FDA Advisors Declare 'FDA Science and Mission at Risk'

Broad-Ranging Report Concludes That Increased Resources Are an Essential First
Step

WASHINGTON, Jan. 29 /PRNewswire-USNewswire/ -- 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 challenges.

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:
http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.012908.witness.list.pdf.
Representatives of the FDA Science Board will be testifying first. Their
report can be found at:
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_00_index.html.

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 & Families

"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 Research

SOURCE Alliance for a Stronger FDA

Bill Hubbard, +1-919-475-0480, or Ladd Wiley, Executive Director,
+1-202-887-4083, lwiley@StrengthenFDA.org, both of the Alliance for a Stronger
FDA