assignments but we will be shuffling
back and forth all day.
With that, let me yield to Mr. Dingell, chairman of the
full committee, for an opening statement, please, sir.
OPENING STATEMENT OF HON. JOHN D. DINGELL, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MICHIGAN
Mr. Dingell. Mr. Chairman, thank you for the recognition. I
want to begin by commending you for today's hearing and for
your fine leadership of this very, very important subcommittee,
and I want to say a word about my friend, Mr. Barton, and I
want to express to him my appreciation of his leadership,
cooperation and ability and the fact that he and I continue our
ability to work together on matters affecting the public
interest, and with that expression of respect and affection, I
want him to know my appreciation for him and his service.
Mr. Chairman, I also want to commend our panel on which I
will comment a little later. As you stated earlier, Mr.
Chairman, the Food and Drug Administration is responsible for
ensuring the safety of nearly $1 trillion of products used by
Americans every day from medical devices to foods to
pharmaceuticals and even pet foods and foods which are
manufactured and products which are manufactured in this
country and around the world. Each of us probably uses a
product or many products each day that has been reviewed,
studied or regulated by FDA, or perhaps not regulated by FDA as
it should for want of resources and ability or personnel to
carry out its responsibilities.
Yet today we will hear more bad news concerning the safety
of these products. This morning the Congress and the American
people will hear again from a panel of world-renown industry
and academic experts who were directed by the Commissioner, Dr.
von Eschenbach, to review the state of FDA. I believe this
committee upon conclusion of its considerations will find that
they aren't doing at FDA as well as they could or should. The
report includes many troublesome findings about the FDA but
mostly it concludes that the agency's mission is now at risk,
an important conclusion, and it means that the health and
safety of Americans are at risk as well. The Congress, the Food
and Drug Administration Commissioner and the Administration
must now focus on these situations and find solutions quickly.
In December 2006, the Commissioner of FDA requested the
Science Board to form a special subcommittee to assess whether
science and technology at the agency is capable of supporting
existing and future regulatory operations, and it is into this
which we will be inquiring today. This subcommittee had
extensive input from 30 external advisors representing
industry, academia and other government agencies. These experts
were chosen based on their extensive knowledge of cutting-edge
research, budget, science and management operations. Their
report is one of the most extensive reviews of FDA that I have
seen and I believe we must pay close attention to what these
experts found. I think that the Nation owes great gratitude to
those who helped compile the report, particularly those who
will testify today, and I express to them my personal
appreciation and that of the committee. Each of them committed
substantial personal time to complete this report. The report
is straightforward with findings that are difficult to face or
to deny. I will note that the practical effect upon each of
them is that they had served 2 years without pay in carrying
forward this important public responsibility.
Their testimonies along with the Government Accountability
Office witnesses and the Congressional Research Service will
describe FDA as an agency that is struggling to keep the
Nation's food and drug supply safe and effective. Specifically,
they are going to describe FDA's difficulties in inspecting
foreign-manufactured drugs and medical devices that are sold in
the United States, something which threatens to us a very real
possibility of a significant calamity befalling our people,
FDA's faltering ability to enforce its own regulations and to
conduct rulemaking, FDA's substantially diminished capacity to
inspect food production facilities, whether farms or processing
plants, FDA's inadequate IT infrastructure that is antiquated,
unstable and incapable of supporting key agency missions and
finally, FDA's lack of human and technological resources and
its effect on its scientific and regulatory responsibilities
and capabilities. I would note that I have not found enough
concern in this report about the number of personnel, the
training and the adequacy of the personnel, the support
facilities which they have or the budget of the agency which
would enable to carry out its responsibility, and those are
matters into which this committee will be going with rather
more diligence.
Sadly, Mr. Chairman, most of these findings are not new to
this committee. This subcommittee had more than five hearings
alone last year documenting these persistent problems
confronting FDA. Our constituents are growing weary of these
events. They are losing confidence in the ability of the agency
to protect them from products they use daily. And I would point
out that this problem of the inadequacies of the agency is not
new. I have had telephone calls with commissioners of FDA over
the years in which they said oh, we are going to be leaner and
meaner, oh, we are going to do more with less, and I have
always had to observe that on the basis of my experience, they
are capable only of doing much less with the much less which
they are being given, something about which we can properly
express great dissatisfaction.
I want to commend the Commissioner for requesting this
review and I look forward to his testimony about proposals to
fix the agency. FDA, HHS and the Administration must address
these failures and vigorously and work with the Congress to
develop a real plan to strengthen FDA and to assure its ability
to carry out the critical mission of FDA for the people of this
Nation. But to assist the Congress in this and to work with us
to achieve a proper solution to the problem, we are going to
have to expect that FDA will be honest with themselves and that
the FDA will be honest with us about budget, personnel,
capabilities in terms of support facilities like the
laboratories which they have been trying under Administration
direction to close, and unless we have an honest appraisal of
these matters, I have serious doubts that FDA is going to be
able to be resurrected in any fashion that will satisfy either
the agency or this committee.
I thank you, Mr. Chairman.
[The prepared statement of Mr. Dingell follows:]
Statement of Hon. John D. Dingell
Mr. Chairman, I commend you for holding today's hearing. As
you stated earlier, the Food and Drug Administration (FDA) is
now responsible for ensuring the safety of nearly a trillion
dollars of products used by Americans every day. From medical
devices, to food, to pharmaceuticals, and even pet food, each
of us probably uses a product everyday that has been reviewed,
studied, or regulated by the FDA.
Yet today, we will hear more bad news concerning the safety
of these products. This morning, Congress and the American
people will hear for the first time from a panel of world-
renowned industry and academic experts who were directed by
Commissioner Von Eschenbach to review the state of FDA. Their
report includes many troubling findings about FDA, but most
importantly, it concludes that the agency's mission is now at
risk, which means the health and safety of Americans are at
risk, as well. The Congress, the Food and Drug Commissioner,
and the Administration must focus on these findings and find
solutions quickly.
In December 2006, the FDA Commissioner requested that his
Science Board form a special subcommittee to assess whether
"science and technology" at the agency is capable of supporting
existing and future regulatory operations.
This subcommittee had extensive input from 30 external
advisors representing industry, academia, and other government
agencies. These experts were chosen based on their extensive
knowledge of cutting-edge research, budget, science, and
management operations. Their report is one of the most
extensive reviews of FDA that I have seen, and we ought pay
close attention to what these experts found.
Mr. Chairman, I think that the Nation owes gratitude to
those who helped compile this report, and particularly to those
who will testify today. Each of them committed substantial
personal time to complete this report. The report is
straightforward with findings that are difficult to face.
Their testimony, along with witnesses for the Government
Accountability Office and Congressional Research Service, will
describe an FDA that is struggling to keep the Nation's food
and drug supply safe and effective. Specifically, they will
describe:
FDA's difficulties in inspecting the foreign
manufacture of drugs and medical devices that are sold in the
United States;
FDA's faltering ability to enforce its own
regulations and conduct rulemaking;
FDA's substantially diminished capacity to
inspect food production facilities, whether farms or processing
plants;
FDA's inadequate IT infrastructure that is
antiquated, unstable, and incapable of supporting key agency
missions; and finally
FDA's lack of human and technological resources
and its effect on its scientific capabilities.
Sadly, Mr. Chairman, many of these findings are not new to
this Committee. This Subcommittee had more than five hearings
alone last year documenting these persistent problems
confronting FDA.
Our constituents are growing weary of these events. They
are losing confidence in this agency's ability to protect them
from the products they use daily.
I commend the Commissioner for requesting this review and I
look forward to his testimony about his proposals to fix this
agency. FDA, HHS, and the Administration must address these
failures and work with the Congress to develop a real plan to
strengthen FDA and ensure its ability to carry out its critical
mission for the people of this Nation.
----------
Mr. Stupak. Thank you, Mr. Dingell.
Mr. Murphy for opening statement.
OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF PENNSYLVANIA
Mr. Murphy. Thank you, Mr. Chairman, for holding this
important hearing on the FDA, and I would like to thank the
witnesses for attending and sharing their expertise with us. I
am especially glad to have Dr. Garret FitzGerald from my home
State of Pennsylvania present and I look forward to hearing
from each of you.
We are here today to take a comprehensive look at the FDA,
its mission, its resources, and from this we have to determine
how to best ensure this agency has both the resources and the
authority to do its job. Of course, this topic is not new to
this subcommittee. We have spent considerable time examining
these issues already. Last year we had four hearings on food
safety and last November we closely examined the FDA's role in
drug safety. Today our witnesses will respond to and comment on
a report recently completed by the Science Board, and this
report concludes the following: The FDA cannot fulfill its
mission because its scientific base has eroded. It cannot
ensure the safety of food supply because too few inspections
and a lack of timely enforcement cripple our ability to respond
to outbreaks. While food imports have increased over the past
35 years, the FDA has experienced a 78 percent reduction in
food inspections, and its IT infrastructure is obsolete and
unstable. I am most concerned that this report does little to
ease my fear that the FDA does not do enough to protect our
food and drug supply.
During a hearing this subcommittee held on November 1,
2007, I asked the witnesses if they would allow their children
to take prescription drugs knowing they contained active
ingredients imported from China. All the witnesses seemed to
reluctantly answer but said yes, yet we know that China has
over 700 firms importing drug products into this country and
yet the FDA only conducted 15 inspections.
While I am concerned we must do more, I know we have the
capacity to responsibly expand the FDA and help it. Recently we
have been successful in expanding the NIH and the CDC. We need
to take a similar approach to the FDA but also help make sure
it has the tools to be efficient and remove bureaucratic
barriers. The FDA is under pressure to be scientifically
thorough, swift in their reviews and getting the needed drugs
to market and absolute in their inspections. They are
criticized for being too slow or too fast. It seems sometimes
they are criticized for being too superficial or too obsessive.
Where they are working to improve food and drug safety, we want
them to be a source of excellence but where bureaucracy stands
in the way, we cannot understand why we can't get rid of that.
During my time in Congress, I remember hearing about the
fact that there are about a dozen different agencies that
administer as many as 35 laws that make up the Federal food
safety program. No single agency oversees them all. This is a
nonsensical and fragmented system which as far as I know still
has this strange division wherein the Department of Agriculture
inspects open-faced meat sandwiches and frozen pepperoni pizzas
while the FDA inspects close-faced sandwiches and cheese
pizzas. I think we can fix that problem, can't we?
I don't know what other kind of changes that we will hear
from the FDA but I am looking forward to hearing any ideas that
will improve the efficiency of this agency so it is not just a
matter of putting more money into but it is a matter of giving
the tools they need to become better and faster and more
thorough.
I look forward to the testimony of today's witnesses, and I
yield back.
Mr. Stupak. I thank the gentleman.
Mr. Melancon, I understand you are going to waive your
opening and therefore I go to Mr. Waxman for an opening
statement, please.
OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Mr. Waxman. Thank you very much, Mr. Chairman. I don't know
how much more evidence we need to realize that FDA is in a
crisis. Our choice really is clear. Either we are going to make
sure this agency has the ability with the resources necessary
to do its job or we are going to watch it continue to
deteriorate. We have had a number of outside reports. We are
now going to hear about the Science Board report from within
FDA itself. The Institute of Medicine and the Government
Accountability Office both documented the chronic underfunding
of the agency and we know what that has meant as we have seen
illnesses and even deaths associated with unsafe foods, drugs
and medical devices. This is concerning in and of itself but it
has also made us acutely aware of the bare thread by which FDA
now hangs and of just how close we are to a large-scale
catastrophe.
The Science Board has done an outstanding job. They have
highlighted the erosion of FDA's scientific capacity that has
left it unable to fulfill the frightening number of critical
regulatory and public health responsibilities. FDA, they say,
lacks the staff, the IT infrastructure to conduct appropriate
inspections of drugs and medical device manufacturers, to
oversee the ever-increasing number of imported products
entering the country and to protect against tainted and unsafe
foods, just to name a few.
While, as the Science Board indicated, we know that there
are dedicated and hardworking FDA staff to thank for the fact
that we have avoided more catastrophes with our food, drugs and
medical devices, we can't expect them to remain working under
these grueling conditions for long. We need in order to fix
this situation the best information from the Administration on
how much funding FDA needs to resume its position as the gold
standard for the rest of the world, and I was disturbed that
when the FDA asked its science committee to make
recommendations, that is one area where they asked them not to
make recommendations, not to spell out how much money they may
need to fulfill their responsibility. I hope that is not an
indication of what we are going to see when we get the
President's fiscal year 2009 budget. The Science Board report
very clearly lays out the problems with which the agency is
grappling. It should be seized upon by this Administration to
make its case for why FDA needs more resources. We absolutely
must have accurate and specific numbers that reflect the
urgency of the Science Board's findings.
I thank you, Chairman Stupak, for holding this critically
important hearing. I hope the Science Board report will be the
last report we have to read about the desperation at the Food
and Drug Administration.
I want to yield back my time and tell you I am looking
forward to the testimony of the witnesses. Unfortunately, there
are two other hearings at the same time that I will also be
trying to attend so I won't be here personally to hear every
statement by the witnesses but I thank you for being here and I
assume we will have a chance to review your testimony.
Mr. Stupak. Thank you, Mr. Waxman.
Mr. Burgess for opening statement, please.
OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF TEXAS
Mr. Burgess. Thank you, Mr. Chairman, and I also am going
to thank you for holding this hearing. It is a shame that there
are so many hearings going on at the same time. This is an
important subject but there are important subjects going on
across the hall, which is why you see so many of us come in and
out. Over the past year this subcommittee has undertaken a
serious investigation regarding the safety of the Nation's food
supply, and I thank the leaders of this committee on both sides
of the dais for their leadership and their dedication to this
important issue.
I would also like to thank the leadership of the FDA,
Commissioner von Eschenbach, for his personal mission to
increase safety in his own Federal agency. Although many
problems have been apparent for decades, it was Commissioner
von Eschenbach who in December of 2006 requested the detailed
self-assessment from the Science Board. Specifically, the board
was asked with the duty to assess whether the science and
technology of the agency is capable of supporting the existing
and future regulatory operations. It is a large task. Both the
FDA Commissioner and the members of the Science Board
subcommittee dutifully undertook this task and I thank everyone
involved for working so hard on this vital mission.
The report we have before us today is very candid and
reveals many things that we might not have wanted to admit. The
first two major findings are extremely telling and frankly
somewhat disturbing. Finding number 1: The FDA cannot fulfill
its mission because its scientific base has eroded and its
scientific organizational structure is weak, and specifically
in the report it cites the staff and the information technology
resources for its surveillance mission. Finding number 2: The
Food and Drug Administration cannot fulfill its mission because
its subcommittee workforce does not have sufficient capacity
and capability, and again, they cite recruitment and retention
challenges.
Considering that the FDA is responsible for almost 80
percent of the food we eat and regulates 25 cents out of every
dollar spent in this country, these two findings should trouble
not only everyone in the room but everyone in the United
States. As we all know, our committee is responsible for
passing legislation that helps to solve all sorts of ailments
in the society: problems with food, prescription drugs,
imported products, just to name a few. However, as I learned in
my practice in medicine for 25 years, the only way to truly fix
a patient's ailments is to make certain that the entire system
was healthy. If a patient presents with an acute febrile
illness because of bacterial pneumonia, he might be transiently
helped with an aspirin but if you don't treat the underlying
infection, you are not really doing the patient any good.
Commissioner von Eschenbach and the Science Board
subcommittee are to be commended for their actions of trying to
make the entire system healthy but also we understand there is
some disagreement and confusion as to whether or not this
report is final. After reviewing the findings, it seems hard to
believe that this report can be anything but final, and I hope
some of these questions are resolved today as regards to the
finality of the report.
We all know the issue of increased resources will be a
common theme today. We heard Ranking Member Barton address just
his fact but he also referenced the work that was done by this
committee on the National Institutes of Health reauthorization
and we authorized a 5 percent increase in funding for the
National Institutes of Health for the next 5 years. We were
criticized because that wasn't a large enough investment in
science and research in this country, and yet when a different
party was in power this last summer and we had the opportunity
to appropriate money for the National Institutes of Health,
what did we do? We bumped it up 2 percent, not the 5 percent
that was authorized. So clearly there is a disconnect between
what happens at the level of this committee where we set the
funding levels and at the level of the Appropriations
Committee, and Mr. Chairman, I hope we are dutifully observant
when we go through the budgetary and appropriations process
that is just before us in the next few months to ensure that
what we decide as far as the FDA's authorized budget limit is
in fact met and funded when the appropriators meet later on in
the year.
There is no doubt in my mind that an increase in resources
is needed at the Food and Drug Administration but the resources
obviously have to be invested wisely. We all know putting a
band-aid on a broken arm, although it is a therapeutic agent,
is not going to result in the desired cure. Our efforts will
again fall short and the American people are the ones who will
pay the price.
Thank you, Mr. Chairman, and I will yield back.
Mr. Stupak. Thank you, Mr. Burgess.
Mr. Green for an opening statement, please.
OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TEXAS
Mr. Green. Thank you, Mr. Chairman, for holding the hearing
today on the FDA's recent self-assessment. When the Food, Drug
and Cosmetic Act was passed in 1938, the FDA was a small agency
with a relatively manageable task of ensuring compliance in
regulatory issues. Today, no new pharmaceutical products or
medical technologies can be used without FDA approval. Also,
over the years the role of FDA has been expanded to review the
safety of human food, animal feed, additives, new human and
animal drugs and human biological products. The role of FDA is
vitally important to the economic health of the United States.
It is estimated the agency regulated more than $1 trillion in
consumer products. However, while the number of products the
FDA regulates grows, the budget of the FDA has been under
considerable constraints. Last year incidences of tainted
consumer products including spinach, peanut butter and pet food
called attention to the FDA and their failure to ensure the
safety of these products. Subsequent hearings on these issues
by this committee revealed many of the issues including the
inability to ensure the food safety of products from China and
other countries.
What deeply concerns me is, I represent the Port of
Houston, which is the busiest port in the United States in
terms of foreign tonnage, second busiest in the United States
in terms of overall tonnage, and the tenth busiest in the
world. Many of the products that are imported through the Port
of Houston arrive from these countries whether it is China,
Mexico, Latin America or anywhere in the world but an FDA
inspection lab is not located anywhere near the port or not
even in Texas. I have met with FDA inspectors at the Port of
Houston but we need more resources to test and inspect these
products.
This report outlines a number of scientific operational
resource and technology concerns the FDA is currently facing.
It gives us a clearer picture of the ability of the FDA to
support its necessary regulatory functions. Unfortunately, the
picture painted by this report is bleak. The time to act on the
recommendations is now and I hope the FDA and this committee
will seriously consider the recommendations in the report on
the Subcommittee on Science and Technology and move quickly to
act on them.
I want to thank our witnesses for appearing today, and also
I thank you, Mr. Chairman, for continuing these hearings and
hopefully more in the future. Thank you.
Mr. Stupak. Thank you, Mr. Green.
Ms. Blackburn for an opening statement.
OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TENNESSEE
Ms. Blackburn. Thank you, Mr. Chairman. I thank you for the
hearing and I want to welcome all of our witnesses that are
here today, and I also want to be certain that the Commissioner
knows that I appreciate the request for an analysis of the FDA
Science Board to assess whether the science and technology at
the agency can meet and support the current and future
regulatory needs. The report concludes much of what is already
known about the current state of the FDA, and of course we have
all talked about it this morning. The agency is extremely
deficient in its ability to inspect and secure the Nation's
food and drug imports and is not currently situated to meet its
regulatory responsibilities.
Reports of a crisis at the FDA have been cited for years
and yet the agency's mission continues to expand as it assume
more and more responsibility over consumer safety issues and
acts if deficiencies are really no problem, just kind of
standard operating procedure, and today we will hear testimony
from several witnesses on the massive burdens placed on the FDA
with regards to regulating the Nation's food supply,
pharmaceuticals and more, and I am concerned with the problems
the agency faces in order to meet the current regulatory
obligations while others are talking about wanting to pile on
another monumental task that would be requiring the FDA to
regulate tobacco. Regulating tobacco would not only divert
attention and resources from the agency's core competencies and
missions but also would force the FDA into what would be
uncharted waters.
This Congress should focus on improving the FDA's current
regulatory system before it heaps additional responsibility on
the agency. With the agency's documented weaknesses, logistical
challenges and sporadic review capabilities, I am hopeful that
today's witnesses can help this committee understand how it can
best assist the FDA in reducing the incidences of such
problems. The FDA, in my opinion, has yet been able to
articulate a systematic processes best practices used to
achieve and carry out their mission. That I would offer is a
very serious problem.
While concern exists that the FDA does not receive adequate
resources to fulfill its regulatory duties, I am wary of
increasing FDA funding without increased accountability for how
that money is going to be spent. I believe Congress should
invest wisely in the agency. Then we should closely monitor the
agency to be certain that they are aggressively seeking to
carry out their mission, that they are working on timelines,
that they have benchmarks, that they understand the process of
best practices and that they understand that a continuing
appropriation does not allow them to continue to be ineffective
and inefficient. They are required to carry out their mission.
They owe it to the taxpayers. It is not their money that they
are spending. It is the taxpayers' money that they are spending
and the taxpayers have grown very, very ill and fatigued with
the lack of responsiveness from this agency.
Again, I want to welcome our witnesses. I am looking
forward to hearing how we should move forward in making
consumer safety priority number one with the FDA. It has the
potential to save millions but also the opportunity to expose
many people to risk and harm. It is a challenge. It should be a
balancing act of priorities. It is going to require your best
efforts, and I look forward, Mr. Chairman, to the balance of
the hearing.
Mr. Stupak. I thank the gentlewoman.
Ms. DeGette for an opening statement.
OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF COLORADO
Ms. DeGette. Thank you, Mr. Chairman. I was going to waive
my opening statement but then I looked at these startling
statistics that I think we need to really think about as we
talk about what the FDA is and should be doing. As you know, I
have been working a lot on food safety over the last year or
two and it is really shocking how at the same time we are
bringing more and more food into this country from foreign
countries, our inspection is less and less of this food.
For example, during 1990 to 2005, imports of FDA-related
food increased from 2 to 15 million lines a year, which was a
650 percent increase, but at the same time Congress gave only a
13 percent increase in field personnel to the FDA. So here is
what happened with food inspections. In 1973, the FDA inspected
34,919 food establishments. In 2006, when you have a burgeoning
amount of our food coming from foreign countries, they
inspected 7,783 establishments, a 78 percent reduction in food
inspections at a time when we are showing that the food
industry is rapidly expanding and going overseas.
So if anybody thinks that we don't need, number 1, a new
way of thinking at the FDA, which the Bush Administration
agrees with, but number 2, a vast amount of increased resources
to make these things happen, then they are fooling themselves
and we are only going to see an increasing number of newspaper
and media accounts about the terrible problems that we are
having with food, and unfortunately, this is going to go to the
heart of what most of us consider our jobs to be as members of
Congress, which is to protect the health, safety and well-being
of our constituents.
And with that, Mr. Chairman, I yield back.
Mr. Stupak. I thank the gentlewoman.
Mr. Walden for an opening statement, please.
Mr. Walden. Mr. Chairman, I am going to waive my opening
statement so we can get on to the witnesses. Thank you, sir.
Mr. Stupak. Very good. Thank you.
That concludes the opening statements by members of the
subcommittee. On our first panel we have Dr. Gail Cassell, vice
president, scientific affairs, and distinguished Lilly research
scholar for infectious diseases at Eli Lilly and Company, Mr.
Peter Barton Hutt, senior counsel at Covington and Burling,
welcome. Dr. Catherine Woteki, global director of Scientific
Affairs at Mars Incorporated, Dr. Garret FitzGerald, professor
of medicine and professor and chair of pharmacology, Department
of Pharmacology at the University of Pennsylvania School of
Medicine, welcome, and Dr. Dale Nordenberg, managing director,
Healthcare Industry Advisor at PriceWaterhouseCoopers. I thank
all of you for being here and for your work.
It is the policy of this committee to take all testimony
under oath. Please be advised that witnesses have the right
under the rules of the House to be advised by counsel during
your testimony. Do any of you wish to be represented by counsel
during your testimony? Let the record reflect all witnesses
indicated that they did not wish to be represented by counsel
during their testimony.
So therefore I will ask you to please rise and raise your
right hand to take the oath.
[Witnesses sworn.]
Mr. Stupak. Let the record reflect that the witnesses
replied in the affirmative. You are now under oath.
Dr. Cassell, we will start with you, please. Again, I thank
each and every one of you for your work, especially on your
scientific board report, and Dr. Cassell, as chair of that we
would start with you, please.
STATEMENT OF GAIL H. CASSELL, PH.D., VICE PRESIDENT, SCIENTIFIC
AFFAIRS AND DISTINGUISHED LILLY RESEARCH SCHOLAR FOR INFECTIOUS
DISEASES, ELI LILLY AND COMPANY
Ms. Cassell. Mr. Chairman, members of the subcommittee, as
Mr. Stupak has said, I am Gail Cassell, vice president for
scientific affairs at Eli Lilly and Company. I am a member of
the Institute of Medicine of the National Academy of Sciences
and am currently serving a second term on its governing board.
Of relevance to my testimony today, I have previously been a
member of the advisory committees of the directors of both the
Centers for Disease Control and the National Institutes of
Health. I also co-chair the congressionally mandated review of
the NIH intramural program. I appear before you today as a
member of the FDA Science Board, which you now know is advisory
committee to the FDA Commissioner. I served as chair of the
subcommittee that wrote the report of which you have already
heard discussion this morning.
I want to point out that the report was unanimously
endorsed by each of the 33 members of the subcommittee and also
by the full Science Board that met and heard the findings of
the report on December 3. On that day, the Science Board
accepted the report as final. In other words, we understood and
were told that the report in fact would be independent of those
additional reviews that we recommended be done and undertaken
by the Science Board. There is a letter to that effect here in
the briefing book from Dr. Schein, who was then chair of the
Science Board. The record of the proceedings of that meeting
will show that due to the seriousness of the deficiencies found
and the urgency of the situation, the Science Board was adamant
that the report be broadly disseminated amongst the public and
policymakers including it be published in the Federal Register
so that the public would have full access to our findings.
I would like to point out a few things that we think make
this report unique and the subcommittee unique. You have heard
there were several other reports in the past. Our report is
unique, first, in that it is only the second time in over a
century that the agency has been reviewed by an external
committee as a whole entity, and we can elaborate on why we
think that is important in the discussion. Second, the
committee was composed of leaders, not from a single sector but
as you have heard this morning, leaders from industry, academy
and other government agencies. The expertise and level of
accomplishments of the members are almost unprecedented in a
single committee of this type, especially considering their
breadth and knowledge and regulatory science and understanding
of the mission of the agency. Just to point out that the
subcommittee did include expertise ranging all the way from a
Nobel laureate in pharmacology to 14 members of the National
Academies of Sciences including two engineers and also included
a former assistant Secretary of Health, a former chief counsel
of the FDA, and the first Undersecretary of Food Safety to
USDA. You will hear from the latter two this morning.
For over a year this group of experts worked for thousands
of hours including nights, weekends and holidays. It was the
norm, not the exception, that when we met even by phone call we
would have as many as 30 members actively engaged in discussion
for 2 hours plus. Let me assure you this level of engagement by
so many very busy people with diverse expertise is rare in such
a committee, let alone that there would be such rapid consensus
about its findings. How then do we explain this rapid consensus
and the commitment to this exercise? It became rapidly
apparent, I would say actually at the end of our first meeting,
that the FDA suffers, as you have heard already this morning,
from serious scientific deficiencies and is not positioned to
meet current or emerging regulatory responsibilities. If we
think there are problems today, wait until the future and the
future is already here in terms of the challenges that the
agency will face.
Importantly for this group to understand, these
deficiencies we found are agency-wide. They are not limited to
a single program. They are not limited to a single center. In
fact, the body of the report reports on and emphasizes those
issues that were found throughout the agency that are
crosscutting. The individual appendices, on the other hand, are
independent reviews by our committee of each of the centers and
three of the different programs. Since every regulatory
decision at FDA must be based upon the best scientific evidence
available, we concluded because of the deficiencies we
identified that American lives are at risk. The level of
concern by all members of our subcommittee and the members of
the Science Board was and remains high, and thus the intensity
of our commitment to this review and our insistence that the
findings be broadly communicated and that immediate action be
taken by the agency to address these deficiencies. The Science
Board report discussed dozens of specific findings and concerns
about FDA's ability to protect Americans. However, we will only
emphasize seven of the principal findings in today's hearing.
First, there is no more quintessential governmental
responsibility than the protection of basic commodities of
American life such as our foods and drugs. Our subcommittee
concluded that FDA is at risk of failing to carry out this
mandate and as such are beginning to turn to unregulated
products for solutions, as you have heard this morning.
Throughout most of its 100-year existence, FDA has been
recognized as one of the Federal Government's most trusted
entities but this most valuable of agencies is deteriorating
for lack of resources to fulfill its mission.
You will hear from Peter Barton Hutt that the demands upon
the FDA have soared in recent years, as you will hear also from
the Congressional Research Service and others. But not only
have FDA resources not kept pace with its responsibilities, the
agency's core programs have lost 1,000 people over the past
decade. You will hear this morning from Dr. Cathy Woteki, the
first Undersecretary of Agriculture and a former dean of a
veterinary school and now with the food industry, that the FDA
cannot ensure the safety of our food supply. You will hear from
Dr. Dale Nordenberg, formally of the Centers for Disease
Control and head of information technology for the Center for
Infectious Diseases there that FDA's information technology
systems are woefully outdated and inadequate, posing a concrete
threat to the agency's public health mission. You will hear
from Dr. Garret FitzGerald from the University of Pennsylvania
that innovations and advancements in science are outstripping
FDA's capacity to regulate them, threatening not only the safe
introduction of new technologies but also American leadership
in pharmaceuticals, vaccines, biotechnology, medical devices,
and by the way, food, and in fact we would argue that if this
deficiency is not corrected, we will not realize the benefit
from the large investment that this country has made and
rightly so in biomedical research in this country. The patients
will not in fact receive those new therapies in a timely manner
and they will not get the review that they should based on the
new science and advances in science if we don't correct what
Dr. FitzGerald will describe to you this morning, and at a time
in which U.S. competitiveness in science and medicine are under
increasing challenges from overseas, a weak FDA will be a break
on the very technologies that the United States is relying on
for its medical and technological future, even from an economic
standpoint.
