[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]


 
THE FOOD AND DRUG ADMINISTRATION'S CRITICAL MISSION AND CHALLENGES FOR 
                               THE FUTURE 

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

                                HEARING

                               before the

                         COMMITTEE ON OVERSIGHT
                         AND GOVERNMENT REFORM

                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED TENTH CONGRESS

                             FIRST SESSION

                               __________

                              MAY 1, 2007

                               __________

                           Serial No. 110-24

                               __________

Printed for the use of the Committee on Oversight and Government Reform


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             COMMITTEE ON OVERSISGHT AND GOVERNMENT REFORM

                 HENRY A. WAXMAN, California, Chairman
TOM LANTOS, California               TOM DAVIS, Virginia
EDOLPHUS TOWNS, New York             DAN BURTON, Indiana
PAUL E. KANJORSKI, Pennsylvania      CHRISTOPHER SHAYS, Connecticut
CAROLYN B. MALONEY, New York         JOHN M. McHUGH, New York
ELIJAH E. CUMMINGS, Maryland         JOHN L. MICA, Florida
DENNIS J. KUCINICH, Ohio             MARK E. SOUDER, Indiana
DANNY K. DAVIS, Illinois             TODD RUSSELL PLATTS, Pennsylvania
JOHN F. TIERNEY, Massachusetts       CHRIS CANNON, Utah
WM. LACY CLAY, Missouri              JOHN J. DUNCAN, Jr., Tennessee
DIANE E. WATSON, California          MICHAEL R. TURNER, Ohio
STEPHEN F. LYNCH, Massachusetts      DARRELL E. ISSA, California
BRIAN HIGGINS, New York              KENNY MARCHANT, Texas
JOHN A. YARMUTH, Kentucky            LYNN A. WESTMORELAND, Georgia
BRUCE L. BRALEY, Iowa                PATRICK T. McHENRY, North Carolina
ELEANOR HOLMES NORTON, District of   VIRGINIA FOXX, North Carolina
    Columbia                         BRIAN P. BILBRAY, California
BETTY McCOLLUM, Minnesota            BILL SALI, Idaho
JIM COOPER, Tennessee                ------ ------
CHRIS VAN HOLLEN, Maryland
PAUL W. HODES, New Hampshire
CHRISTOPHER S. MURPHY, Connecticut
JOHN P. SARBANES, Maryland
PETER WELCH, Vermont

                     Phil Schiliro, Chief of Staff
                      Phil Barnett, Staff Director
                       Earley Green, Chief Clerk
                  David Marin, Minority Staff Director





















                            C O N T E N T S


                              ----------                              
                                                                   Page
Hearing held on May 1, 2007......................................     1
Statement of:
    Kennedy, Donald, Ph.D., former Commissioner, 1977 through 
      1979, Food and Drug Administration; Frank Young, M.D., 
      Ph.D., former Commissioner, 1984 through 1989, Food and 
      Drug Administration; David Kessler, M.D., J.D., former 
      Commissioner, 1990 through 1997, Food and Drug 
      Administration; and Andrew C. von Eschenbach, M.D., 
      Commissioner, Food and Drug Administration.................     9
        Kennedy, Donald..........................................     9
        Kessler, David...........................................    27
        von Eschenbach, Andrew C.................................    35
        Young, Frank.............................................    17
Letters, statements, etc., submitted for the record by:
    Davis, Hon. Tom, a Representative in Congress from the State 
      of Virginia, prepared statement of.........................     6
    Kennedy, Donald, Ph.D., former Commissioner, 1977 through 
      1979, Food and Drug Administration, prepared statement of..    12
    Kessler, David, M.D., J.D., former Commissioner, 1990 through 
      1997, Food and Drug Administration, prepared statement of..    29
    von Eschenbach, Andrew C., M.D., Commissioner, Food and Drug 
      Administration, prepared statement of......................    38
    Young, Frank, M.D., Ph.D., former Commissioner, 1984 through 
      1989, Food and Drug Administration.........................    21


THE FOOD AND DRUG ADMINISTRATION'S CRITICAL MISSION AND CHALLENGES FOR 
                               THE FUTURE

                              ----------                              


                          TUESDAY, MAY 1, 2007

                          House of Representatives,
              Committee on Oversight and Government Reform,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 1:15 p.m., in 
room 2154, Rayburn House Office Building, Hon. Henry A. Waxman 
(chairman of the committee) presiding.
    Present: Representatives Waxman, Cummings, Kucinich, 
Tierney, Higgins, Braley, McCollum, Cooper, Hodes, Murphy, 
Sarbanes, Davis of Virginia, Platts, Cannon, Duncan, Issa, 
Marchant, Foxx, and Bilbray.
    Staff present: Phil Schiliro, chief of staff; Karen Nelson, 
health policy director; Andy Schneider, chief health counsel; 
Sarah Despres, senior health counsel; Ann Witt, health counsel; 
Robin Appleberry, counsel; Steve Cha, professional staff 
member; Earley Green, chief clerk; Teresa Coufal, deputy clerk; 
Rachel Sher, counsel; Kerry Gutknecht, Will Ragland, and Miriam 
Edelman, staff assistants; David Marin, minority staff 
director; Larry Halloran, minority deputy staff director; 
Jennifer Safavian, minority chief counsel for oversight and 
investigations; Keith Ausbrook, minority general counsel; Ellen 
Brown, minority legislative director and senior policy counsel; 
Howie Denis and Susie Schulte, minority senior professional 
staff members; Brian McNicoll, minority communications 
director; and Benjamin Chance, minority clerk.
    Chairman Waxman. The meeting of the committee will come to 
order.
    Before I make any specific comments on today's hearing on 
FDA, I want to say a few words about an important initiative 
this committee is undertaking.
    One of the most important debates in modern politics is the 
role of government. Some believe in the smallest government 
possible and live by the old joke that the scariest words 
imaginable are ``I'm from the Federal Government and I have 
come to help.''
    I and others have a fundamentally different view. I think 
government can be a tremendous instrument for good, and I have 
seen it help Americans in countless ways. The Social Security 
system transformed this country. Landmark health and 
environmental laws have improved the quality of life for 
millions of Americans. Regulatory and consumer agencies have 
made financial stability, basic safety precautions a part of 
our everyday life.
    In this regard, FDA has had a remarkable record of 
achievements. It has been and by and large remains an agency 
with highly qualified and dedicated staff doing a big job under 
difficult circumstances. It is our job to ensure that it has 
the resources to continue to perform with competence.
    We have reason to be concerned, to examine the strengths 
and weaknesses of this agency in the light of ever-increasing 
demands and to ensure that it remains strong. Because we know 
from other areas that without proper support or without 
deliberate strengthening of the agency and support for the 
agency's leadership, or without making sure there is not 
unwarranted outside interference, things can change. We need 
only look at FEMA. FEMA once was one of the most prominent and 
well-respected agencies of Government, but something has gone 
very wrong in recent years.
    We saw government at its worst during the Hurricane Katrina 
disaster. FEMA completely failed American citizens. We saw it 
break down again at Walter Reed Hospital in the deplorable 
conditions provided to our bravest Americans. And we have seen 
profound problems from government's handling in the Iraq war, 
where there was flawed basic intelligence to failure to supply 
our troops with the right armor and equipment.
    In all of these cases, we know that incompetent government 
can have deadly consequences, so one of the most important 
responsibilities for our committee is to understand what has 
gone wrong, how did some of the best Government agencies become 
so weak, and we need to work together in a bipartisan way to 
get Government back on track.
    I know colleagues on both sides of the aisle share my view 
on this. We don't want Government programs to be ineffective; 
we want them to be models of excellence. So over the next year 
our committee is going to hold a series of hearings on making 
government effective again by looking at the performance of a 
number of different agencies.
    We start today with FDA. By the end of these hearings, we 
will have a better idea of the impact of budget cuts and 
cronyism on current problems. I expect we will have legislative 
solutions that would ensure taxpayers get the Government they 
deserve.
    Today we start this effort. We are in the fortunate 
position of looking first at an agency that has not been 
decimated by the pressures placed upon it or the lack of 
resources made available to it, but there have been a number of 
public health crises, from the belated withdrawal of Vioxx to 
deadly bacteria in spinach to contaminated pet food. These have 
revealed alarming cracks in the foundation of FDA's ability to 
protect the American public.
    The warning signs are clear. FDA is an agency in crisis. We 
need to act now and to learn from the vast experience of those 
who have managed the agency through the years.
    Today we are fortunate to have an unprecedented assembly of 
experts, including three former FDA Commissioners and the 
current Commissioner, Dr. Andrew von Eschenbach, in addition to 
former Commissioners whose schedules did not allow them to be 
here in person. We will submit written testimony.
    I especially want to thank the Commissioner for 
accommodating the committee's request that he testify on the 
same panel as the other witnesses. I recognize it is the 
administration's policy for Governmental officials to testify 
on panels without non-governmental witnesses, and today's 
arrangement is not intended to nullify that policy. Since this 
hearing presents a highly unusual circumstance, gathering the 
former and current head of a single agency, we appreciate the 
Commissioner's departure from the general agency practice 
today. Thank you very much.
    FDA oversees thousands of products so routine that we don't 
even notice them: oatmeal, aspirin, even microwaves and cell 
phones. FDA also oversees products for the times in our life 
that are anything but routine, days we need emergency surgery, 
chemotherapy, or a blood transfusion.
    FDA's mission is vast and daunting, but not impossible. The 
agency's history is full of success stories, whether it was 
protecting consumers from rotten meat in the early 1900's, 
saving lives by refusing to let thalidomide on the market in 
the 1950's, or speeding aged drugs to patients in the 1990's. 
But, as I have said, recent years have brought signs of trouble 
at the FDA, and at this hearing we hope to learn the causes of 
these problems, and we will look at four major areas of 
concern.
    The first and most critical issue facing FDA is simple--
resources. The agency, in my opinion, is vastly under-funded, 
relying on an already shrinking budget to tackle a rapidly 
expanding list of responsibilities. In fact, FDA's entire 
budget for fiscal year 2007 is less than the budget for 
Montgomery County Maryland's schools, the whole system, for 
this year.
    A second major concern is scientific integrity at the 
agency. In recent years, key decisions at FDA have been made 
under the cloud of real or perceived political interference, 
undermining FDA's most basic foundation.
    A third are of concern is enforcement. Investigations by 
our staff and other analysts have found that across the agency, 
from post-market drug trials to drug advertising to the 
handling of fresh produce, FDA's enforcement activity has 
declined. Strong enforcement is a critical component of FDA's 
work, and I am concerned to see how it has atrophied in recent 
years.
    Finally, we must look closely at FDA's legal authorities to 
examine whether its governing provisions are outdated or 
inadequate. One prominent example is in the area of food 
regulation, where our standards are literally a century old.
    On the topic of food safety, I want to acknowledge that 
this morning the FDA announced that it will create a new 
position for food protection at the agency. This idea of a food 
safety czar seems like a reasonable idea, and I support FDA in 
taking steps to increase the priority of food safety at the 
agency.
    I hope that as the agency begins to undertake long-term 
strategic thinking, I think the need remains for an immediate 
response to the current crisis, and hope that today's 
announcement will be followed by concrete and effective action.
    For all its challenges, FDA remains one of our Nation's 
greatest assets. I called this hearing because I believe in 
this agency and I want to see it work. As the primary oversight 
committee of the House, it is the committee's responsibility to 
identify and begin to address the urgent challenges facing the 
FDA, and we will see in other hearings other agencies, as well.
    I hope that this series of hearings will lead to real 
solutions for FDA and for Government, restoring the full 
capacity and preparing this agency and others to serve its 
critical mission many years into the future.
    I thank our witnesses for being here today. I look forward 
to their testimony.
    Before we call on them and recognize them, I want to have 
the ranking member of our committee, Mr. Davis, have time to 
make an opening statement.
    Mr. Davis of Virginia. Thank you, Mr. Waxman. I know how 
important these issues have been to you over the years, and you 
really hit it on the head: it is about governance. Some on my 
side just think we ought to have very little government. Let's 
starve it, let's not give it the funding. There are others who 
think the more government the better, that we can accomplish 
more. But we don't focus enough on the governance issues, and 
that is getting it right and making it efficient.
    I want to thank you for holding today's hearing to consider 
the critical mission of the FDA and the many challenges the 
agency faces, keeping pace with rapidly evolving science and an 
increasingly global marketplace.
    The FDA's basic mission is to promote and protect public 
health by approving and monitoring the marketing of safe and 
effective products. The agency is also responsible for 
providing current science-based information to the public on 
key health issues.
    In recent years the FDA has stumbled through some high-
profile mis-steps. The withdrawal of the pain killer Vioxx 
caused many to ask if drugs were being approved too fast and 
monitored too little after reaching the marketplace. The 
shortage of vaccine for the 2004-2005 flu season raised 
questions about how best to regulate and stimulate production 
of biopharmaceutical products. The FDA role in food safety 
arose again when e-coli contamination was found in fresh 
spinach this year, and most recently with the nationwide recall 
of Peter Pan peanut butter.
    Most Americans believe that once something gets FDA 
approval it carries the Federal Government's equivalent of the 
Good Housekeeping Seal of Approval. It can be used without 
worry or risk. We need to be sure that confidence is not 
misplaced or grounded only on the legend of an infallible FDA 
or the myth of risk-free products. We should indulge neither 
legend nor myth when entrusting critical questions of safety, 
efficacy, and risk to Federal decisionmakers, but we should do 
everything possible to ensure the FDA has the statutory tools, 
the talent, and the resources necessary to operate effectively, 
efficiently, and transparently.
    I don't want you to have any cause to doubt that, even if 
they sometimes get it wrong. The FDA is guided only by the best 
science available and acts solely in the interest of the 
American consumer.
    At stake in the FDA getting it right is the health and 
safety of the American people and the viability of a huge and 
growing sector of our economy. Industries regulated by the FDA 
generate hundreds of millions of dollars in sales revenue, 
support important research, and create high-value jobs. 
Continued loss of confidence in the FDA takes us down a path we 
simply cannot afford either financially or in terms of public 
health.
    The FDA has to stand out as a trusted, unbiased, vigilant 
watchdog over the Nation's food and drug supply. Nevertheless, 
recent high-profile recalls and contaminations heighten 
concerns about the capability and credibility of the Federal 
agency charged to ensure the safety and effectiveness of so 
many medicines, foods, cosmetics, and other products millions 
of Americans use every day.
    So we ask: how can we strengthen the security and safety of 
foods that now travel around our country and across the world 
with unprecedented speed? How can FDA work with regulated 
industries to better ensure the safety of approved drugs and 
medical devices? What can be done to improve product 
manufacturing and handling practices? How can post-marketing 
surveillance of approved products be strengthened, and who will 
pay for it? And do current adverse event reporting systems 
capture the reliable and timely data FDA needs to inform sound 
regulatory decisions?
    This committee has looked at some of these questions 
before. Mr. Chairman, I convened similar oversight hearings on 
drug safety and post-marketing surveillance issues surrounding 
withdrawal of Vioxx from the market. We also investigated FDA 
oversight of reprocessed single use medical devices. Hearings 
were held on efforts to address the growing problems of illegal 
pharmacy Web sites. We have closely monitored food safety and 
dietary supplement issues. Our investigation into the flu 
vaccine shortage resulted in more-frequent FDA inspections of 
vaccine manufacturing facilities.
    With regard to these major issues, it can't be said we 
didn't do some oversight. I am happy Chairman Waxman had chosen 
to keep the focus on these important issues. He believes 
fervently in the need for a strong, independent, effective FDA 
and has worked over many years to sustain and strengthen the 
agency's capabilities.
    Given that bipartisan consensus, I look forward to a 
thoughtful discussion today on the future of the FDA and how to 
address the many complex challenges faced by the critical 
Federal agency.
    We are fortunate to have before us such a distinguished 
panel of witnesses. All have held the top leadership post at 
the FDA and share invaluable experience running one of the 
Nation's most important public health and consumer protection 
agencies. We look forward to their testimony, their insights, 
and their perspectives.
    [The prepared statement of Hon. Tom Davis follows:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
    Chairman Waxman. Thank you very much, Mr. Davis.
    We do have a very distinguished panel before us. We have 
our first witness, Dr. Donald Kennedy. He was the FDA 
Commissioner appointed by Secretary Joseph Califano in April 
1977 and served until 1979. During his tenure, the agency dealt 
with the repercussions of the attempt to ban saccharin, 
attempted to overhaul the drug provisions of the Food, Drug, 
and Cosmetic Act in the proposed Drug Regulation Reform Act of 
1978. He is an internationally recognized neurophysiologist who 
headed both the FDA and Stanford University, and at the present 
time serves as the editor in chief of Science.
    We are pleased to have you with us.
    Our next witness will be Dr. Frank Young, who was the FDA 
Commissioner sworn in by Secretary of Health and Human Services 
Margaret Heckler in August 1984 and served until December 1989. 
During his tenure, he initiated the user fee process and 
approved the first drug to combat AIDS and instituted a fast 
track approval system for AIDS drugs. He was also appointed by 
President Reagan and confirmed by the Senate as the U.S. member 
of the Executive Committee of the World Health Organization. He 
is currently the chairman and CEO of the Cosmos Alliance, a 
partner in Essex Woodlands Health Ventures, and serves on the 
Board of Directors of five companies.
    We are pleased to have you, Dr. Young.
    Our third witness will be Dr. David Kessler, the FDA 
Commissioner appointed by President George H.W. Bush in 1990 
and reappointed by President Clinton, serving until 1997. 
During his tenure he acted to speed approval of new drugs, 
placed high priority on getting promising therapies for serious 
and life-threatening diseases to patients as quickly as 
possible. He introduced a number of new programs, including: 
nutrition labeling for food, user fees for drugs and biologics, 
preventive controls to improve food safety, and the MEDWatch 
program. He served as the Dean of the Yale University School of 
Medicine, and is currently the Dean of the School of Medicine 
and the Vice Chancellor for Medical Affairs at the University 
of California, San Francisco.
    Dr. Kessler, we are pleased to have you.
    And the final witness will be Dr. Andrew von Eschenbach, 
who was sworn in as the 20th Commissioner on December 13, 2006. 
At the time of his appointment he was the Director of the 
National Cancer Institute. Dr. von Eschenbach is a nationally 
recognized urologic surgeon and oncologist.
    We are pleased to have you, as well.
    It is the practice of this committee for all witnesses to 
have them sworn in, and so I do ask you to please rise and 
raise your right hands.
    [Witnesses sworn.]
    Chairman Waxman. The record will reflect that each of the 
witnesses answered in the affirmative.
    Now we would like to call on the witnesses. Our first 
witness is Dr. Kennedy.

