<DOC>
[110th Congress House Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:38161.wais]
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
Available via the World Wide Web: http://www.gpoaccess.gov/congress/
index.html
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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:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
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:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
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:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
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.]
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