And lastly then, I would just say that in conclusion, our
report's findings echo, as you have heard this morning, study
after study by the Institute of Medicine of the National
Academy of Sciences, congressional committees, the Government
Accountability Office and other expert bodies that have
documented FDA's shortfalls and the resulting public health
threat. We have been told that our report is the most
comprehensive review done of FDA but not only an external group
with access to the agency but it contains the most
comprehensive analysis simultaneously by the agency itself and
the capacity, their capacity and relationship to their
regulatory authority. The last two appendices of the report are
actually a self-assessment of FDA staff, the leaders of FDA, if
you will. We asked them to identify what are the major
scientific gaps not only in terms of technology but expertise
in terms of allowing you to do your job and then by the way
tell us how that links directly back to the regulatory mission.
To my knowledge, this is the first time in history where you
would have had this happen simultaneously and parallel but
independently both by an external group of experts but also by
your internal leaders. It is rare indeed.
Together we think these do represent a blueprint as well as
the report on drug safety by the Institute of Medicine and some
of the reports that you will hear today from GAO and others. We
believe this gives a blueprint for moving forward to correct
these serious deficiencies. Thus, it is now time, we would
argue, for the reviews to stop and to take the necessary action
to correct the deficiencies. We don't need to wait on more
reviews. We need to begin to correct these urgent deficiencies
that we have noted.
First and foremost, our subcommittee believes very strongly
that there must be a strong commitment on the part of the FDA
to undergo the structural changes recommended in this and
previous reports to strengthen the scientific base of the
agency and to recruit and retain the most outstanding leaders
in regulatory science. The American public and Congress deserve
no less. The Congress and the Administration need to provide
the resources necessary to bring the agency into the 21st
century. That is not to say that we also don't need increased
accountability, as Mrs. Blackburn has also pointed out.
We recognize that adequate resources, human and financial,
will not be sufficient to repair the deteriorating state of
science at FDA, which is why our committee also recommended
significant restructuring, as I have already alluded to, but
without a substantial increase in resources, the agency will be
unable to meet either the mandates of Congress or the
expectations of the American public regardless of management or
leadership changes.
On behalf of our subcommittee, we thank Chairman Stupak and
Chairman Dingell and Ranking Members Barton and Shimkus for
holding this hearing and for your recognition of the
seriousness of the deficiencies that we have identified and the
urgency with which they need to be addressed. I must say on a
personal note, I am very encouraged to have heard the
statements given this morning by you, Mr. Stupak, and members
of your committee and others that in fact you too recognize the
seriousness of the deficiencies that have been noted.
In summary, however, I want to emphasize, please be assured
that our findings and recommendations were made in the spirit
of deep respect for the FDA, for its dedicated service to the
public health provided 24/7. The urgency of our advisory is
simply predicated upon the fact that we see signs of an
increasingly chaotic environment descending upon FDA and the
need to address the deficiencies that we have identified.
Without immediate action, injuries and deaths from an
overwhelmed regulatory system are certain and the costs to our
society will be far greater than any dollar figure upon which
we can arrive for rebuilding the agency. Currently I would
point out that the each American pays about a penny and a half
a day for the FDA. An increase to 3 cents a day would not in
our view be a great price to pay for assurance that our food
and drug supplies indeed are the best and the safest in the
world. Thank you.
[The prepared statement of Ms. Cassell follows:]
Statement of Gail H. Cassell, Ph.D.
Mr. Chairman and Members of the Subcommittee, I am Gail H.
Cassell, Vice President for Scientific Affairs and a
Distinguished Research Scholar for Infectious Diseases of Eli
Lilly and Company and Professor. I am also Professor and
Chairman Emeritus of the Department of Microbiology of the
University of Alabama Schools of Medicine and Dentistry. I am a
member of the Institute of Medicine of the National Academy of
Sciences and am currently serving a second term on the
governing board of the IOM. Of relevance to my testimony today,
I have previously been a member of the Advisory Committees of
the Directors of both the Centers for Disease Control and the
National Institutes of Health. I also co-chaired the
congressionally mandated review of the NIH intramural program.
I appear before you today as a member of the FDA Science Board,
Advisory Committee to the FDA Commissioner. I served as Chair
of the Subcommittee on Science and Technology of the Science
Board, which authored the report "FDA Science and Mission at
Risk".
In December 2006, the Commissioner charged the Science
Board with establishing a subcommittee to assess whether FDA's
current science and technology can support the agency's
statutory mandate to protect the nation's food and drug supply.
The subcommittee was comprised of three Science Board members
and 30 other experts. The subcommittee formally presented its
report to the Science Board and FDA on December 3.
The report was unanimously endorsed by each of the 33
members of the Subcommittee and the full Science Board. On
December 3, the Science Board accepted the report as final and
dissolved the subcommittee. The record of the proceedings of
that meeting will show that due to the seriousness of the
deficiencies found and the urgency of the situation, the
Science Board was adamant that the report be broadly
disseminated among the public and policy makers, including
posting it in the Federal Register.
The subcommittee review was unique in many respects. First,
it is only the second time in over a century that the agency
has been reviewed by an external committee as a whole entity.
Second, the committee was composed of leaders, not from a
single sector, but from industry, academia, and other
government agencies. The expertise and level of accomplishments
of the members are almost unprecedented in a single committee,
especially considering their breadth and knowledge in
regulatory science and understanding of the mission of the
agency.
The subcommittee included expertise ranging from a Nobel
laureate in pharmacology, 14 members of the National Academy of
sciences (including two engineers), a renowned economist and
specialist in workforce issues, a leader in health care policy
and technology assessment, a former CEO of a large
pharmaceutical company, a former Assistant Secretary for Health
and Human Services who also headed global regulatory affairs
within a large company for over 20 years, a former Chief
Counsel for the FDA, and the first under Secretary for Food
Safety at the U.S. Department of Agriculture overseeing the
Food Safety and Inspection Service and coordinating U.S.
government food safety policy.
For over a year, this group of experts worked intensively
for thousands of hours, including many nights, week-ends, and
holidays conducting their review. It was the norm, not the
exception, that when we met, even by teleconference, we would
have as many as 30 members actively engaged in discussion for
over two hours. Let me assure you, this level of engagement by
so many very busy people with diverse expertise is rare in such
a committee let alone that there would be such rapid consensus
about its findings. How then do you explain the consensus and
commitment to this exercise?
It became rapidly apparent that the FDA suffers from
serious scientific deficiencies and is not positioned to meet
current or emerging regulatory responsibilities. It is agency
wide, i.e. not limited to a single program or Center. Since
every regulatory decision must be based upon the best available
scientific evidence in order to protect the public's health, we
concluded that American lives are at risk and that there is an
urgent need to address the deficiencies. The level of concern
by all members of the Subcommittee and the Science Board
members was, and remains, high.and thus the intensity of their
commitment to this review and their insistence that the
findings be broadly communicated.
What we found is quite simply, demands of FDA have soared
over the past two decades. Resources have not! Furthermore, we
found that the Agency has not adapted in order to maximize
existing resources by capitalizing upon the scientific
resources in the academic community and other government
agencies. The demands upon FDA have soared due to the
extraordinary advance of scientific discoveries, the complexity
of the new products and claims submitted to FDA for pre-market
review and approval, the emergence of challenging safety
problems, and the globalization of the industries that FDA
regulates. The result is that the scientific demands on the
Agency far exceed its capacity to respond. This imbalance is
imposing a significant risk to the integrity of the food, drug,
cosmetic and device regulatory system, and hence the safety of
the public.
Briefly the Subcommittee found that:
The FDA cannot fulfill its mission because its
scientific base has eroded and its scientific organizational
structure is weak.
There is a fire-fighting regulatory posture
instead of pursuing a culture of proactive regulatory science,
especially related to food safety. Consequently, The nation's
food supply is at risk.
FDA cannot adequately monitor development of new
medical products and adequately evaluate the safety of existing
products because it is unable to keep up with scientific
advances (genomics and related areas of science, wireless
healthcare devices, nanotechnology, medical imaging, robotics,
cell- and tissue-based products, regenerative medicine, and
combination products).
The FDA cannot fulfill its mission because its
scientific workforce does not have sufficient capacity or
capability.
The FDA cannot fulfill its mission because its
information technology infrastructure is sorely inadequate. It
is problematic at best-and at worst it is dangerous.
Although our Subcommittee was asked to review gaps in
scientific expertise and technology and not to assess available
resources, it rapidly became apparent that the gaps were so
intertwined with two decades of inadequate funding that it was
impossible to assess gaps without also assessing resources. Our
Subcommittee, therefore, spent considerable effort garnering as
much information as possible about the current roles and
responsibilities of Agency staff, available resources, the
current status of science within the Agency, and the
implication of emerging science for the future of FDA and the
public's health.
Specifically, we found that FDA's shortfalls have resulted
in a plethora of inadequacies that threaten our society-
including, but not limited to:
inadequate inspections of manufacturers
a dearth of scientists who understand emerging
new technologies,
inability to speed the development of new
therapies,
an import system that is badly broken,
a food supply that grows riskier each year, and
an information technology infrastructure that was
identified as a source of risk in every Center and program
reviewed by the Subcommittee.
We concluded that FDA can no longer fulfill its mission
without substantial and sustained additional appropriations.
The current situation has developed over many years, the
question is not why or how we got here but rather how do we
strengthen FDA going forward? Our subcommittee strongly
believes our report provides the required blueprint.
The report is unique in yet another important way. It not
only provides an assessment by a rigorous review of the Agency
by a diverse team of experts from the public and private
sectors, but it also includes a simultaneous assessment by
leaders of the FDA (as contained in Appendices L-M). Our
Subcommittee requested staff to not only identify science and
technology gaps but to link each directly to their specific
regulatory mission. This comprehensive external/internal
analysis--done at the same point in time for an entire Agency--
is indeed rare.
We recognize that adequate resources-human and financial-
alone will not be sufficient to repair the deteriorating state
of science at FDA, which is why our committee also recommended
significant restructuring. But without a substantial increase
in resources, the Agency will be unable to meet either the
mandates of Congress or the expectations of the American
public, regardless of management or leadership changes. Our
findings are supported by many recent GAO reports as you will
hear today as well as recent reports form the National Academy
of Sciences.
It is now time for the reviews to stop and to take the
necessary action to correct the deficiencies. First and
foremost, there must be a strong commitment on the part of the
FDA to undergo the structural changes recommended in this and
previous reports to strengthen the scientific base of the
agency and to recruit and retain the most outstanding leaders
in Regulatory Science. The American public and Congress deserve
no less. Then, Congress and the Administration need to provide
the necessary resources to bring the Agency into the 21st
Century.
On behalf of our Subcommittee, we thank Chairmen Stupak and
Dingell and ranking members Barton and Shimkus for holding this
hearing and for your recognition of the seriousness of the
deficiencies we have identified and the urgency with which they
need to be addressed.
Please be assured that our findings and recommendations
were made in the spirit of deep respect for the FDA and for its
dedicated service to public health provided 24/7. We fully
recognize the extraordinary efforts of the committed FDA staff.
It is apparent that they are the very reason further
catastrophic food and drug events have been averted. The
urgency of our advisory is simply predicated upon the fact that
we see signs of an increasingly chaotic environment descending
upon FDA, and the need to address the deficiencies we
identified. Without immediate action, injuries and deaths from
an overwhelmed regulatory system are certain, and the costs to
our society will be far greater than any dollar figure upon
which we can arrive at. I have attached a synopsis of our
Subcommittee report to my statement and request that it be
included in the recording of this hearing. Other members of the
Subcommittee here with me today will summarize the most
important findings and those in need of the most urgent
attention.
FDA SCIENCE AND MISSION AT RISK
SYNOPSIS OF A REPORT OF THE FOOD AND DRUG ADMINISTRATION'S SCIENCE
BOARD
DECEMBER 2007
Introduction
The Food and Drug Administration's (FDA) Science Board is
an advisory committee to the Commissioner of FDA, chartered to
assist the agency on a range of scientific matters, one of
which is how the agency's scientific capabilities can be
maintained so as to ensure that the agency can carry out its
increasingly complex responsibilities. In December 2006,
Commissioner of Food and Drugs Andrew VonEschenbach charged the
Science Board with establishing a subcommittee to assess
whether FDA's current science and technology can support the
agency's statutory mandate to protect the nation's food and
drug supply. The subcommittee was comprised of three Science
Board members, complemented by 30 other experts from industry,
academia, and other government agencies. Upon its completion
after a year of intensive examination of FDA's programs and
organization, the subcommittee's report was unanimously
endorsed by all 33 members of the Subcommittee and the full
Science Board. As the report's title suggests, the Board has
concluded that FDA is an agency at risk of failing to carry out
its mandate, and thus the nation and its citizens are at risk
of grievous harm if the FDA is not committed to greatly
strengthening its scientific base and if it is not given the
means to ensure the safety of our foods, drugs, medical devices
and other consumer products for which FDA is responsible.
A Successful FDA is Essential to a Safe Society
There is no more quintessential governmental responsibility
than the protection of basic commodities of American life such
as our foods and drugs. That fact was recognized over a century
ago, when Congress created the Food and Drug Administration as
one of the nation's first regulatory agencies. The Science
Board report emphasizes that the need for an effective FDA is
greater than ever before: FDA regulates 80% of the nation's
food supply; plays a critical role in assuring the safety of
therapeutic such as drugs, vaccines, and medical devices;
regulates a vast number of other consumer products, ranging
from television sets and cellular telephones to cosmetics,
blood, and pet food; and has historically been the agency to
which governments around the world look to make determinations
about the safety of new products. Moreover, FDA is increasingly
important to the nation's economic health, as it regulates a
quarter of consumer expenditures, and the industries it
regulates are innovative leaders in science and technology and
among the few American industries with a positive trade balance
with other nations. Further, FDA will be a critical component
in combating emerging threats such as intentional contamination
of the food supply and the threat of chemical, biological and
radiological attack-as well as naturally occurring threats such
as SARS, West Nile virus, Mad Cow disease and avian influenza.
FDA's Exemplary Record Must be Maintained
Throughout most of its 100+ years existence, FDA has been
recognized as one of the Federal government's most respected
and trusted entities. The agency led the way in creating an
effective, science-based "safety net" for consumer products.
FDA's record of accomplishment is a long and distinguished one:
new drugs are approved for marketing as fast or faster than
anywhere else in the world; state-of-the art standards for safe
food production have been established; a nascent medical device
industry was helped to develop and grow into one of our most
innovative; FDA decisions and procedures have been emulated by
country after country around the world; products were labeled
so as to give physicians and consumers reliable information
about the products they prescribe and use; polls have
consistently placed FDA at the top of any list of most trusted
Federal agencies; and threat after threat was taken on and
defeated, from unsafe pesticide use to improperly manufactured
drugs to radiation emitted from a host of consumer products.
FDA's scientists are widely considered among the most skilled
and dedicated of our civil servants, and their commitment to
excellence is unequaled.
A Record of Success is Threatened
The FDA Science Board concluded that FDA's rich tradition
of excellence has been slowly and steadily "hollowed out" by a
failure of the Agency to strengthen its scientific
organizational structure and by progression of budget cuts and
inattention to the agency's needs. That deterioration, in turn,
means that not only can the agency not fulfill its public
health mission, but that the safety of our citizens and the
well being of our economy are being undermined. Further, as the
agency falls farther and farther behind, the public is
increasingly losing confidence in the government's ability to
protect them-already more and more citizens turn to unproven
therapies that have not been subjected to FDA's rigorous
scientific standards; and states are stepping in to regulate in
FDA's absence, portending a balkanized, inefficient regulatory
system without one national set of safety standards.
More specifically, the Board has identified a range of
problems and program areas that need immediate attention,
including the following:
The demands upon the FDA have soared due to the
extraordinary advance of scientific discoveries, the complexity
of the new products and claims submitted to FDA for approval,
the emergence of heretofore unknown health threats, and the
globalization of the industries that FDA regulates. The metrics
alone are daunting, for example, 125 new statutes added to
FDA's workload by Congress in the past two decades, most
without resources to implement them; 375,000 establishments
making FDA-regulated products; a tripling in a decade of R&D in
drugs and medical devices; an exponential increase in drug
adverse reaction reports; and the emergence in recent years of
extraordinary new health threats, such as SARS, E coli 0157H:7,
AIDS, BSE, and many more. Perhaps most emblematic of this trend
is the ten fold increase in the past decade of imports from
other countries. Today, 15% of our food supply is imported from
more than 100 nations, along with over half of our drugs, yet
FDA has been given virtually no new authorities nor resources
to address a dramatic change in the sourcing (and associated
risk) from products made overseas, often in developing
countries with little or no tradition of scientific rigor.
FDA's resources have not only not kept pace with
its responsibilities, many critical agency programs have
sustained actual cuts. For example, FDA's food headquarters
program has lost 20% of its scientists in just the past three
years, despite an upswing in outbreaks of foodborne disease in
the United States and a steady increase in contaminated
seafood, produce and other foods being imported from foreign
countries. Similarly, FDA has lost several hundred inspectors
due to budget cuts since 2003, leaving the agency not only
incapable of inspecting domestic manufacturers but also
ensuring that most of the nation's ports have no FDA
inspectors. Although one FDA function, new drug and device
review, has received additional funding from industry-paid user
fees, the agency as a whole as lost 1000 people over the past
decade.
Innovations and advancements in science are
outstripping FDA's capacity to understand and regulate them,
threatening not only the safe introduction of new technologies
but also American leadership in pharmaceuticals, vaccines,
biotechnology, and medical devices. The United States is on the
cusp of another "revolution" in therapeutics that holds great
promise for effective treatments of cancer, Alzheimer's,
Parkinson's, and other previously incurable conditions.
Breakthroughs in human genome research, molecular biology,
nanotechnology, food processing technology, computational
mathematics, in vivo imaging and many more are likely to change
the face of medicine and food production, yet FDA has not been
given the capacity to prepare for those breakthroughs. Tens of
billions of dollars are being spent by both the public and
private sector on the development of such products, yet FDA has
been denied the relatively minor funding necessary to ensure
their rapid and safe entry to market. At a time in which U.S.
competitiveness in science, medicine, and food production are
under increasing strain from overseas, a weak and under funded
FDA will be a brake on the very technologies that the United
States is relying upon for its medical and technological
future. Furthermore, they have gaps in major areas of
scientific expertise and they are no longer able to recruit the
best and brightest in regulatory science nor to retain the ones
them if recruited.
FDA cannot ensure the safety of our food supply.
It is difficult for leading scientists to reach such a dire
conclusion, but the report's authors saw a food safety system
in which basic inspection, enforcement, and rulemaking
functions have been severely eroded, as has the agency's
ability to respond rapidly to foodborne disease outbreaks and
to keep pace with new regulatory science. FDA's food safety
program is characterized as one steadily dropping in staffing,
and in funding for essential functions such as development of
its scientists and travel to scientific fora. The inspection
rate of food processors can only be described as "appalling,"
resulting from budget cuts for food safety that has brought the
agency from doing 35,000 domestic food inspections in 1973 to
fewer than 8000 this year (meaning FDA inspects most facilities
on average only every ten years). The foreign inspection rate
is even worse, as the agency may manage to inspect a dozen
foreign food manufacturers on 2008, despite the thousands of
overseas producers sending food to our shores. The agency has
no resources to conduct inspections of retail food
establishments or of food-producing farms. Moreover, as FDA's
leadership in food safety erodes, other countries are
presenting themselves as the appropriate model for food safety
standard setting, even though such standards can be
unscientific and disguised trade barriers, to the detriment of
principles of sound science and to market access for American
food exports.
FDA's Information Technology systems are woefully
outdated and inadequate, posing a concrete threat to the
agency's public health mission. The report's authors were
extremely disturbed by the state of FDA's IT infrastructure.
They found a situation problematic at best, at worst dangerous.
Many of FDA's systems are far beyond their expected life span,
and systems fail frequently (even email systems are unstable).
Reports of product dangers are not rapidly compared and
analyzed, inspectors' reports are still laboriously hand
written, and the system for managing imported products cannot
communicate with Customs and other government systems. These
inadequacies do not only cause inefficiencies and waste, but
more importantly mean that dangers lurking in information
coming to the FDA are simply missed-such as drug adverse
reactions that are duly reported but not flagged for attention
due to incapacities in information management.
CONCLUSION
The findings and recommendations of the Science Board are
not novel. Recent studies by the Institute of Medicine of the
National Academy of Sciences, Congressional committees, the
Government Accountability Office and other expert bodies have
documented FDA's shortfalls and the resulting public health
threat. It is now time for the examinations to stop and to take
action. FDA's resource constraints cannot be reversed without a
determined effort by Washington decision makers to rebuild this
bulwark of our system of consumer protection. The report makes
recommendations for significant restructuring of science at the
FDA but it is also apparent that management nor leadership
changes can be expected to have a significant impact, in the
absence of very significant increases in resources. Without
action, injuries and deaths from an overwhelmed regulatory
system are certain, and the costs to our society will be far
greater than any dollar figure upon which we can arrive at.
----------
Mr. Stupak. Thank you.
Mr. Hutt, opening statement, please, sir.
STATEMENT OF PETER BARTON HUTT, COVINGTON & BURLING LLP
Mr. Hutt. Mr. Chairman and members of the subcommittee, I
am Peter Barton Hutt. I am a senior counsel at the Washington,
D.C., law firm of Covington and Burling and a lecturer and food
and drug law at Harvard Law School. During 1971 to 1975, I was
privileged to serve as chief counsel for the Food and Drug
Administration.
It is meaningless to discuss the scientific needs of FDA
without first analyzing the resources, both money and
personnel, currently available to the agency to accomplish its
public health mission. I therefore have volunteered to prepare
for our subcommittee a report that would document both the
increasing responsibilities imposed upon FDA by Congress during
the past 2 decades and the reduced appropriations provided by
Congress for the agency during this period. Because of its
central importance in demonstrating the need for additional
congressional appropriations for FDA, I request that my report
be included in full in the record of this proceeding.
Mr. Stupak. Without objection, it will be.
Mr. Hutt. Thank you, sir.
Science at the Food and Drug Administration today is in a
precarious position. In terms of both personnel and the money
to support them, the agency is barely hanging on by its
fingertips. FDA has become the paradigmatic example of the
hollow government syndrome, an agency with expanded
responsibilities, stagnant resources and the consequent
inability to implement or enforce its statutory mandates. For
the reasons set forth in my report, Congress must commit to a
2-year appropriations program to increase FDA employees by 50
percent and to double the FDA funding, and then at least to
maintain a fully burdened yearly cost-of-living increase of 5.8
percent across all segments of the agency. Without these
resources, the agency is powerless to improve its performance,
will fall only further behind and, as Gail said, will be unable
to meet either the mandates of Congress or the expectations of
the American public.
My report first addresses the tremendous problems
encountered by FDA in implementing the burgeoning number of new
statutory responsibilities imposed by Congress each year. Table
1 of my report lists more than 100 statutes that directly
impact FDA enacted by Congress only in the last 20 years since
1988. That is an average of more than six new statutes a year.
In the history of our country, no other Federal regulatory
agency has ever faced such an onslaught of new statutory
mandates without appropriate funding and personnel to implement
them. These unfunded mandates cascade down on FDA from all
sides of the political spectrum. It is not a problem caused by
bipartisan politics but the country cannot withhold the
requisite scientific resources from FDA and then complain that
the agency is incapable of meeting our expectations.
The lack of adequate scientific personnel and the resources
to support them has had a major adverse impact on important FDA
regulatory programs to assure the continued safety of marketed
products. Ten specific examples are provided in pages 10 to 12
of my report.
Tables 4 and 5 of my report cover FDA appropriations for
the 20-year period of 1988 to 2007. From 1994 to 2007, the
agency's appropriated personnel decreased by 1,311 people and
FDA's appropriated funding during this time increased by only
about two-thirds the amount needed to keep up with inflation.
It thus is obvious that FDA has become increasingly impossible
to maintain its historic public health mission.
The deterioration of the FDA Field Force has been severe.
The science functions within the FDA Center for Food Safety and
Applied Nutrition which include, of course, dietary supplements
and cosmetics, have been hit especially hard.
In conclusion, science is at the heart of everything that
FDA does. Without a strong scientific foundation, the agency
will flounder and ultimately it will fail. The scientific
resources needed by FDA to carry out its statutory mission
cannot be sustained on a minimal budget. Congress must commit
to doubling the current FDA funding together with a 50 percent
increase in authorized personnel over the next 2 years if this
agency is to do its job.
Thank you, sir.
[The prepared statement of Mr. Barton Hutt follows:]
Statement of Mr. Hutt
Major Points
1.Science at FDA today is in a precarious position. In
terms of both personnel and the money to support them, the
agency is barely hanging on by its fingertips.
2.To correct this problem, Congress must commit to a two-
year appropriations program to increase the FDA employees by 50
percent and to double the FDA funding, and then at least to
maintain a fully burdened yearly cost-of-living increase of 5.8
percent across all segments of the agency.
3.During the past 20 years Congress has enacted more than
100 statutes that directly impact FDA, without providing money
and personnel to implement them.
4.There are numerous unfinished FDA safety programs because
of a lack of FDA resources.
5.During the past 20 years, faced with its ever-increasing
responsibilities, FDA appropriations have resulted in a gain of
only 817 employees and a loss of more than $300 million to
inflation.
6.FDA regulation of food, dietary supplements, and
cosmetics have been hit especially hard.
7.The deterioration of the FDA Field Force has been equally
severe.
8.Science is at heart of everything that FDA does. Without
a strong scientific foundation -- adequately funded by Congress
-- the agency will flounder and ultimately fail.
Testimony
Mr. Chairman and Members of the Subcommittee, I am Peter
Barton Hutt. I am a Senior Counsel at the Washington, D.C. law
firm of Covington & Burling LLP and a Lecturer on Food and Drug
Law at Harvard Law School where I have taught a course on food
and drug law for the past fifteen years. During 1971-1975 I
served as Chief Counsel for the Food and Drug Administration
(FDA). I appear before you today in my capacity as a consultant
to the Subcommittee of the FDA Science Board that prepared the
recent report on "FDA Science and Mission at Risk."
It is meaningless to discuss the scientific needs of FDA
without first analyzing the resources -- both money and
personnel -- currently available to the agency to accomplish
its public health mission. At the first meeting of the
Subcommittee I therefore volunteered to prepare a report that
would document both the increasing responsibilities imposed on
FDA by Congress during the past two decades and the reduced
appropriations provided for the agency. My report is included
in the Subcommittee's report as Appendix B and is attached to
this testimony. Because of its central importance in
demonstrating the need for additional congressional
appropriations for FDA, I request that my report be included in
full in the record of these hearings.
Introduction
Science at the Food and Drug Administration (FDA) today is
in a precarious position. In terms of both personnel and the
money to support them, the agency is barely hanging on by its
fingertips. The accumulating unfunded statutory
responsibilities imposed on FDA, the extraordinary advance of
scientific discoveries, the complexity of the new products and
claims submitted to FDA for premarket review and approval, the
emergence of challenging safety problems, and the globalization
of the industries that FDA regulates -- coupled with chronic
underfunding by Congress -- have conspired to place demands
upon the scientific base of the agency that far exceed its
capacity to respond. FDA has become a paradigmatic example of
the "hollow government" syndrome -- an agency with expanded
responsibilities, stagnant resources, and the consequent
inability to implement or enforce its statutory mandates. For
the reasons set forth in my report, Congress must commit to a
two-year appropriations program to increase the FDA employees
by 50 percent and to double the FDA funding, and then at least
to maintain a fully burdened yearly cost-of-living increase of
5.8 percent across all segments of the agency. Without these
resources the agency is powerless to improve its performance,
will fall only further behind, and will be unable to meet
either the mandates of Congress or the expectations of the
American public.
Congress and the nation therefore have a choice. We can
limp along with a badly crippled FDA and continue to take
serious risks with the safety of our food and drug supply, or
we can fix the agency and restore it to its former strength and
stature. If Congress concludes to fix FDA, however, this cannot
be done cheaply. It will be necessary to appropriate
substantial personnel and funds to reverse the damage done to
FDA in the past two decades.
Accumulating Unfunded FDA Statutory Mandates
My report first addresses the tremendous problems
encountered by FDA in implementing the burgeoning number of new
statutory responsibilities imposed by Congress each year. Table
1 lists more than 100 statutes that directly impact FDA enacted
by Congress only since 1988 -- an average of more than six each
year. These are in addition to the core provisions of the
Federal Food, Drug, and Cosmetic Act of 1938 itself and another
90-plus statutes directly involving FDA that were enacted
during 1939-1987.
Each of these statutes requires some type of FDA action.
Many require the development of implementing regulations,
guidance, or other types of policy, and some require the
establishment of entire new regulatory programs. Virtually all
require some type of scientific knowledge or expertise for the
agency adequately to address them. Yet none of these statutes
is accompanied by an appropriation of new personnel and
increased funding designed to allow adequate implementation. In
the history of our country, no other Federal regulatory agency
has ever faced such an onslaught of new statutory mandates
without appropriate funding and personnel to implement them.
Instead, the agency is expected to implement all of these new
unfunded congressional mandates with resources that, in the
corresponding time, represent at best a flat budget. Not
surprisingly, many of the new congressional mandates languish
for years or cannot be implemented at all.
In addition to the laws listed in Table 1, which directly
require FDA to take action, Congress has enacted a number of
statutes of general applicability that place a large
administrative burden on FDA in conducting its daily work.
Representative statutes of general applicability that require
substantial FDA resources for compliance are listed in Table 2.
