The U.S. Food and Drug Administration has requested a 33% increase in their FY 2011 budget allowance over the previous allocation of $4.3 billion, according to a press release on February 14, 2011.

In supporting the request, Margaret A. Hamberg MD, Commissioner of the Food and Drug Agency stated, “The breadth of this mandate means that FDA responsibilities continue to grow.” She was referring to the recently enacted but as yet unfunded Food Safety Modernization Act. The critical initiatives that will require an increase in budget include:


  • Transforming the Food Safety and Nutrition Initiative: The $324 million requested will be devoted to the Food Safety Modernization Act and to activities which will encourage citizens to make healthier food choices. Prevention of food-borne diseases will be carried out in cooperation with state and local partners.
  • Advancing the Medical Counter Measure Initiative: The $70 million will be required to develop medical countermeasures to respond to national security threats. The legal, regulatory and policy framework of the program will be updated.
  • Expanding the Protecting Patients Initiative: Funded at $124 million this program will establish approval for “biosimilars” (analogous to generics) similar in clinical action to existing FDA-approved biological products.
  • Intensifying the Regulatory Science Facility Initiative: The $49 million requested would be applied to strengthen the regulatory scientific capacity required to support FDA missions.

Given the current opposition by the House to budget increases, the FDA will be hard pressed to justify increased funding and it is possible that many of the provisions of the Food Safety Modernization Act will not be realized in the foreseeable future.