SCIENCE AND MISSION AT RISK: FDA’S SELFASSESSMENT 

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ONE HUNDRED TENTH CONGRESS 

SECOND SESSION 

JANUARY 29, 2008 

Serial No. 110–83 

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SCIENCE AND MISSION AT RISK: FDA’S SELF-ASSESSMENT 

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SCIENCE AND MISSION AT RISK: FDA’S SELFASSESSMENT 

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 

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Printed for the use of the Committee on Energy and Commerce 

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COMMITTEE ON ENERGY AND COMMERCE 

JOHN D. DINGELL, Michigan, Chairman 

HENRY A. WAXMAN, California 

EDWARD J. MARKEY, Massachusetts 

RICK BOUCHER, Virginia 

EDOLPHUS TOWNS, New York 

FRANK PALLONE, JR., New Jersey 

BART GORDON, Tennessee 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

BART STUPAK, Michigan 

ELIOT L. ENGEL, New York 

ALBERT R. WYNN, Maryland 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

Vice Chairman 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANE HARMAN, California 

TOM ALLEN, Maine 

JAN SCHAKOWSKY, Illinois 

HILDA L. SOLIS, California 

CHARLES A. GONZALEZ, Texas 

JAY INSLEE, Washington 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

DARLENE HOOLEY, Oregon 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

CHARLIE MELANCON, Louisiana 

JOHN BARROW, Georgia 

BARON P. HILL, Indiana 

JOE BARTON, Texas 

Ranking Member 

RALPH M. HALL, Texas 

FRED UPTON, Michigan 

CLIFF STEARNS, Florida 

NATHAN DEAL, Georgia 

ED WHITFIELD, Kentucky 

BARBARA CUBIN, Wyoming 

JOHN SHIMKUS, Illinois 

HEATHER WILSON, New Mexico 

JOHN B. SHADEGG, Arizona 

CHARLES W. ‘‘CHIP’’ PICKERING, 

Mississippi 

VITO FOSSELLA, New York 

STEVE BUYER, Indiana 

GEORGE RADANOVICH, California 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE FERGUSON, New Jersey 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

PROFESSIONAL STAFF

DENNIS B. FITZGIBBONS, Chief of Staff 

GREGG A. ROTHSCHILD, Chief Counsel 

SHARON E. DAVIS, Chief Clerk 

DAVID L. CAVICKE, Minority Staff Director 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

BART STUPAK, Michigan, Chairman 

DIANA DeGETTE, Colorado 

CHARLIE MELANCON, Louisiana 

Vice Chairman 

HENRY A. WAXMAN, California 

GENE GREEN, Texas 

MIKE DOYLE, Pennsylvania 

JAN SCHAKOWSKY, Illinois 

JAY INSLEE, Washington 

JOHN D. DINGELL, Michigan (ex officio) 

ED WHITFIELD, Kentucky 

Ranking Member 

GREG WALDEN, Oregon 

MIKE FERGUSON, New Jersey 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

JOE BARTON, Texas (ex officio) 

(II)

(III) 

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 

Page

IV 

Andrew C. von Eschenbach, M.D., Commissioner, Food and Drug Administration—Continued 

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 

(1) 

SCIENCE AND MISSION AT RISK: FDA’S SELFASSESSMENT 

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 

2 

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. 

3 

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:] 

4 

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. 

5 

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 obsoVerDate Nov 24 2008 15:30 Mar 19, 2009 Jkt 037690 PO 00000 Frm 00011 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\47433_3 SCOM1 PsN: JIMC
6 

lete 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 inspecVerDate Nov 24 2008 15:30 Mar 19, 2009 Jkt 037690 PO 00000 Frm 00012 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\47433_3 SCOM1 PsN: JIMC
7 

tors, 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 

8 

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. 

9 

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 

10 

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 

11 

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 

12 

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. 