For example, in order to promulgate a regulation, FDA must at a
minimum include, in the preamble, not only full consideration
of all the substantive issues raised by the regulation itself,
but also a cost-benefit analysis, an environmental impact
discussion, a federalism evaluation, a small business impact
statement, a determination whether there is an unfunded mandate
impact on state or local governments, and an analysis of
paperwork obligations. The proposed and final regulations must
be reviewed and approved by the Department of Health and Human
Services (DHHS) and the White House Office of Management and
Budget (OMB). However well-intentioned, these responsibilities
place a major burden on FDA and require that scientific
resources be diverted from other areas in order to assure
compliance. This has led FDA to avoid rulemaking wherever
possible and to substitute informal guidance or to take no
action whatever on important regulatory matters.
The statutes of general applicability are not the only
directives that have a strong impact on FDA. Every President in
the past 40 years has issued one or more Executive Orders that
impose additional obligations on FDA. A representative sample
is set forth in Table 3. These Executive Orders have the same
binding status as a statute and can have as great or greater
impact.
The combined weight of these unfunded FDA statutes,
statutes of general applicability, and Executive Orders is
tremendous. Each includes additional responsibilities for the
agency without commensurate appropriations for personnel and
funds. The result is that, with relatively flat funding and a
very large increase in what the country expects from the
agency, FDA is falling further and further behind.
These unfunded mandates cascade down on FDA from all sides
of the political spectrum. It is not a problem caused by
partisan politics. Nor does my report question the
justification for these mandates. Rather, it is the undeniable
fact that these mandates are unfunded, and thus that FDA lacks
the capacity to implement them, that is objectionable. The
country cannot withhold the requisite scientific resources from
FDA and then complain that the agency is incapable of meeting
our expectations.
Unfinished FDA Safety Programs
The lack of adequate scientific personnel and the resources
to support them has had a major adverse impact on important FDA
regulatory programs to assure the continued safety of marketed
products. For example, on several occasions FDA has established
comprehensive reviews of products after they have been
marketed, either at the direction of Congress or on its own
initiative. Virtually all of these reviews remain unfinished
for lack of agency resources. Ten specific examples are
provided on pages 10-12 of my report.
Lack of Adequate FDA Appropriations
No one outside FDA has enough information about the agency
to conduct a zero-based budget analysis for FDA. It is likely
that FDA itself has numerous materials that would bear upon
such an analysis, but the agency states that it is not able to
make those public.
My report therefore pursues a different approach. Attached
are tables that present a partial statistical history of the
congressional appropriations for FDA personnel and funds for
the past 20 years, compiled from publicly-available sources.
Tables 4 and 5 cover the 20-year period of 1988 - 2007. As the
last column in Table 5 shows, from 1988 to 1994 FDA's
appropriated personnel and funding kept even with its
increasing responsibilities and exceeded inflation. The
agency's appropriated personnel increased from 7,039 to 9,167
(a gain of 2,128 people) and its funding from $477.504 million
to $875.968 million (a gain of $398.464 million). In 1994,
however, FDA hit a brick wall. From 1994 to 2007 the agency's
appropriated personnel decreased from 9,167 to 7,856 (a loss of
1,311 people), returning it almost to the same level that was
appropriated 20 years earlier. FDA's appropriated funding
during this time increased by $698.187 million, but this was
only about two-thirds the funding needed to keep up with FDA's
fully burdened cost-of-living increase of 5.8 percent,
compounded yearly. Thus, over the entire 20 years FDA gained
only 817 employees -- an increase of 12 percent -- and lost
more than $300 million to inflation, while faced with
implementing the new statutes listed in Table 1 and the
agency's substantial other core responsibilities under the 1938
Act. Confronted with a burgeoning industry as documented in
Table 6, it became increasingly impossible for FDA to maintain
its historic public health mission.
My report contains numerous examples of the impact of this
lack of personnel and funds on FDA programs, particularly
dealing with food and regulatory enforcement. The science
functions within the FDA Center for Food Safety and Applied
Nutrition (CFSAN) -- which include dietary supplements and
cosmetics -- have been hit especially hard. In the 15 years
from 1992 to 2007, CFSAN suffered a reduction in force of 138
people, or 15 percent of its staff. During the same period,
Table 1 shows that Congress enacted several important new laws
creating major new responsibilities for CFSAN, all of which
required substantial scientific expertise for implementation.
The deterioration of the FDA Field Force -- which must
daily make scientific evaluations of FDA-regulated products --
has been equally severe. Between 1973 and 2006 there was a 78
percent reduction in food inspections. FDA conducted twice the
number of foreign and domestic food establishment inspections
in 1973 (34,919) then in did for all FDA-regulated products in
2006 (17,641). The inability of FDA adequately to police the
importation of food and drugs into the United States has been
well documented by Congress during the past two years.
Conclusion
We must all recognize that FDA can increase its attention
to high priority issues, or take on entirely new
responsibilities, only in the following two ways. First, FDA
can divert personnel from other priorities, thus leaving those
other areas neglected. This is what happened with contaminated
pet food, one of the many areas which have been neglected
because of a lack of agency resources. Second, Congress can
determine to provide adequate funding for all of the
responsibilities that the country expects FDA to implement. But
it is clear that, unless Congress adopts this second approach,
FDA will of necessity be forced to follow the first.
Science is at the heart of everything that FDA does.
Without a strong scientific foundation, the agency will founder
and ultimately fail. The scientific resources needed by FDA to
carry out its statutory mission cannot be sustained on a
minimal budget. Congress must commit to doubling the current
FDA funds, together with a 50 percent increase in authorized
personnel, within the next two years. From then on, it is
essential that the FDA budget at least keep up with inflation
and perhaps even more. Another report should be prepared in
five years to offer advice on the state of science at FDA at
that time and the resource needs that remain.
----------
Mr. Stupak. Thank you.
Dr. Woteki, it is time for your opening statement, please.
STATEMENT OF CATHERINE E. WOTEKI, PH.D., GLOBAL DIRECTOR OF
SCIENTIFIC AFFAIRS, MARS, INC.
Dr. Woteki. Thank you, Mr. Chairman. I am Catherine Woteki.
I am global director of scientific affairs for Mars,
Incorporated, a global food and pet care business. Prior to
joining Mars, I was Undersecretary for Food Safety in the U.S.
Department of Agriculture and also dean of agriculture at Iowa
State University.
I am pleased to have the opportunity to appear today to
present the findings of the FDA Science Board's review of the
Center for Food Safety and Applied Nutrition and the Center for
Veterinary Medicine. Between them, these two centers are
responsible for assuring the safety of the Nation's food and
feed supply, cosmetics, veterinary drugs and dietary
supplements and for assuring that information on labels is
truthful and not misleading. All together, this segment of the
U.S. economy amounts to a staggering $466 billion in domestic
and imported food sales, $18 billion in dietary supplements,
$60 billion in cosmetics, $5 billion in veterinary drugs, $35
billion in animal feed sales and $15 billion in pet food sales.
Our committee's key finding is, and I am going to quote
directly from the report, that ``FDA does not have the capacity
to ensure the safety of food for the nation. Crisis management
in FDA's two food safety centers, the Center for Food Safety
and Applied Nutrition,'' or CFSAN, as it is called, ``and the
Center for Veterinary Medicine,'' or CVM, ``has drawn attention
and resources away from FDA's ability to develop the science
base and infrastructure needed to efficiently support
innovation in the food industry, provide effective routine
surveillance and conduct emergency outbreak investigation
activities to protect the food supply.'' That is the end of our
direct quote. The committee's recommendation as you have heard
is to double FDA's appropriation over the next several years.
The crisis within FDA and particularly in these two food
safety centers is the result of decades of neglect and erosion
of CVM and CFSAN's resources needs. The current situation is
not a reflection on the outstanding staff who do a commendable
job under enormous pressure. They set priorities, they focus on
the most important public health issues and they develop
innovative ways to leverage what they have.
Rather, our review led us to conclude that CVM and CFSAN's
basic functions of inspection, enforcement and rulemaking are
severely eroded. Some examples you have already cited in your
opening statements. Over 35 years, there has been a 78 percent
reduction in inspections with food establishments, now
inspected on the average once every 10 years. The recent pet
food crisis strained an already overtaxed system. The Center
for Veterinary Medicine received more than 18,000 telephone
calls related to the melamine pet food contamination but they
only have two full-time people who are devoted to working on
pet food issues.
Since 2003, just in the last 5 years, CFSAN's workforce
declined from 950 FTE to 771, and CFSAN no longer has the
ability to generate the science needed to fulfill it human
nutrition regulatory responsibilities.
Now, why has this happened? Well, a good part of that
answer is the dramatic increase and diversification of the
responsibilities assigned to these two centers. Since 2003, a
half dozen new laws have been enacted that require significant
investment of personnel and resources to implement. They
include provisions that are related to food contact substances,
the Bioterrorism Act, food allergen labeling, trans fat
labeling, egg food safety, pandemic flu planning, and minor use
and minor species health. These new responsibilities increase
the complexity of the centers' tasks and increase the
scientific demands that are placed on them but no additional
funding has been provided to enable the centers to implement
these new responsibilities.
My written testimony provides more specific findings and
recommendations and I request that that be inserted into the
record, and I am happy to answer any questions that you may
have.
[The prepared statement of Ms. Woteki follows:]
Statement of Dr. Woteki, Ph.D., R.D.
Mr. Chairman and members of the Committee, thank you for
the opportunity to appear today to present the findings of the
FDA Science Board's review of the Center for Veterinary
Medicine and the Center for Food Safety and Applied Nutrition.
Between them, these two centers are responsible for assuring
the safety of the nation's food and feed supply, cosmetics,
veterinary drugs, and dietary supplements and for assuring that
information on labels is truthful and not misleading. All
together, this segment of the US economy amounts annually to
$466 billion in domestic and imported foods sales; $18 billion
in dietary supplements, $60 billion in cosmetics, $5 billion in
veterinary drugs, $35 billion in animal feed and $15 billion in
pet food sales.
Our committee's key finding is that "FDA does not have the
capacity to ensure the safety of food for the nation. Crisis
management in FDA's two food safety centers, Center for Food
Safety and Applied Nutrition(CFSAN) and Center for Veterinary
Medicine (CVM), has drawn attention and resources away from
FDA's ability to develop the science base and infrastructure
needed to efficiently support innovation in the food industry,
provide effective routine surveillance, and conduct emergency
outbreak investigation activities to protect the food supply"
(Report of the Subcommittee on Science and Technology, FDA
Science and Mission at Risk, November, 2007, p. 3).
This crisis is the result of decades of neglect and erosion
of CVM and CFSAN's resource needs. In contrast to drug
discovery and development, FDA's food evaluation methods have
not kept pace with evolving risks, and evolving science These
centers are strapped for resources and can accomplish little
beyond addressing the top priority of the moment. Major issues
of public health concern are not being addressed such as
cosmetic safety and the many regulatory responsibilities FDA
has for human nutrition
The current situation is not a reflection on the
outstanding staff who do a commendable job under enormous
pressure. They set priorities, they focus on the most important
public health issues, and they develop innovative ways to
leverage what they have.
Rather, our review (which was conducted in winter and
spring of 2007 against a backdrop of cascading product recalls)
led us to conclude that CVM and CFSAN's basic functions of
inspection, enforcement and rulemaking are severely eroded.
Over 35 years, there has been a 78% reduction in inspections
with food establishments now inspected, on average, once every
10 years.
The CVM workforce consists of 375 FTE, 4% of FDA total, but
it faces unique challenges in the number and diversity of
species it must address as well as maintaining a human health
orientation. The pet food industry is a $15 billion a year
business and largely falls under FDA's regulatory purview. The
recent pet food crisis strained the already overtaxed system.
CVM received more than 18,000 telephone calls concerning
melamine pet food contamination. Estimates are that about 1
percent of the total volume of pet food was involved with a
potential economic impact of $200 million. However, CVM is able
to devote only two people working full time on pet food issues.
Since 2003, CFSAN's workforce declined from 950 FTE to 771
FTE. CFSAN no longer generates the science needed to fulfil its
human nutrition regulatory responsibilities. The dietary
supplement industry has grown to more than $20 billion in
annual sales, and millions of Americans use those products
every day. But the legislation authorizing FDA regulation of
those products has never been funded, the practical effect
being that the products and their health claims are essentially
unregulated. The same can be said of the cosmetics industry,
which has more than $60 billion in annual sales, but is
overseen by an FDA staff of less than 20 people supported by
$3.5 million budget.
Why has this happened? Most importantly, CVM and CFSAN have
experienced a dramatic increase and diversification of their
responsibilities. Since 2003, a half dozen new laws have been
enacted that require significant investment of personnel and
resources to implement. The new laws include FDAMA provisions
related to food contact substances, the Bioterrorism Act,
FALCPA-food allergen labeling, trans fat labeling, egg safety
food cGMP, pandemic flu planning, and minor use and minor
species health. These new responsibilities increase the
complexity of the Centers' tasks and increase scientific
demands, but do not provide funding to enable the Centers to
implement their new responsibilities.
Our finding is not a new one. In 1991, a previous committee
reported to the Secretary of HHS its "deep concerns about the
viability of the foods program and the lack of Agency priority
for food issues. Decline in resources and program initiatives
during the past 10-15 years indicate a lack of Agency
management attention and interest in this area, although public
interest in, and concern for, an effective food program remain
high" (Report of the Advisory Committee on the Food and Drug
Administration to the Secretary of HHS, May, 1991).
Center for Veterinary Medicine - specific findings and recommendations
CVM faces a spectrum of regulatory issues requiring high
levels of science. These include methods to identify residues
(synthetic and natural chemicals) and emerging infectious
diseases; antimicrobial resistance monitoring (science and
informatics base of NARMS); biotechnology (genetic engineering,
cloning, use of phages, biopharma); and new technologies in
drug manufacturing and delivery (nanotech, genetics,
biomarkers, new approaches to characterizing microbial
resistance). The key stressors that CVM faces are: the
convergence of massive data volume and complexity with newly
developed products from the "omics revolution"; developing and
maintaining unique databases with respect to species,
endpoints, human health; and under staffing (375 FTE),
vacancies in key scientific positions, and lack of funds (>80%
of budget in salary). Our committee's recommendations are to:
bolster CVM's in-house scientific capability in emerging areas
relevant to veterinary medicine; improve IT capability, and
integrate within FDA and with CVM partners (CDC, USDA),
eliminate paper storage; and foster integration with cutting
edge science activities across FDA and with external partners;
and to expand the FDA Fellow Program.
Center for Food Safety and Applied Nutrition - specific findings and
recommendations
CFSAN's regulatory responsibilities require high levels in
diverse sciences: food production sciences; risk mitigation at
the source; consumer understanding of nutrition and food safety
information; better labeling for public health; immunology;
detection and prevention of foodborne viral diseases; safety of
cosmetics; and adverse event reporting and analysis. The key
stressors on the Center include: lack of resources (950 FTE in
2003 vs. 771 FTE in 2007; new mandates; elimination of research
programs); globalization of the food supply; new food
processing technologies; new threats to public health; ongoing
response to emergencies; outmoded IT systems and laboratory
instruments; and the fact that they are addressing only the
highest priorities. Our committee's recommendations pertaining
to CFSAN are to: add resources to attract, retain and leverage
scientific expertise and regulatory research in priority areas;
invest in 21st century regulatory science that could anticipate
future food safety issues; and develop a cadre of professionals
capable of applying the new science to emerging challenges;
leverage research programs sponsored by NCTR, ARS, CSREES, CDC,
NIH and DHS and conduct this activity with the Chief Scientific
Officer; and not neglect cosmetics and nutrition.
Thank you, Mr. Chairman, I will be happy to answer
questions.
----------
Mr. Stupak. Thank you, Doctor.
For the witnesses, any attachments to your testimony will
be made part of the record, and again, we appreciate those.
There are some good charts and statistics for us.
Dr. FitzGerald, please, opening statement, sir.
STATEMENT OF GARRET A. FITZGERALD, PROFESSOR OF MEDICINE AND
PROFESSOR AND CHAIR OF PHARMACOLOGY, DEPARTMENT OF
PHARMACOLOGY, UNIVERSITY OF PENNSYLVANIA SCHOOL OF MEDICINE
Dr. FitzGerald. Thank you, Chairman Stupak and members of
the committee. My name is Garret FitzGerald. I am a professor
of medicine, chair of the Department of Pharmacology and
director of the Institute of Translational Medicine and
Therapeutics at the University of Pennsylvania. I have worked
in the area of basic and clinical research relating to drug
action for the past 30 years.
The FDA is charged with a mission fundamental to the safety
of the Nation. Recent events--the cardiovascular hazards of
COX-2 inhibitors, the uproar over the anti-diabetic drug
Avandia, and the confusing and contradictory messages in the
press about the lipid-lowering drug Vytorin have undermined our
belief that the agency can safeguard the public and just as
importantly communicate informed and unbiased information about
drug safety.
The recent episodes of pet food and toothpaste
contamination remind us that the bulk production of drugs,
chemicals and cosmetics that reach the United States have
largely moved offshore.
Serious as each of these incidents is, they are merely
warning signs of a gathering storm. We ignore them at our
peril. The FDA is the safeguard for the integrity of our drug
supply and our food supply. Failure of the FDA to fulfill its
mission would expose each and every one of us to danger, either
from the willful intent of terrorists or the incompetence of
manufacturers. Both the Institute of Medicine report and our
subcommittee report, ``FDA Science and Mission at Risk'' have
identified in plain terms a disturbingly systemic set of
problems in the agency.
These include the politicization and instability of
leadership, attrition of manpower, poor morale, structural and
organization inadequacies, depleted infrastructure, and most
importantly, critical gaps in scientific expertise and
technology, as emphasized in this report.
These factors, many but not all reflecting a serious
erosion of necessary resource, compound to undermine seriously
the science base at the agency and its ability to fulfill its
mandate.
How have we let the FDA get to this point? We have failed
to maintain and upgrade the FDA over the past 50 years. Complex
organizations, just like complex machines--and planes are good
example--can continue to function effectively if preventively
and reactively maintained. Last year a 57-year-old seaplane
lost a wing and fell into the sea, killing 20 people on board.
It had been poorly maintained, literally papering over the
crack. However, the National Transportation Board assigned
blame not just to the airline but also the Federal Aviation
Agency (FAA) for not amending the rules with the times and
having the appropriate regulatory requirements in place.
How can we move to restore the ability of the FDA to face
the challenges of the world in 2008, not those of 1958? We must
empower the FDA to cope with the rapidly changing science of
drug development to ensure a pipeline of safe, innovative and
effective medicines for our present and our future.
Firstly, we must reorganize the structure of science at the
FDA. Unlike many agencies, this one must be grounded in science
and science must permeate its activities and decisions.
Amazingly, FDA presently lacks a chief scientific officer. We
believe that such a position of leadership is necessary to
guide the restructuring of the agency and provide constant
advice to the Commissioner.
As Dr. Cassell has emphasized in her opening remarks, the
FDA does not subscribe to rigorous peer review of their
scientific programs and centers. To our knowledge, the Center
for Drug Research and Evaluation and the Office of Regulatory
Affairs have never been peer reviewed in their totality. Those
centers that have been peer reviewed have been subject to this
process so infrequently and not in a formal process.
Secondly, agency scientists need to become reengaged with
the scientific community through attendance at meetings and
encouragement to publish on regulatory science and through
training.
Third, the presently segregated approaches to drug review
and evaluation before and after approval for marketing must be
integrated. Our information about how a drug works and how
safely it works is fragmentary at the time of drug approval. We
must exploit enhanced mega databases of clinical information,
accessed in real time by agency scientists to assess drug
safety post approval, and you will hear more from Dr.
Nordenberg on this issue.
It took 7 years from the time we first predicted that Vioxx
and Celebrex would cause heart attacks and stroke for the
evidence to accumulate and this message to be delivered in
unequivocal terms to consumers. This reflected a failure to
integrate different types of scientific information and a
reliance on a passive form of surveillance for safety signals
once these drugs had reached the market. We must and we can do
better.
Fourth, agency scientists may indeed be suspicious of
safety signals but lack the freedom, the expertise and often
the site where confirmatory tests must be pursued. We believe
the FDA needs access to a neutral testing ground, a jet
propulsion lab for the FDA.
So what is a JPL? When Boeing comes to the Department of
Defense with a new engine for jet fighters, DOD doesn't say
wonderful, let us write you a check. They may not have the
facilities or the expertise to put it through its paces in
Washington but they can turn to their collaborating experts in
the JPL in Pasadena and subject it to rigorous assessment. The
JPL provides a technologically advanced site for assessment. It
provides independence and it provides expertise. This is the
model we need for the FDA--academic sites where they can
interact with experts in the emerging sciences to pursue
evidence that is important to the regulators to clarify drug
safety or efficacy, both before and after drug approval.
Presently, we approve drugs based on the ability to detect
large average effects of benefit or risk in studies of large
populations. This approval is clearly inadequate and
essentially unchanged for the last 50 years. People vary
strikingly in their response to most drugs, differences
determined by the interaction of factors within their
environment and their individual complement of genes. What
matters most to most people is not whether there is an average
affect in a population but how a drug will work with them.
The FDA is poorly placed to react, either to the challenges
or the opportunities of this revolution in technology and
medicine. Information from these new sciences is already
providing an understanding of biological networks, which just
as the interstate superhighway system lets us navigate the
country will allow us to understand more comprehensively how
our body works in health and how and where these highways are
blocked in disease.
The FDA is not on this superhighway. It is stuck on a rural
dirt track trying to get from place to place in a Model T. It
needs a major infusion of resource to give it modern, fuel-
efficient cars to get them on that superhighway. It also needs
the drivers who can cope with the traffic and roads of the 21st
century. We propose that it hires some drivers but gets up to
speed by renting the rest part-time from the scientific fast
lane, the academic sector.
It is unrealistic, short of the reintroduction of the
military draft, to believe that the agency could ever recruit a
sufficient number of individuals skilled in these emerging
sciences to assess and interpret the information that will
derive from them. The inability of FDA scientists rigorously to
review these products will not only result in lost lives in
some cases but in others will result in the failure of critical
innovative life-saving medicines to reach the bedside, as you
have heard from Dr. Cassell. For example, the only relevant
expertise that the agency has in house in genomics, the most
advanced of these new sciences, is fragmented, uncoordinated
and paltry. Expertise in virtually every other aspect of the
emerging sciences is essentially nonexistent in the FDA. Our
subcommittee concluded that science in the FDA is indeed in a
precarious because, as Dr. Cassell has emphasized, every
regulatory decision that the agency makes is based on science
and the deficit must be addressed.
It is realistic and desirable that the agency recruits or
retrains a small cadre expert in these emerging sciences.
However, their impact can be magnified if they are integrated
into a larger network, a consortium of extramural scientists at
academic sites--a jet propulsion lab for the FDA.
Besides amplifying the science base of the agency in the
area of its greatest weakness, this JPL would provide a site in
which the agency expands its capacity to assess medicines using
the most modern technologies and a framework for educational
exchange. This initiative should also revolutionize our
approach to drug development, hastening the time to drug
approval and detecting more efficiently and faster problems
with drug safety. This initiative will empower the agency by
harvesting the talent of the U.S. academic sector, the largest
biomedical and bioengineering enterprise on the planet and one
funded largely by the U.S. taxpayer.
In summary, we concluded that the FDA is in crisis. Its
ability to fulfill its mandate has eroded to a critical degree
and will rapidly deteriorate unless they are provided
appropriate resources and the agency itself takes radical
restructuring action. Both the Institute of Medicine and the
Science Board reports identify steps that will enhance greatly
the ability of the agency to guarantee the safety of the food
we eat and the drugs and devices we are prescribed. This will
require provision of a substantial increment in resources.
However, best to do this while the levees are leaking rather
than after the hurricane has hit.
[The prepared statement of Mr. FitzGerald follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Stupak. Thank you, Doctor.
Dr. Nordenberg, your testimony, please, sir.
STATEMENT OF DALE NORDENBERG, M.D., MANAGING
DIRECTOR, HEALTHCARE INDUSTRY ADVISORY, PRICE
WATERHOUSECOOPERS
Dr. Nordenberg. Good morning, Mr. Chairman and members of
the committee. Thank you for inviting me to appear this
morning. I am Dr. Dale Nordenberg. I am testifying this morning
on behalf of the Subcommittee on Science and Technology of the
FDA Science Board for which I served as an advisor while I was
an associate director at the National Center for Infectious
Diseases at the Centers for Disease Control, responsible for
informatics. When I became a managing director with
PriceWaterhouseCoopers 4 months ago, I am not here this morning
on behalf of PriceWaterhouseCoopers nor does my testimony in
any way reflect the policies or positions of
PriceWaterhouseCoopers. I am a CDC-trained medical
epidemiologist and my area of expertise is health information
technology. I have approximately 25 years of experience in this
field. Accordingly, I would like to focus my comments on the
FDA's information technology capabilities and the demands
placed on them.
The subcommittee found that an information crisis is
putting the agency's mission at risk. Although there is recent
evidence of some progress in information technology of the FDA,
there is a dual and compounding risk. The FDA is struggling
with a too-slow modernization of its current information
network while it is challenged to regulate products based on
rapidly emerging sciences, particularly genomics, as you have
heard from Dr. FitzGerald. Based on our evaluation, let me
offer several examples of how the FDA's mission is being
affected.
We found that the FDA's information systems were to a great
extend obsolete, unstable and unsecured. For instance, 80
percent of network servers were beyond their recommended life.
An example of the consequences of an unstable technology
infrastructure is the e-mail outage that occurred during the
FDA's response to a national foodborne outbreak of E. coli in
2006.
The FDA has lacked consistent leadership in information
technology. The agency has had four chief information officers
in the past 5 years. While the FDA's information technology
professionals display commendable dedication, they need strong
leadership, the resources to deliver quality and programs that
build skills and expertise, particularly in the areas of
emerging technology and science The FDA's information system
which it depends on to evaluate product safety and efficacy are
inefficient. Inspectors' reports are still handwritten and slow
to work their way through the compliance system. The system for
managing imported products cannot communicate with Customs and
other government systems and often misses significant product
arrivals because the system cannot even distinguish, for
example, between road salt and table salt.
Clinical trials data were often buried in paper-filled
warehouses. The FDA cannot electronically search must of its
data, which meant that possible side effects of drugs cannot be
tracked and additional uses for existing therapeutics cannot be
identified.
Finally, the agency lacks the capability to manage the
complex data information challenges associated with rapid
innovation. This can affect the FDA's ability to ensure the
timely and safe introduction of products in such areas as
nanotechnology, genomics, wireless products, medical imaging
and cell-based products that could bring hope and results to
people waiting for breakthrough treatment.
The FDA's information technology crisis can be solved.
Adequate funding for information technology is crucial. The
subcommittee believes that the information technology budget at
the FDA must be increased. The overall IT budget for the FDA is
approximately $200 million compared to approximately $500
million for the CDC, although the FDA regulates, as numerous
people have mentioned, $1 trillion in consumer products and 80
percent of the Nation's food supply and is responsible for
monitoring hundreds of thousands of sites that distribute it
globally.
Increasing the budget would allow the FDA to upgrade and
modernize its technology, support develop of its professional
staff and establish the information systems it needs to fulfill
its mission. Extramural investments are critical to stimulate
the private sector to develop and implement integrated
information-sharing networks that support both pre-market
clinical trials as well as post-market pharmacovigilance
activities to evaluate safety and efficacy and to support
industry innovation. The subcommittee believes that the FDA
affects the lives and well-being of Americans, the health of
our economy and the security of our Nation as much as any other
institution, public or private. Providing the FDA with the
tools it needs to fulfill its mission is essential, and in the
information age, ensuring that the FDA effectively deploys
modern information systems is one of the most important tools
of all.
Mr. Chairman, I thank you again for the opportunity to
appear, and I would be pleased to answer any questions.
[The prepared statement of Dr. Nordenberg follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Stupak. Thank you, Doctor, and once again let me extend
my sincere gratitude to this committee and the fine work you
did. We are going to go with questions with members. We will go
5 minutes and we will move this along as we can.
Dr. Cassell, now that the report is accepted, your report
is accepted, let me ask you, what really comes next? I notice
on page 56 of the report, conclusion states, and I want to read
it, ``We therefore urge the FDA to develop a comprehensive plan
that includes how and when the agency will respond to these
recommendations and report that plan to the Science Board. We
also recommend that this plan be aligned with the 2009 budget
process in order to align the resources with the proposed
response.'' Is the Science Board still meeting? I mean, you are
saying in here ``and to report that plan to the Science
Board.'' It sounds like Science Board wants to continue to
assist the FDA and American people in implementing your
recommendations but are you still in existence? Do you still
have some input into this process?
Ms. Cassell. Thank you for asking the question. You may
recall that our committee that issued this report was a
subcommittee of the Science Board. While our subcommittee was
considered to have issued a final report in terms of those
areas that we reviewed, and so therefore we were dissolved as a
subcommittee. Some of us still remain members of the Science
Board. The Science Board obviously does continue to meet as
advisory to the Commissioner. So as far as this subcommittee
per se, we do not continue to meet or to have purpose since we
were dissolved. However, we fully anticipate that the Science
Board will be the body and it would be actively involved in the
plan. You can rest assured, however, that the subcommittee will
follow with great interest and are committed to help you and
others do what is necessary to see that the recommendations of
this report are implemented.
Mr. Stupak. You said the Science Board expects to be
involved.
Ms. Cassell. Yes.
Mr. Stupak. In order to be involved, the Science Board,
since you are all outside of the FDA, you have to be invited by
the Commissioner to work on this plan of implementation, does
it not?
Ms. Cassell. Yes. The Science Board is a permanent
subcommittee, and Dr. Woteki and myself are members of the
Science Board. So we will continue to be involved in the
assessment of the FDA's plan when in fact there is a plan to
address the recommendations of the report. I could just hasten
to say that the subcommittee anticipated that a plan would
rapidly be developed to address these urgent areas that we have
pointed out.
