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Media release: February 2, 2010

ALLIANCE FOR A STRONGER FDA “DISAPPOINTED” BY PRESIDENT’S FY 11 BUDGET REQUEST FOR FDA

Three Years of Above-Inflation Increases Have Not Offset the Impact of a Decade of Neglect

WASHINGTON, D.C., February 2, 2010 –While acknowledging that the U.S. Food and Drug Administration (FDA) received a budget increase while many federal agencies did not, the Alliance for a Stronger FDA today expressed disappointment with President Obama’s FY 11 funding request for FDA. The President’s request is for an increase of $146 million, which would bring FDA’s appropriated funding to $2.508 billion (see associated chart).

The Alliance said the President’s request is consistent with the amount by which FDA’s costs increase each year. It will sustain FDA’s current programming and personnel in FY 11. It will not enable FDA to add necessary new programs or personnel.

“We are grateful that the President has proposed an inflationary increase of about 6 percent for FDA in a year in which most domestic discretionary programs will be frozen or cut,” said Wayne Pines, President of the Alliance.

“However, the FDA needs a real increase if it is to establish needed new programs and hire new people to carry them out. The American people must rely on FDA to assure the safety of products that constitute 25 cents of every consumer dollar spent. Continuing chronic underfunding of FDA affects our public health, our economy and our national security.”

Pines added: “We are disappointed in the President’s budget request and our Alliance will seek to work with the Congress and the Administration to increase FDA’s budget for FY 2011 beyond a simple inflation increase. We will have the support of our entire membership in this goal.”

The Alliance for a Stronger FDA is a coalition of more than 180 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.

“Even with funding increases over the last three years, FDA’s appropriation in FY 10 supported about the same number of full-time employees as 1994, a time period in which FDA faced fewer challenges in both number and complexity,” said Nancy Bradish Myers, Vice President of the Alliance and President of Catalyst Healthcare Consulting. “A larger financial investment is necessary to help alleviate the agency’s severe resource constraints caused by years of chronic underfunding and a rapidly growing list of complex public health challenges.”

The erosion of FDA’s budget has coincided with a time in which the agency’s workload has soared to include major public health initiatives such as H1N1 influenza, bioterrorism, and the inspection of an unprecedented amount of food and medical products from around the globe. “The imbalance between FDA’s funding and its expanding portfolio of public health responsibilities has left the agency overextended and ill equipped to effectively carry out its mission as the world’s premier protector of public health,” Pines said.

“Currently, FDA lacks the regulatory tools, expertise and processes to help spur the development of life-saving therapies from emerging biomedical fields such as stem cells and personalized medicine,” said Dan Perry, an Alliance board member and Executive Director of the Alliance for Aging research. “Our broad and diverse Alliance of more than 180 members looks forward to ensuring that policymakers are apprised of FDA’s need for consistent multi-year budget increases to bring FDA’s scientific and regulatory capacities up to speed with these sophisticated new areas.”

“We realize that the President is committed to reducing the deficit, including lowering overall government spending,” said Caroline Smith DeWaal, an Alliance board members and Food Safety Director at the Center for Science in the Public Interest. “Investments in FDA that prevent foodborne outbreaks and intentional contamination are important to achieving these goals as they reduce overall health care costs and losses to industry.”

More information about the Alliance can be found at http://www.StrengthenFDA.org.