FDA requests another major year-over-year budget increase

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Pharmaceutical Technology Europe

Less than a week after president Obama proposed a spending freeze on non-security related federal programs, the FDA released its fiscal year 2011 budget request, calling for a 23% increase.

Less than a week after president Obama proposed a spending freeze on non-security related federal programs, the FDA released its fiscal year 2011 budget request, calling for a 23% increase. The FDA is asking for a total of $4.03 billion in FY 2011 “to promote and protect public health,” according to an agency release.

The FDA’s FY 2010 budget included a 19% increase over FY 2009 and totaled $3.28 billion. The new proposed budget, which would begin 1 October 2010, would include a $146-million increase in budget authority and $601 million in industry user fees. Of these user fees, approximately $667 million would be derived from the Prescription Drug User Fee Act (PDUFA) and, if the related legislation is passed, $38 million would come from human generic drug fees. If the President’s spending freeze goes through, this overall budget increase would enable the FDA — as a non-security discretionary federal program — to have a budget of $4.03 billion for the fiscal years 2011, 2012 and 2013.

“The budget request reflects the FDA’s resolve to transform food safety practices, improve medical product safety, protect patients, and modernize FDA regulatory science to advance public health,” says the release. FY 2011 funding would also go toward the agency’s new regulatory authority over tobacco products, including cigarettes (see back story, “FDA Opens Center for Tobacco Products”).

Specifically, FDA intends to focus FY 2011 funds on four initiatives, according to the agency release:

  • Transforming food safety (+ $318.3 million): FDA will set standards for safety, expand laboratory capacity, pilot track-and-trace technology, strengthen its import-safety program, improve data collection and risk analysis, and begin to establish an integrated national food safety system with strengthened inspection and response capacity.
  • Protecting patients (+ $100.8 million): FDA will support the safety of drugs, devices, and vaccines, as well as the nation’s blood supply. The agency will also be able to increase inspections to “improve the security of the supply chain and reduce the potential for harm” with its medical product safety initiative, according to the agency press release.
  • Advancing regulatory science (+ $25 million): FDA will begin to strengthen its core scientific capacity to realize the benefits of recent discoveries and technologies. For example, with improved scientific infrastructure, the agency may work to establish improved pathways to product development and approval for new medical-treatment technologies.
  • Tobacco (+ $215 million): With an increase in tobacco user fees, FDA will to continue to implement the Family Smoking Prevention and Tobacco Control Act.

The FY 2011 Health and Human Services (HHS) budget also includes $302 million for “ongoing pandemic influenza preparedness activities” within the Centers for Disease Control and Prevention, the National Institutes of Health (NIH), theFDA, and the Office of the Secretary. In addition, remaining balances from the $7.65 billion that Congress appropriated to HHS last June for H1N1 swine-flu and pandemic influenza preparedness and response would carry over to the FY 2011 budget. These balance funds would specifically go toward HHS development of “cell-based and recombinant vaccines, antivirals, respirators, and other activities to help prepare for future potential pandemics,” according to the budget proposal.

Of note, the proposal calls for $39 million in budget authority for the FDA to consolidate at its headquarters at the White Oak (MD, USA) location and $112 million to repair and maintain FDA-owned facilities throughout the US.

Finally, NIH would be appropriated an increase of $1 billion for a total of $32.2 billion to support innovative biomedical research projects.

Click here to read President Obama’s full FY 2011 budget proposal for HHS.

Click here to read a related blog post: "Federal Spending Freeze Could Threaten Supply-Chain Security”