FDA Budget Set To Expand

Under President Barack Obama’s proposed fiscal 2012 budget, the Food & Drug Administration is slated to receive a total of $4.4 billion, an increase of $987 million, or 29.3% compared with the agency’s current operating budget. The increase includes $605 million in industry-paid user fees. Whether Congress will approve such a dramatic boost remains to be seen.

The total amount of user fees in the 2012 budget request for FDA is just over $1.6 billion, a 59.8% increase compared with current user-fee levels, and equal to 37.1% of the agency’s total funding. In contrast, the 2012 budget would provide more than $2.7 billion in federal allocations, a 16.2% increase.

The extra funding comes at a time when FDA’s responsibilities have become increasingly complex because of the glob­alization of the food and drug supply. The agency has also taken on the jobs of regulating tobacco products, implementing a recently enacted food safety bill, creating an approval pathway for generic versions of biologic drugs, and enhancing regulatory science.

Food safety will be a high-priority area for FDA in 2012. The proposed budget provides FDA’s Transforming Food Safety & Nutrition Initiative with $1.4 billion, an increase of $324 million, or 31.1%. Funds for this program will be spread across multiple centers within FDA, including foods, animal drugs, toxicological research, and the Office of the Commissioner. The extra resources will help FDA move toward a prevention-based food safety system—a key component of the Food Safety Modernization Act, which was signed into law earlier this year.

FDA also has requested $70 million for its Advancing Medical Countermeasures Initiative. The effort aims to accelerate the development of new tools and technologies for responding to emerging diseases, such as pandemic influenza, as well as chemical, biological, and nuclear threats.

The 2012 budget request provides FDA with $124 million for developing an approval pathway for generic versions of biologic drugs, often referred to as biosimilars. FDA is also set to receive $49 million to beef up its regulatory science capacities—an effort to better prepare FDA staff when it comes to approving products with new and emerging technologies, such as nanotechnology and stem cells.

FDA’s tobacco program would see a huge increase in 2012. The proposed budget provides FDA with $455 million for tobacco-related activities, an increase of $238 million, or 110% compared with current levels. FDA’s entire tobacco program is paid for with industry user fees.

The Alliance for a Stronger FDA, a group that has long lobbied for increased resources at FDA, applauded the President’s 2012 budget proposal. “The President has demonstrated his understanding of FDA’s critical mission, particularly in the food safety area, and has proposed funding consistent with the demands being placed on the agency,” says Nancy Bradish Myers, president of the alliance.

But some people say the proposed increase is not enough. “The Congressional Budget Office (CBO) has calculated that it would require $1.4 billion over the next four years to implement the newly enacted Food Safety Modernization Act,” points out Wenonah Hauter, executive director of the advocacy group Food & Water Watch. “Unless the Administration plans to increase its requests in future years, the FY 2012 request is half what CBO estimated it would require to implement the new law.”

Any budget increases, however, will have a tough time getting through Congress during the current economic climate. The President had requested a hefty increase for FDA for fiscal 2011 (C&EN, Feb. 15, 2010, page 42), but Congress has yet to pass the 2011 appropriations bill, so FDA is still operating at 2010 funding levels. The House of Representatives passed a bill on Feb. 19 that would slash FDA’s current operating budget by nearly $70 million for the remainder of fiscal 2011.

The possibility of cuts at FDA worries House Democrats. “I have been raising concerns for years about the state of funding at FDA,” Rep. John D. Dingell (D-Mich.) said during a hearing on Feb. 17. “I find it curious that some of my colleagues who express concern about the speed with which medical products are approved in this country are prepared to vote to cut funding for the agency responsible for approving drugs and devices—an agency that has been systematically starved of resources over decades.”