Mr. Stupak. The subcommittee expects that the plan would be
rapidly implemented by the Commissioner. Have you discussed it
with the Commissioner? Has he given you any assurances that the
recommendations, final recommendations made, will they be
implemented? What is his timeline? Has he indicated that to
you?
Ms. Cassell. No, not at this point in time.
Mr. Stupak. Mr. Hutt, you mentioned--I want to make sure I
have this right. The money the FDA should receive, you said it
is a hollow government syndrome. The FDA basically receives
about $1.6 billion a year, just over $2 billion when you get
PADUFA fees for new drug applications. You said over the next 2
years you should double that, so are you saying in 2009 the
budget then including the user fees should be $4 billion and
then the year after that be $8 billion?
Mr. Hutt. No. What I said was, over the next 2 years the
entire budget should be doubled and the number of people
increased by 50 percent. That is over a 2-year time so----
Mr. Stupak. So in 2009 we would go from 2 billion to 1
billion if you did half of it, then in 2010 you would go the
extra 2 billion or to 4 billion?
Mr. Hutt. Yes.
Mr. Stupak. And use that money in a period of time to
increase employees by 50 percent?
Mr. Hutt. That is correct.
Mr. Stupak. OK.
Mr. Hutt. That is appropriated funds that I am talking----
Mr. Stupak. Correct. Then you say maintain at 5.8 percent
yearly to maintain increases in cost of living and other fees
you have?
Mr. Hutt. Yes, because that is where Congress has failed to
keep up with the times. FDA's budget has been basically over
many years relatively flat. It hasn't kept up with inflation.
Mr. Stupak. I agree, and 100 more statutes, as you pointed
out, in the last 20 years.
Mr. Hutt. Yes.
Mr. Stupak. Let me ask you this then. I am a little
confused. There is some concern expressed that the Science
Board overstepped its mandated because it focused on review,
not merely on scientific concerns at the agency but also the
lack of resources that Mr. Hutt has pointed out, and in your
report it says, I will quote again, ``Although this
subcommittee was asked to review gaps in scientific expertise
and technology and not to assess available resources, it
rapidly became apparent that the gaps were so intertwined with
2 decades of inadequate funding that it is impossible to assess
technology without also assessing the resources,'' which Mr.
Hutt did. So what is the rationale for asking you to do your
work, to point out the scientific shortfalls but not discuss
the resources necessary to improve that scientific resource or
base of knowledge since every decision, as you said, Dr.
Cassell, at the FDA should be based on science?
Mr. Hutt. Well, let me respond to that. At the first
meeting of the subcommittee, I pointed out that it would be a
disconnect to talk about pure science and not to talk about
resources. That is the reason that I undertook to write a
separate report on A, resources, and B, responsibilities. I
will let Dr. Cassell to her views on this also.
Ms. Cassell. Yes. We were in fact discouraged from looking
at the resource issue but as Mr. Hutt said, it was rapidly
apparent that it would be almost criminal to identify the gaps
without also trying to address the resource issue. Therefore,
we did give this a lot of attention in terms of our review.
Mr. Stupak. My time is up, but I am sure we are going to
come back for another round so I will have a chance to ask more
questions. Just one comment, Mr. Hutt. If we go 5.8, double
that amount to 5.8 each year, we are the authorizing committee,
I am sure we are happy to do it but I think the appropriators
will have a different view on it, and I would think the
Commissioner would love you on his Science Board, especially
with those numbers and the assistance you are willing to put
forth.
Mr. Hutt. Well, I am not a scientist so he will----
Mr. Stupak. But you are a financial man, which they need
obviously.
Mr. Shimkus for questions, please.
Mr. Shimkus. Thank you, Mr. Chairman.
A couple things. My response on most Federal Government
operations is, we always over-promise and we always under-
deliver. That is endemic of government and it is unfortunate
and I think the report kind of highlights that and it is a
challenge that we have to face.
Dr. Woteki, in my opening statement I mentioned the 600
investigators that we moved after September 11 and they are now
gone. Can you talk about that real quick, where they went to,
why, what happened?
Dr. Woteki. Well, quite frankly, that is not an area that
we looked into. We have the statistic on----
Mr. Shimkus. But you were nodding when I mentioned that.
Dr. Woteki. Yes, because it is, I think, a good indication
of the resource constraints under which FDA is operating. The
fact that the bump-up in inspectors, which was badly needed,
that they were not able to maintain that in subsequent years is
a symptom of how deeply stressed they are for resources.
Mr. Shimkus. Briefly, Mr. Hutt?
Mr. Hutt. Mr. Shimkus, it was a simple matter of
appropriations. The appropriations were not there to sustain
that number of inspectors and therefore they were lost.
Mr. Shimkus. Over-promising, under-delivering. Now, I was
at another meeting obviously but Mr. Hutt called you--is it
Cassell or Cassell? What is the proper pronunciation?
Ms. Cassell. It is Cassell.
Mr. Shimkus. OK. The first question I have for you is, what
are the top three areas of the FDA where you believe there
could be bipartisan support for significant funding increases?
Ms. Cassell. I believe first and foremost, no one could
argue with the urgent situation of the information technology
situation. That has to be corrected. Secondly----
Mr. Shimkus. And if I could jump in real quick. When I
talked to my constituents and they say what can Congress do in
an election year and smaller objectives. Information technology
is I think something that in a bipartisan way there could be
movement on. Continue, please.
Ms. Cassell. The second would be the food importation
situation and associated food safety situation. The other thing
would be the drug safety and the recommendations that the IOM,
the Institute of Medicine, recommended that be put in place so
that we have a safe drug surveillance system. While the PADUFA
funding did increase funds for those recommendations, they
certainly fall short of what is needed to fully implement them,
and we think this is a very serious problem.
Mr. Shimkus. Let me follow up with you on the PADUFA and
the user fee question. Are there avenues--I mean the
appropriations is going to be the appropriations battle and I
don't think it matters who is in charge. A slice of the pie is
going to be always difficult. PADUFA has been successful. Are
there other ways that we can use a system like that in other
areas to--I mean, I think there is actually more accountability
too. When you have the user folks paying in, they are going to
make sure that there is a better response. Is there another way
in which we can use that?
Ms. Cassell. I think that perhaps Dr. Woteki might address
that.
Dr. Woteki. Yes. The Center for Food Safety and Applied
Nutrition and CVM have not had a user fee situation. They have
relied on direct appropriations, and I have to admit that as
Undersecretary for Food Safety in a different administration, I
testified on behalf of user fees to support our inspection area
for meat and poultry. At that time it was not a viable option
and at this time it arises again with respect to support for
the food side and the veterinary side of FDA. The one thing
that we did conclude in our review of the financial situation
with respect to FDA in these two centers is the need for new
appropriation and that that has to come from Congress.
Mr. Shimkus. OK. It will be interesting to see what my
livestock folks have to say about some of that.
Dr. Nordenberg, it kind of goes back to the technology. Are
you familiar with FDA's automated import entry system, Predict,
and did you evaluate this in your review?
Dr. Nordenberg. I am not familiar with that system.
Mr. Shimkus. I think we should probably throw that in as
far as concern from the subcommittee and evaluate that with
respect to these concerns.
With that, my chairman is not here so I could gavel it
closed but I think I would get wrestled. I yield back my time,
Mr. Chairman.
Mr. Stupak. Thank you, Mr. Shimkus.
Mr. Melancon for questions.
Mr. Melancon. Thank you, Mr. Chairman.
I guess I have got one general question for the entire
panel. There have been numerous reports that have spoken to the
demise of FDA over the period of years. Being the Cajun I am
and with the storm effect, and the gentleman just reminded me
of a story. After the storm, Boudreau was at his house and the
water was up to the front porch. It was continuing to rain and
a levee had broken and a neighbor came by in a boat and said,
you know, get on board, I will take you with me. He said no, I
am going to wait for the Lord to save me. And then the next
boat came by and he was on the second floor and the next boat
came by, he was on the roof. Finally he is on the top of the
chimney and a helicopter came by and he said thanks but I am
waiting on the Lord. He got to heaven's gate and he was upset
and he wanted to know why the Lord didn't do anything and the
Lord said I sent three boats and a helicopter, what else do you
need.
I mean, we have seen these reports. In each of your minds,
what exactly would you suggest to the Congress, to the
Administration or to anyone else that we can do or that can be
done to put right this agency and move it in the direction that
we have to move it to make it a viable agency to be responsive
to the needs of this country?
Ms. Cassell. Very quickly, that was the most appalling
thing to our committee, I think, that we observed and that is,
that what we were finding certainly was not new. It had been
reported in the past as long ago in terms of food safety as we
heard in the 1950s and in a 1991 report. So the question is why
in fact have these recommendations not been implemented. One
obviously is resources and lack of resources to implement them.
That is one thing. So what can we do? We can make certain that
we do get increased appropriations. But in addition to that, I
would say that this committee as well as the Science Board can
request and should request frequent updates in terms of what
has been done to implement the recommendations or to find out
why they are not being implemented and not to let this report
and other reports that you will hear about this morning sit on
a shelf and we are back here 5 to 10 years from now basically
having the same conversation because I think by that time we
won't have an agency to really talk about. Mr. Hutt has
recommended there be another similar review in 5 years. Our
report strongly recommends that there be external advisory
committees, standing committees that would review processes
continuously within each of the centers and to review progress
in terms of implementation and to critique advances, and I
think this has been one of the major deficits in the past.
There hasn't been that external peer review that other agencies
do utilize, welcome and in fact I think don't get in a
situation that we currently have with the FDA, and I think Mr.
Hutt also has some----
Mr. Melancon. And I would like to ask to have everybody
continue that line, but let me ask, do you or anyone have any
knowledge of these reports being done and they are just put on
the shelf or did the administrators in the past or present take
them, go to OMB, come to the Congress appropriations or did
they just ignore the vital signs were bad?
Ms. Cassell. I am aware of one recent report in 1997 called
the Horn report that actually specifically looked at science
within the agency and have been told that in fact it really
never saw the light of day. I am--I don't know for certain
about previous reports and conversations with OMB but a lot of
what the Horn Report recommended quite honestly would not have
required a lot of additional increased resources.
Mr. Melancon. When in the light of day was suggested that
this report not show up, whose suggestion was it that it not
appear anywhere? Do you have knowledge of that?
Ms. Cassell. I don't know. I don't know, but I can just
tell you that was one of the great concerns of our committee.
You can imagine the busy people I talked about. I had to
continually assure them our report would make a difference, and
we did repeatedly ask Commissioner von Eschenbach, will this
report be taken seriously, in fact, will you consider the
recommendations. This was before we had specific
recommendations but before investing ourselves in the task, we
wanted to be certain it wouldn't end up like previous reports.
Mr. Hutt. Mr. Melancon, the basic problem is that every
citizen in the United States assumes that our oldest and most
important Federal regulatory agency is out there doing its job.
No one knows that Congress has had a flat budget. No one knows
our Field Force has been decimated. We assume that there are
FDA inspectors all across the country, and when they are lost,
as they have been, there is no major story about it. It is not
the kind of story that our news media report every day. So it
is up to all of us, everyone in Congress on a bipartisan
effort, everyone in this room, all of us in this committee, to
get the word out there that this is a serious problem and to
bring it to the attention of the public so that everyone knows
what the situation really is.
Mr. Melancon. Any special specific recommendations or is
that included--I mean, other than money, and we know that is
one as the chairman had indicated----
Mr. Hutt. Well, I call on our national press, many of which
are in this room and are extremely fine people, to focus on the
budgetary aspects of FDA and to delve down deeply into, as we
did, each of the centers to delve down into the functions
within each of the centers such as Dale said, the Field Force.
To me, the heart of FDA is the Field Force. They are the people
out across the country. They aren't sitting in Washington. They
are in every city in the country trying to make sure that our
food is safe and our drugs have the integrity that they should.
Ms. Cassell. But actually the Office of Regulatory Affairs,
which would include some of the aspects of the Field Force, has
never had an external review as far as we know.
Mr. Stupak. Thank you.
Mr. Burgess for questions, please.
Mr. Burgess. Thank you, Mr. Chairman.
I guess, Dr. Woteki, let me ask you and perhaps Dr. Cassell
can address this as well. When we had our food safety hearings
earlier or rather last year, between the USDA and the FDA
oversight over food products in this country, for foreign
countries, USDA has 20 percent, FDA has 80 percent. Within the
USDA, the concept of equivalency exists. In another country if
they don't do things exactly like we do, it still has to be
equivalent to our processes, and FDA, to my understanding, does
not have that same concept of equivalency. Is that something
that the FDA needs as far as the oversight of imported foods?
Ms. Cassell. Cathy, I think you are in a better position.
Dr. Woteki. Yes, and I know Peter as well has strong
feelings about this, but you are absolutely right with respect
to the difference in the authorizations that FSIS has with
respect to FDA for imported foods. Under the meat and poultry
inspection acts, FSIS requires before any country will export
meat or poultry products to the United States that they, one,
have an equivalent system of inspection from a legal as well as
from a functional perspective, and secondly, an inspector must
actually visit the plants from which the meat that will be
exported in which they are slaughtered and processed. So then
in addition, the imports undergo an inspection when they
actually reach our shores so there is at least two levels of
inspection that occur for meat and poultry products.
Mr. Burgess. At the USDA?
Dr. Woteki. That is at USDA. FDA is quite different. Their
authority starts at the shore, and I understand from reading
some interviews with the Commissioner that there are some ideas
being proposed to strengthen the FDA presence overseas. I don't
know the specifics of what the regulatory authority is under
which they will be doing it but I do think it is appropriate to
strengthen FDA's presence overseas.
Mr. Burgess. So if they need legislative authority to
strengthen that oversight overseas, that would be something you
would be in favor of us providing?
Dr. Woteki. Most definitely, yes.
Mr. Burgess. Let me just ask you this because we heard this
testimony in one of our hearings earlier this year, and I was
just astounded. This is just a little bit off topic, but if
someone, a company that is importing from overseas finds that
they have a supplier with a problem, they are not obligated to
report to other suppliers that they have found a problem so if
their competing entities are using that same importer, the
problem may not be stopped. Furthermore, they are under no
obligation to disclose that to the FDA or to any regulatory
agency, and that seems like a very weak link in our chain that
if we have got someone overseas who is actively engaged in the
process of importing food over here and they find that one of
their suppliers has put whatever in--has contaminated a product
with whatever, I guess because of competitive reasons they
don't want to disclose that to other importers but it seems
like there has got to some way, some reporting mechanism so
that the agency charged with keeping us safe can know that and
at the present time I guess there is no mechanism in place for
that to happen. Is that correct?
Dr. Woteki. Well, Peter can also intercede on that question
as well. I would just like to point out that the Grocery
Manufacturers Association has put together a proposal for
strengthening food safety and does deal specifically with this
issue of reporting requirements and I would urge you to
consider their proposals with respect to strengthening FDA's
authority with respect to imported foods.
Mr. Hutt. Mr. Burgess, let me just briefly comment. First,
FDA has current statutory authority to inspect establishments
abroad. That is in the statute. There is no limitation about
inspecting in the United States and in fact FDA inspectors do
go abroad and do inspect today. The problem is, there aren't
enough of them to really do the job. That is the problem. Once
again, it's not statutory authority. It is resources. And
second, I agree completely with Dr. Woteki that a voluntary
program by the industry to address some of these would be an
extremely good thing for Congress to review because if industry
can do it by itself, it will do a much more thorough job more
efficiently and quickly.
Mr. Burgess. You know, in general I would agree with that
philosophically but again I was just astounded that that does
not already occur, and in my mind it raises a question if there
should not be some obligation, hey, we found this in this stuff
that we are importing and report that to whatever the
regulatory agency is, whether it be FDA or USDA. It just seems
common sense that our agency would require that type of
reporting if a serious problem with a foodborne illness or
contaminant in a food product was identified.
Mr. Hutt. Well, sir, that is a very complex issue because
if you are going to set up a system of that kind, there will
have to be a whole new mechanism, far more resources in FDA in
order to implement it, resources that might better be spent on
other things. But if industry can do it itself, then the
government resources will not be needed and can be used frankly
for better use.
Mr. Burgess. Again, I will concede that philosophically I
would agree with that but it doesn't seem to be happening and
my concern is that if someone finds a problem, they just keep
quiet about it and then the poor FDA is left trying to catch up
the best they can. So to put it in the obligation that under
certain circumstances this voluntary program that I welcome the
Grocery Manufacturers Association setting up but under some
circumstances they are obligated to take that data to whatever
the regulatory is.
Mr. Chairman, I know I went over. I will yield back.
Mr. Stupak. Would you care to answer?
Mr. Hutt. Well, no, I think we could continue this
discussion perhaps at a later time.
Mr. Stupak. Mr. Inslee for questions.
Mr. Inslee. Thank you. I wanted to ask the panel about this
medical device scam disaster we have a little bit, and you
heard me talk about a couple tragedies that have befallen some
folks and I want to talk about this one situation to just put
it in context. This article in the Seattle Times, the report I
was reading is about a fellow who in the 1980s developed a
machine he said could cure a host of illnesses, allergy and
cancer. He called it the EPFX. His name was William Nelson. The
USDA basically shut him down and ordered him to stop selling
the machine. He refused. He was indicted on felony fraud
charges, left the country and he is now in Budapest, Hungary,
and one would like to think that was the end of the story,
success, mark of achievement by the FDA but we now find out
that he is in Budapest, Hungary, selling these devices
worldwide. He sold 10,000 of them in the United States, 10,000
of them, and here we have a situation where the FDA has
identified a known problem, a known machine, a known potential
disaster for people and there are 10,000 of them that we
haven't succeeded in stopping this from happening. Now, to me,
that is just extraordinary to think that such a known problem
could exist. It is one thing to have a product, an adulterated
product we didn't know about. It is another one to have it
known and having a wholesale failure to solve this problem.
Now, that failure could result from I think multiple
circumstances. One, failure to have enforcement agents
available in the field, as Mr. Hutt suggested. Two, allowing
some loopholes and there are other stories of how people have
used the independent review boards as a loophole to continue to
allow marketing while supposedly it is in a clinical trial.
Third, just a lack of IT resources to be able to track this and
see where these devices were but if any of the panel could help
us understand what you believe would be the source of that
failure, I would like to know. Mr. Hutt?
Mr. Hutt. Mr. Inslee, I am as horrified as you are by that
story. As a personal matter, during my tenure at FDA I drafted
the medical device amendments of 1976 and that statute had
substantial legal authority for FDA to stop exactly what you
are describing, and I am sure Dr. von Eschenbach is as
horrified as both of us. The problem is FDA enforcement
resources. The agency can't be cut back in terms of its field
personnel, which, as I said a few moments ago, is the heart of
compliance activity in the agency. We can't cut those back and
then expect that they will be able to solve the problem that
you described. So the answer is to strengthen the FDA field.
That is why I feel it should be doubled in the course of 2
years, over the next 2 years. Most of those resources would go
to the Center for Food, Center for Veterinary Medicine and the
FDA Field Force where they have been cut back over the years so
that this kind of problem could be dealt with immediately.
Obviously it wasn't dealt with. It wasn't dealt with
effectively at all. It should have been. But I urge you to look
at the cause of why it wasn't dealt with and it is the lack of
appropriations from Congress.
Dr. Woteki. I might also add that in the area of dietary
supplements, there are many false claims that are being made as
well, and it is an area where again because of priorities and
resources, the agency can't address.
Mr. Inslee. Let me ask you if there is another problem
here, and that is, in reading these horror stories, what I read
a lot about, there are devices that have been originally
approved as biofeedback devices or devices involving some
seemingly benign-sounding mechanism but then go into a person
who uses it who says this is going to cure cancer, this will
cure chronic fatigue, this can alleviate your allergies when
you have the individual using the device making these
representations. Do we have a problem in the lack of consistent
enforcement between the FDA and the locals, because a lot of
these local people are under local licensing as physical
therapists or counselors or, you know, whatever. Do we have a
problem in those two agencies not working hand in glove in that
regard?
Mr. Hutt. Well, the local, State and food--State food and
drug officials coordinate very, very closely with the Food and
Drug Administration. Indeed, there is a specific provision in
the Federal Food, Drug and Cosmetic Act that allows FDA to
commission the local, State food and drug inspectors to act on
behalf of FDA. So once again, there is not a lack of authority,
but in order to make that work, FDA needs funds to help the
State, local people do that job and they don't have sufficient
funds to do that.
Mr. Inslee. By the way, do we have extradition authority on
this, these kind of cases? Here is a fellow who has been
indicted on felony charges. Do we not have extradition
authority? Do you know?
Mr. Hutt. FDA has no extradition authority but the
Department of Justice may well.
Mr. Inslee. Thank you.
Mr. Stupak. Mr. Walden, do you have questions? It is your
turn.
Mr. Walden. I appreciated the witnesses' testimony and
answers to the questions. I have been listening to some of that
in the background.
I want to follow up on a couple of points. Let us take for
granted that there is a need for more money in the agency for a
moment and let us say, Mr. Hutt, Dr. Cassell, others, that
money is all shoved over here to FDA. Is that just going to
solve the problem? Too often government just says here is the
check, gee, we are solved. Are there other deficiencies within
the agency that need to be met? I have been in small business
21 years. You know, sometimes it is cultural, sometimes it is
the people. Dr. Cassell, address that.
Ms. Cassell. Yes. Our committee felt very strongly that
just adding the additional resources would not solve all the
problems. However, without them, you actually could not expect
to bring about correction of the major deficiencies. One is
structural, and that is, you heard Dr. FitzGerald say there
needs to be a strong chief scientific officer. During our
review, there was a deputy commissioner appointed but that
person's title is deputy commissioner and chief medical
officer. We would argue that it would be almost impossible, we
think, to have a person that would be the chief medical officer
of the agency and in addition be the chief scientific officer.
Then we also made the recommendation that within each center
there needs to be a strong scientific leader, that these
individuals should be responsible for helping to develop in
fact the science infrastructure, strategic plan for the
different centers and a very strong vision communicated in
terms of what is the science base of the FDA, how important is
it within the FDA, and also then to be able to communicate and
articulate that vision so that in fact you would be able to
muster the appropriate resources. So that would be one of our
strongest recommendations. The other, I might hasten to add,
has to do with the recruitment and retention of the scientific
personnel. FDA has twice the turnover----
Mr. Walden. I saw that in your testimony.
Ms. Cassell. Twice the turnover rate than other agencies,
and not only that, but two of the center directors, the two
largest ones, in fact, left their positions during the review.
Mr. Walden. Thank you.
Dr. Woteki, I had the opportunity to tour the Banfield Pet
Hospital facility in Oregon, and I know Mars owns Banfield.
Dr. Woteki. Yes.
Mr. Walden. I was very impressed with the IT system that
you all used to care for animals and track their healthcare.
Then I read this report about FDA's typewriter IT system, if
you will. I mean, we are going back several generations. Can
you compare and contrast how you all operate an IT system and
is that--I mean, I would like to see that for human healthcare,
by the way. It is great for animals.
Dr. Woteki. Exactly.
Mr. Walden. Can you talk to us about that and your
recommendations and that side of this equation?
Dr. Woteki. In essence----
Mr. Walden. That seems to be the other important part.
Dr. Woteki. In essence, the Banfield system that you are
referring to is the computerized hospital record but for your
pet. Each physician, or each veterinarian who practices in the
Banfield system as he or she is examining a cat or a dog is
entering all of his observations or her observations into this
computerized system. So it does enable Banfield to be able to
do epidemiological types of studies as well as surveillance on
the pet population. So it is a very valuable resource and one
in which hospitals for people have also for many years had an
interest in creating a similar type of system. From the FDA's
perspective, as you heard, there are many aspects of the IT
system that need to be addressed, and when you start de novo
with a company like Banfield did in building their system, it
is easier to do than to step into an agency that has been for
over its whole history of introduction of computer systems
building separate systems----
Mr. Walden. Right, that don't talk to each other.
Dr. Woteki [continuing]. To address each individual center
and even programs within the center.
Mr. Walden. And one of the things we found in other
oversight hearings is that some of the reports of drug
interaction, problems that people have had, seem to go off into
a wasteland and never get integrated in, and that is what
struck me about the similarity with what you all do at Banfield
is that integration. It seems to be lacking not only at FDA but
in other agencies. Would it be better just to start over with a
new system?
Dr. Woteki. Well, Dr. Nordenberg would be more competent to
answer that question.
Mr. Walden. Thank you.
Dr. Nordenberg?
Dr. Nordenberg. This question comes up frequently, and the
language around it is telling. People often speak about a
system but in fact there is no single system. I reflect back on
the Internet. Is the Internet a system? It is more of a system
of systems that nobody owns. What the country needs and what
the FDA needs to catalyze the development of is a system of
systems that will share the type of data you are talking about
for purposes of clinical trials and for purposes of post-market
pharmacovigilance to look for adverse events. It does that by
investing in extramural activities to stimulate both academia
and private industry, the hospitals, the payers, whoever might
be a stakeholder in the type of data that we need to collect so
that at any moment they could look at that data and say oh,
this product is out there and this is what is happening to our
people. Now, one of the peripheral components is exactly what
you are talking about. That component would be the electronic
health record in the case of human beings but in the case of
animals, it will be the animal health record, if you will.
Mr. Walden. Thank you. I know my time is expired, Mr.
Chairman. Thanks for your indulgence.
Mr. Stupak. Thank you. We are going to go another round
here. This is a great panel and I have a number of questions.
Dr. Nordenberg, there is a lot of questions on IT. Let me
ask you this question. I think we have had four or five IT
officers in the last few years at the FDA so everyone brings a
different system with them and none of them working together.
So doesn't it make more sense to have the FDA's IT budget and
that of the CDC and NIH targeted at the department level and
the FDA, the CDC and the NIH become clients of HHS and you can
then predict concepts at the front end of all agencies. Then if
there is a consolidation of food agencies under HHS, which is
being proposed by Congresswoman DeLauro, and a separate drug
and device agency, you do not have to duplicate the IT systems
for managing important programs for foods, drugs or devices.
Does that make sense?
Dr. Nordenberg. The requirement at hand is very complex.
The ability to collect data from all the different points of
contact, if you will, is something that no agency or department
can control. In fact, if you look at the Nation, 85 percent of
our infrastructure is privately owned. We talked about
preparing this response. Eighty-five percent of the
infrastructure is privately owned. So the question really is,
how does government stimulate the development of these
capabilities at the point of care, for example, in terms of
electronic health record and how does it influence development
of the interoperability or the ability to exchange or integrate
data, and in fact HHS is leading an effort out of the Office of
the National Coordinator for Health Information Technology. If
you go back 5, 10, 15 years ago, we didn't have the technology
required to do what we are talking about so some of this is
organic and inherent within limitations of the FDA, the changes
in leadership, the lack of resources. Those type of things, if
we can fix those we can rapidly fix the intramural, the intra-
agency challenges. But if you want to affect the extramural,
these data-sharing networks, these require investment again in
academia and in the points of care, if you will, so they can
evolve their capability. For example, we not only would deal
with HHS as a department but Homeland Security would be
important here in terms of we have to deal with Customs so then
you bring it above those two departments so really the overall
standards are set at a department level but the various
agencies interact with their stakeholders and then hopefully
there's interoperability.
Mr. Stupak. Well, that is what I was suggesting. If we had
a department and each agency could plug in, I just think you
would----
Dr. Nordenberg. Within each agency there is that--there is
where the comment about the chief information officer is so
critical. For example, HHS has a chief enterprise architect----
Mr. Stupak. Correct.
Dr. Nordenberg [continuing]. That interfaces with each of
the----
Mr. Stupak. Agencies.
Dr. Nordenberg [continuing]. Agencies with their chief
enterprise architect and there is that attempt to standardize.
But this going to be--this is a large, complex project moving
forward.
Mr. Stupak. Dr. Cassell, on December 1 last year, the New
York Times ran a piece on the Science Board report entitled
``Advisors Say FDA Flaws Put Lives at Risk.'' Your report on
page 6 also notes that lives are at risk. How are lives at
risk? Give us an example that we could identify with, clearly
identify with.
Ms. Cassell. I think that you and all of us have
unfortunately read about these in the news over the last year
and a half, many of them related to foodborne illnesses. Many
in fact have been associated with situations where we should
have been able to perhaps better predict the risk as well as
the benefits of new therapies, and I would say that if in fact
you look in almost in every area in terms of the deficiencies
that we have pointed out, we say lives are at risk because you
don't have the appropriate checks and balances in place. One of
the things that was pointed out in the self-assessment by FDA
was indeed the fact that vaccine adverse events reports today
are still being reviewed manually. We also made the
observation, as have others, that there has been a tremendous
increase in adverse drug events that as Mr. Hutt found when he
was putting together his white paper, in fact while you have
this tremendous increase in adverse-event reporting you did not
increase the number of the staff within FDA that were reviewing
those adverse events so that in fact the time being spent on
each adverse-event report to try to better understand what was
going on were far fewer. I think Peter actually tried to
calculate the exact number of minutes that could be spent on
ones today versus several years ago. Collectively then, I think
you can't reach another conclusion other than the fact that
American lives are at risk in terms of almost every area where
FDA oversees products. Now, mind you, this is not to frighten
people to the extent today that you stop eating or stop taking
your medications but rather to say in fact it is urgent the
deficiencies that have been noted and they have to be
corrected, to no longer delay them waiting on yet additional
reviews of yet additional committees. I think the point is that
they are--we are at the breaking point, if you will.
Mr. Stupak. Well, 6 years ago I wrote legislation saying
put an 800 number for adverse effects, not to scare anyone,
just so that it can be reported. That doesn't do us any good
if--again, FDA still hasn't put out the 800 number. We are
still waiting 6 years later. But even if they did, there is no
one to receive it or to review the documentation for doing it
by hand.
Let me ask each of you, and if you can do it quickly
because my time is up, in 60 days if we were to come back and
have Commissioner von Eschenbach come back before this
committee, instead of being on the third panel I will put him
on the first panel if he tells me how he is going to implement
your recommendations. What is the one recommendation you would
say do in the next 60 days that would make a significant change
at the FDA and how they are doing? If they had 60 days, what
would it be? Dr. Cassell, I will start with you and go right
down the line.
