Rep. Waxman Urges Strong Response to Report on FDA Resource Shortfalls

WASHINGTON, Dec. 3, 2007-Today House Committee on Oversight and Government Reform Chairman Henry Waxman wrote to FDA Commissioner von Eschenbach, Secretary Leavitt, and OMB Director Nussle regarding the FDA Science Board’s Subcommittee on Science and Technology report that found that funding shortages at FDA have undermined science and endangered public health. Chairman Waxman urges these agencies to request adequate funding and resources for FDA. The letters are below and the report is attached.

December 3,2007

The Honorable Andrew C. von Eschenbach, M.D.
Commissioner
U.S. Food and Drug Administration
5600 Fishers Lane, Room 15-47
Rockville, MD 20857

Dear Dr. von Eschenbach:

I am writing to express my profound concern about the findings of the FDA Science
Board's Subcommittee on Science and Technology, which were released last week. According
to the Subcommittee's report, funding shortages at FDA have endangered public health. As the
Subcommittee reported:

In contrast to previous reviews that warned crises would arise if funding issues
were not addressed, recent events and our f,rndings indicate that some of those
crises are now realities and American lives are at risk.l

In recognition of the critical role that FDA plays in the overall health and well-being of
Americans, you requested that the Science Board examine whether FDA's science and
technology capacity is adequate to support the agency's current and future regulatory needs. The
Subcommittee's report paints a dire picture of a chronically underfunded public health agency.
The Subcommittee found that the FDA's scientific capacity has been so eroded that it can no
longer fulfill a frightening number of critical regulatory and public health responsibilities.

We found that FDA's resource shortfalls have resulted in a plethora of
inadequacies that threaten our society - including, but not limited to, inadequate
inspections of manufacturers, a dearth of scientists who understand emerging new
technologies, inability to speed the development of new therapies, an import
system that is badly broken, a food supply that grows riskier each year, and an
information infrastructure that was identified as a source of risk in every Center
and program reviewed by the Subcommittee. We conclude that FDA can no
t Subcommittee on Science and Technology, FDA Science and Mission at Risk,6 (Nov.
2007) (online at http://www.fda.gov/ohrms/dockets/acl0Tlbriefing/2}}7 4329b_02_01_FDA%
20ReportYo20 ono/o205 cience%o2} and%o2}T echnolo gy.pdf).

longer fulfill its mission without substantial and sustained additional
appropriations. ... [I]f these gaps are not addressed immediately, FDA is in
jeopardy of losing its remaining dedicated staff. The extraordinary efforts of
these committed FDA staff members are the very reason further catastrophic food
and drug events have been averted.'

The Subcommittee further recognized that the severe loss of scientific capacity at FDA
threatens not only the health of our citizens, but the viability of the industries FDA regulates, the
speed of medical innovation, and the security of our nation.'

The report cited two primary causes for the grave deficiencies it identified: the everincreasing
number of demands on the agency combined with resource levels that are wholly
inadequate to allow the agency to keep pace with those demands. Consequently, according to
the report, the agency has been reduced to "management by crisis."*

These are urgent and compelling findings. I would like to know what steps you intend to
take to restore FDA's capacity to ensure the safety of food and drugs and protect the public
health.

There is much that you can do to strengthen FDA so that it is prepared to meet these
challenges, starting with requesting adequate funds and resources for FDA. I urge you to ensure
that the budget request you submit to the Department of Health and Human Services includes
suff,rcient resources for FDA.

I request that you brief me and my staff no later than January I l, 2008, on the Agency's
response to the Subcommittee report and its plans for ensuring that the budget requests made by
the FDA are adequate to address its findings. If you have any questions, please contact Stephen
Chaat(202)225-5056 or Rachel Sher at (202)225-3976.

Sincerely,

Henry A. Waxman
Chairman
cc: Tom Davis

December 3,2007

The Honorable Michael O. Leavitt
Secretary
U.S. Department of Health and Human Services
200 Independence Avenue, SVy'
Washington, DC 2020I

Dear Mr. Secretary:

I am writing to express my profound concern about the findings of the FDA Science
Board's Subcommittee on Science and Technology, which were released last week. According
to the Subcommittee's report, funding shortages at FDA have endangered public health. As the
Subcommittee reported:

In contrast to previous reviews that wamed crises would arise if funding issues
were not addressed, recent events and our findings indicate that some of those
crises are now realities and American lives are at risk.l

In recognition of the critical role that FDA plays in the overall health and well-being of
Americans, Commissioner Andrew C. von Eschenbach requested that the Science Board
examine whether FDA's science and technology capacity is adequate to support the agency's
current and future regulatory needs. The Subcommittee's report paints a dire picture of a
chronically underfunded public health agency. The Subcommittee found that the FDA's
scientific capacity has been so eroded that it can no longer fulfill a frightening number of critical
regulatory and public health responsibilities :

We found that FDA's resource shortfalls have resulted in a plethora of
inadequacies that threaten our society - including, but not limited to, inadequate
inspections of manufacturers, a dearth of scientists who understand emerging new
technologies, inability to speed the development of new therapies, an import
system that is badly broken, a food supply that grows riskier each year, and an
t Sub"o--ittee on Science and Technology, FDA Science and MÌssion at Risk,6 (lrtrov.
2007) (online athftp:llwww.fda.gov/ohrms/dockets/acl07lbÅefing/2007 4329b_02_01_FDA%
2OReport% 20 ono/o205 cienceo/o2} andYo2}T echnolo gy.pdf).

information infrastructure that was identified as a source of risk in every Center
and program reviewed by the Subcommittee. 'We conclude that FDA can no
longer fulfill its mission without substantial and sustained additional
appropriations. ... [I]f these gaps are not addressed immediately, FDA is in
jeopardy of losing its remaining dedicated staff. The extraordinary efforts of
these committed FDA staff members are the very reason further catastrophic food
and drug events have been averted."