STATEMENTS OF DONALD KENNEDY, PH.D., FORMER COMMISSIONER, 1977 
THROUGH 1979, FOOD AND DRUG ADMINISTRATION; FRANK YOUNG, M.D., 
 PH.D., FORMER COMMISSIONER, 1984 THROUGH 1989, FOOD AND DRUG 
ADMINISTRATION; DAVID KESSLER, M.D., J.D., FORMER COMMISSIONER, 
1990 THROUGH 1997, FOOD AND DRUG ADMINISTRATION; AND ANDREW C. 
       VON ESCHENBACH, M.D., COMMISSIONER, FOOD AND DRUG 
                         ADMINISTRATION

                  STATEMENT OF DONALD KENNEDY

    Mr. Kennedy. Mr. Chairman, thanks very much. It is a 
pleasure to appear before the committee. I want to thank you 
especially for organizing this splendid reunion.
    You asked me to provide some information that might be 
helpful to the committee in examining its responsibilities for 
oversight of the Food and Drug Administration as it faces new 
challenges. I am going to touch briefly on some of those before 
turning to an analysis of other factors.
    Among the current problems, as you have noted, are food 
safety, difficult questions surrounding the safety of already 
marketed drugs, preparations for pandemic influenza, and an old 
problem that owes much to the unavailability of a sound adverse 
reaction reporting system, problems in monitoring the safety of 
already marketed drugs.
    These problems naturally arise within the orbit of FDA's 
own statutory and regulatory authority, but there are some 
problems that seem to have arisen from the outside. Let me just 
mention those briefly.
    For only a fraction of the past 6 years has FDA had at its 
head a Commissioner confirmed by the Senate. I think we all 
know that the FDA could function pretty well for short periods 
without a leader. It has a competent, highly graded, technical 
Civil Service staff. But FDA enjoys frequent external 
challenges that must be met by leadership that is fully 
authorized and credible and in place, and too often it has not 
had that kind of leadership. I am glad it does now.
    A second problem is that FDA has for some time been 
chronically under-funded and under-staffed. If you compare the 
2003 budget with the current one for 2007, it is a 
disheartening story. To conserve its purchasing power from 1 
year to the next, FDA would require an increase of about 5.8 
percent in that-year dollars, and at that rate of increase 
FDA's 2007 budget would have been about $1.924 billion and, in 
fact, its actual appropriation was $1.558, a shortage amounting 
to an under-budgeting of 20 percent below what was needed.
    I think my fellow ex-Commissioners would agree that an 
appropriated budget of $2 billion in fiscal year 2008 would be 
needed to restore FDA's capabilities to the level at which it 
functioned in 2003.
    FDA is, furthermore, a payroll-intensive agency, and I am 
sure it is no mystery to members of this committee that it has 
the same problems that a small business has, and that is with 
the rising share that benefits programs, especially health 
benefits programs, take of the budget.
    So, as a consequence, FDA not only has less money in 2007 
than it had in 2003; surprisingly, it has a disproportionately 
lower number of FTEs. So it is a truly difficult situation for 
the agency.
    It might be asked whether an increase in user fees couldn't 
substitute for appropriated funds. I don't think so, for two 
reasons.
    First, some citizens, on hearing that the drug industry 
contributes significantly to FDA's work, may wonder whether 
that opens the door to subtle influence. I am convinced that it 
does not, but the perception may be more general than we hope.
    Far more important is that FDA's user fees are restricted 
to activities related to the new drug approval process. They 
are, thus, not equivalent to appropriated funds, which must 
cover the full spectrum of FDA activities. The user fees permit 
the hiring of more drug reviewers, but don't pay the external 
cost that any additional FTE undoubtedly brings to the rest of 
the organization. So when the drug approval process succeeds, 
food suffers.
    I want to echo a point made by the recent study of the 
Institute of Medicine of the National Academies. It makes a 
point that there is a large disparity between the resources 
available for the new drug review and approval processes at FDA 
and those available for the monitoring of drug safety.
    The IOM report makes some useful recommendations concerning 
the capacity of FDA to undertake risk assessment and risk 
management with respect to already marketed drugs, which I will 
mention a little bit more later.
    I hope the Congress will examine with special care those 
recommendations about the public availability of the results of 
clinical trials actions. In agreement with several major 
medical journals, IOM urges that the industry sponsors be 
required to register at clinicaltrials.gov all of the clinical 
trials that they are about to conduct through phase four.
    The key here is that full information about the conduct of 
these trials and the problems that may arise with them should 
be made available to the public. Are they? FDA has invested 
significant labor in making those records available at its Web 
site. This appears to be an appropriate response to section 5.1 
of the IOM report, but to call it publicly available in any 
real sense is not right.
    With the help of the director of clinicaltrials.gov, I got 
walked through that Web site to find records of the trials for 
Ketek, a drug about which important safety issues have arisen. 
One can get to the right pages, but although the trials are 
listed there, there is no information about the institutions, 
the investigators, or the problems that might have arisen in 
the course of those trials. One can get to the right pages, but 
you can't learn very much from them.
    Even the list is impossible to find unless one knows what 
one is looking for, and the studies cannot be linked to from 
clinicaltrials.gov.
    I think that, with some support for information technology, 
the navigability of this site could be improved to validate 
FDA's promise that this vital information is publicly 
available.
    I want to make two more very quick points related to that 
topic.
    First, the IOM report asks Congress to give FDA authorities 
that it could apply to require conditions for distribution of 
already marketed drugs. These would include the capacity to 
make FDA-initiated changes in drug labels, a moratorium on 
direct consumer advertising if that were deemed necessary, or 
various other conditions.
    As with other needs, this is going to require appropriated 
funds and not user fees.
    I also want to make a quick mention of another serious risk 
that FDA confronts now in the drug area, namely antibiotic 
resistance. That problem is bad both on the supply side and the 
demand side. The demand side doctors and patients are not 
conforming to the most risk-averse kind of behavior, and need 
some encouragement, as do hospitals. More important, perhaps, 
on the supply side there is a good case for a kind of orphan 
drug protection for new antibiotics where already-existent 
antibiotics have shown serious resistance problems and may need 
replacement.
    Mr. Chairman, FDA had to explain repeatedly to the Congress 
back in my day that it was difficult to pursue a comprehensive 
program for evaluating the safety of already marketed products. 
The reason is that in order to calculate an adverse reaction 
rate you need to know the numerator, the number of observed 
problems, and the denominator, the number of prescriptions that 
are out there. You can't find the rate without both.
    FDA's numerator depends on a largely voluntary reporting 
system involving doctors and firms. The denominator has to be 
constructed, for example, through a prescription system in 
which an extra copy recording only the drug's identity and the 
dosage is made centrally available for data storage.
    That, unfortunately, is not available, and the ironic 
result of the Vioxx study done by FDA is that it had to be done 
at Kaiser Permanente, the only health care organization, HMO, 
that had enough patients and a good enough record keeping 
system so that you could get both the numerator and the 
denominator. That is a problem that really needs fixing.
    I will conclude with just a couple of other quick summary 
notes.
    This is an important agency, as you know. It accounts for 
about 25 cents out of every consumer dollar spent in this 
country. If we expect to have our spinach uncontaminated, our 
pet food safe, Congress needs to provide FDA with the resources 
and the authorities it needs, especially on that broken food 
side, of which I know you will hear more from Dr. Kessler.
    I hope your staff and your colleagues on the committee will 
continue your diligence about pursuing FDA resource needs.
    Unfortunately, to hear the bad news you have to rely 
occasionally on old-timers like me, because budget authorities 
at HHS and OMB prohibit present officials in the agency from 
speaking out publicly as enthusiastically as they would like 
about the need for more funding.
    I used to squirm about this in my day, but it is a fact of 
life. I know this is no news to you, but I hope that the 
American public, which expects a lot from the FDA, knows that 
when its officials express satisfaction with their budget 
allocations, they have their fingers crossed underneath the 
witness table.
    Thank you very much, Mr. Chairman.
    [The prepared statement of Mr. Kennedy follows:]

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
    Chairman Waxman. Thank you, Dr. Kennedy.
    Dr. Young.