Ms. Cassell. I would certainly like to hear from my other
colleagues. I would put IT at the first of the list, what would
be done to actually address the recommendations that have been
pointed out by the subcommittee. Right underneath that I think
you have to address this issue of recruitment and retainment of
the scientific personnel that are needed.
Mr. Stupak. OK, IT, recruitment of scientists, get back the
science base.
Ms. Cassell. And then the importation issue.
Mr. Stupak. And importation.
Mr. Hutt?
Mr. Hutt. I approach it somewhat differently. FDA can do
relatively little to implement our report, in fact, almost
nothing, without additional funding. It is up to Congress. It
is not up to FDA to help solve this problem. FDA is ready to
change, I am certain of that. But if you say it is the old
issue that one of the members of the subcommittee, of your
subcommittee said, telling people to do more with less is
impossible. I believe Mr. Dingell made that point. They are
going to do less with less, and that is what they have been
doing for the last 20 years. So asking them now to implement a
report of our nature on the basis of what they have today is
asking the impossible.
Mr. Stupak. Correct, but if they don't submit a plan to
Congress and ask for it, the appropriators are going to look at
them and say you are not serious about it and----
Mr. Hutt. That is correct.
Mr. Stupak. If you go back and look at the budget----
Mr. Hutt. I agree----
Mr. Stupak [continuing]. There have been no increase
requests.
Mr. Hutt. The one thing they could do is lay out a
blueprint and they could lay out, if they are permitted, and
they may not be permitted, to put money against everything that
they want to do.
Mr. Stupak. The blueprint has to be with dollars just like
you. You were told to look at this report but you are not
allowed to look at the resources necessary. You can't have one
without the other.
Mr. Hutt. But Mr. Stupak, this is the real world. The
Commissioner can't go against the President's budget. The
Commissioner can't come in here and say the President has set
this budget, he is wrong, I want a higher budget. That is
unrealistic. That is not going to happen.
Mr. Stupak. And if he is bound by the President, then how
do we break that impasse?
Mr. Hutt. I can't solve that problem.
Mr. Stupak. We are working on it.
Dr. Woteki?
Dr. Woteki. Well, my one recommendation was going to be
that you request a forward-looking plan that would say if you
are going to be appropriated this number of dollars, how would
you use it, and then use that to provide the appropriate
oversight.
Mr. Stupak. Dr. FitzGerald?
Dr. FitzGerald. Yes. I believe that a plan denominated with
dollars is what is requested, and I think within our report we
have had the temerity to suggest ways in which the problem can
be fixed.
Mr. Stupak. Mr. Nordenberg?
Dr. Nordenberg. I would also say that the plan is critical.
I would also say that needs to be prioritized so that aspects
of the technology of the infrastructure that are currently
unstable and at risk should be identified and remediated as
soon as possible. I look at the PADUFA language here for the IT
plan. They talk about a 12- to 24-month period of focusing on
completing plans. Twelve to 24 months is way too long. There
needs to be an immediate assessment of things that are
unsecured and unstable and have those remediated.
Mr. Stupak. Thank you. My time is up.
Mr. Burgess?
Mr. Burgess. Thank you, Mr. Chairman. I feel obligated to
say these hearings that we have where we have the head of a
Federal agency in, we require that person to spend the whole
day with us. I think that structurally is unfair and I just
want to register my displeasure with how these hearings are
structured. This is an individual who as we heard from
testimony today, he is got an enormous job on his hands and we
are tying up a full day, and this is the second time we have
done that, and I for one want to register my displeasure. I
don't want to see us repeat this trajectory again in the
future. If we have to call the head of a Federal agency in, let
us afford him the due courtesy that we would the head of any
Federal agency, allow him to give his testimony first and then
get on with the business of running his agency.
Mr. Stupak. I will give you my word that in 60 days if we
have another hearing and have Commissioner von Eschenbach come
back to implement the plan that we are hearing about today, I
think it is important----
Mr. Burgess. Reclaiming my time----
Mr. Stupak [continuing]. That if he does it--I will extend
your time--then I may put him on the first panel, and then he
can tell us how he is implementing it. How about that?
Mr. Burgess. It should be unequivocal that he is on the
first panel every single time he testifies before this
committee or any other, the same that would be afforded to any
Administration, whether Republican or Democrat, regardless of
who is in charge in the House of Representatives. This is a
foolish way that we are going about this, and personally I just
take great umbrage to it and I think it reflects poorly on the
subcommittee, and that is something that I think is a serious
problem. We have an approval rating of 10 percent right now,
for crying out loud. How are we ever going to do--we have no
political capital left. How are we ever going to do the things
that have correctly pointed out to us when we continue to
behave in this manner?
Dr. Nordenberg----
Mr. Stupak. The way to do it is to have oversight of FDA,
and again, 60 days to have Commissioner von Eschenbach back and
see if he is implementing his plan----
Mr. Burgess. Reclaiming my time. No problem with
oversight----
Mr. Stupak [continuing]. And we will have him----
Mr. Burgess [continuing]. But for heaven's sakes----
Mr. Stupak [continuing]. On the number 1 panel.
Mr. Burgess [continuing]. Let us do it correctly.
Mr. Stupak. We are.
Mr. Burgess. There is no precedent for doing things this
way.
Dr. Nordenberg, let me ask you a question about the
information technology because that comes up all the time. How
did we--did we just buy the wrong equipment originally or did
we buy the right equipment and now it has degraded over time
because we haven't invested the proper amount in maintenance or
software upgrades? Where is the difficulty? I mean, it seems to
me--let me just tell you my problem. We hear from people on
both sides of the dais in this committee and in fact in the
full Congress that the way to solve our problems with
healthcare in this country is that every doctor needs to come
up in the 21st century with health information technology. So
we propose vast unfunded mandates on our medical personnel
across the country and we can't even do it right in a Federal
agency. I mean, they are going to come back to me and say look,
this hearing you just had and you couldn't even do it right
within probably the most premiere Federal agency in the United
States government. How are we to go to our physician colleagues
with a straight face and say you need to upgrade your computer
technology? How did it get like this within the FDA?
Dr. Nordenberg. So as I mentioned, if you look back 5, 10,
15, 20 years, everybody I think is very much aware of how
rapidly technology has evolved. You take a large organization
or enterprise, they start to buy technology, they start to
implement it. The ability for them to keep pace with changes in
technology is very difficult. So when we----
Mr. Burgess. Let me stop you there for just a minute. Is
that because they are a bureaucratic Federal agency or because
it is just difficult to keep up with technology?
Dr. Nordenberg. It is difficult to keep up with technology.
However, for the reasons you mentioned, this agency, which is
one of our premiere agencies in this country, which is so
critical for protecting the people in this country as well as
for helping industry innovate and bring that innovation to
market, it is critical that this enterprise as much as any
stays abreast and so when we look at our recommendations, it is
possible to go out and make an investment, and our report
actually states that we believe that there are good people on
the ground and with the appropriate investment they can
modernize their basic infrastructure. There is no reason why
that cannot happen and can't happen expeditiously. On the other
hand, the extramural challenges of building these complex,
multi-partner data-sharing networks is not a quick fix. On the
other hand, it is absolutely critical because those networks
will be the networks that enable the FDA to exploit regulatory
science and to evaluate the safety profiles and efficacy
profiles of the products that it regulates.
Mr. Burgess. Yes, and that is--pardon me for interrupting
because my time is going to run out but that is exactly what
concerns me. We sat here last June in a very self-
congratulatory time talked about what a good job we were doing
as far as database management and providing the FDA with the
tools it needed for database management so that, as you point
out, the pharmacosurveillance and post-marketing studies can go
forward, and now you are telling us it doesn't even exist?
Dr. Nordenberg. So essentially what I would say is the way
I look at this problem, you have to look at it as a supply
chain problem. People--for example, the FDA is actually
regulating projects that are built by complex supply chains. It
doesn't matter if it is a device, a therapeutic or food. On the
other hand, the information it needs to regulate these products
has to come from a supply chain. If you were to--and I did this
exercise in my former role at the CDC. We asked individuals, do
you know what information you need to have to perform a
specific task. Even that elemental question is difficult for
people to answer. So we are really in a different phase, if you
will, a stage of industrialization and so we need to help the
FDA and other agencies and the private sector to move and
leverage technology more efficiently. Start with the question,
what is our information supply chain, what do we need to know,
where does the data come from, how do we stimulate the
development in entities we don't own to develop that
capability. Hospitals--a small hospital that doesn't have that
much money, how do you stimulate them to buy an electronic
health record and then integrate these electronic health
records? It is being worked on but it is very complex.
Mr. Burgess. Let me ask you this, because you alluded just
a moment ago to the 12- to 24-month time frame was woefully
inadequate. Now, Mr. Stupak is saying that we need to hear back
from this panel within 60 days. Are you going to be able to
report to us favorably within 60 days developing this type of
advanced network that we are going to have within our
information technology structure?
Dr. Nordenberg. Two things. I think it falls on the FDA to
come back to us, thankfully, and secondly, the way I divided up
this problem is twofold. One is intramural, so I believe that
the FDA can assess its intramural technology deficiencies and
that can be remediated expeditiously.
Mr. Burgess. Let me just stop you there for a second. Have
we not already done that with this panel, with this
subcommittee, with this board? Was that not your job to
identify those----
Dr. Nordenberg. Our job was not to get down to the nitty-
gritty level, for example, of identifying how many boxes need
to be replaced and what software applications specifically
might need to be replaced. Our job was, the way I understand
it, is to evaluate what capability does the FDA have. So for
example, if there is a system that exists to look at imports
but you interview and you speak with people across the agency
and senior levels of multiple centers and you say are you
getting the data and information you need with regards to the
imports, the importation of products that the FDA regulates,
and they answer universally no, the best system in the world is
moot. The information supply chain does not exist or it is
broken. So----
Mr. Burgess. That is your current assessment at the FDA
now?
Dr. Nordenberg. Our assessment, the subcommittee found that
the information supply chains at the FDA are insufficient. The
way it mentions the pre-market clinical trials, the post-market
pharmacovigilance, the way data is flowing around imports, and
this is not just a technology problem. This is a process
problem. This is an information supply chain problem. When you
look at the task at hand, they have to monitor what is going on
at hundreds of thousands of sites be it manufacturing,
warehousing, transportation.
Mr. Burgess. No quarrel that it is a big job but again a
few moments ago you said a 12- to 24-month time frame was
unrealistic, way too much time to devote to that. What is the
current amount of time? When should this subcommittee be able
to come back to the FDA and have some assurance that at least
we are on the right track as far as developing the right kind
of information supply chain that you keep alluding to?
Dr. Nordenberg. So let me try to answer that one more time.
So if we look at what is inside the FDA and the environment
that it controls, that could be remediated in months. Go assess
what is deficient, buy the products, hire the people, whatever
you need to do or dispatch your own people and remediate that.
That is not solving the second issue that you are addressing,
the large, complex, multi-stakeholder networks. That is not a
couple of months fix. In fact, the country already is working
on this at multiple levels of the government. This gets back to
the chairman's comment around, you know, what level should this
be controlled. So HHS is already working from a healthcare
perspective. It doesn't address--well, it probably doesn't
address the animals as well. So from an overall healthcare
perspective, as a chief enterprise architect, it has an office
of health information technology but the FDA has specific--a
specific mandate around assuring product safety and product
efficacy for the products it regulates, and that longer-term
challenge is much more complex that than shorter-term challenge
that I mentioned, so you have to look at those two things
entirely separately.
Mr. Burgess. So can you give us estimates on what a
reasonable time period is for the short-term challenge and the
long-term challenge, what should----
Mr. Stupak. I would ask you to answer that and that will
have to be it. It has been 10 minutes now, Mike.
Dr. Nordenberg. So the short-term challenge of assessing
the intramural technology deficiencies and having a plan to
mitigate that, that should easily be able to be done within 60
days.
Mr. Burgess. And the longer-term challenge?
Dr. Nordenberg. The longer-term challenge is--that will
be--to develop a plan for that is closer probably to a 6-month
effort. It is going to have to be a staged capability
assessment. So what do they want to be able to do in 6 months,
12 months, 18 months, 24 months is much more complex. In fact,
I believe it would require--and I believe the subcommittee has
stated as such that it requires extramural collaborations both
in terms of academia and the private sector to address that
latter problem. Advisory groups have to be stood up,
collaborations have to be established. It is not something the
FDA can do alone.
Mr. Hutt. And there are no funds to do it.
Mr. Burgess. We are going to get you the funds. Chairman
Stupak has promised that. Are we going to become an
appropriating committee, because that would just be a lot
easier.
Mr. Stupak. If you want to go the appropriations committee,
that is fine with me.
I would go next to Mr. Melancon for questions, please.
Mr. Melancon. Yes. My colleague was talking about I guess
etiquette. After a number of hearings and a number of reports
and allowing for the administrator to be the first person up,
we still haven't gotten any answers, and here we are in 2008
and there is an article in the New York Times that the current
agency would need at least 27 years to inspect every foreign
medical device plant, 13 years to check every foreign drug
plant, 1,900 years to examine every foreign food plant. You
know, that is kind of disappointing to hear. And in reviewing
generally the presentation that was going to be given by the
administrator, I find it vague. So having this group up here to
tell us what we need to be looking at, to understand what the
problems are internally, whether it is political, financial or
otherwise, I think it is about time that it got here because
maybe now we can ask the question and hopefully the
administrator can give us good, straight answers on those
questions so that we can help him fix the problems within this
agency. You know, it takes money, and when we are $9 trillion
in projected deficits, it is hard to fix much of anything. But
at the same time, if we can't protect America, what are we here
for?
I don't know that I have a whole lot of questions because
what we are talking about, I think, and tell me if I am off
base, we are going to have one-time items that are going to be
pretty sizable across the board from the bottom up to get this
thing back rolling and then we are going to have some numbers
that are going to have to be projected out over the next couple
of years so that we can rebuild the force, rebuild the
technology and put all the infrastructure back in place to make
this agency a viable agency. Is there any place in there, can
you see any place where we can cooperate with USDA, with maybe
NOAA or maybe anybody that is out there that has inspection
capabilities to help us through this process or are we faced
with agencies that will not cooperate with each other? Is that
a problem anywhere?
Dr. Woteki. Well, I can respond from the food and
veterinary medicine side, and yes, there are opportunities to
leverage what FDA has, particularly with respect to inspection
capabilities and FSIS and also with respect to outreach to the
academic community that Dr. FitzGerald spoke about. Trying to
get the NIH, for example, or the Agricultural Research Service
as another example or the Cooperative State Research Education
and Extension Service to focus on the regulatory science needs
of the Food and Drug Administration would go a long way towards
helping CFSAN and CVM to have the science base that they need
to do their jobs. So how to get that leverage for FDA with the
research agencies to address their problems and so that those
research agencies in turn in the grants that they provide to
the academic community will be shaping those grants so that
they are focusing again on the regulatory science needs is the
kind of leveraging that FDA needs. We do make a recommendation
in the report that is in the section towards the back where the
individual agency reports are that providing funds to FDA that
they could actually then use to leverage with the research
funding agencies, partnering in essence to fund this regulatory
science agenda would go a long ways towards helping to rebuild
that science base that they need.
Ms. Cassell. I would also just point out that NASA many
years ago began to develop methodologies to detect microbial
contamination in the air-handling system and the water systems
of the space shuttle. Then the Department of Defense and
Homeland Security have capitalized on these and have invested
millions and billions of dollars over the last few years in
particular on improved systems for microbial sampling of food
and water and in addition have invested heavily in information
technology in terms of data mining and other capabilities as it
relates to handling of large amounts of data, and it would seem
that there would be ways that one could capitalize on that
investment that has already been made and to leverage that. But
as Dr. Woteki has said, I think with the agency, i.e., FDA
having resources to bring to the table to help allow that
leveraging and also the personnel internally to bring that
leveraging back into the agency would be extremely important,
and we do make these recommendations in the report, but you are
absolutely right about leveraging. We have to do this.
Mr. Melancon. I yield back my time.
Mr. Stupak. Thank you.
Well, let me thank this panel once again. We could go on
for a long time but we do have two more panels. I want to thank
this Subcommittee of the Science Review Board and all the
experts on the Science Review Board. For the last year you have
given up many, many hours of your time and your expertise and
you put in thousands of hours because you truly care about the
FDA and improving and reforming the FDA as you indicated, and I
think every member up here too, we have deep respect for the
FDA but it is an issue that we feel needs attention, whether it
is resources, whether it is--but your input is greatly
appreciated and I hope the Commissioner would take your
comments to heart and work with you and not just dismiss this
panel and the expertise you bring to this issue because it
truly for the benefit of the American people. Thank you, each
and every one on this panel. You are excused. Thank you.
I would like to call our second panel of witnesses to come
forward. On our second panel, we have Dr. Marcia Crosse,
director of the public health and military healthcare issues at
the U.S. Government Accountability Office, Miss Lisa Shames,
director of food and agriculture issues at the U.S. Government
Accountability Office, and Dr. Donna Porter, specialist in life
science, Science Policy Research Division at the Congressional
Research Service.
It is the policy of this subcommittee to take all testimony
under oath. Please be advised that witnesses have the right
under the rules of the House to be advised by counsel during
their testimony. Do any of you wish to be represented by
counsel? Everyone indicating--our witnesses indicate they do
not. So I am going to ask you to please rise and raise your
right hand to take the oath.
[Witnesses sworn.]
Mr. Stupak. Let the record reflect the witnesses replied in
the affirmative. You are now under oath. We will begin with a
5-minute opening statement. As I indicated in the last panel,
if you have attachments, they will be submitted for the record
with your full testimony, so if you want to summarize it, you
have 5 minutes each.
Dr. Crosse, we will begin with you, please. Thank you.
STATEMENT OF MARCIA G. CROSSE, PH.D., DIRECTOR, HEALTH CARE,
U.S. GOVERNMENT ACCOUNTABILITY OFFICE
Ms. Crosse. Thank you, Mr. Chairman, members of the
subcommittee. I am pleased to be here today as you examine
FDA's capacity to carry out its mission.
I testified before this committee in November on FDA's
program to inspect foreign manufacturers of pharmaceuticals for
the U.S. market. At that time I discussed how FDA's programs
were not keeping up with the globalization of drug
manufacturing. I testified about FDA's infrequent inspections,
weaknesses in its data systems and challenges unique to foreign
inspections. You asked that we conduct a similar examination of
FDA's medical device inspection program and our findings mirror
the weaknesses that we found for drugs. GAO has also examined
concerns regarding the safety of the food supply, on which my
colleague will testify.
FDA is required by statute to inspect every 2 years all
domestic establishments manufacturing medical devices
classified as being of high risk, such as pacemakers and
defibrillators, or medium risk, such as syringes and hearing
aids. There is no comparable time requirement for inspecting
foreign establishments but FDA is responsible for ensuring that
they meet the same standards required of domestic
establishments. Inspections of products at the border cannot
substitute for onsite inspections to determine if products are
manufactured under proper conditions.
We found that for medical devices, just as for drugs, FDA
has not met the statutory requirement for domestic inspections.
FDA inspects domestic establishments about every 3 years for
high-risk devices or 5 years for medium-risk devices. Foreign
medical device establishments are inspected less frequently,
about every 6 years for high-risk devices or 27 years for
medium-risk devices. As with drugs, China is the foreign
country with the largest number of establishments registered to
manufacture medical devices for the U.S. market and it is in
China that the mismatch between the number of establishments
and the number of inspections is the largest. Almost 700
Chinese device establishments are registered, and in the 6-year
period that we examined, a total of 64 inspections were
performed.
FDA faces particular challenges in managing its foreign
inspection program. Two FDA databases contain inaccuracies that
create very different estimates of the number of foreign
medical device establishments subject to inspection. As we have
heard today, these systems cannot exchange information, and any
comparisons are done manually. In addition, inspections of
foreign device establishments pose the same challenges to FDA
in human resources and logistics as we found for drug
inspections. FDA depends upon volunteer inspectors, has no
independent translators, and has difficulty altering the travel
itinerary if problems are uncovered that might warrant further
review.
Over the years there has been interest in using third
parties to supplement FDA's inspection resources. The Medical
Device User Fee and Modernization Act of 2002 required FDA to
accredit third parties to inspect certain establishments and
FDA has implemented two such voluntary programs. These programs
allow for a single inspection that can meet the requirements of
FDA and of other countries, which serves as an incentive by
allowing a company that markets its devices in many countries
to reduce the number of inspections. Disincentives to using
third-party inspectors include bearing the cost for the
inspection and exposing the company to possible regulatory
action. This last point is of particular note because hiring a
third-party inspector ensures that an inspection will take
place whereas it could be many years before FDA arrives for an
inspection. We found that few inspections have been conducted
through FDA's programs. In the 4 years since FDA first cleared
an accredited organization to conduct independent medical
device inspections, a total of seven inspections have been
conducted.
In conclusion, our findings are consistent with the Science
Board's findings regarding FDA's ability to fulfill its
regulatory responsibilities. Our findings also support the
Science Board's conclusions that the agency's work is
jeopardized by information technology and human resource
challenges. In addition, the small number of inspections
completed by accredited third parties has not assisted FDA in
meeting its regulatory responsibilities. This raises questions
about the ability of such third-party programs to quickly help
FDA fulfill other responsibilities.
Mr. Chairman, this concludes my prepared remarks. I would
be happy to answer any questions you or other members of the
subcommittee may have.
[The prepared statement of Dr. Crosse follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Stupak. Thank you, Dr. Crosse.
Ms. Shames, opening statement, please.
STATEMENT OF LISA SHAMES, DIRECTOR, FOOD AND AGRICULTURE
ISSUES, U.S. GOVERNMENT ACCOUNTABILITY OFFICE
Ms. Shames. Chairman Stupak and members of the
subcommittee, I am pleased to be here today to discuss FDA's
resources to meet its responsibilities for food safety.
There have been dramatic changes in the volume and variety
of foods FDA regulates. Further, changing demographics and
consumption patterns underscore the urgency for effective FDA
oversight. More of the population is and increasingly will be
susceptible to a foodborne illness. In addition, we are eating
more foods that are often associated with foodborne illness
such as leafy greens.
Today I will focus on three topics: GAO's designation of
the Federal oversight of food safety as a high-risk area,
opportunities to leverage resources in FDA's Food Protection
Plan that was released last November, and tools that can help
agencies address management challenges.
First, regarding food safety, FDA is one of 15 agencies
that collectively administer over 30 laws addressing food
safety. This fragmentation, as been noted earlier, calls into
question whether the government can promote the integrity of
the food supply. It is a key reason GAO added the Federal
oversight of food safety to its high-risk list and cited the
need for a government-wide reexamination of the system. For
many years we have reported on problems with the food safety
system including inconsistent oversight, ineffective
coordination and the inefficient use of resources. One such
problem worth nothing today is the mismatch between the
government's resources for food safety and agencies'
responsibilities. That is, as been noted, FDA regulates about
80 percent of the food supply but receives about 20 percent of
food inspection resources. To help the government as a whole,
we have recommended enacting comprehensive and risk-based
legislation and reconvening a council on food safety. Further,
with pressing fiscal challenges, a government-wide plan can
help Congress balance trade-offs when resource allocations are
made.
Second, FDA released its Food Protection Plan. This plan
proposes several positive first steps that are intended to
enhance food safety. GAO has recommended many of these
proposals over the last few years such as opportunities for FDA
to better leverage its resources, which is especially important
for FDA's food safety responsibilities. Unlike FDA's programs
for drugs and medical devices, FDA is not authorized to charge
user fees for its food safety activities. Some of our
recommendations are for FDA to establish equivalence agreements
with other countries, certify third parties and accredit
private labs for testing food.
We also found that FDA's food safety activities overlap
with, if not duplicate, other agencies' activities. To use
resources more efficiently, FDA could, for example, authorize
the Department of Agriculture to inspect jointly regulated food
processing plants and conduct joint inspector training programs
with USDA.
It is also important to note that FDA plans to request the
authority to order a food recall. As you know from the hearing
your subcommittee held last spring, food recalls are voluntary.
Federal agencies including FDA have no authority to compel
companies to recall contaminated foods except for infant
formula. In contrast, FDA has authority to recall unsafe
biological products and medical devices. Other agencies that
regulate the safety of products such as toys and tires have
recall authority and have had to use it when companies did not
cooperate.
While the Food Protection Plan proposes these positive
first steps, more-specific information about the resources and
strategies to implement the plan would facilitate oversight.
FDA officials told us resource information would be released
during the budget process. We were also told that
implementation plans detail timelines, actions and
deliverables. FDA officials do not intend to release these
implementation plans but will keep the public informed of their
progress. Nevertheless, without more information, it will be
difficult for Congress and others to assess the likelihood of a
plan's success.
Lastly, the Science Board cites numerous management
challenges that have contributed to FDA's inability to fulfill
its mission. GAO has identified some tools that agencies can
use to address their management challenges. For example, a
chief operating officer can elevate, integrate and
institutionalize responsibilities to address these challenges.
FDA recently spelled out the responsibilities for such a
position. GAO has found that a performance agreement can
promote further accountability. In addition, a well-designed
commission along the lines of the Science Board can produce
specific, practical recommendations that Congress can enact.
In conclusion, it is imperative that FDA is able to help
ensure the safety of the Nation's food supply in the most
efficient, effective, accountable and sustainable way. To do
so, leveraging resources and building capacity will be
critical.
This concludes my statement, and I would be pleased to
answer any questions.
[The prepared statement of Ms. Shames follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Stupak. Thank you, and thank you for your testimony.
Dr. Porter, your opening statement, please.
STATEMENT OF DONNA V. PORTER, PH.D., R.D., SPECIALIST IN FOOD
SAFETY AND NUTRITION, DOMESTIC SOCIAL POLICY DIVISION,
CONGRESSIONAL RESEARCH SERVICE
Ms. Porter. Thank you, Mr. Chairman. I would like to thank
you and the members of the subcommittee for inviting me to
speak today. My name is Donna Porter. I am a specialist in food
safety and nutrition in the Domestic Social Policy Division of
the Congressional Research Service. I am accompanied today by
my colleagues, Judith Johnson, Susan Thaul and Erin Williams.
Today, CRS is releasing a report that is a 28-year history of
the FDA's budgetary and statutory authority. I would ask that
the full report be included in the hearing record.
CRS takes no position on whether the FDA has the necessary
resources to meet its statutory responsibilities. However, the
report that we have prepared examines the agency's budget and
increasing statutory authority since 1980. It is intended to
help inform the debate on whether FDA's budget has kept pace
with the increasing demands that have been placed on the
agency.
In response to the CRS request for historic data, FDA cited
constraints on its staff time and indicated it would only be
able to provide data to us for very recent years. The data in
the report that we have completed was taken from the annual FDA
Budget Justification documents, which despite some limitations
provide reasonably consistent information over time.
I would like to describe four figures that are in the
report that I feel illustrate how the agency has fared in the
last quarter-century. Figure 1 shows the 28-year history of the
FDA budget and FTEs. Direct congressional appropriations to the
agency, adjusted for inflation, doubled during the time period
that we looked at. Over that same time, FDA received a 12-fold
increase in other funds, primarily user fees. As a result, the
overall FDA budget in fiscal year 2007 is 2\1/2\ times what it
was in fiscal year 1980.
Personnel, measured as full-time equivalent positions, or
FTEs, reflects a similar impact of user fees. Comparing the
fiscal year 1980 budget with fiscal year 2006 budget, the last
year for which complete FTE data was available, budget
authority-funded FTEs stayed about the same and the FTEs funded
by user fees increased 4-fold. Overall, there was a 19 percent
increase in total FTEs.
In general, direct appropriations have either been in line
with inflation or have gradually increased over time. The
exception was in fiscal year 2002, when Congress increased
direct appropriations to FDA by 23 percent in response to the
domestic terrorist attacks and the anthrax scare.
In figure 2, we have presented the FDA's food budget and
FTEs, and let me just say parenthetically the figures in my
testimony are numbered differently in the full report when you
go to the full report. Overlaid on this graph are the 11 major
statutes that were added to responsibilities to the food
program since 1980. Funding of the foods programs does not
include user fees, as you are all well aware. The slight budget
increases in the early 1990s can be attributed to the passage
of the Nutritional Labeling and Education Act and the somewhat
larger increase in the late 1990s can be attributed to former
President Clinton's Food Safety Initiative. Funding increased
markedly following the 2001 domestic terrorist attacks but
since then the foods budget has remained flat at its higher
level.
In figure 3, we have the human drugs budget and FTEs with
an overlay of the 14 new major statutes adding responsibility
to its program. This provides an interesting contrast to the
food programs' grab that we just looked at because of the
impact of user fees that have primarily supported drug review.
The apparent increase in FTEs and dollars in fiscal year 1983
through fiscal year 1987 reflects an agency reorganization that
combined human drugs and biological activities during that 5-
year period. We determined there was no way to decipher how
much was spent in each area during those years so we just left
them combined.
Starting in fiscal year 1994, user fees, which are the
upper parts of the bars that you are looking at, have become an
increasingly proportion of the overall resources available for
human drugs while at the same time congressional appropriations
have remained relatively flat. This figure also shows with the
growing gap between the two FTEs that the overall increase in
human drugs personnel is supported by user fees.
Finally, figure number 4 shows some information about FDA's
research program, which supports its regulatory mission. The
figure represents a 15-year history of FDA research spending in
the five major areas: foods, human drugs, biologics, animal
drugs and devices. Overall, the FDA research budget in fiscal
year 2007 has declined by about 50 percent since fiscal year
1993. Unfortunately, this was as far back as the data was
available for us to use.
Mr. Chairman, that completes my testimony. My colleagues
and I would be pleased to address any questions that you and
the committee may have.
[The prepared statement of Dr. Porter follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Stupak. Thank you, and thank you all for your
testimony.
Dr. Crosse, let me start with you, if I may. Did your audit
find that one database at the FDA showed that their foreign
inspections, the roughly 3,000 that there be in existence,
roughly 3,000 foreign firms and another database showed there
is approximately 7,000 foreign firms sending drugs here to this
country?
