F.D.A. budget under scrutiny

by Keith Nunes
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WASHINGTON — The Food and Drug Administration is requesting a budget of $4.3 billion as part of its fiscal year 2012 budget request, a 33% increase compared with the F.D.A. budget for fiscal 2010. The proposed budget covers the period of Oct. 1, 2011, to Sept. 30, 2012.

Implementation of the recently passed Food Safety Modernization Act takes up a significant portion of the requested budget increase. The agency has requested an additional $324 million to “establish a prevention-focused food safety system…,” according to the agency.

“F.D.A. protects and promotes the health of all Americans through every stage of life,” said Margaret A. Hamburg, M.D., commissioner of the F.D.A. “The breadth of this mandate means that F.D.A. responsibilities continue to grow. The new budget contains new resources so that F.D.A. can fulfill its growing responsibilities to the American public.”

Other increases in the proposed budget include $70 million for an advancing medical countermeasures initiative; $124 million for a protecting patients initiative; and $49 million for a regulatory sciences and facilities initiative.

A week before the President issued his budget proposal the Alliance for a Stronger F.D.A. said it is concerned about proposed cuts to the F.D.A. set to be included in the House Appropriations Committee’s FY 11 Continuing Resolution (C.R.). The alliance includes more than 180 members spanning not-for-profit consumer, patient, and research advocacy organizations; associations representing health professions and industry; and individual companies, and was formed to work for increased appropriations to strengthen the Food and Drug Administration.

“Our nation needs an effective F.D.A., which requires continuing increases for an agency that has been chronically underfunded for several decades,” said Nancy Bradish Myers, president of the alliance and president of Catalyst Healthcare Consulting. “We certainly understand the need to reduce the federal budget, but want to be sure that Congress has a clear picture of how F.D.A. contributes to economic growth and national security, as well as protecting our public health.”

As part of its proposal, the House Appropriations Committee is recommending the F.D.A. be cut by $220 million below the president’s request level for fiscal 2011. The amount would be about $74 million less than fiscal 2010 funding, which is the level at which the agency has received and spent funds thus far in fiscal 2011, the alliance said.

“F.D.A. touches every American multiple times each day through its jurisdiction over drugs, biologics, medical devices, 80% of the food supply, cosmetics, dietary supplements and varied consumer products,” said Margaret Anderson, vice-president of the alliance and executive director of FasterCures. “Altogether, the agency oversees nearly 25% of consumer spending in the United States. F.D.A. funding should reflect that the agency’s responsibilities and workload increase each year – through globalization, scientific complexity, and the growth of industry, as well as through new mandates.”
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