                    STATEMENT OF FRANK YOUNG

    Dr. Young. Mr. Chairman, it is a pleasure to be with you 
again and to have the opportunity with uncrossed fingers to 
talk about the agency.
    I would like to mention a few things based on my experience 
of 12 years in Government, part in the FDA, part in the Office 
of the Assistant Secretary, and also part as a citizen, as a 
pastor, a person that works in industry as well as with 
consumers, and focus on the point that this is the single most 
important consumer agency in the world.
    We are the gold standard. Much of the world follows the 
FDA. At least in our time, when the FDA sneezed, the world got 
pneumonia. It is an agency that is watched and has been looked 
at for guidance.
    Yet, unfortunately, this agency is suffering, and it is 
suffering significantly. It is suffering from neglect of short-
term Commissioners, it is suffering from a workload that 
greatly outstrips its resources, it is suffering from 
accelerating technological challenges without the ability to 
recruit the people that are necessary for those new fields. It 
needs to be at the forefront of science. We are in the world 
now of genomics, proteomics, variety of nanotechnologies, a 
program where we are looking at cellular therapy, cellular 
regeneration, as well as the classical issues of the drug 
safety, food safety, veterinary safety, cosmetics.
    The new challenges cannot be addressed without a steady 
stream of recruitment of personnel at the forefront of their 
science fields, and importantly an opportunity for their 
continual education, continued training, and I would definitely 
submit research.
    As you know and this committee knows, the research at the 
Center for Biologics Evaluation and Research has been 
eviscerated. There is very little research at the Center for 
Drug Evaluation and Research. Yes, we do have coordination with 
NIH, but it is, in my opinion, important to have a research 
program available within FDA, itself.
    Similarly, there are problems with the research programs in 
the Center for Foods.
    I would submit that the agency requires much more than a 
bandage. In fact, as important as additional resources are, 
they are not the sole solution. I would like to point out some 
of these other points that are necessary for you to make a 
diagnosis of what is safe for the professionals and those 
outside the agency that rely on it, and what is effective to 
restore this agency to its previous strong state.
    I would like to start exactly where Dr. Kennedy did. The 
turnover in the short-term Commissioners in recent years has 
been scandalous. It is very difficult for the agency to have a 
directed focus if it has a revolving door syndrome at the 
agency. The career professionals are outstanding, but without 
guidance and direction of where the agency should be going and, 
yes, protection at congressional hearings and other events, it 
is difficult for the agency to function.
    I would also submit and would recommend that you look at 
the recruitment process at FDA for Commissioners. Dr. Kennedy 
an I were recruited by search committees. We were able to be 
appointed by the secretarial process. Dr. Kessler had a 
lightning swift hearing for confirmation. I guess he said it 
was about 8 days. There have been months and months of 
prolonged foot dragging of getting Commissioners confirmed. I 
wonder whether it would not even be better to return to the 
pre-confirmation status. I would ask you to look at that.
    I would also suggest that you consider a 6-year term for 
the Commissioner. There needs to be stability, and for an 
individual to know that this is his mandate or her mandate for 
a period of time and our professional leader of the agency.
    When I was in the agency I converted to a professional 
status in the Commission Corps and stayed in Government for the 
rest of my professional life in medicine. I think that concept 
of being recruited to come to Government for service is very 
important. It is a lot easier for lawyers to come in and out of 
Government, harder for professionals in health science to come 
in, but I would urge that we make that possible.
    The next thing that I would like to urge your Members to 
look at is really the strength of the scientific base. In 
addition to the topics that I mentioned earlier is the need to 
allow professionals to have training and time to pursue their 
own studies. When I was running a large lab I had about 33 
people with me when I was at the University of Rochester. I 
stumbled onto the fact that I would get much more productivity 
out of a post-doc or a graduate student if I asked them to work 
80 percent on my effort and 20 percent on their own. Some of 
the best leads came from their time, not my imaginations.
    I think it is important that the professional staff of the 
agency have time for professional renewal and, when 
appropriate, research in the very areas that they are 
regulating.
    In my watch we recruited Cathy Zoom from NIH at the very 
time when interferon was being looked at for evaluation. She 
was skilled and actually did research on that. It was one of 
the fastest approvals of new biologics because she could weigh 
the safety, the effectiveness, and was familiar with it. That 
familiarity I think is key in the scientific personnel.
    I also would recommend that there be a comprehensive review 
of the drug and biologic evaluation process. The last one 
occurred over 20 years ago. There have been many excellent 
initiatives that have been added, but they have sort of been 
added like onion rings around the surface of the small nub, and 
each administration adds a larger and larger number of onion 
rings, and for those on the outside looking, whether it is 
clinical trial research and results, food safety, or the 
persons trying to submit proposals for evaluation to FDA, it 
becomes a morass of conflicting, overlapping, difficult-to-
understand regulations.
    I would urge that all of this, in this time when there is a 
review of FDA, be looked at and possibly seen as a way to go 
forward and revise this sort of a program.
    I think unequivocally a comprehensive drug safety program 
is essential.
    I would also like to take this opportunity to look just 
briefly at the budget distortions that PDUFA made. I had the 
privilege, as you mentioned, of initiating that. my good 
friend, David Kessler, continued it. Neither of us ever thought 
that the distortions that have occurred would occur here, where 
the one portion of the budget stays high and the other goes 
down. Very, very difficult to manage the agency. And drug 
safety has been left behind.
    I would urge that if at all possible that there be a 
program to have an appropriated budget for that. It is what I 
favor. However, if it is not possible, we cannot delay in some 
sort of a program where a data base is built with a small 
charge, maybe a nickel a script, so that we can have a Kaiser-
like system over the entire drug safety review. In that way FDA 
could point out what reviews need to be done and, if necessary, 
folks in the private sector could undertake those analyses. But 
to let this go one more congressional session without strongly 
addressing drug safety would be a charade and an abuse of the 
American public that relies on safe and effective medicines.
    I would also urge that we bring a screeching halt to 
unfunded mandates. During the time that I was Commissioner 
there were 22 of them. We scrambled around. We, as a 
Coordinating Council, met to try to see where we could shift 
resources, but it was very hard. You know and I know very well 
of the act that bears your name, the Hatch-Waxman Act. I had 
the privilege of trying to implement that. It was under-funded. 
We had a terrible time trying to bring those standards in.
    You are now looking at follow-on biologics. I would urge 
strongly that the greatest caution be taken in devising the 
law, implementing the new regulations, and providing both the 
resources for evaluation but also enforcement. We had great 
problems in the early days of enforcement with the Hatch-Waxman 
Act. I think that needs to be looked at.
    The inspectional staff in FDA is under-funded, under-
manned, and overwhelmed. I remember at one hearing at OMB I 
brought in a dead chicken. We left it out deliberately for 
about 24 hours, put it on Barry Clendenin's desk. It was at 
room temperature, also. And then we brought a pacemaker. I said 
the Department of Agriculture has over 12,000 inspectors. They 
watch those chickens go by. We have heart-implanted devices, 
pacemakers, valves, and there are 1,400 FDA inspectors. I can 
smell a dead chicken that is rotten; I can't smell anything on 
a pacemaker or an artificial valve. We need the proper 
inspections.
    When the new initiative comes like follow-on generics, 
biologics, if it does, my goodness, we can't steal from 
anything else to leave the protection for us under-manned.
    I would also urge that we have an equal playing ground and 
playing field for imports versus domestic products. Inspecting 
at about 3 to 5 percent, getting caught is a cost of doing 
business. We really need to have high-quality foods, drugs, 
devices, biologics coming into the United States in a good 
system to make sure that they play on that equal field.
    Finally--and maybe I shouldn't say finally--I think having 
the appropriates in agriculture is sort of a historical 
accident and silly. It would be as silly as having the 
Congress' Health and Labor Committee oversee the Defense 
budget. We have now moved to a different era where we have a 
need for having those committees that appropriate health and 
labor budgets oversee the budget of FDA. This is a major 
problem. I think that Congress can have and should have the 
will to deal with that.
    There is one other little piece of suggestion that I could 
humbly make, or maybe not so humbly. Possibly it would be 
considered to reduce the overlapping authorities that oversee 
FDA. I think there were about nine different committees that I 
testified in the over 100 testimonies that I gave, and it was 
very difficult to go to this committee, this committee, and 
this committee. If we could have a coordination in oversight as 
you are doing today and focusing on the agency from a 
comprehensive standpoint, I think it would be very, very 
helpful.
    [The prepared statement of Dr. Young follows:]

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    Chairman Waxman. Thank you very much, Dr. Young. Those are 
very helpful and specific ideas. I appreciate them.
    Dr. Young. Thank you, Mr. Chairman.
    Chairman Waxman. We are going to review them very 
carefully.
    Dr. Kessler.

                   STATEMENT OF DAVID KESSLER

    Dr. Kessler. Mr. Chairman and members of the committee, 
thank you for the opportunity to participate in today's 
hearing. Most importantly, Mr. Chairman, thank you for your 
belief and support for the mission of the FDA.
    The opportunity and challenges this Congress has before it 
now to equip the Food and Drug Administration to meet the 
public health challenges of the 21st century are as pivotal as 
those the Congress faced in 1938 and 1962 when it gave the 
agency the fundamental responsibility of insuring drug safety 
and efficacy.
    We are seeing a confluence of factors--chronic under-
funding, a lack of enforcement authority, severely outdated 
scientific and regulatory frameworks that are creating a lack 
of confidence in the FDA and its many dedicated and talented 
people.
    At the same time, there are considerable challenges the 
agency must be able to address if it is to remain the world 
standard for public health protection. This includes 
globalization of markets, particularly in food and drugs, and 
the imminent and profound shift toward a new era in medicine in 
which treatments are geared toward individuals rather than mass 
markets.
    I want to focus, Mr. Chairman, if I may, on food safety. My 
written remarks address many of the issues that my colleagues 
have already talked about, but let me focus my oral remarks, if 
I may, on food safety.
    Simply put, our food safety system in this country is 
broken. We have no structure for preventing food-borne 
illnesses in this country. The reality is that there is 
currently little mandate, little leadership, little resources, 
nor scientific research base for prevention--and I underline 
the word prevention--of food safety problems.
    The fact is there is no one in the executive branch with 
the clout and authority who focuses, whose job it is to prevent 
food-borne illnesses.
    FDA can react to outbreaks, but the emphasis needs to be on 
preventing outbreaks before they happen. Over the past 20 
years, there has been robust debate about FDA's role in drug 
approval and safety. The focus on drugs also has been reflected 
in agency funding and management attention, and legislation 
currently under consideration will continue to strengthen our 
drug safety system. Now it is time, indeed overdue, to address 
the same attention and concern to the agency's food safety 
mission.
    In 1938, when the statute was written, people were not 
thinking about food safety in terms of global markets and 
worldwide supply and distribution networks. Spending weeks or 
months tracing bad cases of food-borne illnesses to their 
origin, although important, is too much like chasing the horse 
after it has left the barn, and too often with devastating 
results in illness and death.
    Congress and the administration should act urgently to 
strengthen FDA by meeting its resource needs and by unifying 
and elevating food safety leadership within FDA and the 
Department of Health and Human Services.
    Food safety cannot compete with drug or device safety for 
resources and leadership. Food safety cannot be delegated to 
second-tier management within the agency. The fact is that food 
safety has been a second-tier priority within the FDA.
    In addition, the current structure in the agency for food 
safety is fragmented. Responsibilities for food are spread 
across the Center for Food Safety and Applied Nutrition, the 
Center for Veterinary Medicine, and the Office of Regulatory 
Affairs. There must be clear recognition within HHS that food 
safety is an essential part of protecting the public health, 
and it cannot be housed in the Department of Agriculture, 
because the Secretary of Agriculture does not speak for public 
health.
    We need a Commissioner of Foods at FDA who is responsible 
and accountable for all that FDA does on food safety at 
headquarters and the field who reports directly to the 
Secretary.
    Our focus today needs to be on prevention, not just 
reaction, if we are to have any hope of averting future 
failures in the food safety system.
    FDA must have the scientific capability to do the research 
and to develop the right processes and controls. Producers and 
suppliers must be required to take steps to protect their link 
in the food chain, and the agency must have the authority to 
hold producers and suppliers accountable for the failure to 
establish the necessary protections and standards.
    Mr. Chairman, I appreciate your longstanding interest in 
these issues and your willingness to devote your time and 
energy and that of the committee to finding the solution to the 
challenges confronting this very, very important agency. I 
offer to you whatever help I can to you as you work toward 
strengthening the ability of the FDA and the Federal Government 
to continue to protect the health of the American people.
    Thank you very much.
    [The prepared statement of Dr. Kessler follows:]

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    Chairman Waxman. Thanks very much, Dr. Kessler.
    Dr. von Eschenbach.