13 

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 buVerDate Nov 24 2008 15:30 Mar 19, 2009 Jkt 037690 PO 00000 Frm 00019 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\47433_3 SCOM1 PsN: JIMC
14 

reaucracy 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 largescale 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 

15 

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 misVerDate Nov 24 2008 15:30 Mar 19, 2009 Jkt 037690 PO 00000 Frm 00021 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\47433_3 SCOM1 PsN: JIMC
16 

sion. 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. 

17 

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 

18 

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. 

19 

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. 

20 

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 

21 

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 

22 

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 selfassessment 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 unVerDate Nov 24 2008 15:30 Mar 19, 2009 Jkt 037690 PO 00000 Frm 00028 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\47433_3 SCOM1 PsN: JIMC
23 

dergo 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′′. 

24 

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). 

25 

• 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. 

26 

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. 

27 

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 

28 

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 missedsuch 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. 

29 

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. 

30 

[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 

31 

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 zerobased budget analysis for FDA. It is likely that FDA itself has numerous materials 

32 

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 twothirds 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. 

33 

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 

34 

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 

35 

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 

36 

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 lipidlowering 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. 

37 

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 unVerDate Nov 24 2008 15:30 Mar 19, 2009 Jkt 037690 PO 00000 Frm 00043 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\47433_3 SCOM1 PsN: JIMC
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derstand 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 parttime 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:] 

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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 CDCtrained 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 

55 

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:] 

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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 

64 

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 

65 

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 

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tions 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 

67 

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 

68 

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 

69 

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. 

70 

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, 

71 

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 

72 

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. 

73 

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? 

74 

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. Eightyfive 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 reVerDate Nov 24 2008 15:30 Mar 19, 2009 Jkt 037690 PO 00000 Frm 00080 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\47433_3 SCOM1 PsN: JIMC
75 

ports 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 adverseevent 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 imVerDate Nov 24 2008 15:30 Mar 19, 2009 Jkt 037690 PO 00000 Frm 00081 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\47433_3 SCOM1 PsN: JIMC
76 

plement 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 

77 

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 

78 

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 

79 

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 levVerDate Nov 24 2008 15:30 Mar 19, 2009 Jkt 037690 PO 00000 Frm 00085 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\47433_3 SCOM1 PsN: JIMC
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els 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 defiVerDate Nov 24 2008 15:30 Mar 19, 2009 Jkt 037690 PO 00000 Frm 00086 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\47433_3 SCOM1 PsN: JIMC
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cits, 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. 

82 

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. 

83 

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 concluVerDate Nov 24 2008 15:30 Mar 19, 2009 Jkt 037690 PO 00000 Frm 00089 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\47433_3 SCOM1 PsN: JIMC
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sions 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:] 

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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 highrisk 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 governmentwide 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. 

116 

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:] 

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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 21⁄2 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 

137 

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:] 

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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 

144 

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 

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cifically 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. 

146 

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 

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times 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. 

148 

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 

149 

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. 

150 

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 sciencebased 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, 

151 

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 

152 

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:] 

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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? 

164 

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—— 

165 

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. 

166 

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 

167 

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 postmarket 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 

168 

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. 

169 

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. 

170 

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 

171 

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. 

172 

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 

173 

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 

174 

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 reVerDate Nov 24 2008 15:30 Mar 19, 2009 Jkt 037690 PO 00000 Frm 00180 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\47433_3 SCOM1 PsN: JIMC
175 

liever. 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. 

176 

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 shortterm, 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 

177 

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 freeVerDate Nov 24 2008 15:30 Mar 19, 2009 Jkt 037690 PO 00000 Frm 00183 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\47433_3 SCOM1 PsN: JIMC
178 

dom 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 

179 

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. 

180 

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 

181 

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? 

182 

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? 

183 

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 incremen- tally 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. 

184 

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. 

185 

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 

186 

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? 

187 

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. 

188 

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. 

189 

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 peerreview, 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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Æ 


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