Tobacco Facts.

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

FDA’s FY 2010 budget included a 19% increase over the FY 2009 budget and totaled $3.28 billion. The new proposed budget, which would begin Oct. 1, 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 and, if the related legislation is passed, $38 million would come from human generic-drug fees. If the president’s spending freeze is enacted, then this overall budget increase would enable FDA—as a nonsecurity 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,” said the press release. FY 2011 funding would also go toward the agency’s new regulatory authority over tobacco products, including cigarettes (see “FDA Opens Center for Tobacco Products”).

FDA intends to focus FY 2011 funds on the following four initiatives:
1. 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.

2. 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 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.

3. 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.

4. 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 US Department of 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), FDA, 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 FDA to consolidate at its headquarters at the White Oak, Maryland, location and $112 million to repair and maintain FDA-owned facilities throughout the US.

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

Feb 4, 2010
By Angie Drakulich, Pharmaceutical Technology

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