F.D.A. subcommittee says U.S. food supply at risk

by Bryan Salvage
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WASHINGTON ― America’s food supply is at risk, as are the regulatory systems in place to oversee the nation’s drug and device supplies, according to a subcommittee of the Food and Drug Administration's (F.D.A.) Science Board in a report to be presented Dec. 3. The subcommittee attributed the deficiencies to soaring demands on the F.D.A. and resources that have not increased in proportion to those demands.

The study’s authors conclude "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 panel of experts, the subcommittee’s 300-page report concluded the state of the F.D.A.’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.

"Over the last decade, complex scientific advances, globalization and challenging new safety issues have combined to multiply the responsibilities of the F.D.A.," said Dr. Mark McClellan, commissioner of the F.D.A. and chairman of the Reagan-Udall Institute. "As this new report makes clear, our expectations cannot exceed the resources we give F.D.A. to accomplish its mission. In this regard, more is definitely better."

The viability of the F.D.A. has been an ongoing topic of discussion in Washington and throughout the food industry. In September 2006, the Coalition for a Stronger F.D.A. was formed that consists of national patient advocate groups, consumer groups, industry organizations and former government officials The latter include three former secretaries of Health and Human Services: Tommy G. Thompson (secretary 2001-05), Donna E. Shalala (1993-2001) and Dr. Louis Sullivan (1989-1993). The former secretaries are serving as co-chairs of the coalition.

"F.D.A. can’t improve its science, prepare for the future, or protect American consumers without significant additional resources," said Dr. Don Kennedy, a former commissioner of the F.D.A. and editor-in-chief of Science magazine. Congress is negotiating F.D.A.’s FY 2008 (current year) budget right now and can start to fix this critical problem."

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