             STATEMENT OF ANDREW C. VON ESCHENBACH

    Dr. von Eschenbach. Thank you, Mr. Chairman, Ranking Member 
Davis, and members of the committee, I am pleased to join you 
this afternoon for what I know will be a productive discussion 
of the future of the Food and Drug Administration.
    I have been at the helm of the FDA as a fully confirmed 
Commissioner for approximately 5 months, obviously a period of 
time that pales in comparison to the combined experience of the 
three former Commissioners that I am proud to have surround me 
on this panel.
    Although my tenure at FDA has been brief, I am no stranger 
to the radical changes, the radical changes in science and 
technology that over recent years have transformed the health 
care environment in which the FDA must achieve its mission of 
protecting and promoting the public health.
    Whether caring for cancer patients or conducting research 
or heading the National Cancer Institute, I have witnessed 
discoveries at the molecular level that are transforming 
medicine, health care, and are impacting our regulatory 
environment across the full continuum of food and drugs, 
biologics, devices, and other consumer products.
    Now, from my current vantage point as Commissioner of the 
FDA, I have the privilege of being able to create and implement 
a strategic plan that will enable the agency to remain the 
world's leader and gold standard, a record my predecessors can 
be justifiably proud of. Our focus, therefore, today and our 
theme is not simply to address repairing the FDA of the old, 
but, most importantly, to build the FDA of the future in the 
context of the radical changes that are occurring in the world 
around us.
    I am committed to leading an FDA that, in addition to 
responding in a visionary and strategical manner to these 
challenges, will also be effectively and efficiently managed. 
It must and will be a regulatory agency that is always science 
based but also science led, and engaged in the full life cycle 
of the products that we must regulate, whether they are foods, 
drugs, devices, or commodities.
    Americans still want the assurance and the security of 
knowing that life-sustaining and life-enhancing products will 
be rapidly available to them to promote their well-being, but 
at the same time they also want to know that the latest 
scientific and technological advances are being brought to bear 
in the prevention and detection of adverse outcomes that could 
impact their health.
    To meet these expectations in this radically different and 
new environment will require a modern FDA that, as my 
colleagues have indicated, is adequately resourced to fully 
implement its regulatory authorities and new scientific tools.
    Since arriving at the FDA, we have worked with the FDA 
staff and leadership to develop a plan for increased resources, 
and I am grateful to the Congress for its support in fiscal 
year 2007 and look forward to the increased resources that are 
proposed in the President's budget for fiscal year 2008, which 
will account for an additional $77 million more than 2007.
    We are well into formulating a continuation of this 
trajectory of increases as we formulate our strategic budget 
proposals for fiscal year 2009. I will look forward to 
continuing to work with all Members of Congress during this 
appropriations process.
    To address the increases in funding, we are also 
supplementing the taxpayer dollars with increases that are also 
being proposed as you address reauthorization of the 
Prescription Drug User Fee Act and the Medical Device User Fee 
Modernization Act, as well as consideration of additional fees 
for out ability to continue to manage the increasing demands 
posed by regulation of generic drugs.
    Congress is also interested in FDA's legal authorities and 
whether they need to be altered or increased, and we will 
continue to contribute to those discussions, as well. However, 
I believe it is important to not only address how additional 
essential resources we could use effectively to be able to 
enhance the authorities that we currently already have. 
Efficient and effective measures such as guidances and 
rulemaking can be powerfully important tools when they have the 
resources to be fully utilized, as opposed to unfunded mandates 
and statutes that are ultimately doomed to failure.
    FDA now has permanent, confirmed leadership and 
organizational changes are occurring that can lead us to 
greater efficiency and effectiveness. I pledge that we will 
continue this effort as we continue to look at the FDA's 
responsibilities and opportunities and challenges of the 
future.
    Some organizational changes have already occurred that 
address many of the concerns my colleagues have raised. For 
example, the appointment of Dr. Janet Woodcock specifically as 
Deputy Commissioner and FDA's Chief Medical Officer to oversee 
our scientific portfolio and to be able to lead its 
modernization and amplification, particularly benefiting from 
the current effort that is underway by our Scientific Advisory 
Board to totally reassess the scientific portfolio of the FDA 
to find greater opportunities for integration, efficiency, and 
also the ability to find strategic areas in which we can 
enhance that scientific effort.
    She is also responsible for addressing many of the issues 
with regard to career development of our current staff and, 
most importantly, is taking on a very aggressive effort to 
create an FDA-credentialed training and fellowship program that 
we expect over the next 3 to 5 years will bring approximately 
2,000 fellows into the agency.
    More recently, I named John Guyer, a seasoned executive 
with executive government experience, as Deputy Commissioner 
and Chief Operating Officer. He will bring streamlined 
management processes to our planning and budgeting for the 
future.
    We are also strengthening the agency's infrastructure. A 
new Chief Information Officer is now in place with the mandate 
of modernizing FDA's information systems so that we will be 
equipped and prepared to fully integrate into the rapid changes 
that are occurring in the health care environment where we 
will, in fact, have access to data bases that are being 
developed and health care infrastructures such as the one that 
Dr. Kennedy alluded to, and therefore be able to provide a 
rapid, seamless, efficient way of being able to data mine and 
learn and understand about the utilization of these devices, 
drugs, biologics, and products in the real world.
    We will continue much of the effort of modernization, even 
including the opportunities for new facilities that are 
becoming available to us as we build out our consolidation of 
much of FDA at our new White Oak campus, and we expect that to 
pay dividends in the synergies and productivity and efficiency 
of the organization.
    Mr. Chairman, we at the FDA concur with you that we must 
focus on the future and address the increasingly emerging 
challenges, but also the unbelievably exciting opportunities 
that this new world of science and technology is providing for 
us, and, most importantly, is hoping and offering to the 
American people and the world for greater solutions to their 
problems.
    I am honored to be leading this proud agency whose mission 
today, tomorrow, and as always as in the past will be to 
promote and protect the public health. I would be pleased to 
continue this dialog with you and my colleagues as we explore 
that new future.
    Thank you, sir.
    [The prepared statement of Mr. von Eschenbach follows:]

