President Barack Obama released his budget proposal for fiscal year (FY) 2012, which shows an increase in funding for FDA. The FY 2012 budget requests $4.4 billion for FDA, a net program-level increase of $1 billion, or 33% compared with FY 2010. The FY 2012 budget proposal includes increased investments to implement the FDA Food Safety Modernization Act, advance medical countermeasures, and improve drug safety. The release of the President’s proposed budget is the first step in the budget process as spending and revenue measures are considered by Congress.
FDA’s budget is included under the budget for the Department of Health and Human Services (HHS). Approximately 84% of the $892 billion in outlays for the FY 2012 budget proposal for HHS is allocated to entitlement programs, 54% for Medicare and 30% for Medicaid. Proposed program funding for FDA in FY 2012 is $4.36 billion, of which the largest portion is allocated to human drugs at $1.15 billion, an increase of $275 million over FY 2010, and food at nearly $1.04 billion, an increase of $252 million over FY 2010. The proposed FY 2012 FDA budget includes nearly $1.62 billion in various user and other fees, including $856 million from fees collected under the Prescription Drug User Fee Act and $40 million from user fees for human generic drugs from proposed legislation, bringing the total FY 2012 budget authority for FDA to $2.74 billion, an increase of $380 million compared with FY 2010.
The proposed FY 2012 HHS budget also includes $32.0 billion for the National Institutes of Health, which represents an increase of $745 million compared with the FY 2010 enacted level, to support basic and clinical research. In FY 2012, NIH estimates that it will support a total of 36,852 research project grants, including 9158 new and competing awards. In FY 2012, NIH plans to establish the National Center for Advancing Translational Sciences (NCATS) as a mechanism for bridging the gap between basic science and therapeutic applications. With the creation of NCATS, the National Center for Research Resources will be abolished, and its programs will be transferred to the new center or other parts of NIH.
The proposed FY 2012 HHS budget also includes additional funding for medical countermeasures, or medications, vaccines, equipment, and supplies needed for health emergencies such as pandemic flu. HHS issued a report in August 2010, the Public Health Emergency Medical Countermeasures Enterprise Review: Transforming the Enterprise to Meet Long-Range National Needs, which reviewed the federal government’s system for medical countermeasures. The FY 2012 federal budget includes funding of $665 million for the Biomedical Advanced Research and Development Authority, an increase of $345 million, to improve and develop medical countermeasures to mitigate the medical consequences of potential chemical, biological, radiological, and nuclear threats.
The budget also includes $100 million to establish a strategic investment corporation that would function as a public–private venture-capital fund for companies developing medical countermeasures. The budget also allocates $70 million for FDA, which builds off the $170-million request in FY 2011, to establish teams of public-health experts to support the review of medical countermeasures, related manufacturing approaches, regulatory policy, and legal frameworks. NIH also will dedicate an additional $55 million for expanding the Concept Acceleration Program to assist researchers with early-stage medical countermeasure products, but limited product development experience, to facilitate development and testing of their products. Finally, the proposed HHS budget includes $665 million, an increase of $59 million compared with FY 2010, to replace expiring products in the Strategic National Stockpile. The budget also includes $242 million for ongoing pandemic influenza preparedness activities at the Centers for Disease Control, NIH, and FDA.