Ms. Crosse. That is correct. One system showed about twice
as many firms shipping drugs to the United States as were
registered in the other system.
Mr. Stupak. OK. And your report also found the FDA was
having significant difficulty with their statutory mandate
regarding these drug inspections. In fact, despite the experts
telling this committee that drug firms should be inspected
about once every 2 years, your audit found that overseas FDA
was only able to inspect on an average of once every 13 years?
Ms. Crosse. That is correct. We estimate that without any
growth in the number of firms overseas, at the current rate
they would only be able to get there about once every 13 years.
Mr. Stupak. OK, and then in medical devices, FDA by statute
again is supposed to inspect firms every 2 years domestically
and that has taken as much as 6 years to inspect high-risk
firms making class III devices?
Ms. Crosse. That is correct. The firms that are making such
devices as cardiac stents and the catheters that are used in
angioplasty procedures, and pacemaker electrodes, those firms
are being inspected about once every 6 years.
Mr. Stupak. OK, and then class II medical devices, they are
being inspected about once every 27 years?
Ms. Crosse. At their current rate, they are getting there
about once every 27 years. That is correct, for the foreign
firms.
Mr. Stupak. So if I am the FDA Commissioner, I am trying to
figure out what to do, would it be smarter then to use the
limited resources--we heard a lot about resources in the last
panel and I know you sat through these panels. Would it be
smarter then to direction to class III or to class II, or can
you not do it that way, prioritize it by severity or health
risk of the device being implanted in a human body?
Ms. Crosse. Well, I think they are doing some
prioritization. Clearly they are putting more resources into
getting to the class III device establishments more frequently
than the class IIs but they are not making that choice
completely to go to the class III facilities, to get to all of
the class III facilities before they do class IIs. That is a
choice they have not made.
Mr. Stupak. Well, the FDA recently announced last week that
they are going to establish offices overseas and especially
like China and India. Does the FDA have the regulatory
authority overseas to do what has to be done for a class II or
class III medical device inspection? Is there some question
about that?
Ms. Crosse. Well, certainly they don't have the same
authority to demand entry at a facility overseas as they do in
the United States but they do have the ability to stop those
products from being imported if those manufacturers do not
cooperate in an FDA inspection. I think it is a very positive
thing that they are trying to establish some presence overseas
because part of what these staff in the countries could do is
just to verify the information that is in the registration
system to even determine what facilities exist, where they are
located and what they are making.
Mr. Stupak. Well, besides just establishing an office
overseas, should you not have some kind of verification system
of manufacturing practices and certify the plant or the labs
that are producing these devices, especially for a class III
device?
Ms. Crosse. We certainly think the inspections are
absolutely needed as well. It is not just the verification. We
believe that they do need to be inspecting facilities at the
manufacturing site.
Mr. Stupak. Thank you.
Ms. Shames, let me ask you this. On page 11 of your
testimony, and you repeated it but I just want to--you note,
and I am quoting, ``FDA officials have declined to provide
specific information on how much additional funding it believes
will be necessary to implement the Food Protection Plan, saying
that finalizing the amounts will take place during the budget
process.'' Do you have any confidence that what will be
proposed in the budget process will be anything close to what
may actually be needed to implement these plans?
Ms. Shames. Well, of course we will have to see what does
come out in the President's budget that will be released in
February. Just give some examples again from the Science Board,
to update some of the guidelines, the food safety guidelines
that we are talking about, the Science Board estimates that it
will cost over $200 million. To update the IT system that was
discussed earlier, they said that it would cost hundreds of
millions of dollars. So FDA acknowledges that it is going to
cost more money but does not provide any specifics.
Mr. Stupak. In the past couple years' budget areas that you
looked at, has the FDA ever asked for a significant amount of
money to improve or implement these plans?
Ms. Shames. Well, in fact, the appropriations have gone up
slightly on the food side. In nominal terms they have gone up
slightly. In real terms they have actually declined. The point
that we have noted over the last couple of years is that GAO
has made numerous recommendations where FDA could leverage its
scarce resources by working with USDA to work jointly with some
of the training and some of the inspections. FDA can bring in
other parties as part of the food inspection, for example,
looking for equivalence agreements. It is only now in the Food
Protection Plan that was released a couple of months ago that
FDA appeared to be moving forward with that.
Mr. Stupak. Dr. Porter, let me ask you, if I may, on page
11 of your report is the following statement: ``Some members of
Congress have also expressed concern over FDA funding level and
have voiced their frustration at the inability to obtain
clarification from the agency on the adequacy of the FDA
budget.'' Your report then goes on to describe that many FDA
commissioners have while in their official positions said that
the agency does not need resources yet when they leave the
agency they tell a different story. In fact, you quote former
Commissioner Donald Kennedy who said the following, and I
quote, ``I hope you and your staff will be diligent in pursuing
FDA resource needs but you may have to rely on grizzly veterans
like me because budget authorities at HHS and OMB specifically
prohibit present officials in the agency from speaking out
publicly about the need for more funding. It is important that
the American public know that when they hear FDA officials say
they are satisfied with their budget allocations, they have
their fingers crossed under the witness table.''
Dr. Porter, as an expert on budget matters and given the
extensive concerns related to the lack of resources at the FDA
as described in the Science Board report, how would you advise
Congress to obtain the accurate figure of what the FDA truly
needs to protect the American public?
Ms. Porter. Well, Mr. Chairman, those kinds of comments
from Donald Kennedy and others were very consistent. There were
lots more of them that we might have put in the report but it
would have been totally redundant. What we did discover was,
there are several alternatives that are used by other agencies
in terms of communicating with Congress. One of those is the
professional judgment budget that Congress frequently asks the
CDC for and the alternative budget that the National Institutes
of Health Cancer Center provides, and I think that perhaps
there are some alternatives like those kinds of mechanisms that
might be used that Congress could explore with the agency as
ways to have something that doesn't go through the normal
budget process and filters out perhaps what the agency believes
is needed for various priorities.
Mr. Stupak. Well, I know like veterans have the independent
budget and then there are other organizations. Is there any
organization outside of the FDA that would advocate for a
different budget, an independent budget, a professional budget,
whatever you want to call it, has there ever been an
organization that would do that other than the Science Board
that gave their recommendations today?
Ms. Porter. Well, I am not aware of anything until very
recently. I mean, there is, you know, considerable literature
out there where people have talked about the agency's problems
over the years but I think that it has been more individuals
until very recently when the alliance was formed of people who
are former agency officials, commissioners, secretaries of
health and various other high-ranking people, who have
expressed considerable concern and much of their experience is
from inside knowledge of the agency. Now that they have stepped
away from the agency, they are more comfortable I think with
expressing what they feel is needed for the agency so that it
can go forward.
Mr. Stupak. Right, and Mr. Hubbard has testified once or
twice before this committee but that is recent vintage. I don't
know of any other organization or group.
Ms. Porter. I am not aware of any other organizations per
se. Well, there have been a couple of organizations out there
who feel that what FDA does is that they have too much
authority and they shouldn't be doing some of the things----
Mr. Stupak. Well, you are always going to find that.
Ms. Porter. Those are the only other organizations I know
of.
Mr. Stupak. Thank you.
Mr. Shimkus.
Mr. Shimkus. Thank you, Mr. Chairman. I appreciate the
second panel being here. Sorry about how crazy our lives are.
Dr. Porter, 1980, is there a reason why 1980 was chosen?
How far--I mean, in a timeline of the FDA, which is very old,
why 1980?
Ms. Porter. I should start by saying I climbed on board at
CRS in 1980 so my----
Mr. Shimkus. It works for me.
Ms. Porter. But more importantly, that was the year that
Mr. Reagan was elected President and he wasn't real hip on
regulatory agencies and started a major effort to re-regulate
parts of the government or at least do regulatory reform, and
in some of my reading back over what had happened in the last
30 years, that seemed to be a good point at which to start to
look at where FDA as well as many other regulatory agencies
were falling behind in terms of the budgets that they had, you
know, had up until that point and the cutbacks began.
Mr. Shimkus. The issue is the 1980, 1981 would be really
Carter Administration budgetary numbers, fiscal year.
Ms. Porter. Yes, just for a year though.
Mr. Shimkus. Just raising that for the sake of clarity and
transparency. Let me move on because----
Ms. Porter. We had budget documents going back that far so
that partly was our starting point since we were unable to get
the information out of the agency.
Mr. Shimkus. Right. That is fine. Resourcing is a clear
issue that has been raised, and I think that has been really
well vetted. I think there is valid concern. In the chairman's
opening statement, and I felt very proud to hear it, was that
it is not always resourcing, it is also efficiency, it is also
management, it is also transforming. You go from 1980 until
today: Who heard about biologics? Who heard about the
importation? Third World countries sending drugs to this
country? And it is really a different era. So my focus will be,
again, accepting the premise that resourcing has been vetted,
what about management? And I want to turn to Dr. Crosse. You
encountered in your evaluation at the FDA some problems that
also were not just resource identified. Is that correct?
Ms. Crosse. Yes, I would say so, although we were not doing
a systematic evaluation of the management of the program. In
trying to gain information from the agency, we asked for such
things as copies of whatever monthly reports they put together,
whatever information they might have for managing their
resources and how they were allocating their workload, at what
rate staff were meeting the established goals, and we were told
that they don't have such reports. Now, how much of that is
traceable to IT problems, I can't say, but clearly they were
not setting out with the mindset of trying to manage the
program and all of the human resources that they have in place.
It just wasn't the way they were approaching this work.
Mr. Shimkus. Which is a valid point. Our Federal employees
do a great job, given the paradigm that they find themselves in
Federal agencies, but many of us believe--of course, they don't
have the pressure that is placed on them from the competitive
market to not only provide a great service at a low cost but
also when business has to do that, they are going to be held
accountable for the safety of that through litigation system or
through consumers fleeing the product, and so the built-in
process of reevaluation sometimes you don't find in a Federal
agency. Is there anything you can point to, an example of where
that might be true in the FDA evaluation?
Ms. Crosse. Well, I don't think I would put it down to the
lack of the kind of competitive pressures that exist in the
private sector.
Mr. Shimkus. I am a competitive-market Republican so I
believe that everything is solved by that.
Ms. Crosse. I mean, I think these folks are working
extremely hard to try to work within the limited resources that
they have. I think to some extent, or at least in some parts of
the organization, that the mindset though is more of trying to
deal and wrestle with some of the scientific challenges that
they have rather than taking an orientation to specifically try
to manage it in the way that someone with an MBA background
might.
Mr. Shimkus. Right, and I think that is the flipside of
this coin on resourcing is, management--I mean, we are willing
to talk about resourcing with the Majority but of course there
will be a desire to see results and real transformation of an
agency to be able to be accountable, to be able to pull up
documents, to be able to follow through the processes and not
experience the difficulties that some folks had in trying to
gather information, and I hope that we move in that direction.
Mr. Chairman, I yield back.
Mr. Stupak. Let me ask a couple questions while all the
members are coming down here. We were talking earlier about not
getting the numbers, financial numbers as to some of these
plans. Back in November, the President's Interagency Working
Group on Import Safety submitted this action plan for import
safety. This is November of 2007. And then the other one again
right around November, again November 2007, Food Protection
Plan. Did any of you come across any evidence that these were
being implemented, either the Food Protection Plan or the Plan
for Import Safety?
Ms. Shames. Both documents are high-level frameworks of
proposed actions. At least for the Food Protection Plan, we
found that those proposals are consistent with recommendations
that GAO has made over the last couple of years and that is why
we feel as a start it is very positive.
Mr. Stupak. Well, they recognized it, but did they begin
implementing it?
Ms. Shames. No, no, we are told that their implementation
plans have specific time frames, deliverables, accountable
parties. We are told that they are not going to be made public,
and while we recognize that implementation plans need to be
nimble and flexible and the real world is very dynamic, on the
other hand certain transparency helps in terms of
accountability, allows you to see exactly what progress is
being made. Likewise plans can engender some buy-in for what
FDA's priorities ought to be. There is a shortage of resources
and clearly there needs to be some sort of priority.
Mr. Stupak. In fact, actually in your testimony you said,
``Without a clear description of resources and strategies, it
will be difficult for Congress to assess the likelihood of the
plan's success in achieving the intended results.'' It would be
also difficult to get any kind of resource commitment from
Congress if we don't know what the plan is.
Ms. Shames. Exactly.
Mr. Stupak. Are these the ones where you couldn't get any
monetary, the resources it would take or the cost it would take
to implement these plans? You could not get the financial
information? Is that correct?
Ms. Shames. Well, we are interested in more detailed
information overall, but certainly in light what the Science
Board is saying for resources, that of course is of critical
importance. We have noted too though that FDA is one of 15
agencies. So if are you looking at food safety, it really needs
to be looked at from a government-wide perspective. There is a
structural imbalance in terms of the resources that USDA gets
versus FDA despite the responsibilities that each agency has.
Mr. Stupak. Let us go from food safety to drug safety, Dr.
Crosse. I read somewhere that about 80 percent of the active
ingredients for pharmaceuticals come from overseas now.
Ms. Crosse. That is my understanding, yes.
Mr. Stupak. OK. And we were talking about inspection
earlier, like 27 years for class II medical devices. I am
looking at your report, page 25. It is table number 2, the
FDA's inspection of foreign establishments involved in the
manufacture of drugs in the U.S. market, and China by far is
the largest. It has grown since 2002 to a number up there, 714
different establishments, we believe, but yet they are only
inspecting 10 to 15 per year, correct?
Ms. Crosse. That is correct, yes.
Mr. Stupak. So if you have 714, we are inspecting 10 to 15
per year, if my math is correct, that would be about 40 to 50
years before you would get around to inspecting them again.
Ms. Crosse. Yes, if the rates do not increase, that is
correct.
Mr. Stupak. Now, India and China are the largest producers
of these pharmaceutical ingredients that are coming here to the
United States. When you open an office in India or China, you
still need some kind of a jurisdiction to make the number and
resources to make the inspections that are necessary to close
that gap of 40 to 50 years down to 2 or 3 years as it is
domestically, correct?
Ms. Crosse. Yes, they would have to add resources to be
able to do that.
Mr. Stupak. The question is probably obvious, but would you
explain to us why is it important that you have these
inspections? What is so important about it? How do you
guarantee the safety of the drug being made or the
pharmaceutical being manufactured? Just explain in your own
words for pharmaceuticals and medical devices, why is it so
important to do these inspections?
Ms. Crosse. Well, I think they need to go to the facilities
to see what kind of physical infrastructure exists in these
locations, to see what the production lines are, to see what
kind of quality control procedures the facility has in place,
how they are doing their own testing and measurement of either
the drugs or the devices, to ensure that they are meeting the
specifications. These are not products that one can readily
just check at the border in the way that you can take a small
sample from a food shipment perhaps and send to the lab. A
medical device may be a very expensive piece of equipment. They
may come in small quantities. You would have to essentially
destroy that piece of equipment in order to test it against
specifications, or it would no longer be sterile. So your best
approach there is to actually see what kind of production line
is in place and what kind of quality procedures that company
has to ensure production of a piece of equipment.
Mr. Stupak. Well, isn't this what the FDA has said in some
of these reports that what the FDA calls building quality into
the system? Is that what they are talking about by doing more
inspections at the manufacturing site?
Ms. Crosse. Well, I think that is one component of what
they are talking about. I think there are a number of kinds of
checks and balances that they hope to put in place but
certainly inspections are one piece of that.
Mr. Stupak. Thank you.
Mr. Shimkus?
Mr. Shimkus. Just for a second, Mr. Chairman, just to
follow up on this debate. My colleague makes a good point in
the setup of this discussion. We will never have enough
resources. If the growth continues in these areas, I mean, how
do we ever get there? So what we will need is, what is the
solution? Where should we go or how do we manage this? I don't
know if we have the answer but that is the great thing about
the Oversight and Investigation Subcommittee. We start posing
the questions, and the committee's jurisdiction, part of us
will start trying to address those, but maybe it is training
and really international agreements based upon training in
which we are partnering with these countries that want access
to our markets where we are spreading the risk and we can be
assured of the quality. Otherwise if we expect it to all be
done in our arena, I am not sure how we ever get there, but it
is a great question and I just pose that as a solution. There
are probably many more. But that is a concern. I don't know if
anyone wants to comment on that. Dr. Crosse?
Ms. Crosse. I would just comment, I mean, I think something
like the accredited persons inspection program held great
promise. It held out the possibility of a company having one
inspection performed to meet the requirements of multiple
countries, so many of these are international firms. I think
the great disappointment there is that it has not been taken up
by industry. Really, industry has been very, very slow and in
fact has been slow to cooperate in allowing the inspectors to
be trained to participate in this program. And so that would
have provided or may still yet provide an opportunity to
leverage resources where you are not having to just build the
FDA inspection force, you have outside inspectors who can be
accredited to do the inspections to meet the standards of all
of these countries. So far it has been very, very slow in
taking off.
Mr. Stupak. If I may, but why would you go to a voluntary
inspection plan if you know the FDA isn't going to show up for
at least 27 years, or if it is active pharmaceuticals, 40 to 50
years, why would I, as a manufacturer, why would I submit
myself to a voluntary thing because I know they will never
come?
Ms. Crosse. I think that is one of the reasons that it has
not taken off more quickly. I would agree that given the very
low rate of inspections by FDA in some of these countries,
there is no incentive.
Mr. Shimkus. I don't have anything to add other than we
would just hope for better, and I appreciate the time. Thank
you, Mr. Chairman.
Mr. Stupak. This idea about opening offices overseas came
up last fall after we had our inspectors in China and India,
both the Minority and Majority staff were over there in August
and they came up with great ideas, and that was just one of
them. I think we will have the Commissioner next and we can
explore that a little bit further with him.
Thank you to this panel. Thank you very much for your time
and your insight into this issue. Thank you.
We would now like to call our last witness and the third
panel would be Dr. Andrew von Eschenbach, Commissioner of the
FDA. It is the policy of this subcommittee to take all
testimony under oath. Please be advised, sir, that you have the
right under the rules of the House to be advised by counsel
during your testimony. Do you wish to be represented by
counsel?
Dr. von Eschenbach. No, sir.
Mr. Stupak. OK. You are already standing, so we will take
the oath.
[Witness sworn.]
Mr. Stupak. Let the record reflect the witness replied in
the affirmative. You are now under oath, sir. If you would
please give your opening statement, and thank you for being
here and thank you for sitting through this hearing today. We
appreciate it.
STATEMENT OF ANDREW C. VON ESCHENBACH, M.D., COMMISSIONER, FOOD
AND DRUG ADMINISTRATION
Dr. von Eschenbach. Thank you very much, Mr. Chairman, Mr.
Shimkus and members of the subcommittee. I want to truly
express my gratitude to you and your colleagues for the
opportunity to discuss the importance of maintaining a strong
scientific foundation at FDA. This is the science that is
necessary to enable the agency to not only respond to a rapidly
and radically changing world but even more important to lead
the future of FDA's regulatory processes and decisions. Our
work must be both science-based and led by science.
I have invested my entire professional career in the world
of scientific discovery and development that has led and made
possible fields like genomics and molecular biology and frankly
a whole host of disciplines that were unknown when FDA began
its mission to protect and promote the public health or even a
few decades ago. However, this science now makes it possible to
do things like protecting and eliminating chemical and
microbial contamination of water, our food and the environment.
This science can give hope to patients with incurable cancer,
to those living with AIDS or diabetes or in fear of
Alzheimer's, stroke or heart disease. So as science makes these
solutions possible, it is and must be science that will enable
the FDA to ensure that these solutions, these products are safe
and efficacious when they are delivered to the American people.
As Commissioner of Food and Drugs, I take that responsibility
very seriously to be able to modernize and improve FDA's
scientific infrastructure as it is a critical element for
success in the future of our regulatory mission. But the real
questions, Mr. Chairman, are what science and how best to
create a portfolio that is different because by its very nature
of its regulatory purpose, the science and research being
conducted at FDA is unique and different from that at NIH and
academia and perhaps even in industry.
Mr. Chairman, based on all my experience, I know that FDA
must ask the question not whether our science is excellent but
more importantly, is our science aligned for the challenges of
today and of tomorrow. And in order to help address that issue
and issues regarding our scientific portfolio, I asked the
chairman of our Scientific Advisory Board to help us look
ahead. The Board reached out beyond its membership to include
ad hoc experts to make up a subcommittee to conduct the review.
They worked for nearly 12 months to prepare the report that we
are discussing today. Let me state, I am extraordinarily
grateful for the incredible hard work and productivity of this
committee and they have provided important insights into both
the opportunities and the challenges facing the agency. I take
their report very seriously and I want to assure them and the
committee that it will be used to formulate the initiatives and
serve as a basis for resource investments that will perpetuate
the scientific excellence of FDA as a regulatory agency.
We already have work underway to address some of the
challenges and opportunities that they have defined. Let me
focus on one brief example to confirm the statement. Allow me
to address an issue of information technology, which was a
major theme of the report and something that has been
highlighted repeatedly in today's testimony and even by your
opening statement. FDA needs a modern information technology
infrastructure to support a science-based and a science-led
regulatory agency, and if I could have the chart portrayed for
you or the graphic that is up on the screen.
[Slide.]
In 2006, when I arrived at the FDA and assessed that
information technology infrastructure, we were dealing with a
wide diversity of servers or equipment. Much of it had an
average age of more than 8 years and was only working at about
30 percent efficiency. We rapidly began to reform and
rejuvenate this information technology infrastructure, and you
can already see by this year in 2008, we have made progress in
streamlining the system, replacing antiquated equipment and
improving the efficiency and our targeted and projected by
virtue of the information technology plan that we have put in
place to be able to totally modernize that system within the
next two years. The work has begun but the work is not
finished. We have much that needs to be done and this report
will be an important contribution as FDA continues on that
trajectory, not only in information technology but all the
other elements of our scientific portfolio.
Let me be frank, Mr. Chairman. I am here today to testify
to Congress and the American people that we should be proud of
the performance of FDA as it remains the world's gold standard
as a regulatory agency but more importantly, I am here today to
work together with you to address the challenges that we face
and how important it is to continue to make this agency even
greater and able to respond to the rapidly changing world
around us. We are not here today because of what is wrong with
the FDA but what is right and must get even better. There are
nearly 10,000 individuals in that agency who serve the public
every day and the caliber and quality of our current scientists
is unparalleled and the commitment of our workforce is truly
amazing. Every day these public servants work to protect the
American people, whether it is preventing botulism in canned
food or evaluating medical devices that are saving lives. Each
and every employee is serving this country well, and I assure
you, Mr. Chairman and the public, that the FDA employees are as
committed as you to continuously improving this agency. It has
become the world's standard because of our science and we are
here to work together to determine how best to continue that
proud tradition.
The American people are blessed and grateful for the fact
that their FDA has the world's finest scientists with this
unparalleled track record and we need to continue to assure
that they have the tools of modern science and technology
available to them to continue that record of accomplishment, to
expand their size and skills of that workforce and to be
certain that they have state-of-the-art laboratories whether it
is in the field or currently in development at our facility on
the White Oak campus, and I am happy to be here today to
discuss the plans that we have to achieve the mutually
important goal that you have laid out for us. Thank you, Mr.
Chairman.
[The prepared statement of Dr. von Eschenbach follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Stupak. Thank you, Commissioner. I thank the Science
Board, and I hope the questions and comments by the members up
here show the deep respect we do have for the FDA and its
employees. There is no doubt that some of the problems we see
facing the FDA is not just the FDA's own creation. All of us up
here also share some of that responsibility, and sometimes we
express that frustration. It should not reflect our deep
respect for those employees who work day in and day out for the
FDA.
Dr. von Eschenbach. Thank you, Mr. Chairman.
Mr. Stupak. The Science Board report, I take it you have
read it?
Dr. von Eschenbach. Yes, sir.
Mr. Stupak. What were one or two things that were most
surprising to you with that Science Board report? And by the
way, thanks for putting together Science Board. I did say in my
opening it was you that put it together in 2006 and we do
appreciate that, and I have more questions about that but go
ahead. What were one or two things you found most surprising
about this report?
Dr. von Eschenbach. Well, sir, let me be candid and tell
you that I didn't generally find things that were surprising
about the report. I did appreciate the very significant
emphasis that the report placed and the appreciation that they
were able to develop about the importance and insight into many
of our scientific needs. I would tell you that for example,
their attention to the importance of information technologies
and that infrastructure and that would be required to support
our endeavor was an extremely important contribution. Their
ability to lay out the scientific portfolio that helped us to
be able to define and address new trajectories of science
including, for example, references to nanotechnology and to
systems biology, for example.
Mr. Stupak. Well, let me ask you this. On page 6 of the
Science Board report, and it has been quoted earlier, it says
because the agency lacks resources in many key areas that lives
are now at risk, and I quote directly from the Science Board:
``In contrast to previous reviews that warned crisis would
arise if funding issues were not addressed, recent events and
our findings indicate that some of the crises are now realities
and American lives are at risk.'' You didn't find that
surprising?
Dr. von Eschenbach. No, sir, because I think that is
consistent with all of the things that I have been stating and
addressing and attempting to approach. We have recognized the
world has radically changed around us. We are recognizing that
we have to change within FDA to be able to adapt to the
challenges.
Mr. Stupak. One of things to help you change will be
resources. When you were at the Cancer Institute, did you not
have a budget other than the administration's budget that was,
what, a bypass budget?
Dr. von Eschenbach. Congress in 1971 would have passed the
National Cancer Act providing unique authorities for the
National Cancer Institute to have the opportunity to present a
budget directly to Congress.
Mr. Stupak. Is that a bypass budget or a professional
budget, I think was another word we heard?
Dr. von Eschenbach. Euphemistically referred to as a bypass
budget.
Mr. Stupak. Has there been anything like a bypass budget or
anything similar to that at the FDA?
Dr. von Eschenbach. I am not aware of that being available
to any other agency within NIH or to the FDA.
Mr. Stupak. Well, you heard Mr. Hutt's testimony about how
you have a hollow government syndrome here, that in the next 2
years there should be 50 percent more employees over 2 years at
the FDA, double the funding for 2 straight years then maintain
a 5.8 percent yearly budget. Do you agree with that?
Dr. von Eschenbach. I agree that the FDA needs additional
resources. I have asked for those additional resources as I
came to FDA. I think what I have continuously stated has been,
it is first and foremost to define what needs to be done. That
is why I asked for this report. Once we have defined that----
Mr. Stupak. But do you agree with Mr. Hutt?
Dr. von Eschenbach [continuing]. Create the business plan.
Mr. Stupak. But do you agree with Mr. Hutt's estimations
what you need?
Dr. von Eschenbach. I cannot agree with Mr. Hutt's
estimations because they are just that, estimations.
Mr. Stupak. OK. Then what----
Dr. von Eschenbach. I need to be able to bring forward an
appropriate investment strategy that would----
Mr. Stupak. What is your investment strategy then for the
2009 budget?
Dr. von Eschenbach. That will be presented by the President
next week.
Mr. Stupak. OK. But what is your recommendation? You said
you have made recommendations. What was your recommendation to
the OMB, Office of Management and Budget, to Mr. Nussel for the
FDA to improve resources?
Dr. von Eschenbach. My involvement was to present to the
Secretary----
Mr. Stupak. OK, Secretary Leavitt.
Dr. von Eschenbach [Continuing]. Request for additional
resources.
Mr. Stupak. OK. Did you request additional resources?
Dr. von Eschenbach. Yes, sir, I did.
Mr. Stupak. How much?
Dr. von Eschenbach. That will be presented in the
President's budget.
Mr. Stupak. So you don't want to tell us?
Dr. von Eschenbach. It is the purpose of the President to
present his budget next week.
Mr. Stupak. Oh, sure, and the President may agree or not
agree with you so we would like to have a yardstick, a baseline
to measure by. Did he accept your numbers or did he go lesser
or more?
Dr. von Eschenbach. I will along with you await the
President's declaration of his budget.
Mr. Stupak. I don't have the President here so I guess I
have to ask you. What is the amount you----
Dr. von Eschenbach. I don't have the President here either,
sir. When he is presenting his budget----
Mr. Stupak. So you are not allowed to testify what your
request is?
Dr. von Eschenbach. I am not in a position to testify today
to the President's budget.
Mr. Stupak. Why aren't you in a position to testify?
Dr. von Eschenbach. Because he hasn't released it yet.
Mr. Stupak. So you are not allowed to say anything until
the President releases his budget?
Dr. von Eschenbach. After he releases the budget, we can
speak to the budget.
Mr. Stupak. So then you will come back then in 60 days and
talk about his budget?
Dr. von Eschenbach. I will be happy to come back in 60 days
once the budget is released.
Mr. Stupak. Will you come back in 60 days to talk about
implementation and what you have done to implement the Science
Board's recommendations?
Dr. von Eschenbach. Yes, sir, I look forward to that and I
would also even at this point assure you that we have been
consistently working to both implement many of the things that
the report surfaced as important agendas for FDA and in
addition to that following the report's presentation to the
last meeting of the Scientific Advisory Board and that report
became public, I disseminated that report within the agency and
have asked each of our center directors to directly respond to
the recommendations in that report and bring forward their
operational plans. Many of those things are already underway.
Mr. Stupak. Great.
Dr. von Eschenbach. And I would be happy to come back and
report----
Mr. Stupak. Is 60 days enough time?
Dr. von Eschenbach. In 60 days I will be able to report to
you progress and I will look forward to continuously reporting
progress. This is not going to get fixed, Mr. Chairman, within
one intervention.
Mr. Stupak. Oh, I know that.
Dr. von Eschenbach. It will be an ongoing effort with
ongoing investment in the resources that it is going to take.
It is not a 1-year budget solution and it is not a plan that
can be accomplished in 1 year.
Mr. Stupak. Right. And you know me. I will follow through.
This is I think our fifth hearing with the FDA and I expect at
least five more before the end of the year. Since I have to ask
Secretary Leavitt when he comes about the budget and I know he
is coming in a couple weeks to talk about the whole of the HHS
budget, we will ask about FDA.
