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Media Release: January 29, 2008

FDA ADVISORS DECLARE “FDA SCIENCE AND MISSION AT RISK”

Broad-Ranging Report Concludes that Increased Resources are an Essential First Step

WASHINGTON, D.C. – 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 target=_blank. 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. For more information, e-mail Ladd Wiley, Executive Director or phone him at 202-887-4083.