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    Chairman Waxman. Thank you very much, Dr. von Eschenbach.
    I will start the questioning. Each Member will get 5 
minutes on the first round.
    I think all of you have done a superb job in giving us a 
perspective at the FDA. The job of the FDA is varied. You deal 
with drugs, devices, food, different products, and there are 
different issues that come up. I think all of the suggestions 
are very worthwhile, and we want to take them under advisement.
    I am going to pursue one area, and that is enforcement of 
the rules. It goes to the heart of FDA's mission. Without a 
strong enforcement arm, the standards set by the FDA are 
meaningless, and over the years experience has proved that a 
strong FDA enforcement leads to broader compliance with the 
law--we know when laws are enforced people are more likely to 
obey the law; greater consumer confidence, because the public 
knows that the law and the rules are being enforced; and 
improved public health, because that is what the rules are all 
about, to make sure that the public health is protected.
    Dr. von Eschenbach, I want to ask you about, first of all, 
the field staff that is available to do the work of the 
inspections that are required. I understand that there are 
3,460 full-time employees at FDA focusing on field inspection 
activities. Is that a correct number?
    Dr. von Eschenbach. Yes, sir. Without having the exact 
numbers before me, that is my recollection, as well.
    Chairman Waxman. We have a poster on the side, if you would 
take a look at it. That poster indicates there was a sharp 
increase in field staff at FDA in 2003, and that was after the 
passage of the Bioterrorism Act, followed by a steep decline. I 
assume that, even though there has been a steep decline, there 
has not been a reduction in the FDA's responsibilities that 
would explain this decrease. Is that an accurate statement?
    Dr. von Eschenbach. That is correct, sir.
    Chairman Waxman. I understand that FDA oversees over 
200,000 food establishments in the United States. There are 
probably at least tens of thousands of other firms, including 
manufacturers of medical devices or biologics or drugs or 
animal feed, and that means the FDA field staff has to look at 
all those establishments, as well. Do you know, or maybe you 
want to provide for the record, how many establishments FDA 
oversees in each of these categories that I mentioned?
    Dr. von Eschenbach. I cannot give you a breakdown in terms 
of the categories. We will provide that for you as far as the 
record is concerned.
    Chairman Waxman. Thank you. That would be helpful.
    Let's assume that all of the field staff were just for food 
establishments. They are not, but let's just say that they 
were. In 2006, there were 1,962 field staff, most of whom are 
inspectors on food programs; is that a correct statement?
    Dr. von Eschenbach. Yes, sir.
    Chairman Waxman. And, based on the total number of food 
establishments in 2006, 210,000, and 1,962 field staff, that 
translates to roughly one inspector for every 60 food 
establishments. I understand that in 2006 the total number of 
field personnel who visited and evaluated all regulated 
facilities was 3,460. We know that there are far more regulated 
firms than food establishments, since there are also all of the 
firms involved in these medical devices, drugs, biologics, 
animal feed. But even if all of the field staff focused only on 
food, that would mean only one inspector for every 107 
establishments. I want to know if you think that is a correct 
statement?
    Dr. von Eschenbach. I think your statistics are very well 
taken in that they point out exactly what the important 
challenge is going forward, and that is, with this large 
proliferation of sources from which these products come, what 
we must do is not simply look at the size of the work force, 
because it never would be equivalent to that number of that 
large a need, and so therefore the opportunities are how we 
strategically deploy that work force. That has been the 
strategy in terms of, No. 1, taking a risk management approach 
where recognizing among that large diversity there is a lot of 
heterogeneity in which some are considered to be of high risk, 
and therefore we focus our inspections on those particular 
firms, and that is based on product, the kind of product that 
they are producing and what level of risk comes from that, 
prior track record or source in which we know that there may be 
a concern.
    So I think it is not only an issue of resources, but how 
those resources are applied strategically in a risk management 
basis that is an important way of going forward into the 
future.
    Chairman Waxman. Do you look at the food side of the FDA 
responsibility as less risky than the drug or medical device 
side?
    Dr. von Eschenbach. No, sir, absolutely not.
    Chairman Waxman. And do you devote more resources or less 
resources to food than you do in the other areas?
    Dr. von Eschenbach. I think the resources, as I indicated, 
are being applied strategically, and investigators or field 
investigators are applying scientific tools that can, in fact, 
be applicable under certain circumstances to food, and at other 
times they can even be applicable to medical devices. As we are 
seeing science and technology improve, what we are attempting 
to do is bring some of those tools out of the laboratory and 
into the hands of field inspectors at the point of inspection, 
and therefore that is an additional part of what you have seen 
in our proposal this year for our Office of Regulatory Affairs 
reorganization, which is a strategic way of enhancing 
inspections, the quality of the inspections, better tools for 
inspection, and focus strategic application of those inspectors 
to areas where we see concerns regarding risk.
    Chairman Waxman. Thank you very much.
    Mr. Davis.
    Mr. Davis of Virginia. Over the past year we have seen a 
number of stories of food contamination, including the 
nationwide recall of fresh spinach due to e-coli, salmonella in 
peanut butter, and poisoned pet food. Several of you mentioned 
in your testimony that FDA is responsible for regulating 80 
percent of the food supply, while the USDA receives 75 percent 
of Federal food safety budget. How is FDA's food safety program 
different from the USDA's?
    Dr. von Eschenbach. Mr. Davis, the Food and Drug 
Administration concentrates its oversight over food for 
products that have to do with vegetables, produce, and seafood, 
and the USDA is addressing beef, poultry, and certain egg 
product derivatives.
    What we do is work very closely with USDA in a 
collaborative, cooperative relationship, as well as work 
effectively with State agencies so that we are addressing that 
full continuum of our food portfolio.
    Mr. Davis of Virginia. Is it efficient or is it very 
duplicative as they work together? I guess I ask, if FDA had 
the resources, what best practices and authorities would you 
want to borrow from USDA to create----
    Dr. von Eschenbach. Well, along with USDA what we are 
increasingly addressing is the realization of being engaged in 
the full life cycle of these products as they are changing 
radically with regard to how they are being produced and 
distributed.
    The chairman has already made reference to the fact that, 
for example, we are seeing now going from farm to fork in a 
much more rapid way the use of fresh products that are eaten in 
the fresh state rather than cooked. These are creating new 
challenges with regard to our ability to assure safety, so USDA 
and FDA are both working to address those changes that are 
occurring in a collaborative way, and we are approaching it by 
building quality in by working with producers and, in our case, 
growers, as well as being able to utilize our inspections 
further on down the line in distribution.
    Mr. Davis of Virginia. OK. Anybody else want to add 
anything to that? Dr. Kessler.
    Dr. Kessler. Congressman, there have been certain model 
programs in USDA, for example, the ground beef program, which I 
think could serve as best practices. Again, it is focused on 
preventing problems before they start.
    I think the American people don't understand that if you go 
in and you order a pizza, that is regulated by FDA, but if you 
put pepperoni on it, it is U.S. Department of Agriculture. And 
in some ways that doesn't make sense, but, again, as I think 
the chairman indicated in his numbers----
    Mr. Davis of Virginia. And if you have a beer with it, you 
get the Alcoholic Beverage Control on it.
    Dr. Kessler. I mean, do you want to be chasing the problem 
after it happens or do you want to have a system of preventive 
controls in place? That is what USDA, to its credit, did after 
the Jack-in-the-Box episode a number of years ago. I think we 
can learn lessons. But, again, the focus has to be on 
prevention standards, and that has not been at the core of our 
food safety system to date to the vast majority of products.
    Mr. Davis of Virginia. OK. Dr. Young.
    Dr. Young. Thank you for that question. I think there is 
another problem that possibly emanates from where the 
appropriations come. There is a great imbalance in the amount 
of inspectional and enforcement authority in FDA versus 
Agriculture. As Dr. Kessler absolutely appropriately said, we 
need to focus on prevention, but with the numbers that are 
there it is very difficult to make that initiative work.
    Mr. Davis of Virginia. OK. Let me go to how prepared is the 
FDA against the threat of terrorist attacks against food 
supply? Have you given any thought to that? Are there specific 
actions and programs FDA has implemented over the past few 
years, and has FDA partnered with other Federal agencies and 
industry to protect against what we call agro-terrorism?
    Dr. von Eschenbach. Yes, sir. We have approached the food 
issue from both the food safety perspective, which we have been 
discussing, and also from food defense, which takes a very 
specific view of where our vulnerabilities might be to 
intentional contamination, as opposed to unintentional. That 
has been done in collaboration with a variety of other Federal 
agencies. We have adapted models that have been developed in 
the Department of Defense, referred to as the Carver Shock 
Models, to begin to understand vulnerabilities that occur 
within our food chain and how they will need to be addressed 
from the point of view of protection against what would be 
considered a terrorist intentional effort to harm our food 
supply.
    Chairman Waxman. Thank you very much, Mr. Davis.
    Ms. McCollum.
    Ms. McCollum. Thank you, Mr. Chair.
    Thank you, gentlemen. This has been very, very interesting, 
especially in light of what has happened with the pet food 
issue in China and how imported foods aren't inspected. I am 
wondering if you could elaborate on that a little more and what 
you would recommend to Congress to do about this, because this 
is very disturbing. It was very open in China and for people 
who even scratched the surface on how there is little or no 
inspection and how they have had many, many failures in the 
past.
    And then, Dr. Kennedy, if you could elaborate a little more 
on antibiotics resistance, especially with what we are seeing 
with HIV and tuberculosis and the extreme resistance to some of 
the antibiotics.
    Dr. von Eschenbach. Ms. McCollum, with regard to your 
important question, I want to echo a theme that Dr. Kessler has 
emphasized, and that is the issue of prevention. As I indicated 
to the chairman, whether it is food or drugs, the FDA has taken 
the approach of the full life cycle of that product, and we 
have been addressing the need to build quality in with regard 
to the production of food, so not only issuing good 
agricultural practices for growers within our own borders 
within the United States; we have been working with foreign 
countries, their governments as well as their producers, to 
begin to help assure quality of those products at those sites 
of production, because we have seen a continuous increase in 
the amount of food that is imported into this country each 
year. So we are attempting to provide those good agricultural 
practices, work with the governments, engage in inspections in 
terms of how these products are being produced, and create 
corrective measures at the very front end as a preventative 
strategy, and then apply the risk management to our borders.
    Ms. McCollum. Doctor, I heard that all in the testimony. I 
think Dr. Young was going to say something.
    When you go to a grocery store and you pick something up in 
the U.S. grocery store as a consumer, you already feel that you 
have the assurance, so telling me that you are going to try to 
provide assurances doesn't make me feel much better.
    Dr. Young, you looked like you had something you wanted to 
contribute.
    Dr. Young. One of the major draw-backs, in my opinion, is 
an inability to adequately certify that the inspectional 
capability, their regulatory capability of the country of 
origin is similar to or equivalent to our country. This is a 
real problem, and I think you hit the nail on the head by 
focusing on the pet food concern.
    If the standards are not comparable and they have a low 
level of inspection when these products come into the United 
States, then it truly is the canary in the cage, and it is not 
dealing with the front-end prevention. We need to be able to 
negotiate these international type regulatory treaties. We have 
some very good ones and good manufacturing practices in drugs. 
We have some others in regards to devices. The food area has 
not been focused on as well and, as you aptly pointed out, more 
and more is coming from different countries that may not have 
and, in fact, do not have the same standards of inspection that 
the United States does. This loophole needs to be closed.
    Mr. Kennedy. I think you asked a question about antibiotic 
resistance, Ms. McCollum?
    Ms. McCollum. Yes.
    Mr. Kennedy. Thanks. With respect both to multiply 
resistant bacteria, staphylococcus, particularly, vancomycin 
resistance, there is dramatic growth even since 1985 in the 
proportion of hospitals that are reporting un-managed 
infections. As somebody once said to me, the good news is that 
your surgery went beautifully and everything is safe and it is 
wonderful. The bad news is you have an infection against which 
we have no treatment.
    What can be done at the supply side end of that is to offer 
some real incentives to drug manufacturers to get back into 
that business, because it has dropped steadily over the past 10 
to 15 years. One way of doing that would be if the Congress saw 
fit to engage with it in a statutory fashion by creating a 
specifically tailored orphan drug kind of exemption for an 
antibiotic that could replace an antibiotic that was already 
encountering substantial resistance in the target bacteria.
    It would have to be so limited that you couldn't offer it 
carte blanche to anybody that developed a new antibiotic, but 
there ought to be some special intellectual property rewards 
for somebody who goes after an antibiotic that could replace 
one to which there is resistance.
    Dr. Young. Could I add one additional point to that 
question?
    Chairman Waxman. Yes, Dr. Young.
    Dr. Young. One of the things that I have learned in my more 
recent activities in the industrial side of the marketplace is 
that the companies that are looking for a return on their 
investment, which is frequently the taxpayers' investment in 
insurance funds and others, gave what the agency is doing and 
what is likely to be difficult to get evaluation expeditiously 
and what is likely to be hard, so there is a marketplace that I 
must tell you is already shifting to devices from early startup 
biotech companies. So the very thing that Dr. Kennedy is 
talking about in areas that are judged to be risky, the private 
equity funds and the venture funds are decreasing. Part of that 
relates to what I try to point out as the difficulty in 
understanding what these overlapping rules are and where the 
incentives are. That, again, is a topic that I strongly support 
what Dr. Kennedy said is extraordinarily critical in the field 
of antibiotics.
    If you would like to I could tic off about ten other areas 
that we really need to look at that are high need and similarly 
are problems in regards to the regulatory structure.
    Chairman Waxman. Thank you, Ms. McCollum.
    Ms. Foxx.
    Ms. Foxx. Thank you, Mr. Chairman.
    I am going to give you back some of the statements that 
some of you all have made and then ask you if you could respond 
to them, and then ask a general question, I guess.
    Have any of you or all of you made these same kinds of 
recommendations in the past? And are there reports, those of 
you who were formerly there, are there reports that we could 
get our hands on showing that you have made these same kind of 
recommendations for improvements at the FDA? If you would just 
answer me yes or no and then give us the dates on those reports 
or approximate dates and let our staff find them.
    Dr. Young.
    Dr. Young. Yes. It is difficult to give you the reports 
because we don't take documents out of the Government.
    Ms. Foxx. I understand, but do you have----
    Dr. Young. But yes, you could give the general period of 
