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Posted: January 29, 2008
FDA advisors declare 'FDA science and mission at risk'
(Nanowerk News) The nation's public
health is at risk, as are the regulatory systems that oversee the nation's
drug and device supplies, according to an FDA Science Board report being
presented at a House Energy and Commerce Committee hearing today. The
committee attributed the deficiencies to soaring demands on the FDA; and
resources that have not increased in proportion to those demands. They
conclude that "this imbalance is imposing a significant risk to the
integrity of the food, drug, cosmetic and device regulatory system, and
hence the safety of the public."
"Over the last decade, complex scientific advances, globalization and
challenging new safety issues have combined to multiply the
responsibilities of the FDA. As the FDA Science Board report makes clear:
our expectations cannot exceed the resources we give FDA to accomplish its
mission. In this regard, more is definitely better," commented Mark
McClellan, MD, former FDA commissioner and chairman of the new Reagan-Udall
Institute designed to enhance FDA's readiness for future scientific
The result of a year-long review by a distinguished panel of experts,
the 300-page report concludes that the state of FDA's scientific and
regulatory programs could not be separated from the lack of resources
available to support the agency's scientific base, hire and train a
broadly-capable scientific workforce, and build a sophisticated and modern
information technology infrastructure.
"FDA can't improve its science, prepare for the future, or protect
American consumers without significant additional resources," said Don
Kennedy, PhD, former FDA commissioner and editor-in-chief of Science. "The
Administration and Congress are starting now on the FDA's FY 2009 budget
and must fix this critical problem."
The House Energy and Commerce Subcommittee on Oversight and
Investigations hearing starts at 10 a.m. on Tuesday, January 29 in 2123
Rayburn House Office Building. The committee agenda can be found at:
f. Representatives of the FDA Science Board will be testifying first. Their
report can be found at:
About the Alliance for a Stronger FDA
In response to the unmet resource needs of the FDA and the threat this
poses to America's health, safety and commerce, the Alliance for a Stronger
FDA was formed to educate and advocate about the importance of FDA and the
need for better funding. The Alliance has more than 170 members, including
consumer and patient groups, professional organizations, trade
associations, companies and individuals.
Quotes from Members of the Alliance for a Stronger FDA regarding the report, FDA Science and Mission at Risk
"That FDA needs more resources should be obvious. What makes this
report so extraordinary is the qualifications of the individuals who wrote
it, the year-long process to put it together, and the depth of analysis
that supports its conclusion: FDA's mission is at risk for lack of support
for its scientific capabilities."
---Jane Henney, MD, former Commissioner of FDA; Senior Vice President
and Provost for Health Affairs, University of Cincinnati
"The quality of FDA science is integral to the hopes of patients with
chronic diseases. FDA must be an innovative regulator, evaluating
cutting-edge drugs and devices and efficiently separating those ready for
patients from those that are not. Without necessary expertise, and
supporting information systems, key questions can't be answered and
everything slows down. Dr. Cassell and her subcommittee have provided
additional insight into why FDA needs more resources to meet the needs of
the seriously ill."
--Diane Dorman, Vice President, Public Policy, National Organization
for Rare Disorders
Americans rely on the FDA's scientific competence, every day and in
many ways. Consumers want and need a stronger FDA to assure safe foods,
drugs, biologics, and devices. It is encouraging that members of the FDA
Science Board, along with a number of external advisors, have so
unequivocally come down on the side of more resources."
---Diana Zuckerman, President, National Research Center for Women &
"Consumers and industry are working together with FDA to improve the
safety of America's food supply. It is frustrating that FDA does not have
the scientific capacity and personpower to get the job done."
--Caroline Smith DeWaal, Center for Science in the Public Interest
"Industry is committed to a safe food supply based on scientific
principles for management, control and targeting. We welcome the conclusion
of this report: science is FDA's most important tool and it cannot be fully
effective without the resources to support science, hire trained people,
and use information technology to support food safety."
---Honorable Cal Dooley, Grocery Manufacturer's Association
"Americans expect 'gold standard' FDA oversight of innovations like
nanotechnology to ensure that benefits are available promptly and the
products are safe, but FDA can't do this without 'gold standard' scientific
capacity and expertise to ask the right questions and make prompt, rigorous
reviews. As the FDA Science Board report makes clear, FDA's science base
has declined to a point that jeopardizes the ability of patients and
consumers to capitalize on America's enormous investment in technological
innovation. FDA's eroded science base is a 'penny wise and pound foolish'
situation that has to change."
---Michael Taylor, former FDA & USDA official; Research Professor, The
George Washington University
"FDA is trying to transition from a heavily paper/manual system to an
all electronic system that is reliable, secure, and can analyze data on new
and existing products to quickly recognize safety issues. All the centers
need to work on the same IT platform, one capable of handling the volume
and complexity of data submitted. None of this can be achieved until the
FDA has enough appropriated money dedicated to a technology overhaul and
maintenance. Notably, the Subcommittee report identifies IT deficiencies as
one of its three major findings."
--Phyllis Greenberger, President and CEO, Society for Women's Health