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Obama Seeks 19 Percent Budget Hike For FDA

New proposal includes higher industry fees

May 7, 2009

The requested outlay, which covers the period of Oct. 1, 2009, through Sept. 30, 2010, includes increases of $295.2 million in budget authority and $215.4 million in industry user fees.

The FDA budget proposes two major initiatives for FY 2010: Protecting America's Food Supply and Safer Medical Products. It also includes increases for current law user fees and for infrastructure to support critical agency operations.

The FDA is also proposing four new user fees to facilitate review of generic drugs, register and inspect food manufacturing and processing facilities, re-inspect facilities that fail to meet Good Manufacturing Practices and other safety requirements, and issue export certifications for food and feed.

"This historic increase in the FDA's budget is a great investment in public health," said Joshua Sharfstein, M.D., acting commissioner of food and drugs.

The budget requests $259.3 million for increased efforts to protect the food supply in the wake of a number of serious foodborne illness outbreaks. The most recent was the peanut-related salmonella outbreak in the first three months of 2009 that killed as many as nine people and made more than 600 others sick.

The budget seeks $166.4 million for an effort to improve the safety of human and animal drugs, medical devices, vaccines, blood, and other medical products. It will allow the FDA to strengthen safety and security of the supply chain for medical products. The initiative also includes $46.6 million in new user fees for generic drug review and new fees to reinspect medical product facilities that fail to meet safety standards.

Meanwhile, Obama's pick to head the FDA, former New York City Health Commissioner Dr. Margaret Hamburg, faced a Senate confirmation hearing Thursday, saying she wants to restore public confidence in the FDA. In prepared remarks, she assured lawmakers she will reorganize the agency to make it more effective in protecting the food supply and preventing illnesses.

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