what was focused on, yes.
    Ms. Foxx. And could you do that today?
    Dr. Young. Yes.
    Ms. Foxx. Not necessarily now, but if you could do it.
    Dr. Young. I would be happy to do it for the record.
    Ms. Foxx. OK.
    Dr. Kessler.
    Dr. Kessler. Yes, Congresswoman, I testified on food safety 
enforcement authority several times, and would be happy to 
provide you with those references.
    Ms. Foxx.
    And let me ask you, did you say then that the food safety 
system is broken?
    Dr. Kessler. I don't believe I did quite in as stark terms. 
I would have to go back and review my testimony and refresh my 
recollection. I believe I said the tools were significantly 
outmoded. In fact, we were dealing with tools that were enacted 
close to a century ago, and not for the current environment. 
But I think recent events have shown us that the problems 
continue to persist, and they really do require our attention.
    Ms. Foxx. And Dr. Kennedy.
    Mr. Kennedy. My associates were kind enough to count while 
I was Commissioner, and I testified 47 times, and I do believe 
that at least six or seven of them dealt primarily with foods, 
and I think I could probably dig them up.
    Ms. Foxx. OK.
    Let me ask you a question. How much money do you all think 
it would take to guarantee a fail-safe program? You indicate 
that is possible to have, so what would you predict it would 
cost to have a fail-safe food safety program in this country?
    Dr. Kennedy, start with you, since you answered last.
    Mr. Kennedy. I think the candid answer has to be more money 
than you have.
    Ms. Foxx. OK.
    Mr. Kennedy. I don't believe in perfect safety. We used to 
argue with Congressman Delaney that probably it wasn't a good 
idea to insist on complete safety. And so I think we could 
tailor a system that would be substantially improved and that 
it would reduce the risk level, but I think it would not reduce 
it to zero.
    Ms. Foxx. Dr. Kessler.
    Dr. Kessler. I agree with Dr. Kennedy. There will be no 
fail-safe system. There will be no system that assures 100 
percent safety. I think, as Dr. Kennedy taught me years ago, 
the real mission of FDA is to create the incentors for the 
purveyor of the product to produce as safe a product as 
possible. That is really what FDA is all about.
    Ms. Foxx. Thank you.
    Dr. Young, would you comment?
    Dr. Young. Again, there is no absolute safety. I believe 
that the budgets can be projected to reduce risk. I would be 
happy to provide information.
    Ms. Foxx. OK. With your comments, though, you all indicate 
that throwing money at this issue would provide such a program, 
and that is why I wanted to ask you that, because it always is 
that if you will just put more money, more money, more money 
into agencies then we can get results, and I am always 
interested that if we have a responsible and accountable 
person, as I think Dr. Kessler said, who reports to the 
Secretary, then you can guarantee a safe program.
    I don't think that in our bureaucracy we ever really have 
people lose their jobs because of lack of performance or that 
are really held responsible. What I would be curious in the 
particulars that you might have made before is did you set up 
an organization in such a way that people would be held 
responsible, because in the bureaucracy we don't do that, and I 
believe that unless we devise a system where people 
individually are held responsible at every step of the way for 
a certain level of performance, that no amount of money is 
going to create the kind of system you are talking about.
    What I am interested in is you all, in the jobs you have, 
and the current person, are those the kinds of recommendations 
you are making, because, again, just putting money into it 
without standards, performance standards, we are not going to 
have it.
    Last question I would ask you, and I guess would just ask 
for a yes or no, do you think it is possible we could have food 
inspection treaties with other countries? Would you make that 
as a recommendation?
    Dr. Young. If I could respond first, when I was 
Commissioner we had the opportunity in the biotechnology 
revolution and we made those treaties through OECD and through 
WHO, where I was a representative for the United States in 
both.
    In regards to GNP, those initiatives were done at that 
time. Dr. Kessler and others continued them.
    We have not had the same focus on imports as it relates to 
foods, and one of the problems that we have is we are bringing 
in products, and unless we have these treaties, unless we have 
an inspection that goes with them, I don't think it would work.
    I also tried to say that the agency requires more than a 
bandage of additional resources, as important as they are, and 
I tried to focus on the need to address this incredibly bad 
swinging door that we have had at FDA. That has been a real 
difficulty, because there is not a continuity of leadership.
    But in the last point I would say yes, there have been 
people that have lost their jobs. I will just give you two 
prominent ones, and I will go back in history rather than 
current, but the Assistant Secretary who oversaw the swine flu 
problem, that was Dr. Ted Kennedy, lost his job, and at that 
time the head of CDC lost his job. The Secretary had the 
cranberry bog problem. We have had others, and there are a lot 
of difficulties that people have had along the way.
    The problem isn't accountability as much as it is the 
ability to build a system that is proactive in a culture to 
make a secure environment where people can make a decision 
without fear of political punishment. I am talking about 
regardless of whether it is Democratic administration or 
whether it is a Republican administration. Those issues can 
paralyze an agency. Without a Commissioner, it is even more 
striking.
    Chairman Waxman. Thank you, Ms. Foxx.
    Did any of the others of you want to comment on her 
question?
    Dr. von Eschenbach. Well, Mr. Chairman, if I can add, I 
both agree and disagree with Dr. Kessler. I disagree that our 
food system is broken, but I agree that we will never have a 
totally 100 percent fail-safe.
    The approach for the FDA going forward is to be 
collaborative, cooperative with all the other parts of this 
equation in our food chain, to work with growers, to apply our 
protection at the borders, to work with USDA as we embrace 
models like the Hassop Model or the hazard analysis that he 
referred to, and to see this as a systems solution to a systems 
problem, with the FDA providing the leadership and the 
integrating force, but not see this as simply solved by just an 
inspections issue or just a trade treaty issue, but a real 
comprehensive approach that I think is really ultimately the 
best assurance to the American people that what they take home 
and feed to their children is, in fact, safe.
    Chairman Waxman. Thank you very much.
    Mr. Braley.
    Mr. Braley. Thank you, Mr. Chairman. I would like to thank 
our panelists for appearing today.
    Dr. Young, you made a comment, I think, a drug safety 
program is absolutely essential.
    Dr. Young. Yes.
    Mr. Braley. What I would like to do is, for the panel, sort 
of review where we have come from in the last 8 years.
    In 1999, the Institutes of Medicine, which most of you have 
referred to, issued this report, To Err is Human: Building a 
Safer Health System, and at that time they projected that 
somewhere between 44,000 and 98,000 people die in hospitals 
every year due to preventable medical errors.
    In March 2001 the IOM issued another report, Crossing the 
Quality Chasm: A New Health System for the 21st Century. Then, 
in 2003, the IOM issued Patient Safety: Achieving a New 
Standard for Care, which had recommendations not only for 
agencies of the Federal Government but also for Congress to 
make proactive steps to improve patient safety, especially in 
the area of medication errors. And then just this year the IOM 
released Preventing Medication Errors.
    What I would like to know is whether we have actually made 
any tangible progress in reducing the 7,000 deaths per year 
identified in those earlier reports due to medication errors by 
adapting some of the technologies and recommendations, or do we 
still have as far to go as it sounds like we do in achieving 
real, tangible benefits in the area of patient safety from drug 
interactions?
    Dr. Young. I fundamentally think that we have a long way to 
go. When we do the pre-market evaluation, at most we are 
looking at 3,000 to 5,000 patients and we derive a basic 
assessment of safety. After that, we do not have a 
comprehensive system that looks at medicines, makes a judgment 
of which ones we should study that year, and then gets the 
denominator and the numerator. Unfortunately, the numbers that 
you cited are probably low. I think it is closer to 100,000 a 
year that have adverse medical responses.
    Now, there are a couple of things that I should bring out. 
One is today's medicines are very complicated. I very 
fortunately had a bypass in 2000. I did not die, like my father 
did at his first and only coronary at 45 years of age. I take 
about five or six different cardiovascular medicines. I am very 
careful about those drug interactions. I read the fine print 
that comes out on these. But I have no way of saying is it 
right for me to take a particular generic model against what I 
am taking as the innovator brand, because I know the innovator 
brand works, and I don't have a large system that I can say 
yes, 500,000 people took this drug with a combination of this 
drug and there was no adverse effect.
    We don't have these large numbers. We need that. That is 
why I said it is essential and a user fee may have to be done.
    Mr. Braley. And let me add this comment, so the rest of the 
panel can also consider this. Two of the recommendations in the 
2003 Patient Safety Report were improvement of computer 
detection rules using boolean search terms, and also data 
mining free tech searches for the exact same problems you are 
talking about. Yet, my perception from talking with public 
health officials is that, with the possible exception of some 
advancements made in our VA electronic medical management 
system, that, by and large, the general public is not that much 
safer from these type of recommendations being implemented in 
the real world than we were in 2003.
    Can anyone comment?
    Dr. Kessler. Congressman, I think that there is a lot of 
science, and that is the good news, that will make our 
pharmaceuticals much safer.
    One of the problems we have had over the last several years 
and the industry has had is this issue of the push for the 
blockbuster. Blockbuster means you have a drug that sells to as 
many people, literally millions and millions of people. What we 
need, and we are finally getting the scientific base to figure 
out the right drug for the right person for the right 
indication at the right dose. That is what personalized 
medicine is all about.
    If I sell a drug to 100 million people but only 1 million 
people are going to benefit, we have to change the system. And 
we are beginning to have the tools to understand who is going 
to benefit and understand that up front. That is going to take 
a lot of resources, and I think it is also going to require the 
FDA to lead in this area.
    Mr. Braley. Let me just offer this observation about that 
comment. I mean, one of the problems that I hear repeatedly on 
how we reduce preventable patient errors is that it is not a 
people problem, it is a system problem. The system problems 
have been identified for a long time, and yet I am not hearing 
that we are making dramatic progress and institution-wide 
implementation of improvements to address the system failures, 
so that is the concern I am raising, and where are we going and 
what are the possible solutions that Congress plays in giving 
health care providers the resources they need to eliminate the 
system breakdowns.
    Mr. Kennedy. Can I try one, please?
    Mr. Braley. Please.
    Mr. Kennedy. I think one thing that the Congress could do, 
and I think it will not be uncontroversial, is to make a 
requirement that there be an additional form on every 
prescription written in the United States that must go into a 
data base with no patient's name but with the dosage, and that 
provides the denominator base for looking at the number of 
adverse incidents and discovering what the rate is, because 
unless you have a rate you can't know.
    Then the other thing Congress can do is to follow the IOM 
recommendation in its most recent report by providing authority 
for FDA to allow limited marketing under certain conditions. 
You can't do direct consumer advertising in this program drug. 
And the other one, there is a labeling requirement that we have 
to initiate.
    I think that giving those additional authorities would 
solve some of the systems problems.
    Thank you.
    Dr. von Eschenbach. Congressman, I agree that we have a 
long way to go, because the health care community has been slow 
to adopt electronic infrastructure in health care. But at the 
same time I think we are traveling that road much more rapidly 
today than we ever have in the past, and we are seeing the 
transition into health care technologies that have been 
developed in other areas like the banking industry, etc.
    Now, FDA must participate in that transition to that new 
future, and part of what we are doing is now, as I indicated, 
immersing much more in post-market surveillance, and engaging 
and staying engaged in what happens to those drugs when they 
are used in the real world, as Dr. Young pointed out, where 
there are multiple drug interactions, working with the VA, 
working with the Center for Medicare and Medicaid services, 
working with some of the private health care delivery systems 
that are creating these electric medical record data bases, and 
using the kind of modern tools that you alluded to for data 
mining, and benefiting from experience that has come from 
organizations such as Google, etc.
    I think we are traveling that road much more rapidly today 
than we could have 5 or 10 years ago when we didn't have those 
technologies, and I anticipate FDA playing a very important 
role in this post-market surveillance opportunity to get to the 
point where we identify the early signals of potential problems 
and intervene, as we protect the lives of people who might 
otherwise be damaged.
    Chairman Waxman. Thank you, Mr. Braley.
    Mr. Cannon.
    Mr. Cannon. Thank you, Mr. Chairman. I can't tell you 
gentlemen how honored I am to be here with you. I have followed 
your work when all of you were in office, and am particularly a 
big fan of Dr. von Eschenbach, who I have spent some time with. 
I have always thought that you had the hardest job on the face 
of the Earth. You have to guarantee people's safety when people 
do, among other things, stupid, human things.
    Dr. von Eschenbach, do you know how many drugs were 
approved by FDA last year, new drugs?
    Dr. von Eschenbach. I think I would answer that for you for 
the record. My recollection is we had 12 new drug applications, 
four biologic license applications.
    Mr. Cannon. That were approved?
    Dr. von Eschenbach. Yes, sir.
    Mr. Cannon. I am going to lecture a little bit, but it will 
lead to a question, I assure you. But I would like to set the 
stage.
    We have talked about several things that are very 
important. Ms. Foxx talked about food safety and whether or not 
we could have a perfect system. The answer is, of course, you 
couldn't have a perfect system, but we could have a system that 
is orders of magnitude better using the new technologies that 
are available and tracking data and using computers that are 
substantial, and maybe even lowering the cost using techniques 
like Google has pioneered.
    Dr. Young talked about large numbers of drugs and how they 
interact, and also I guess Dr. Kennedy talked about a data base 
of all the drugs to see what those interactions are. The fact 
is these are things we can talk about today because we have--in 
fact, I think the gentleman from Iowa talked about a boolean 
search. I am going to go a step farther and talk about Bejan 
statistics, Bejan statistics being, of course, the finding 
correlations and conflicts data. This is a discussion we could 
have today. We couldn't have had it 5 years ago or even 3 years 
ago probably.
    I want to set the stage by saying we are now in a different 
time and we are at a point where we are doing very few drugs, 
if I can characterize 12 that say--go ahead, Dr. von 
Eschenbach.
    Dr. von Eschenbach. May I please correct the record? I was 
giving you the priority approvals, and I apologize. The overall 
was 97 new drug applications and 4 biologics, so 101 total, of 
which what I gave you were priority accelerated approvals, so I 
apologize.
    Mr. Cannon. But in the environment, even 100 is a 
relatively small number, given what several people, or I think 
Dr. Kessler referred to as personalized medicine.
    This is a remarkably important issue, I think, to us as 
policymakers, and it is not partisan, as I think Dr. Young 
pointed out. These issues are very complex. I don't mean to 
simplify them. But we are in a complex environment with hugely 
more capable tools to deal with complexity, so Burt Rutan just 