Let me ask you this and then I will turn it over to Mr.
Shimkus for questions. Are you pleased with what the President
will be presenting in his budget for the FDA?
Dr. von Eschenbach. Well, when the budget is released by
the President, then I will be in a position to be able to
comment.
Mr. Stupak. So you can't determine if you are pleased or
unpleased until it is released?
Dr. von Eschenbach. Not until the President releases the
budget.
Mr. Stupak. You guys got to lighten up. OK.
Next for you.
Mr. Shimkus. Thank you, Mr. Chairman.
Dr. von Eschenbach, thanks for coming. You became the head
December 13, 2006. I really do applaud those political
appointees who answer the call to serve in the final cycles of
an Administration. We saw a lot of people leave in the last
year, the last 2 years to do other things. Thank you for
serving because government service is not all it is cracked up
to be. It is very difficult and very demanding and I do
appreciate it, and thank you. As director of the National
Cancer Institute, a nationally recognized--I can't pronounce
it. I am an infantryman, you are a Navy guy. Infantrymen, we
don't go past two-syllable words. So urologic oncologist and a
cancer survivor listed in the Best Doctors in America
publication, and again, a lieutenant commander in the United
States Navy Medical Corps. So you come with a great background
of service as a practicing physician but also as you move up
the ladder you get involved in major medical institutions and
the management aspects. I wrote down in listening to the
question, I really have--we of all people, I don't--we never
have anybody who comes to Washington, D.C., asking for less
money. We never do. And I don't know of a single scientist who
would ever tell anyone I want less money, because the more
money they have, the more science and the more research they
can do. It is just a fact of life. And then we have the
budgetary authorization battles and the appropriation battles.
We have been trying to focus on management and things that we
can do. You were starting to talk about change and adapt. Are
there some change-and-adapt issues with the Science Board that
you can or already have started implementing that creates
quality assurance and efficiencies that you would like to bring
out?
Dr. von Eschenbach. Absolutely, Mr. Shimkus. I think it is
extremely important for me as, if you will, the CEO of the Food
and Drug Administration, to reflect to Congress and the
American people that it is not just how much money we spend but
how we spend it, and there are extremely important management
issues which need to be addressed at FDA in addition to the
resource issues, and I have been attempting to respond to both
of those challenges. One of those things I did was to bring a
highly skilled, highly reputable chief operating officer, which
is in fact consistent with many of the reports and
recommendations you have heard today. That chief operating
officer has gone through a very systematic process of us being
able to create better administrative and management
infrastructure.
Let me talk about that specifically with regard to then the
hiring of a chief information officer. We have heard that FDA
has had many chief information officers in the past but under
this new system we brought a chief information officer in who
was not only highly skilled but we empowered him to be able to
start an integrative process across the agency which would
create the interoperability that is necessary if we are going
to have the right kind of data systems and databases with which
to extract information that we can make intelligent regulatory
decisions with. What you saw in that display I put up initially
was what was inherited in 2006 was a highly decentralized
system where individuals were buying servers and infrastructure
for very specific needs and they were only running at 30
percent efficiency. They were spending over $200 million a year
just to maintain what had already become antiquated equipment,
and it wasn't an issue of how much money do we need to spend in
IT, we needed to spend more and we have spent more, but how can
we spend it even better, and that is what you are beginning to
see in that trajectory, that even within 2 years we have made
great progress in beginning to create an entirely new IT
infrastructure.
But we didn't stop there. We brought everyone together in
terms of what we now call the Bioinformatics Board, which is
co-chaired not only by our chief operating officer but most
importantly by our chief medical officer, to really ask the
question, what are the right programs that need to be running
on that IT infrastructure so that we will accomplish mission.
And one of the things that we have been working on in that
regard that is indirectly aligned with Congress's issues and
concerns around the implementation of the Food and Drug
Administration Amendments Act is what we would call sentinel
network, and this provides us the information or technology
infrastructure and programs that we will be able to do post-
market surveillance, which I know is an issue of great
importance to this committee.
Mr. Shimkus. Thank you, Mr. Chairman, and I yield back.
Mr. Stupak. Thank you, Mr. Shimkus.
Mr. Dingell for questions, please. Mr. Shimkus is finished.
Mr. Dingell. Mr. Chairman, I am happy to defer to Mr.
Shimkus first.
Mr. Stupak. He already had his questions and now he is
deferring to you.
Mr. Dingell. Very well. I want to thank you, Mr. Shimkus,
and I thank you, Mr. Chairman. First of all, Mr. Chairman, I
ask unanimous consent that the record be kept open to include a
letter from me to Dr. von Eschenbach and his response to us.
Doctor, welcome to the committee. We have a list here of
items which the Science Board makes report to you and quite
frankly, it indicates that FDA has very little capacity to
carry out its mission. We will submit a letter to you asking
how much it will cost each of these items to be fixed and what
you intend to do about each of these. Now, the Science Board
had an interesting remark to make. On page 21 it says, ``During
the past 35 years a decrease in funding for inspection of our
food supply has forced FDA to impose a 78 percent reduction on
food inspections at a time when the industry has been rapidly
expanding and food importation has exponentially increased. FDA
estimates that at most it inspects food manufacturers once
every 10 years and cosmetic manufacturers even less
frequently.'' Is that true?
Dr. von Eschenbach. It is true, sir, that we need to
improve our----
Mr. Dingell. Thank you. Now, Doctor, I note that FDA
inspection of foreign and domestic food establishments is
referred. In the table it says that FDA conducted 35,000
foreign and domestic establishment inspections in 1973. By 2006
this number had fallen to 7,783. In recent investigations by
this subcommittee, your staff told ours that the volume of
imports is doubling every 5 years. Is that true?
Dr. von Eschenbach. The imports are doubling and our
foreign inspections are increasing as well, sir.
Mr. Dingell. It is true. Now, Doctor, the Science Board
report suggests addressing food safety issues will cause
upwards of at least $250 million. Do you agree or disagree with
that statement?
Dr. von Eschenbach. Mr. Chairman, I believe that it is
going to require an investment over time for us to be able to
continue to implement our food protection plan which we
presented. I have requested additional funds for this and have
applied funds in 2008 and will be applying funds in 2009 in a
continuous trajectory.
Mr. Dingell. Now, Doctor, the Science Board again says,
``FDA does not have the capacity to ensure safety of food for
the Nation.'' Is this a true statement or not?
Dr. von Eschenbach. No, sir, I don't believe that is true.
Mr. Dingell. You don't believe it is a true statement? You
disagree?
Dr. von Eschenbach. I believe we are assuring the food
safety.
Mr. Dingell. Let me quote it again. It says, ``does not
have the capacity to ensure the safety of food for the
Nation.'' Do you agree with that statement or not?
Dr. von Eschenbach. No, sir.
Mr. Dingell. You don't agree.
Dr. von Eschenbach. I believe that we need to continuously
expand and improve our capability to respond to the changes
that are occurring in our food supply.
Mr. Dingell. You admit the huge decline in the number of
inspections made both of domestic producers, manufacturers and
processors and of foreign processors and that goes across food,
drugs and cosmetics. Is that not true?
Dr. von Eschenbach. Yes, sir. I believe----
Mr. Dingell. Very good.
Dr. von Eschenbach [continuing]. We need to increase
foreign inspections.
Mr. Dingell. Now, the finding, it says this,
``Recommendations of excellent FDA reviews are seldom
followed.'' This is page 56. Do you agree with that finding or
not?
Dr. von Eschenbach. Sir, under my opportunity to lead this
agency, I have asked for external reviews and I have responded
to this external reviews including the Institute of Medicine
report, including our ability to bring forward----
Mr. Dingell. Doctor, is the statement true or not?
Dr. von Eschenbach. I can only speak to my experience, sir.
In my experience, I have----
Mr. Dingell. So you are telling me that the statement is
not true?
Dr. von Eschenbach. I cannot----
Mr. Dingell. You are going to get some mail on this so you
better answer this question carefully.
Dr. von Eschenbach. Well, I appreciate the question, Mr.
Chairman, but I am attempting to respond to it in the context
of my experience at FDA, not that of my predecessors.
Mr. Dingell. They come forward, Doctor, with another
finding. ``FDA cannot fulfill its mission because its
scientific base has eroded and its scientific organizational
structure is weak,'' page 3. Do you agree with that statement
or not?
Dr. von Eschenbach. No, sir. I believe the scientific base
of the FDA is strong but it needs to be stronger to respond to
the emerging challenges and changes that are occurring in the
world in science and technology and in the products that we are
called upon to regulate. So it is not that it is bad, Mr.
Chairman. It is that it is at a level of excellence that needs
to continue to improve and continue to expand.
Mr. Dingell. Now, I understand that you have not been
allowed to comment on the Science Board report, suggesting that
addressing food safety issues will cost up to $250 million.
Given that, I am curious. How can GAO expect to get the numbers
on these matters either from you or the Administration?
Dr. von Eschenbach. Well, Mr. Chairman, there is nothing
that says I have been told I cannot comment. What I have tried
to express very carefully is that it is important to define
what needs to be done and how that process can be carried out--
--
Mr. Dingell. Well, let us----
Dr. von Eschenbach [continuing]. And then assign a cost to
that.
Mr. Dingell. Let us end the remaining time which I have and
have you tell us how much will be the amount of money which you
will require to carry this out properly.
Dr. von Eschenbach. Mr. Chairman, what I am attempting to
do is to create a plan which I have promulgated, the Food
Protection Plan, which has both authorities that are going to
be required from Congress as well as programs that are going to
require additional appropriations. We will build the business
plan as to what the cost of those investments will be and their
source. Some of it will come from appropriations, some of it
will come from user fees----
Mr. Dingell. Let me raise one last question. Regarding your
IT system, they made some very adverse comments on your
operations in disaster recovery plan having no continuity in
your agency's IT system. Were you surprised by that finding,
yes or no?
Dr. von Eschenbach. No, sir----
Mr. Dingell. Why not?
Dr. von Eschenbach [continuing]. And we are in the process
of addressing that and remedying that.
Mr. Dingell. Now, Doctor, then on page 5 the report notes
that FDA has inadequate emergency backup systems in place and
recent system failures have resulted in loss of FDA data. Is
that true?
Dr. von Eschenbach. Yes, sir, and we are continuously
remodeling----
Mr. Dingell. And it also----
Dr. von Eschenbach [continuing]. And improving that.
Mr. Dingell. It also says that there is no backup of these
records which include invaluable clinical trial data. Is that
true?
Dr. von Eschenbach. The records that we have been receiving
and previously have been primarily in paper form and we need to
transition to----
Mr. Dingell. The answer really to the question I ask is yes
or no, is there backup or is there not?
Dr. von Eschenbach. There needs to be better backup.
Mr. Dingell. Thank you.
Mr. Chairman, I have used your time. Thank you.
Mr. Stupak. Thank you, Mr. Dingell. Mr. Barton for
questions, please.
Mr. Barton. Thank you, Mr. Chairman.
Thank you, Dr. von Eschenbach. I have been watching the
hearing on television as I have scurried before the three
subcommittees that are in action at one time. Mr. Dingell is
setting a record for number of subcommittees meeting
concurrently and it makes it hard for he and I both to be all
three places.
Let me start out by asking about the genesis of this
subcommittee report. How did that come about, the report that
we are reviewing today? Who originated or asked that report be
done?
Dr. von Eschenbach. I did, sir.
Mr. Barton. You did? So this is something that you asked
for?
Dr. von Eschenbach. Yes, sir.
Mr. Barton. Were you forced to ask for it or----
Dr. von Eschenbach. No, sir.
Mr. Barton. You did it of your own initiative?
Dr. von Eschenbach. Yes, sir.
Mr. Barton. Now, would you have been surprised if this
subcommittee had reported back that everything was just hunky-
dory and pink and rosy and they had more money and people and
systems were operating at 100 percent efficiency and they were
really insulted that you asked them to waste their time doing
this report? Would that have surprised you if they had given
you that kind of----
Dr. von Eschenbach. Shock might be a better term.
Mr. Barton. So it is not a surprise that you have asked
this subcommittee to do a thorough analysis of the FDA and how
it can be improved and what its shortfalls were and, and lo and
behold, they gave you such a report. That is kind of what you
expected, isn't it?
Dr. von Eschenbach. Yes, sir, and I think it is important
for me to again compliment the committee because the fact of
the matter is, I have recognized as having been part of the
world that created many of the opportunities that are now
available to us to save lives and to improve the health and
welfare of the American people the gateway or the bridge from
all that discovery and that development whether it is nutrition
or whether it is drugs that are going to eliminate suffering
and death due to cancer, none of that is going to be reach the
American people unless it goes through the FDA, and the FDA
must be the bridge and not the barrier to that new future, and
FDA's ability to do that is based on its science. It has always
been a science-based regulatory agency and I perceive it needs
to be also a science-led regulatory agency, and first and
foremost with the question to look at our scientific portfolio
and ask experts who have that understanding and perspective of
that full continuum of discovery, development and delivery to
look at that portfolio and advise me as to where that portfolio
needs to be modified, where there were gaps, where there was
overlap, and even more importantly, where there were
opportunities to leverage that portfolio with science and
technology that was occurring in other areas like the NIH where
$28 billion has been invested in science and in industry and
other places and they did an extraordinary job and a service to
the agency to come forward with the report that----
Mr. Barton. Now that you have this report, have you put it
on the shelf and said well, good, I have it----
Dr. von Eschenbach. No, sir. I think my track record
affirms the fact that I asked for reports and accept reports
and then go about the process of working with the agency to
properly implement those----
Mr. Barton. So you are interactive with the committee and
you are meeting with them and your associates at the FDA are
meeting with them to prioritize an action plan and develop it.
Is that----
Dr. von Eschenbach. Well, it is important to point out that
the Scientific Advisory Board has been in place since the
1990s. They have been charged by charter to have responsibility
to advise the FDA with regard to its scientific portfolio.
Mr. Barton. Would you hope that this committee would work
with you and your agency and develop a bipartisan plan of
action where we could give you additional funding in high-
priority areas and actually put something before the Congress
and the President at the appropriate time that, you know, here
is where we need more resources and here is how we plan to
spend the money and here is the technology. Would that be
something you hope the committee does or do you want us just to
yell at you and point fingers and try to do gotcha stuff?
Dr. von Eschenbach. Mr. Barton, I have enormous respect for
this committee and I think from the time I have engaged with
the committee and its staff, I would look forward to every
opportunity to work together so that we can create the right
plan and----
Mr. Barton. It is obvious----
Dr. von Eschenbach [continuing]. Implement it in the right
way in service to the American people. That is what we are both
here for.
Mr. Barton. The task force has shown some real areas that
need to be improved and I think Chairman Dingell pointed some
of that out. So our job is to figure out what we need to do and
the best way to give you the resources and if necessary make
statutory changes in terms of structure so that the FDA can be
the best that I can be.
Dr. von Eschenbach. And if I can comment on that, Mr.
Chairman. For example, we have already issued our Food
Protection Plan, which is along the lines of being able to
accomplish what you just said. In that plan, there are requests
for authorities that the FDA doesn't currently have. Those are
specific issues for this committee and we look forward to
working with you on those authorities.
Mr. Barton. My time has expired, and I am on regular time.
I am not on chairman time so I need to--just one final thing.
When Chairman Stupak was asking about your budget submission to
the President, you had declined to answer for the simple fact
that the President's budget has not been made public, and that
is kind of traditional practice that Cabinet agencies and
commissioners don't get out ahead of the President, let him
offer the budget and then you can come up here and comment on
it and at the appropriate time. You will be happy to do that.
Isn't that correct?
Dr. von Eschenbach. Correct, sir.
Mr. Barton. So you weren't being mean to Chairman Stupak,
you are just not allowed to comment until the President's
budget comes out, and if it were a Democratic President, a
Democratic-appointed Commissioner, it would be the same thing.
Isn't that true?
Dr. von Eschenbach. That is correct, sir.
Mr. Barton. Thank you.
Mr. Stupak. Democrat or Republican, I would ask the same
thing. You could at least tell us if you were pleased with the
recommendation without giving a number.
With that, let me go to Mr. Inslee. I think you were next.
Mr. Inslee. Thank you.
Doctor, I want to ask you about these electric energy
devices you may have heard me talking about in my opening
statement.
Dr. von Eschenbach. Yes, sir.
Mr. Inslee. And I want to just take this one case as
illustrative of what may be in the realm of the possible. I
told the story about a fellow who actually had a device that
was subject to false claims. USDA shut them down. He refused to
stop selling it. He actually left the country. I am told there
is a felony warrant for his arrest. But he is still over in
Hungary selling these products and according to an article has
sold 10,000 of these in the United States. To me, it is just
really flabbergasting that we can have somebody who has been
identified as a miscreant who is selling thousands of these
without our ability to really stop that, and I wonder if you
want to give us your thoughts as to whether that is a failure
of our system and if so, what would you identify what needs to
be done to solve that?
Dr. von Eschenbach. First of all, when I listened to your
story as a urologic oncologist who spent my entire career
taking care of cancer patients, I have witnessed how they can
be preyed upon by these kinds of fraudulent and false hopes and
devices, and I am as committed as you are to a system solution
to this problem. I think it is really a systems failure and a
systems solution, that first and foremost we need stop this at
the source. Now, FDA has been working with foreign regulators,
our counterparts in these other countries, so that they can
take appropriate action. Now, obviously there is some
heterogeneity, depending upon which country you may be
interacting with, but I want to assure you and the committee
that we are going right to those foreign sources to get them to
intervene. Number 2, we have put an import alert in place for
this specific product so that we can alert the borders to stop
those products at the border, whether it is, you know, customs
and border protection or whomever but we will stop those at the
border. Clearly some of those get through and we need to
improve that as well and then once they are here we have to
detect them, and local authorities have the jurisdiction and
the authority, since we have taken action against that product,
to eliminate it and prosecute anyone who is marketing is under
those false claims that you alluded to that it would cure their
cancer. So I think we have steps but clearly there are times
when those steps are not sufficient, and that is why in our
strategy I talk about being engaged in the total life cycle of
products, I talk about a process that builds in prevention,
intervention and response as a continuum and in that way really
attempt to really protect and promote the health of the
American people.
Mr. Inslee. Sometimes bold action can help in this regard
too and send signals. Is there an extradition possibility with
this individual, do you know?
Dr. von Eschenbach. I can't tell you about extradition in
terms of the specific country that he is in.
Mr. Inslee. He is in Hungary, I am told in the newspaper.
Dr. von Eschenbach. I don't know enough about the law.
Mr. Inslee. How would that work? Would you go to the
Justice Department and request them to pursue that, or how
would that work?
Dr. von Eschenbach. I cannot----
Mr. Inslee. Or is that just their initiative?
Dr. von Eschenbach. I cannot answer that for you at the
present time. I don't know, and I would have to get our legal
people to tell me what that step would be. I do know that we
have been--in these kinds of cases we work with the local
government for them to take action directly.
Mr. Inslee. May I ask that you pursue that and let me know
what the options are? You know, I am just going on what I have
read in the newspaper but it would seem to me if that is a
legal course of available to the United States, it is a
statement that we should make, and I hope you will let me know
what your progress is on that.
Dr. von Eschenbach. I would be happy to do that, sir.
Mr. Inslee. How much of this--we have been talking about
resources. How much of this is a resource issue? You heard
previous testimony about needing field agents to really track
this down and it seems to me pervasive. You look at the
Internet and these things are all over the place with sparks
and whistles and, you know, obviously these people are blatant
out there. They are not trying to hide this. They want to
advertise it. How much of this is not having agents in the
field to go after these problems?
Dr. von Eschenbach. Well, again, I want to emphasize the
fact that I agree that we need to increase our resources, our
Field Force, our number of inspectors, but I think it is
important to go beyond just looking at the numbers of
inspectors and understand how we will address the problem.
There never will be enough inspectors. When we look, for
example, at the number of foreign facilities that are producing
products that we must regulate, we recognize that what we need
to do is not just increase the number of FDA inspectors but to
increase their effectiveness. One is by doing that on a
targeted risk-based approach that they inspect the right things
that are of greatest concern. Number 2, that we leverage their
impact, and we have asked, for example, for opportunities for
us to have the authority to certify third parties that we could
oversee and control but they could do additional inspections,
to work with foreign governments where their own
infrastructure, their own regulatory processes, their own
inspections would be complementary and integrated with ours. We
have worked with States here within the confines of the United
States where they are doing a significant number of inspections
under FDA's direction and with FDA's certification, if you
will, and that has significantly leveraged our impact. We may
do 7,000 inspections and States have done approximately 8,000,
so we are doubling impact but not necessarily doubling the
number of FDA inspectors. And I express that because I want the
committee to appreciate that I am not looking at this simply
from the point of view of if we had this amount of money, we
would hire this many more inspectors. I think we have to think
more strategically than that, and it is a matter of how can I
maximize the effect of the inspectors, not just increase their
number.
Mr. Inslee. Well, we hope you will put the FDA in zap mode
on this, and good luck. I would like to help you out. Thank
you.
Mr. Stupak. The gentleman's time has expired. He has asked
all day about this EPFX. Why does the FDA even allow them in
the country? You allow them in as a stress reliever.
Dr. von Eschenbach. Well, we have an import alert to keep
them from coming into the country.
Mr. Stupak. Pardon?
Dr. von Eschenbach. We don't allow them into the country.
Now, that is not to say----
Mr. Stupak. According to the article, they are a stress
reliever. If they are being abused, why would you even let them
in?
Dr. von Eschenbach. Mr. Chairman, we do not allow them to
come into the country. There is an import alert that they would
be stopped and seized at the border. You clearly have
indicated----
Mr. Stupak. Whether they are stress relievers or not, so if
they are labeled as stress relievers you are going to seize
them? Stress relievers. FDA has licensed them as stress
relievers.
Dr. von Eschenbach. If there is a claim made that they
would, you know, cure a disease like cancer----
Mr. Stupak. No, stress.
Dr. von Eschenbach. There are certain products that can be
marketed that don't make claims that fall under the Food, Drug
and Cosmetic Act and those things are not subject to our
regulation based on the law and based on our statutes.
Mr. Inslee. Mr. Chairman, may I ask for an additional 1
minute?
Mr. Stupak. Sure.
Mr. Inslee. You have really brought up an important issue
here. What I sense is going on here is that these machines are
being--when they come in, they are identified as stress
relievers or, you know, some other type of benign nomenclature,
and they are being--you are getting through the sieve or the
net through that. Then the folks overseas and other places
basically advertise them on the Internet and by the providers
themselves who tell the patients, who tell the victims this
isn't just a stress reliever, it is a cancer reliever, it is an
allergy reliever, it is an osteoporosis reliever. So the
problem is, I think there is this missing part in our net where
you get the machine in under this benign nomenclature and then
the patient is told that it has all these other miraculous
attributes to it, and I think we need to think about how to
seize that where basically you have to go say at the border
somehow or some other way, if there is anybody else making
claims about this machine, you can't put it in, and this is
where I think there is a little slip between the licensing and
the practitioners and the sales of the machine. Somehow we have
got to get on top of this where people are using these machines
for nefarious purposes. They know that is going on on a
repeated basis and we have to be able to shut those down for
import. Does that make sense?
Dr. von Eschenbach. Yes, sir, I understand.
Mr. Stupak. Mr. Burgess?
Dr. von Eschenbach. I will get you the specific----
Mr. Stupak. I am sorry. Were you done?
Dr. von Eschenbach. That is OK.
Mr. Stupak. Mr. Burgess for questions.
Mr. Burgess. I hate to prolong this agony but, Mr.
Chairman, can I just ask you, is there not an ongoing
investigation by this Oversight and Investigation Subcommittee
on said machines?
Mr. Stupak. We just started to gather the information.
Mr. Burgess. So there is an investigation in progress, and
honestly, I don't want to devote any more to it but I think
both the FDA and the Oversight and Investigation Subcommittee
are on the job and this is something that will be correctly
elucidated at the proper time.
Commissioner, I just want to thank you for your forbearance
and staying with us all day. You have lost well over half a day
from your primary job at the agency and I know there is a lot
of stuff facing you and it does seem unkind that we have tied
you up so long. Let me ask you, you have talked to Ranking
Member Barton about your activities vis-a-vis the report. At
some point this subcommittee will receive the FDA's formal
response to the report that was generated. Is that correct?
Dr. von Eschenbach. Yes, Dr. Burgess. I actually would
welcome the chairman's earlier suggestion that there be a
subsequent hearing of which I have the opportunity to come back
and brief the committee or present to the committee FDA's
progress and initiatives that are directly responsive to many
of the issues that the report has addressed, so I welcome that.
I would do that formally in the context of a hearing. I would
be happy to do that informally and simply as it relates to a
progress report or whatever the committee wishes. But whether
it is to this committee or not, I fully expect to continue to
inform the American people and continue to present what FDA's
process and progress have been because I am not interested in
plans, I am interested in progress and outcomes, and the plans
are only to guide me as to how to accomplish those outcomes.
Mr. Burgess. And just to reiterate the ranking member's
point, this was an activity that was initiated by the
Commissioner's office. Is that correct?
Dr. von Eschenbach. Yes, sir, absolutely.
Mr. Burgess. You know, we heard a lot about information
technology and the problems that you face with the system you
inherited, so presumably that would be one of the top three
things that will come out of this activity, and I do want you
to talk about that but I would also like to hear just briefly
what the other--if we are going to talk about the top three
areas as we develop our short-term, mid-term and long-term
goals, where those issues lie.
Dr. von Eschenbach. Thank you for referring to that. Let me
frame the answer by saying I have assessed the FDA from the
first moment I arrived and I came rapidly to the conclusion
that the two most critical assets at the FDA were its people
and its infrastructure, its tools, IT tools, because
essentially we spend 80 cents of every dollar on people and it
is in fact what is most critical to FDA's success is to have
the right kind of people and sufficient numbers of that. So my
first priority was to address the workforce and what was going
to be required to nurture and develop that workforce, and you
have heard on other occasions about my plan for, for example, a
very expanded credentialed, formalized FDA fellowship program
as one way of bringing additional intellectual capital into the
agency. The other thing that was apparent was that they needed
the right tools and information technology tools were the most
critical if we were going to do post-market surveillance. If we
were simply going to be able to process the data, information
that is coming to the FDA in the form of a drug application or
by virtue of adverse-events reporting, we needed a modern IT
infrastructure. I looked at our IT infrastructure and
recognized immediately it needed to be totally, completely
revamped if it was going to be adequate for the future
challenges that were emerging like post-market surveillance,
and we began that process in 2006, and earlier I showed a brief
slide to indicate what kind of progress we have made in
rebuilding that infrastructure. I would be happy to present to
the committee and to others the very detailed plan,
implementation plan with milestones and outcomes that our chief
information officer has been preparing and we have been
implementing, and I am committed as the report indicates is
necessary and as the Congress wants and is holding me
accountable for to rapidly and radically transfer the
information technology infrastructure at FDA.
Mr. Burgess. Certainly this committee wants to support you
in that endeavor. Now, we heard reference a little bit earlier
to timelines for the, I think it was the information supply
chain. Do you have a sense as to when you will be able to
report back to this committee and what you will be able to
report back as far as the progress that you are making along
those lines?
Dr. von Eschenbach. I would welcome the opportunity to
report to the committee on the progress that we have made thus
far which I believe is important and substantial and I also
would address the timelines and the implementation strategy
that we have targeted 2010 to bring the agency to a point where
it has the appropriate infrastructure and the right
bioinformatics that are operative on that IT infrastructure.
Mr. Burgess. And too we hear from the National Institutes
of Health, Dr. Zerhooni talks about a day that is coming with
partialized medicine. It just seems like if the FDA is going to
be able to adequately participate in that new world, that your
tools that you are building right now are just going to be
absolutely critical to be able to develop that.
Dr. von Eschenbach. And importantly, we are not developing
it in a vacuum. First of all, the first principle of our IT
infrastructure is the fact that within FDA there will be
integration across the centers, and secondly, FDA will be
integrated with the components outside of the agency that are
critical and essential. So, for example, in our sentinel
initiative, we have signed a memorandum of understanding with
the Veterans Administration, with the Department of Defense. We
have a relationship with Center for Medicare and Medicaid
Services with regard to their database. We are engaging with
the private sector and private health plans. We have been
working through the Brookings Institute to create this
nationwide interoperable network that will enable FDA as it
catalyzes the development of that network to have access to
information about the actual experience of drugs and devices as
they are being used in diverse populations so that not only do
we immediately begin to detect patterns that reflect an
unexpected adverse event, but even more importantly, as
physicians we recognize in treating patients there are those
times when you recognize unexpected, incredible efficacious
events that if you capture that and understand it, you can
begin to understand how to use the medicine even better, and I
think that is within our grasp and that is something we are
going to accomplish but we are going to accomplish it as part
of a network, and you have made that possible for me by virtue
of the passage of the Food and Drug Amendments Act and we hope
to do this through the Reagan-Udall Foundation as we get that
up. So I compliment and thank Congress for the opportunity and
authority to do that.
Mr. Burgess. Very good. I will yield back, Mr. Chairman.
Mr. Stupak. The gentleman's time has expired.
Mr. Green.
