```

[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.
                              ----------                              

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                          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

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