got the X-prize for going into suborbital flight twice within a 
week. The next X-prize is for the company that can decode an 
individual's DNA for $1,000. I suspect most people in this room 
would get their DNA decoded if we get to the point where the 
price is that cheap. That means that we can actually really, 
truly personalize medicine and know why something that didn't 
work for Dr. Kennedy, didn't work for Dr. Young, and maybe if 
we had 100 people that used a similar combination of the 
medicines that Dr. Young is taking, why some of those people 
performed better with those drugs than other people.
    That is where we need to get, and FDA as an organization 
has a difficulty getting there, it seems. That is the core of 
the question that I want to get to.
    Let me just take it a little further. You have Merck out 
there that pled guilty recently to promoting an off-label use 
of a drug, and my understanding is I think GlaxoSmithKline is 
now being sued by a plaintiff whose spouse may not have died if 
they had made known an off-label use of one of their drugs that 
would have saved the spouse.
    Is there not a way that we can take advantage of these 
massive changes, the vast decrease in the cost of millions of 
instructions per second on a computer and the vast decrease in 
the cost decoding DNA and the vastly reduced cost of tracking 
food products so that we could make orders of magnitude 
improvement in where we are going?
    In fact, Dr. von Eschenbach, first let me just ask the 
other members of the panel, is it not possible to set up a 
system so that a doctor can suggest a protocol which may 
include a complicated set of drugs or an off-label use of a 
drug that becomes a standard and that the market then allows to 
become a standard and to be used, and that allows us to do what 
Dr. Kennedy was suggesting, which is track how drugs interact? 
Is it not possible to create a system where we know the 
toxicity of a drug and so an agency like the FDA could say that 
is a dangerous or it is not a dangerous protocol, and if it is 
not a dangerous protocol, allow us to track the data in a Bejan 
context and therefore make these orders of magnitude leaps 
forward, where we find out that there is actually a difference 
between Dr. Young's chemistry and my DNA, and therefore I can't 
take the same set of drugs, but maybe Mr. Issa can?
    Let me go to Dr. von Eschenbach first. I would love to have 
all your comments on that.
    Dr. von Eschenbach. Thank you, Mr. Cannon. You have touched 
on a number of very important issues that are part of our 
critical path initiatives to address this entire spectrum of 
how we can begin to accelerate our ability to regulate these 
drugs, while both assuring their safety and their efficacy, so 
we built scientific tools in at the very front end, as Dr. 
Young has indicated, so we understand the patient from a 
genetic and molecular point of view, and the drug, and can 
understand both the impact as it relates to benefit and 
potential risk.
    Then, at the same time, adapted trial designs, the kind of 
opportunities you are addressing in terms of looking at that 
drug and how it behaves in populations, can be also improved 
and be able to get information in real time to be able to 
adjust our subsequent protocols. And then, for finally, the 
ability to have the information tools that we were speaking of 
just a few minutes ago, to be able to monitor what is happening 
in utilization of those drugs in off-label use by physicians 
who are in practice adds the third piece of a full cycle from 
the very production to the very utilization of those drugs 
where we can continuously enhance our effectiveness, and yet 
assure minimum degree of risk.
    Mr. Cannon. I see, Mr. Chairman, that my time has expired, 
but I would like to hear from the rest of the panel, but would 
the Chair indulge me by allowing me to make a very short 
refinement to the question?
    You talked about trial design, and what I am suggesting is 
that in a world where people live and are complicated, if we 
create a system where we can track data, say through a protocol 
that is not created as a scientific design but actually tracks 
what people are doing, does that get us significantly beyond 
the rigid paradigm of FDA?
    Dr. von Eschenbach. As a clinical practice protocol for 
which, like with the CMS data base, we are getting the data as 
that is being done, and analyzing it would be a very important 
step.
    Chairman Waxman. Yes, Dr. Young, did you want to respond?
    Dr. Young. I just wanted to make a quick response on one 
medicine, 5-fluorouracil, that is used very commonly in cancer 
treatment. Recently there has been a development of a test 
called single nucleotide polymorphism [SNIP]. It has been 
discovered that there are 22 SNIPs of different types, 3 of 
which can predict which individuals are likely to get severe 
neurological complications.
    I have managed one patient who is a friend who was in a 
coma for 2 months after taking this medicine, because she had a 
genetic abnormality and could not metabolize the 5-
fluorouracil. Now that is available. That is what we have been 
talking about with personalized medicine. But the incentives to 
switch the market and the incentives to be able to analyze this 
need to be built in.
    It is going to be even more complicated when we look 
between the difference between foods and what foods are 
tolerated versus what aren't.
    The Congress needs to address, the administration needs to 
address this whole development of science and give it adequate 
resources to make it really work an incentives to drive the 
marketplace.
    Dr. Kessler. Congressman.
    Chairman Waxman. Dr. Kessler.
    Dr. Kessler. It is called the field of pharmacogenomics, 
and it is evolving, and you articulated it very well. 
Understand how profoundly it is going to change the 
pharmaceutical industry, because no longer are you going to be 
able to sell a drug just to thousands and thousands of 
patients. We are going to be able to target who is going to 
benefit, who is going to have the adverse reactions. That means 
in some ways smaller markets, and perhaps even higher-cost 
drugs, but it is going to have a major influence on our 
pharmaceutical industry, and I think some of the pains you see 
today that the industry is experiencing is being able to gear 
up for that change.
    One of the most important things is how FDA can help lead 
in the policy formation with the Congress on this.
    Chairman Waxman. Thank you very much.
    Mr. Cannon. Can I just say in closing, Mr. Chairman, since 
I don't think Dr. Kennedy wanted to respond, particularly, that 
we have billions of doses taken annually around the world of 
medications, but if we can start tracking what is happening 
now, that is a vast improvement. That is orders of magnitude in 
reduction of the time and understanding it will be to get to 
that point of thinking.
    Thank you, Mr. Chairman. I yield back.
    Chairman Waxman. Thank you very much.
    Mr. Cooper.
    Mr. Cooper. Thank you, Mr. Chairman. I appreciate your 
sustained focus on these important issues.
    I would also like to thank Dr. Kessler, in particular, for 
fighting the good fight against DTC ads. I am sorry you didn't 
win that battle, but you were pursuing the right cause.
    You were talking a moment ago about pharmacogenomics. I 
would like to ask about pharmacoeconomics, compared to 
effectiveness. I hate to even bring this up before an agency 
that is so over-worked and under-funded, but it seems to me 
that consumers need a reliable guide for value in the 
marketplace, especially when they are confronted with $5 
billion worth of DTC ads on our broadcast television.
    I have countless doctors come up to me complaining about 
these 30-second experts who, because they have seen a beautiful 
couple on TV, they didn't hear any of the warnings that were 
broadcast, but they want some of that, whatever it is. That 
seems to me to not promote the healing process.
    What is the best way for us to pursue comparative 
effectiveness? Is FDA an appropriate agency? Should we do it in 
another way? I know folks like Gail Wolinsky have been talking 
about this, because safety and efficacy is one step of the 
process, but finding value for your money is another.
    Dr. Kessler. Congressman, I think what FDA is very good at 
is the science. I think that is something that I strongly 
believe, and my guess is my colleagues think that is what the 
FDA should focus on.
    When it comes to two drugs and one has a riskier adverse 
event profile than the other, that is something that I think 
FDA should and does deal with.
    I don't think today FDA has the tools nor necessarily you 
would want the FDA to go beyond safety. It is an important 
policy judgment for the Congress, but once you start allowing 
economic judgments to be made, not that they are not important, 
they are vitally important. What good is it if we get drugs out 
for people who work that we discover them and people can't 
afford them? So it is vitally important. The question really 
is: is FDA the right place for those decisions to be made?
    Mr. Cooper. Dr. Young.
    Dr. Young. Thank you for that very thoughtful question. I 
would submit, as Dr. Kessler did, that this is not the place 
that it should be made. Once you start changing the scientific 
risk/benefit analysis and the safety profile and start doing 
the economics, I think you are compromising your standards. I 
also think, as a person who strongly opposed direct-to-consumer 
advertisement when it hit its head up on my watch, I think that 
is something that ought to be looked at and some guidelines be 
put into place, because you want the professional guidance 
primarily influencing what is helpful, safe, and effective for 
a patient, and not a wide manipulation of the market, 
particularly as we are going to more-personalized medicine. 
That makes it much more complicated.
    Mr. Cooper. How about the more limited case of one chemical 
compound that is virtually identical to another, a so-called 
me-too drug? Is it appropriate for FDA to say it really has no 
therapeutic benefit or the number needed to treat is so small 
that it is really virtually identical?
    Dr. Young. I don't think you can say that yet. I will go 
back to my own personal example. I am on a number of medicines. 
I am very careful as to what I switch to, because I might have 
a polymorphism that this drug is slightly different and it 
doesn't work for me, as I tried to answer in the question of 5-
FUDR. So I think that question is not quite right for 
exploitation at this time, as important as it is.
    Mr. Cooper. On another topic, Dr. Kennedy brought up the 
important issue of hospital-borne infections. People want to 
know that the hospital is a safe place to go. It is my 
understanding that no-socomial infections have been, you know, 
about 15 percent per year, but if we were to have a sudden 
resurgence of antibiotic resistant bacteria, that could 
dramatically increase.
    You mentioned giving a price or incentive for the discovery 
of a better antibiotic, but aren't there multiple issues here? 
First, many of our physicians have over-prescribed existing 
antibiotics. There are so many antibiotic soaps and feed for 
cattle and things like that have worn down our resistance. And 
then the simple issue of hand washing and facilities. Many of 
our health providers have not taken the time out to cleanse 
themselves properly between patients. So doesn't that all lead 
to this buildup of antibiotic resistance?
    Mr. Kennedy. Antibiotics are really a unique drug in the 
following sense: that when you prescribe one to a particular 
patient, the cost/benefit ratio is not limited to that patient 
because there are external costs that are spread to the rest of 
the population. I think educating doctors about that is 
terribly important.
    I think that, besides encouraging the supply side to 
develop new antibiotics where there is clear evidence that they 
are needed, because there is a lot of resistance already, the 
other thing is to encourage--and I think probably CDC is the 
target here--as a routine hospital procedure, to do a 
diagnostic sample quickly on all new entering patients so that 
you will know if even the healthy ones are carrying a little 
bit of staphylococcus that can be detected to be antibiotic 
resistant, and they can be either housed separately or dealt 
with in a different way. That would knock down the likelihood 
that future increases in antibiotic resistance are going to 
produce an increase in no-socomial infections.
    Mr. Cooper. I see that my time is expired. If the good 
doctor could just answer the question, how much would that 
entry test cost per patient?
    Mr. Kennedy. I haven't costed it out so I can't give you a 
responsible economist answer. I am told that it is very 
inexpensive, but I don't want to be hung on that.
    Chairman Waxman. Thank you, Mr. Cooper.
    Mr. Duncan.
    Mr. Duncan. Thank you, Mr. Chairman. I had other meetings, 
and I have just been here for about half an hour, so I 
apologize if this has been covered already, but I read in our 
briefing memo that food imports have quadrupled just since 
1999, and they are now in the almost uncountable billions. And 
then there is a story in the Washington Post this morning that 
says about 99 percent of imported foods are simply acknowledged 
by computer and waved ashore, and it goes on to say ``but 
processed ingredients are often nondescript, and in China, 
where a national passion for commerce has far out-paced the 
adoption of regulatory controls, marketers have repeatedly been 
caught adulterating such products, spiking pig feed with diet 
pill chemicals to make swine leaner, for example, and hiding 
sawdust in fish meal.''
    And we have heard reports in the last few days about 
Chinese products being involved in the pet food controversy and 
the product melamine that is used in plastic production. And 
then this morning, as I was driving in, I heard a news report 
saying that now it has been discovered that this Chinese 
melamine and perhaps other products have been placed in chicken 
feed on four huge farms in Indiana, and that it may be in as 
many as millions of chickens now.
    What I am wondering about, I am wondering about the 
situation with China. Dr. von Eschenbach, when you find out 
that a country is doing crooked things, illegal, or what should 
be illegal or immoral type activities, have you given any 
instructions to increase the inspections or the testing of some 
of these food imports from China? Let's talk about China, 
specifically. Or do you intend to increase the inspections on 
Chinese imports?
    Dr. von Eschenbach. Congressman, with regard to your 
specific question, we do have now the opportunity for what is 
known as prior notice, so every shipment of food and products 
coming into this country, we have to be notified ahead of time 
about that food shipment. Any shipper or the source has to be 
registered with the FDA, so that gives us a data base from 
which we can begin to determine where we may see areas of risk 
and concern and areas where we have highly reliable and proven 
track records of confidence. We will focus on those areas.
    So in the case of what you are alluding to specifically 
with regard to the pet food, obviously where there were two 
companies within China that embarked upon a practice that led 
to the adulteration of the melamine into material that would be 
subsequently used for pet food, we would clearly target those. 
Those companies are prohibited or blocked from bringing product 
into the country now. And we have even gone beyond that to look 
at the whole family of products having to do with vegetable 
protections, and we are retaining those and inspecting those.
    So we have a both proactive as well as a responsive 
strategy to continue to focus on areas where we need to enhance 
protection.
    Mr. Duncan. Well, I think that, based on what I have heard 
this morning and what I have read in this Post story, that it 
goes beyond pet food, and now it has gone into the animal feed 
and maybe into the human food supply. I can tell you that I 
think a lot of people are going to be concerned about this. I 
think the American people would appreciate a labeling program 
so they would know where some of this food was coming from, but 
we have been unable to do that in any effective way, so I 
suppose we can't do that, so we have to rely on the FDA and on 
your food safety programs.
    But I think when we just get slapped in the face from the 
same country over and over and over again, that there needs to 
be some special attention paid to these imports, particularly 
from China. Apparently, that is where we are getting the 
largest volume of food imports by far anyway, so I think that 
the inspections and testing on these Chinese imports should be 
picked up substantially.
    Thank you very much, Mr. Chairman.
    Mr. Issa. Will the gentleman yield?
    Mr. Duncan. Sure.
    Mr. Issa. Following up on that, Dr. von Eschenbach, the FDA 
failed to prevent--and I am a California Member, like the 
chairman--the loss of $1 billion to the spinach industry, even 
though we had a registered user which was the single source for 
the e-coli from a single field. Do you want to answer not only 
Mr. Duncan's point, but also perhaps mine, on that point of 