Mr. Green. Thank you, Mr. Chairman, and like my colleagues,
I would like to welcome Dr. von Eschenbach in coming from
Houston. You spent it seems like 30 years with M.D. Anderson as
both a researcher and a physician. I appreciate it. I also
appreciate the job we expect you to do at FDA, although I will
tell you my frustration. You heard it from lots of members on a
bipartisan basis. When someone is appointed by any
administration, and I know we have the same problem in
Democratic administrations, you owe your loyalty to that
person, in this case President Bush or previously President
Clinton, but because of your appointment and confirmation, you
also owe it to the American people, and I have had discussion
with appointees bipartisanally over the years and there is
bound to be, Mr. Chairman, some way where we can draw a line
that says the head of a major department like the Food and Drug
Administration can tell Congress what their request is because
I think we ought to know, and the President would submit the
big budget to Congress but I think we ought to know the wish
list from the FDA or the wish list for, you know, any other
Federal agency, and I guess because in my experience here on
the Hill, I have some other former Texas who are in healthcare
facilities like yours, and after they left that particular
administration, their freedom of speech was suddenly restored,
and it was nice to be able to say well, at that time I had a
different boss, I recognize you have a different boss, and
sometimes we do that too. I understand if you are a committee
chair in the House, you have a different boss and we always do
but it is frustrating because this report raises a lot of
concern, and was on the docks at the Port of Houston with FDA
inspectors and it was frustrating to find out that, you know,
our FDA inspectors are on the docks, we don't have enough of
them, and the headquarters is down in Laredo and Laredo may be
very good because of the land base, biggest land-based port in
the world, I guess, but because of all the foodstuffs that are
imported and other things from Mexico. But I think the report
shows that we have a problem, and in Texas we would say our ox
is in a ditch and we need help getting it out, and I think that
is what bipartisanally you are hearing from us because our
committee is responsible for that. I wish I could tell you we
also appropriate money but that comes from that other
committee, and it is frustrating because we want to give you
the tools but we also--some of it is so money-based, if you
want more inspectors, we have to pay for them. If we want labs
to be able to get the results back quicker, then we have to pay
for them, and those labs have to be close to the places. The
closest lab in Texas FDA has is Arkansas. There is not even one
in Texas. Chairman Dingell, I have this discussion about his
bill that would require some of these testing. Well, I don't
know if we need a lab at the Port of Houston but I know we need
ability to contract for testing that may be closer than
Arkansas is for all the Texas border.
Let me ask you, in the GAO, typically whether it is FDA or
other agencies, FDA had a lot of attention this year with the
reauthorization, and I know you mentioned the aftermarket
studies and that is now in statute and it is very important
that you have the resources to do that in this last year and
maybe your predecessor next year will have it, and what the GAO
I think is telling us in the findings by the Science Board
report as well as GAO working on food safety is, FDA's food
inspection program, FDA's foreign medical device inspection
program together conclude that your agency is facing
considerable resource constraints. Would you agree with that?
Dr. von Eschenbach. Yes, sir.
Mr. Green. And last November the GAO testified on the
average you were able to inspect foreign manufacturers only
about once every 13 years. Is that considered something that
the FDA could agree with?
Dr. von Eschenbach. In terms of the manufacturers, I think
it is important to point out what kind of manufacturer.
Mr. Green. Foreign drug manufacturer.
Dr. von Eschenbach. The overall number is fine.
Mr. Green. And in China the data show that your agency at
present inspection rates would only be able to inspect each
firm every 50 years. Is that----
Dr. von Eschenbach. The way that is arrayed, Mr. Green, let
me try to point out that as it relates to, for example, a new
drug or new device that is being produced beyond our borders,
they all get inspected before that new device or drug is
approved. Some of the inspections that those numbers are
referring to are inspections of plants that are already
operative and underway for which products are approved and we
go back and reinspect, and the point I made earlier and I want
to continue to emphasize is that when one looks at the number
of places that are now engaged in food production and
manufacturing, we cannot simply look at a formulaic number in
terms of how many times we inspect each one of them because
they are not all the same.
Let me talk about devices in terms of the three classes,
which I know was raised earlier by the chairman. Factories that
are making tongue depressors for which there is relatively
little, if any, risk of that product being problematic even
though we regulate it would require a much different frequency
of inspection than a factory that is making cardiac
defibrillators, for example. So I think the numbers are
important overall but it is really important to look beyond the
numbers to how we will improve the effectiveness of FDA's
regulatory function in a risk-based model that extends our
number of investigators and number of inspections to do the
right thing in the right way, and I say that because I
recognize the numbers are being discussed and I respect the
fact we need to do more but I want you to understand I am
trying to do more in a better way.
Mr. Green. Well, and we want you to do that but we also
recognize, and I think on a bipartisan basis, you need to do it
in a better way but we also need to have more resources because
if I am ingesting medication from some other country and we
don't inspect them but maybe every 50 years or 13 years even on
the average, it is different than a defibrillator but I watched
at that dock where these toys were seized by customs agents but
also in some cases counterfeit medication that the FDA
inspectors were also to seize, and so that is why I say those
inspectors on the docks and at the ports of entry have a very
difficult job, and they just need to have reinforcements to do
it and I think that is what the GAO report is probably aiming
at, and whether it is this current Administration or the next
one, this Congress is going to have to make sure that those
resources are there.
Dr. von Eschenbach. Yes.
Mr. Green. Thank you, Mr. Chairman. I appreciate your
patience. I know I am over time.
Mr. Stupak. Thank you, Mr. Green.
Mr. Walden for questions, please.
Mr. Walden. Thank you very much, Mr. Chairman.
Dr. von Eschenbach, thank you for being here today. We
appreciate your patience and your input and your leadership.
Let me see if I can kind of sum this up since I guess I am at
least at this point the last one. You have been there about 2
years as head of the FDA.
Dr. von Eschenbach. Yes, sir.
Mr. Walden. When you got there you found there were
problems at the FDA that are systemic that go back 2 decades.
Dr. von Eschenbach. Challenges at the FDA that----
Mr. Walden. Challenges. All right. Among those are an IT
system that is inadequate for the demands of today.
Dr. von Eschenbach. Right.
Mr. Walden. Among those is a lack of inspectors to keep
pace with the imports that are coming in, especially doing
investigations and inspections overseas because of the shift
that has occurred in our economy. You have asked for reports
from outside and internal entities to tell you what the
problems are and provide you with opportunities to solve them,
and that is kind of where we are at today. Is that accurate?
Dr. von Eschenbach. Yes, sir. I would like, if I can, to
just add that not only have we been identifying these
challenges but we have been working towards systemic solutions
to those challenges. I have referred often to our IT plan. I
looked at initially when I arrived. We were making a $200
million investment in IT. It is up to $247 million. We have
looked at the number of inspections and the challenges of
increasing the need to be more engaged beyond our borders, and
we have increased the number of inspectors and the number of
inspections, but the issue here is that is not going to get
addressed in 1 year or in 2 years but what I want to do is
create a trajectory that continues to keep pace with the
challenge.
Mr. Walden. Then in terms of trying to keep pace, you have
indicated you reached out to do some FDA inspections with
outside organizations maybe in foreign countries. Do you have
MOUs, memorandums of understanding, with foreign governments,
foreign agencies similar to your own to try and get a better
handle?
Dr. von Eschenbach. We are in the process of working
aggressively to create those relationships with those beyond
our borders. Of course, most recently we have addressed the
issues having to do with China. We have two memoranda of
agreement that we signed with the government agencies within
China that are our counterparts. We have been working
unilaterally and bilaterally with many nations, and this is a
strategy that we will continue to pursue.
Mr. Walden. I will just speak for myself but I assume other
members of the committee might be interested over time to
occasionally get updates on those memoranda and where we stand
and the progress you are making on that front. That would be
helpful.
The other thing I have heard today is that your agency and
that of directors prior to you has sort of over time been asked
to do all kinds of new tasks and not necessarily funded to do
those jobs. Is that an accurate assessment?
Dr. von Eschenbach. I believe that the report that was
presented earlier today by Mr. Hutt reflected the number of
additional responsibilities that have been placed on the FDA
for which he did not find a revenue stream to support that. I
have attempted to look at our resources not only from the point
of view of what Congress allocates in the form of budget but
what Congress also allows us to acquire with regard to user
fees and also now the private foundation, the Reagan-Udall
Foundation.
Mr. Walden. And I have only got a minute or so left. I want
to hit two topics. One is the user fee topic, and it seems to
me, given the fight that always occurs up here on the Hill for
general fund money, what about this issue of user fees? I know
there are those who probably even on the panels that have done
investigations that think you don't want to get too cozy with
industry if they are funding it, there won't be that sort of
separation. There are others who say your agency doesn't have
the resources it needs and, frankly, industry benefits by your
stamp of approval.
Dr. von Eschenbach. I mentioned those specifically because
the data that Mr. Hutt presented did not incorporate the
addition of the user fees and what that has done as far as our
ability to increase our workforce. Having said that, we have
recognized that with regard to the user fee program, is
absolutely essential that we keep them restricted and defined
as just that, a fee for service for which the industry deriving
a direct and specific benefit----
Mr. Walden. Right, helps pay for----
Dr. von Eschenbach. Helps pay----
Mr. Walden [continuing]. Regulatory costs----
Dr. von Eschenbach [continuing]. Regulatory costs so it
doesn't become a burden for the taxpayer and that also we have
an absolute firewall such that that fee does in no way shape or
form influence the regulatory decision, and I think if we put
those kinds of safeguards in place, Congress holds us
accountable, that can be an important component of our overall
resource base. I think we have to explore the opportunities for
public-private partnerships and the Reagan-Udall Foundation
that I hope that we will be able to implement has given us the
opportunity to create that because in the public-private
opportunity, for example, I alluded to our surveillance
network, we have great opportunity to leverage and do what the
Science Board report said we should do which is access
expertise and resources that are available in other places to
do what FDA needs to do.
Mr. Walden. The second and final point I would like to
throw your way, there are certainly many Americans, certainly
members of Congress who think we should open the door for
importation of pharmaceutical drugs from foreign countries. We
have had votes on that in the House. There is a lot of pressure
to do that. Can your agency certify if that were to take effect
that the drugs that people would be ordering off the Internet
or coming across our border are safe and are actually what they
would be thinking they were filling a prescription for?
Dr. von Eschenbach. We are committed to continuously doing
everything possible to ensure that the drugs and devices that
Americans use are safe and effective, and in looking at the
import problem, we have been unable to be certain we could
ensure that, even when they are labeled as having come from
what we could consider a reputable source like Canada, the
product itself often is not and they are often coming from
places other than Canada that we have absolutely no control or
confidence in or when analyzed found to either not contain the
active ingredient or to contain ingredients that are in fact
harmful. We have no way of being able to ensure the safety of
reimports.
Mr. Walden. Thank you, Mr. Chairman.
Thank you, Dr. von Eschenbach. We appreciate your testimony
and answers today.
Mr. Stupak. I thank the gentleman.
Let me ask this question. I asked you earlier about the
report. You said you read the Science Review Board report,
correct?
Dr. von Eschenbach. Yes, sir.
Mr. Stupak. And nothing surprised you in that report,
correct?
Dr. von Eschenbach. That was my answer, yes, sir.
Mr. Stupak. But then when Mr. Dingell asked you about the
food safety where the report says you cannot provide for food
safety of the American people, you disagreed with that.
Dr. von Eschenbach. Yes, sir.
Mr. Stupak. So the report says we are not doing a good job
on food safety, we inspect about 1 percent of all the food that
comes in, and you think that is a good job?
Dr. von Eschenbach. Mr. Chairman, let me be specific. I
mean, you asked me if I was surprised about something in the
report. I am not surprised that someone would have a different
opinion than me.
Mr. Stupak. So you are not surprised that the Science
Review Board says we are failing to protect our food supply
coming into this country?
Dr. von Eschenbach. I believe the American food supply is
among the safest in the world. I believe we must continue----
Mr. Stupak. So do you disagree with the Science Review
Board statement then on food safety?
Dr. von Eschenbach. I disagree that food safety today in
the United States is not one of the finest in the world. I
believe that to be the case.
Mr. Stupak. It is not whether it is the finest, whether we
are providing the adequate protection the American people
expect and the Science Review Board says we are not. Do you
disagree with that statement, yes or no?
Dr. von Eschenbach. It is hard for me to say we are not
doing it when it is the finest food supply in the world, or
among the finest food supply in the world, and when we
recognize the nature and complexity of the problem that we need
to continuously----
Mr. Stupak. The food supply, I agree, we have tons of it
coming in. Every 5 years it doubles. The Science Review Board
says we are not doing a good job. Do you agree or disagree
with----
Dr. von Eschenbach. Well, what is the basis for not doing a
good job?
Mr. Stupak. It is all there in the report. We don't have
inspectors, it doubles every 2 years. We don't have any IT, all
these things. We have had hearings on it which you testified.
Dr. von Eschenbach. Mr. Chairman, I am not saying that
there aren't problems and issues with regard to continuously
ensuring the quality of our food supply. That is not my point.
Mr. Stupak. Let me ask you specifically then. It is report
of Subcommittee on Science and Technology 3.1.1, finding, ``The
FDA does not have the capacity to ensure the safety of food for
the Nation.'' Do you agree or disagree with that statement?
Dr. von Eschenbach. It is ensuring the safety of the food
supply. We have one of the finest----
Mr. Stupak. So you disagree with that statement?
Dr. von Eschenbach [continuing]. Food supplies in the
world. That is not to say there aren't challenges that I have
been----
Mr. Stupak. They didn't talk about challenges. They said
you did not have the capacity, the FDA--and I am not trying to
put you on the spot, I am not trying to argue with you. I mean,
do you agree or disagree?
Dr. von Eschenbach. I disagree with that.
Mr. Stupak. OK. In their report, they also talk about
personnel morale, and we talked about IT and I believe Dr.
Nordenberg said that multiple turnovers as the head of your IT
department, like five times in the last couple years, and then
you don't have a chief medical officer. The chief medical
officer is also the deputy director of the department and Dr.
Cassell said that is just way too much for one person, and they
do cite the morale problems. What is the systemic problem with
the morale problem at the FDA?
Dr. von Eschenbach. Let me kind of address some of these
issues specifically, first of all, the turnover of chief
information officers. Since I have been at FDA, I have brought
in a chief information officer but brought one in with unique
and specific expertise but also with a very significant
fundamental change in the charge to that chief information
officer and their authority and responsibilities. We had chief
information officers that were overseeing a totally distributed
fragment system with no authority to be able to integrate or
centralize that system. The very fact is, I not only got a
chief information officer with unique skills and background and
experience but enabled and empowered him to make fundamental
systemic changes----
Mr. Stupak. Do you have a plan to implement your IT then?
You have a new officer. Do you have a plan to implement it?
Dr. von Eschenbach. Absolutely.
Mr. Stupak. What is the cost of that plan to implement your
new IT?
Dr. von Eschenbach. We have invested at this point
incrementally from $200 million when I arrived to now a total
of what is $247 million, and I demonstrated that that has been
successful at being able to put us on a trajectory to totally
continually refurbish that entire infrastructure. So let me try
to be clear about the chief information officer turnover. As it
relates to the other issues of change in leadership, the
director was recruited to be the acting surgeon general of the
United States, and that is not--he didn't leave because there
was a morale problem, he left because he had an opportunity
to----
Mr. Stupak. Sure. I am not saying any one of these people
left because of morale problems. The report cites the morale
problem within the agency. So----
Dr. von Eschenbach. There is clearly from my point of view
a need to address the morale and the needs of the people at
FDA, and that is a process that is underway. It has come about
by, number 1, increasing their numbers and giving them more
modern tools to work with, and quite frankly, giving them
credit for the incredible job that they are doing as the
world's best and finest.
Mr. Stupak. You held up this Food Protection Plan from
November of 2007 in a question from Mr. Barton. This plan
doesn't identify any resources to implement it. How much will
it cost to implement this plan?
Dr. von Eschenbach. The plan is a strategic plan. It is not
a business plan. The business plan to be able to implement that
is part of our budget process.
Mr. Stupak. Are you implementing it?
Dr. von Eschenbach. Yes, sir.
Mr. Stupak. So you have got to have a budget for
implementing it.
Dr. von Eschenbach. Yes, sir.
Mr. Stupak. What is that budget----
Dr. von Eschenbach. We spent 2008 dollars to implement
that.
Mr. Stupak. OK, 2008 dollars. I am sure that is fiscal year
2008.
Dr. von Eschenbach. Yes, sir.
Mr. Stupak. How many dollars have you spent in 2008 to
implement this plan?
Dr. von Eschenbach. I need to give you that specific number
but we have spent 2008 numbers to implement portions of that
plan, and I have----
Mr. Stupak. Well, GAO said that--and again, I asked this
question earlier. Without a clear description of resources and
strategies, it will be difficult for Congress to assess the
likelihood of the plan's success in achieving its intended
results.
Dr. von Eschenbach. The success of the plan, Mr. Chairman,
is not how much money we are spending on it. That is a critical
and important element----
Mr. Stupak. I agree. It is----
Dr. von Eschenbach [continuing]. To achieve success.
Mr. Stupak [continuing]. Not how much money.
Dr. von Eschenbach. But success is what the plan actually
accomplishes.
Mr. Stupak. Here is the list. These are recalls last year,
21 pages. We will measure success when I don't come here with
21 pages of recalls. If we don't have the resources, we are to
continue with 21 pages of recalls of food, fish, all this----
Dr. von Eschenbach. I agree that we need additional
resources and I have requested resources in the budget. I have
also held our leadership at FDA accountable in implementation
of that report.
Mr. Stupak. As Members of Congress, we are trying to help
you. Mr. Dingell, Mr. Pallone and myself have the Food Safety
Bill, which will bring user fees for you. If you put it
together at $50 a line, it comes to approximately $900 million
in extra money could come to the FDA. Has the FDA--and I have
asked you this before and I am sure I going to get the same
answer. Have you taken a position on the Dingell-Pallone-Stupak
Food Safety Bill, yes or no? Before you said no, and I am sure
the answer is still no, right? I can answer that one for you.
Since 1996 we have been doing food safety hearings. Since 1996
the FDA has never, never taken a position. How can we help you
if you won't even take positions on legislation that number 1,
would improve the food safety program which your Science Review
Board says is broken. We are trying to give you the resources.
You won't even comment on it. How can we work together in a
cooperative effort----
Dr. von Eschenbach. Mr. Chairman, there is a request for
additional authorities. You would help me a great deal by
addressing those additional authorities.
Mr. Stupak. Well, we would like to help you with that. You
won't even tell us how much it costs to implement, where you
are getting the resources, what is going to take. I mean, I
don't want to be argumentative.
Dr. von Eschenbach. The authorities for us to have
mandatory recall would not----
Mr. Stupak. No, I asked about the Dingell-Pallone-Stupak
bill. You won't even take a position on it. It is the most
comprehensive bill we have seen in years. It provides you
authorities, provides you recall authority, which you don't
have now on food, and will actually give you the resources and
you won't even take a position on it. So how can we partner to
fix the FDA based on Science Review Board's recommendation when
the FDA as the Commissioner or your legislative affairs
department won't even take a position on simple legislation
designed to assist, provide you with the authority and the
resources you need?
Dr. von Eschenbach. We continuously are committed and
available to provide you any technical expertise you would
require----
Mr. Stupak. Give us the technical expertise on our
legislation. Tell us what you like or don't like. You won't
even tell us that.
Mr. Shimkus. Mr. Chairman.
Mr. Stupak. Yes, Mr. Shimkus. I am sorry I am over my time.
Mr. Shimkus. That Dingell-Pallone-Stupak, would that Stupak
be any relation to you?
Mr. Stupak. That is my brother.
Mr. Shimkus. I just want to mention two things, and I
highlighted your resume earlier just because you have a long
career in public service, working with patients, and again, it
is a good thing to highlight. And I want to address your issue
of how safe is safe, what is the cost. I mean, both Mr. Stupak
and I play sports, we play baseball. You can have a good team,
you can have a very successful team, but that team can always
get better and that team can get better by bringing in new
players, spending--I am not in a big major market area where
the Cardinals can't spend what the Yankees spent or the Dodgers
spend or the Red Sox spend but it is quality and it is
leadership and it is teamwork and it is fitting the pieces of
the puzzle together. That is where our questions--I mean, there
is a resourcing issue. We understand that.
Dr. von Eschenbach. I couldn't agree with you more, sir,
but I have never done an operation in my entire life I didn't
ask how can I do it better no matter how well it turned out. I
am not before the committee to say that FDA does not have the
opportunity to be better and to do more but that is different
than saying it is a failure. It is not.
Mr. Shimkus. Because I am going to continue to be eating
food, you know, tonight and I am going to eat food in the
morning and I am going to eat food at lunch and I am assuming
it is safe and for 99.99 percent of Americans it is going to
be. There is going to be errors. We are going to try to fix
that. My colleagues are right to push the envelope and try to
get zero defects. We can't get zero defects. I think when you
have 21 recalls, I think a broken system would have no recalls.
We wouldn't identify any problems and then the problems would
emerge. So the fact that there are recalls, the fact is there
is a system out there that could be better. We want to help
you. I think you identified authorization stuff that we should
address. We will have to fight the appropriations battle with
our appropriation friends. You have a chance, the fifth time to
come back and talk about your budget request, what actually was
put in the budget and how we can help to add more to that. I
appreciate your time, and there are votes, Mr. Chairman, I
yield back.
Mr. Stupak. Mr. Walden, you have a question or two?
Mr. Walden. Yes, Mr. Chairman, since we are on the third
round here.
I want to follow up too on this issue of the recalls
because I agree with my ranking member, if there were no
recalls we might either be in a perfect world or in a world
ready for disaster, because that means people aren't catching
problems and it is naturally going to occur, right, in the food
chain? You get a contaminant in, some device breaks, something
doesn't happen right. I want to minimize those numbers.
Dr. von Eschenbach. Exactly, and----
Mr. Walden. Explain how that works.
Dr. von Eschenbach. Well----
Mr. Walden. And is that the right metric?
Dr. von Eschenbach. It is an important point because if we
are going to continuously respond to the challenges, our
systems have to address preventing these problems from ever
occurring in the first place, and that is a new area of
opportunity in the FDA. It has to strengthen our interventions,
which is the inspections, but it also has to have this piece
that is the response. When there is a problem, we have to
identify it rapidly and intervene before great harm is done.
There will be recalls. There will be problems that will develop
in these complex systems and, for example, most recently
detecting the problem of botulinin contamination. We went in
and understood why that botulinin contamination occurred, and
not only was that enabling us to fix the problem----
Mr. Walden. Was that in the spinach?
Dr. von Eschenbach. That was in canned foods that was being
cooked. And not only were we able to identify the problem and
get a corrective process there, but disseminate that to other
places and have them make modifications in their cooker to
prevent the problems from occurring in those places.
Mr. Walden. I see.
Dr. von Eschenbach. So response fed right back into
prevention. That is what FDA is engaged in and what FDA is
doing, and that is in response to Mr. Stupak's concern that we
have got to get better, do more and be more effective and that
is our commitment and that is the way I think we can go about
accomplishing that.
Mr. Walden. Dr. von Eschenbach, can you talk to me a little
about that food improvement program you are putting forward?
Now, I would understand that we are not going to learn about
the budgetary costs of that until the President's budget comes
out, so you will have some funding requests I assume in the
President's budget we will learn about in a week or two that
will help underwrite the costs of that. Is that correct?
Dr. von Eschenbach. Right, and in the FDA in the past when
it had to regulate spinach, it was regulating spinach in the
context of what I grew up with my grandmother, namely that she
would take it home and wash it five times and then cook it.
Now----
Mr. Walden. Until it had lost all its nutritional value
too, right?
Dr. von Eschenbach. And FDA has to regulate spinach and
lettuce in the context that we stop off at the supermarket,
bring home a bag, open it up and turn it upside down. The
lettuce comes out already cut along with the croutons and the
salad dressing. That is a much different reality. If FDA
continued to do things the way it did in the past in the
future, we would then fail.
Mr. Walden. So this Food Protection Plan----
Dr. von Eschenbach. Is to modernize and to keep pace with
the new challenges that are emerging so we continue to be the
world's gold standard.
Mr. Walden. And so specifically that is a strategic plan.
Why don't we have the business plan?
Dr. von Eschenbach. It is going to require resources and
authorities. The resources are tracking through the normal
budget process. The authorities are the very specific domain of
this committee.
Mr. Walden. When will you have those requests to us?
Dr. von Eschenbach. Well, the report is published and
available for discussion and commentary and implementation. We
are looking forward to working with Congress around some of
those issues, and many of them have been identified by Congress
and, for example, mandatory recalls.
Mr. Walden. But the business plan itself, when we will see
that?
Dr. von Eschenbach. Well, the business plan will be and is
part of the budget process and clearly we have made some
initiatives and some direction in that regard in 2008. I look
forward to making more and discussing those additional
opportunities in 2009 once the President's budget----
Mr. Walden. And when did you come out with the strategic
plan again?
Dr. von Eschenbach. This plan was introduced just a few
months ago.
Mr. Walden. So you are going to take it from there to a
business plan in what time?
Dr. von Eschenbach. We have already started some of that
business plan process and some of the specifics. I will get to
the chairman for the record an exact accounting of the dollars
that have been applied to this plan as part of our Food
Protection Plan. I just don't have it at the table with me.
Mr. Walden. And regarding the chairman's legislation on
recall and all, have you been invited to testify?
Did we have hearings on that bill yet?
Mr. Stupak. The full committee has not.
Mr. Walden. Has the subcommittee had a hearing on it yet?
Mr. Stupak. This subcommittee doesn't----
Mr. Walden. The Health Subcommittee?
Mr. Stupak. I don't believe they have.
Mr. Walden. You don't think they have had a hearing on your
bill?
Mr. Stupak. No.
Mr. Walden. OK.
Mr. Stupak. But we don't need a hearing to make a decision
on legislation.
Mr. Walden. Well, we haven't this year, no. Last year, not
too many. Anyway, I would be interested to know your opinions
too when there is a hearing and you have the invitation to
testify on that legislation.
Dr. von Eschenbach. If we are called upon to testify, we
certainly would be responsive to that, and asked for technical
assistance we would be responsive to that.
Mr. Walden. Thank you. Thank you, Mr. Chairman. Thank you,
Mr. von Eschenbach.
Mr. Stupak. Well, that is going to have to conclude and we
only have 6 minutes left for a vote, so Dr. von Eschenbach,
thank you again for appearing and we look forward to talking to
you soon, probably in about 60 days.
Dr. von Eschenbach. Thank you.
Mr. Stupak. That concludes the questions. I want to thank
all of our witnesses for coming today and for the testimony and
members for their devotion to this hearing today. I ask for
unanimous consent that the hearing record will remain open for
30 days for additional questions for the record. Without
objection, the record will remain open.
I ask unanimous consent that contents of our document
binder be introduced into the record. Without objection, the
documents will be entered in the record.
[The information appears at the conclusion of the hearing:]
Mr. Stupak. That concludes our hearing, and without
objection, this meeting of the subcommittee is adjourned.
[Whereupon, at 2:55 p.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
Statement of Hon. Jan Schakowski
Thank you, Mr. Chairman - and thank you for your initiative
in bringing this important issue before us today. I am eager to
hear from our witnesses, many of whom have been immersed in
issues surrounding FDA operations for years, and bring
particular insight to our hearing today. Thank you for being
here.
American's assume that the products they use every day have
been tested and approved for safety and effectiveness by some
government agency. They may not always know exactly which
agency this should be - but they make personal care decisions
for themselves and their loved ones based on this assumption.
As we'll discuss today, this is not always the case.
This Sunday's Washington Post showed us that toys from
China aren't the only products we're using that are laced with
dangerous substances. The article, written by Susan D'Amato,
highlights the issue of contaminants in cosmetics; lipsticks
containing lead, mascaras containing mercury and hair
treatments containing formaldehyde.
D'Amato cites a study done by the Campaign for Safe
Cosmetics, which tested 33 lipsticks for lead content - several
of which exceeded the FDA's lead limit for candy. Why use candy
as a benchmark? Because the FDA has yet to set a lead standard
for lipstick - in fact, the FDA doesn't even have regulatory
authority over cosmetics, nor does it subject cosmetic products
or ingredients to premarket approval authority.
On the one hand, we have things that have been approved
that shouldn't have been - but on the other - we have
potentially life-saving therapies which haven't been approved
by FDA - and without a lot of clarity as to why.
Last Spring, amidst cries of foul play, the FDA delayed its
approval of Provenge (a therapeutic vaccine for use in
terminally ill patients with prostate cancer) against the
scientific recommendation of its own advisory committee, which
saw the value in bringing patient's the first nontoxic
treatment for prostate cancer. This decision has raised
concerns of both FDA's ability to review emerging scientific
discoveries - and of the need for transparency into the
approval process pipeline.
These are two very different, but very alarming
illustrations of the challenges which face an outdated,
outpaced, and under-resourced FDA. As our witnesses will
further detail for us today, the United States is depending on
a 1950s FDA facing 21st century demands. This is a stark
reality which demands attention and action.
I look forward to working with this Committee and this
Congress to overhaul the Food and Drug Administration in a way
that will re-establish it as a leader in peer-review,
innovation, collaboration and communication.
Again, thank you to the witnesses for being here - and
thank your Mr. Chairman. I yield back the balance of my time.
----------
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Exhibit Binder Index
1. U.S. Food and Drug Administration (FDA) report, "Food
Protection Plan: An Integrated Strategy for Protecting the
Nation's Food Supply," November 2007
2. Report to the President by the Interagency Working Group
on Import Safety, subject: "Action Plan for Import Safety: A
Roadmap for Continual Improvement," November 2007
3. National Antimicrobial Resistance Monitoring System
(NARMS) Program Review, conducted by the External Subcommittee
of the FDA Science Advisory Board, 5/25/07
4. Federal Register, volume 73, no. 3, subject: "Department
of Health and Human Services, FDA: Request for Comments on the
Science and Technology Report; Establishment of Docket; Request
for Comments," 1/8/08
5. Charter, Science Board to the Food and Drug
Administration, 6/26/06
6. Congressional Research Service Report to Congress by
Judith Johnson, et al.; subject: "The Food and Drug
Administration: Budget and Statutory History, FY1980-FY2007,"
1/24/2008
7. Letter from Kenneth Shrine, from The University of Texas
System, to FDA Commissioner Andrew von Eschenbach, 01/22/08
8. Letter from Kenneth Shrine to Dr. Gail Cassell, member
of the FDA's Science Board, 01/23/08
9. New York Times article by Gardiner Harris, re: "Advisers
Say F.D.A.'s Flaws Put Lives at Risk," 12/1/07
10. FDA's Science Board Budget Justification
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]