The Subcommittee further recognized that the severe loss of scientific capacity at FDA
threatens not only the health of our citizens, but the viability of the industries FDA regulates, the
speed of medical innovation, and the security of our nation.'

The report cited two primary causes for the grave deficiencies it identified: the everincreasing
number of demands on the agency combined with resource levels that are wholly
inadequate to allow the agency to keep pace with those demands. Consequently, according to
the report, the agency has been reduced to "management by crisis."*

These are urgent and compelling findings. I would like to know what steps you intend to
take to restore FDA's capacity to ensure the safety of food and drugs and protect the public
health.

There is much that you can do to strengthen FDA so that it is prepared to meet these
challenges, starting with requesting adequate funds and resources for FDA. I have asked
Commissioner von Eschenbach to ensure that his budget request to the Department of Health and
Human Services reflects the urgency of this report. I urge you to ensurç that the budget request
that you submit to the White House also includes suffrcient resources for FDA.

Sincerely,

Henry A. Waxman
Chairman
cc: Tom Davis
Ranking Minority Member
2 Id. at7.
3 Id. at l-2,26.
o Id. atz4.

December 3,2007

The Honorable Jim Nussle
Director
The Office of Management and Budget
725 lTth Súeet, NW
Washington, DC 20503

Dear Director Nussle:

I am writing to express my profound concern about the findings of the FDA Science
Board's Subcommittee on Science and Technology, which were released last week. According
to the Subcommittee's report, funding shortages at FDA have endangered public health. As the
Subcommittee reported :

In contrast to previous reviews that wamed crises would arise if funding issues
were not addressed, recent events and our findings indicate that some of those
crises are now realities and American lives are at risk.l

In recognition of the critical role that FDA plays in the overall health and well-being of
Americans, Commissioner Andrew C. von Eschenbach requested that the Science Board
examine whether FDA's science and technology capacity is adequate to support the agency's
current and future regulatory needs. The Subcommittee's report paints a dire picture of a
chronically underfunded public health agency. The Subcommittee found that the FDA's
scientific capacity has been so eroded that it can no longer fulfill a frightening number of critical
regulatory and public health responsibilities :

We found that FDA's resource shortfalls have resulted in a plethora of
inadequacies that threaten our society - including, but not limited to, inadequate
inspections of manufacturers, a dearth of scientists who understand emerging new
technologies, inability to speed the development of new therapies, an import
system that is badly broken, a food supply that grows riskier each year, and an
' Subcommittee on Science and Technology, FDA Science and Mission at Risk,6 (Nov.
2007) (online at http://www.fda.gov/ohrms/dockets/acl07lbÅefing12007 4329b_02_01_FDA%
20Reporto/o20 onYoZ}S cienceo/o}} ando/o2ÙT echnolo gy.pdf).

information infrastructure that was identified as a source of risk in every Center
and program reviewed by the Subcommittee. We conclude that FDA can no
longer fulfill its mission without substantial and sustained additional
appropriations. ... [I]f these gaps are not addressed immediately, FDA is in
jeopardy of losing its remaining dedicated staff. The extraordinary efforts of
these committed FDA staff members are the very reason further catastrophic food
and drug events have been averted.'

The Subcommittee further recognized that the severe loss of scientific capacity at FDA
threatens not only the health of our citizens, but the viability of the industries FDA regulates, the
speed of medical innovation, and the security of our nation.'

The report cited two primary causes for the grave deficiencies it identified: the everincreasing
number of demands on the agency combined with resource levels that are wholly
inadequate to allow the agency to keep pace with those demands. Consequently, according to
the report, the agency has been reduced to'omanagement by crisis."4

These are urgent and compelling findings. I would like to know what steps you intend to
take to restore FDA's capacity to ensure the safety of food and drugs and protect the public
health.

There is much that you can do to strengthen the FDA so that it is prepared to meet these
challenges, starting with requesting adequate funds and resources for FDA. I have asked
Commissioner von Eschenbach to ensure that his budget request to Secretary Leavitt reflects the
urgency of this report. I have conveyed the same expectations to Secretary Leavitt for his budget
requests to the Office of Management and Budget. I urge you to ensure that the President's FY
2009 budget request to Congress also includes sufficient resources for FDA.

Sincerely,

Henry A. Waxman
Chairman
cc: Tom Davis
Ranking Minority Member
2 Id. at7.
3 Id. atr-2,26.

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