what are you doing, even when you have registration, in order 
to make it quick and sure that we know what is good and what is 
not good?
    Dr. von Eschenbach. Yes, sir. And specifically with regard 
to the issue and difference having to do with spinach, as that 
process evolved, our first and foremost responsibility was to 
protect the public health, and at the outset, because of the 
fact that we are seeing significant changes in our distribution 
processes, where a product coming from one source gets rapidly 
disseminated into a variety of distribution pathways, as we 
were tracking that outbreak backward, before we even knew where 
the sole source was, we put out an advisory with regard to all 
spinach so that we would be assured that we were doing the 
utmost to protect the American people.
    Once we began to define where that source was and that the 
rest of the supply was, in fact, free of any contamination, 
then it was important to identify the single source, and we 
have not done as good a job with regard to recovery as I think 
we need to with regard to our communications going forward, and 
that is one of the lessons learned and one of the areas where 
we are embarking upon opportunities for improvement so we can 
do exactly what you have requested, rapidly define the source, 
and not only take action against that but assure the American 
people that other options are safe and appropriate. We are 
working on that.
    Chairman Waxman. It is your turn.
    Mr. Issa. I thought the time expired.
    Chairman Waxman. It did.
    Mr. Issa. Oh, and you went right to my time?
    Chairman Waxman. Yes.
    Mr. Issa. Thank you. I thank the chairman.
    Chairman Waxman. I think Dr. Kessler wanted to respond.
    Mr. Issa. I guess I will followup quickly on that, then. I 
hear you, but I am disappointed that you couldn't say--and 
maybe you can say in a followup--if we had it to do over again, 
we would have told the American people with an abundance of 
caution we are concerned about all spinach, even though we have 
isolated so far the outbreaks to a single farm. That was never 
said on the front end, and it destroyed an industry.
    Dr. von Eschenbach. Well, let me be clear about what I 
tried to say. We had to make the announcement about our concern 
about spinach before we had the confidence and knowledge of 
what that single source was. That information did not come----
    Mr. Issa. Doctor, I appreciate that, but, unfortunately, it 
flies in the face of past experience. We have had ground beef 
e-coli in the past. Nobody said don't eat any ground beef. 
Nobody said ground beef is tainted. Even when we had multiple 
outbreaks, the assumption from day one was always it probably 
comes from one source, we have isolated no source or one 
source. You have a history of a lot of outbreaks of ground beef 
contamination. It is practically a seasonal occurrence. And you 
have never done it in a way that destroyed ground beef.
    Certainly, some people got scared and they didn't listen 
that it was only 2-pound packs bearing the name of something-
or-other, but the fact is you destroyed an industry by the 
ineptness of the response. I would hope that when you are 
answering a congressional inquiry that you say, ``Look, not 
only did we have lessons learned, but this is how we would 
prevent this specifically in the future,'' not ``We are trying 
to develop systems to prevent it.'' You didn't need to scare 
the bejezus out of everyone who ate anything green and 
uncooked, and yet that is what happened. The production not 
just of that but of lettuce and lots of other things went down.
    Perhaps I am sensitive because I am a Californian, but the 
fact is it is an important lesson that has to be learned, 
because the next time, if it is ground beef and you treat it 
that way, we are going to have, what, all beef not eaten for a 
period of time?
    Dr. von Eschenbach. Well, your point is well taken, 
Congressman, but I want to emphasize the fact that, as we have 
been talking about today, we have seen radical and rapid 
changes occurring in both production and distribution and 
dissemination of our food supply, and when it is apparent to us 
that potential contamination could affect the entire product, 
we need to warn the American people of that. And as we progress 
with our investigation and get further-refined information, 
communicate that effectively to them, as well as part of the 
recovery.
    Mr. Issa. I appreciate that. I think we are going to agree 
to disagree and I will move on.
    You know, the FDA has dramatically increased the number of 
medical guidebooks or leaflets that have to be given out, and 
yet my understanding is you have not allowed it to come into 
the 21st century where a pharmacist could take an online data 
base that is more accurate than a printed leaflet, print it out 
directly, and hand it to the individual, rather than 
maintaining leaflets. Are you in the process, can we have an 
assurance that is going to happen in the near future?
    Dr. von Eschenbach. Yes, sir. We are in that process. The 
changes we made this year with regard to drug labels were 
specifically intended to move us more effectively into real-
time updates in an electronic format of that drug label, with 
the expectation it ultimately could be distributed by 
pharmacists at the point of service.
    Mr. Issa. OK. And in closing, Dr. Young, I just want to 
thank you for your comments about the specifics of drugs and 
how very small differences in even conventional and certainly 
in follow-on biologics can make a difference and why we cannot 
simply substitute one for the other, even if they are 
dramatically similar.
    I yield back and thank the chairman.
    Chairman Waxman. Mr. Platts.
    Mr. Platts. Thank you, Mr. Chairman.
    Dr. Young. Could I make a brief comment?
    Mr. Issa. I apologize. I didn't mean to cut anyone off.
    Chairman Waxman. Yes, Dr. Young?
    Dr. Young. I wanted to point out one thing, and this is 
different than the question that you asked Dr. von Eschenbach 
about but related.
    One of the problems, if you had a crisis--and I had a 
crisis of the Chilean grapes. We were able to take it off and 
bring it on in 18 days. But the thing that was key for me was 
the ability to have regional labs that are well equipped and 
are able to go in at that site and do the testing and narrow it 
down as fast as possible.
    Once you do have a disaster, as Dr. von Eschenbach said, 
you have to throw everything at it, make the risk, but you try 
to bring it back on as fast as you can. But unless there are 
good laboratories in the region that are able to look at that 
and deal with it--and I would ask, Mr. Chairman, that you might 
want to take a look. I have no idea what the laboratory 
personnel is, but take that same 10 year period of time and 
look and see where we are in regional labs and the ability of 
the FDA labs to work and support the Commissioner's office.
    Mr. Issa. Thank you.
    Dr. Kessler, do you want to respond?
    Dr. Kessler. Congressman, I think we have an obligation, 
the three of us, to push back a little here, if I may.
    I am a Californian, and I will tell you I was very 
concerned about what happened to that industry. That industry 
clearly is over its head scientifically. It wants to do the 
right thing; it doesn't know what the right thing is to do. But 
we are going to have to stop saying--the hardest job, going to 
bed every night, being responsible, whether it is from China, 
whether that ship is coming in from South America and the water 
in that ballast that fresh produce is, you have set up the 
agency not to be able to do its job.
    We haven't changed the food safety laws in decades. We 
haven't given the agency basic scientific resources to do the 
science to help the industry to know how to prevent those 
problems, and we have not established a preventive system of 
controls that help the farmers prevent those kind of 
devastating outbreaks.
    This is not an FDA problem, alone; it is going to require 
the Congress and the industry, with the agency, to recognize 
that we can hold hearing after hearing on whether it is China 
or whether it is spinach or whether it is peanut butter, but we 
have a system that is in major need of reform.
    Mr. Issa. Thank you, Chairman.
    Chairman Waxman. Mr. Platts.
    Mr. Platts. Thank you, Mr. Chairman. I appreciate your 
holding this very important hearing, and your leadership on 
issues related to the Food and Drug Administration.
    I want to raise an issue, and I hope I am not being 
repetitive, with managing several resolutions on the floor and 
other meetings and missing some of the testimony. It is an 
issue, Mr. Chairman, that you have been a leader on back in 
1984 with legislation on generics, and I know recently raised 
with Senator Hatch on the issue of draft guidance on biologics 
and insulin and human growth hormone.
    Dr. von Eschenbach, I wonder if you could give an update. I 
know my Governor, Governor Rendell, wrote to you about 2 months 
back, and I know a good number of Governors have either written 
you or spoken out on this issue about getting the draft 
guidance released to allow the process to go forward for 
generics on these specific biologics.
    I was wondering if you could give us an update of where we 
stand, especially in light of--and correct me if I am wrong in 
my understanding, or at least the general timeframes--as early 
as a decade ago, that FDA committed to providing the guidance 
for these two specific biopharmaceuticals, and then in April 
2002 it is my understanding they actually completed the science 
on the draft guidance regarding these two biologics. So if you 
could give us an update, I would appreciate it.
    Dr. von Eschenbach. I would be happy to pursue that and 
give you the update for that on the record with regard to what 
is occurring at this point. We have addressed this issue with 
regard to ongoing challenges, both with regard to generic, 
small molecules, as well as the need to begin to address the 
issue of generic biologics, or the follow-on proteins, and 
recognize this to be a portfolio in which there is tremendous 
diversity and complexity within that family of proteins, 
ranging from very simple ones like polypeptides to very complex 
molecules.
    And so we take this as an approach in which science and 
scientific portfolio will lead us to be making these decisions. 
This is an area where Dr. Woodcock has really been working and 
focusing on developing our strategies for that scientific 
effort, and I would be happy to provide you the update on where 
we are with the guidance for the record.
    Mr. Platts. If you can provide that to the committee for 
the record, and specifically I guess I would be interested in 
your response to Governor Rendell's correspondence of February 
15th that is specific to insulin and human growth hormone, 
where we stand.
    Dr. von Eschenbach. Yes.
    Mr. Platts. I know that there is a lot of focus. In fact, I 
think the chairman's letter was on that issue back earlier this 
past month in April.
    Dr. von Eschenbach. I appreciate your allowing me the 
opportunity with those two specific things to get the up to 
date information for you and respond to the record.
    Mr. Platts. A followup on that, then, in a broader sense is 
the broad issue of your authority. Is it a belief that FDA, in 
the area of generic versions of biopharmaceuticals, that you do 
not have the current authority to move forward in this broad 
area? And if that is the case, have you looked at the 
legislation that is being considered to address that?
    Dr. von Eschenbach. Yes, sir, that is correct. In terms of 
biologics being included under the Public Health Service Act, 
we did not have a pathway within that particular act to deal 
with abbreviated applications. That is one of the issues that 
Congress is addressing.
    With regard to regulatory authority, we are looking forward 
to continuing providing technical assistance with regard to 
that legislation, particularly from the point of view of 
addressing the unique differences between this family of 
products as opposed to what our previous experience has been 
with small molecules or generic drugs.
    Mr. Platts. On insulin and human growth hormone, that is 
not an issue of authority, right?
    Dr. von Eschenbach. No, that was addressed independently of 
that.
    Mr. Platts. Right. And so then the authority is going to 
these biologics in not addressing that?
    Dr. von Eschenbach. Correct. As you point out here, there 
are two statutes that govern our ability to deal with these 
compounds. Some of them come under the Food, Drug, and Cosmetic 
Act, and the biologics that we are now addressing come under 
the Public Health Service Act.
    Mr. Platts. I do appreciate your following up with the 
committee and for all of us Members on that issue, because, you 
know, the important work of the chairman and Senator Hatch in 
1984 and the access to pharmaceuticals is it is not just that 
we have them, but they are affordable, and so this is 
critically important.
    I know back in Pennsylvania to our PACE program, our 
pharmaceutical contracted elderly program which truly makes a 
huge difference for so many seniors, in that one program this 
advancement, the estimate is, I think, over $100 million a year 
in savings. That means that many more seniors we can help.
    So I hope that we will see progress on the guidance on the 
insulin and human growth hormone, as well as your agency 
working with this chamber and the Senate on legislation that 
broadens the authority for additional authority to your agency 
for generics on the biopharmaceuticals soon.
    I certainly appreciate your leadership today and our 
previous Commissioners for your important work on behalf of 
your fellow citizens. I would be remiss if I didn't acknowledge 
the great dedication of you and your staff, present and past, 
at FDA.
    Thank you, Mr. Chairman, for the time.
    Chairman Waxman. Thank you very much, Mr. Platts.
    Ms. Watson.
    Ms. Watson. Mr. Chairman, thank you so very much. I am so 
pleased that you are fulfilling the oversight function that 
this committee is authorized to do.
    I have some concerns for the FDA, and I think a grievous 
oversight has come from in recent years is that the failure to 
stop the use of mercury in dental amalgams, and there have been 
studies done abroad that have shown empirical evidence that 
mercury is harmful to lactating women, harmful to children 
under 18, and probably harmful to humans. Mercury is always 
evaporating, regardless of how well it is sealed, because our 
teeth move around, they chip, they crack, and so on.
    I am sorry that I was late. I have not heard your 
testimony, but I would like to hear from someone why the FDA 
has not taken on this issue and moved on it. We know that it is 
harmful internally, and why we would have any substance put in 
the mouth so it can go up to the T-zone, affect the meninges of 
the brain, and also go into the systems of women--so can 
someone respond why FDA hasn't taken action on mercury amalgam?
    Dr. von Eschenbach. Madam Congressman, we continue to be 
concerned about issues that you are alluding to and have 
continued to carefully monitor any scientific data and 
information that would impact upon a regulatory decision about 
the amalgams.
    Ms. Watson. Let me take my time back. I would be pleased to 
provide you with the scientific information. That is the 
response I got last year. You are dragging your feet on this 
issue. I wish you would speak to it. I am going to send that 
information to you ASAP, and I would hope that you would 
respond. It is not good enough to say we continue to look at 
it. We know the harm mercury can do. We had a mercury spill 
last year in Virginia. They closed down three high schools for 
2 or 3 days until they cleaned the mercury up. WHO is removing 
mercury from thermometers. We removed mercurochrome off the 
market, and we still allow it to be used in those silver 
fillings in one's mouth. That ought to put a light on and you 
ought to move faster.
    Dr. von Eschenbach. I look forward to that information, 
Madam Congressman.
    Ms. Watson. Thank you, Mr. Chairman.
    Chairman Waxman. Thank you, Ms. Watson.
    Does any other Member have anything else pressing? I think 
our witnesses have been very generous with their time.
    Let me thank you, because I think this has been a very 
helpful session to learn from past experiences, the present 
situation. I hope all of this will help you and help us figure 
out how to make FDA function even better. It is an agency that 
we all support, and I think you got a sense on both sides of 
the aisle that is the case. We want Government to work, and if 
there is any agency of Government that needs to work 
appropriately for the consumers of this country it is the Food 
and Drug Administration.
    I think you have given us very specific and helpful 
suggestions and comments about different issues that you are 
dealing with at the FDA today and the other three have dealt 
with in the past.
    Thank you so much.
    Dr. von Eschenbach. Thank you, Mr. Chairman.
    Chairman Waxman. That concludes our hearing today. We stand 
adjourned.
    [Whereupon, at 3:25 p.m., the committee was adjourned.]
    [Additional information submitted for the hearing record 
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