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Media Release: February 13, 2012

ALLIANCE FOR A STRONGER FDA CONCERNED BY PRESIDENT’S FY 13 BUDGET REQUEST FOR FDA

President Recognizes FDA’s Exceptional Mission, But Proposes No Increase in Appropriated Funds

WASHINGTON, D.C., February 13, 2012 — The Alliance for a Stronger FDA today expressed concern that President Obama’s FY 13 budget request for the US Food and Drug Administration did not include an increase in appropriated funding.

The Alliance, which represents all the major stakeholders affected by the FDA, including regulated industry, professional associations, and patient and consumer groups, noted that the President’s proposed budget for FDA is $4.49 billion. Of that, only $2.5 billion is from appropriated funds, the same as FY 12, with the remainder coming from significant increases in user fees paid by the various regulated industries.

“The FDA’s essential role in protecting public health continues to grow to meet the demands of our time. With no other agency as fallback, we believe that FDA’s funding should be increased to reflect the agency’s vast responsibilities and increased workload,” said Margaret Anderson, President of the Alliance and Executive Director of FasterCures. “Inadequate funding for the FDA has real and immediate consequences as it jeopardizes the public health.”

She continued: “The key thing to watch is the actual budget appropriation, and not the user fees. It is the appropriated dollars that are used to run the agency and pay for overseeing imported goods, assuring food safety, and stimulating medical product innovation and ensuring safety, as well as dealing with inevitable crises, such as seafood safety during the Gulf oil spill.”

“In this year of austerity, we appreciate that the President has proposed the same funding for FDA, even while many other agencies have been cut. However, this is not enough when the FDA mission is expanding and the agency is providing services and protections that Americans value,” added Diane Dorman, Vice President of the Alliance and Senior Vice President for Policy at the National Organization for Rare Disorders. “The Alliance, which represents the entire FDA stakeholder community, is concerned that inadequate funding for the FDA jeopardizes the public health.”

FDA is unusual in that regulated companies pay fees to register manufacturing and other facilities, to process marketing applications for medical products, and to regulate tobacco products.  Included in the FY 2013 proposed budget are new fees for generic drugs, biosimilar drug applications, and for food establishment registration.

Anderson noted that FDA not only protects and advances the public health, but also provides an economic benefit to the US.  The importance of FDA and its regulated industry to the American economy is detailed in the Alliance’s white paper: FDA: A Cornerstone of America’s Economic Future.

The Alliance’s 200 members are comprised of consumer, patient, professional and research groups, companies, trade associations, and individuals who support increased appropriated funding for FDA.  The Alliance is the only multi-stakeholder group that advocates for increasing resources at FDA to match the agency’s responsibilities. More information about the Alliance can be found at www.StrengthenFDA.org.