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FDA Advisors Declare 'FDA Science and Mission at Risk'
Date:12/3/2007

Broad-ranging Report Concludes that Increased Resources Are An Essential

First Step

WASHINGTON, Dec. 3 /PRNewswire-USNewswire/ -- The nation's food supply is at risk, as are the regulatory systems that oversee the nation's drug and device supplies, according to a subcommittee of the FDA's Science Board in a report to be presented today. The subcommittee attributes 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."

The result of a year-long review by a distinguished panel of experts, the Subcommittee's 300-page report concludes that the state of FDA's scientific and regulatory programs could not be separated from the lack of resources. It urged funds to support the agency's scientific base, hire a broadly-capable scientific workforce, and build a sophisticated, modern information technology infrastructure.

The FDA Science Board meets from 8 a.m. to 5:30 p.m. on December 3 at the Gaithersburg, MD Hilton. The Subcommittee is scheduled to present at 12:30 p.m., with discussion continuing until 4 p.m. Its report has been posted on the FDA website in advance of the meeting and is available at: http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_00_index.html .

Comments on the report:

"Over the last decade, complex scientific advances, globalization and challenging new safety issues have combined to multiply the responsibilities of the FDA. As this new report makes clear: our expectations cannot exceed the resources we give FDA to accomplish its mission. In this regard, more is definitely better."

--Mark McClellan, MD, former FDA commission
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SOURCE FDA Alliance
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