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Chitra Sethi, Managing Editor, BioPharm International
Health and Human Services Secretary Mike Leavitt has announced that his agency is amending its budget request for FY 2009 to include an additional $275 million for the FDA.
Health and Human Services Secretary Mike Leavitt has announced that his agency is amending its budget request for fiscal year (FY) 2009 to include an additional $275 million for the US Food and Drug Administration (FDA). The increase brings the HHS’s total proposed increase in the FDA's budget for FY 2009 to $404.7 million-a 17.8% boost in funding from FY 2008.
The additional funds will expedite implementation of the strategy outlined in the Action Plan for Import Safety and the complementary Food Protection Plan, both released in November 2007.
According to Leavitt if the proposed budget is approved, the FDA will be able to expedite steps to improve import safety, including:
The budget amendment proposes the following increases for core FDA programs:
Safer Drugs, Devices, and Biologics (+$100 million)
An increase of $100 million for the FDA’s medical product programs would strengthen the FDA’s ability to ensure the safety and effectiveness of medical products, from product development and pre-approval testing, through approval and postapproval safety surveillance. The FDA faces growing challenges from the globalization of medical product development and manufacturing. The increase for medical product programs will allow the FDA to respond to this trend.
Modernizing FDA Science and Workforce (+$50 million)
The budget amendment also proposes increases to strengthen the FDA’s capacity to support product safety and development in areas of emerging science such as nanotechnology, cell and gene therapies, robotics, genomics, advanced manufacturing, and the Critical Path initiative. The FDA will also improve laboratories and other facilities that are essential to carrying out the FDA’s mission and invest in science training, professional development, and fellowship programs to strengthen and modernize the FDA workforce.
Protecting America’s Food Supply (+$125 million)
The increase would allow FDA to intensify actions to implement FDA’s Food Protection Plan. Announced on November 6, 2007, the Food Protection Plan is an integrated, risk-based strategy to help ensure the safety of domestic and imported food and feed. The $125 million increase adds to the $42.2 million increase proposed for food protection in the budget announced in February 2008.
The program increases listed above include $65 million to modernize the FDA’s information technology infrastructure.
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