FDA Seeks $4.5 Billion For Food Safety, Medical Product Development
February 15, 2012 FDA is requesting a budget of $4.5 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2013 budget — a 17% increase over the FDA enacted budget for FY 2012. Industry user fees would fund 98% of the proposed budget increase. The FY 2013 request covers the period from Oct. 1, 2012 through Sept 30, 2013.
In addition to recommending new user fees to support the review of generic drugs and biosimilars, the FDA budget also contains increased funding for priorities such as import safety, medical countermeasures and research facilities to protect patients and consumers.
Highlights of the FDA FY 2013 budget include:
Transforming Food Safety Initiative (+$253 million) will bolster FDA’s efforts to build a strong, reliable food safety system — as envisioned in the landmark Food Safety Modernization Act (FSMA). With the support of new user fees, FDA will foster a prevention-focused domestic and import food safety system to protect the health of American consumers. Under this initiative, FDA is also proposing new user fees to support its cosmetic and food contact substance programs.
Food and Drug Inspections in China: The Transforming Food Safety and Protecting Patients Initiatives include $10 million in new resources for FDA to enhance collaboration with our Chinese counterparts and increase the agency’s presence in and expertise on China. This investment will strengthen the safety of the food and drugs produced in China for export to the U.S.
Medical Countermeasures (MCM) Initiative (+$3.5 million) will help meet America’s national security and public health requirements for MCM readiness.
Data Consolidation and IT Savings (-$20 million) initiative will produce savings to meet the requirements of recent executive orders that promote government efficiency and assure environmental, energy, and economic performance. FDA will also reduce redundant computer equipment and achieve other IT savings.
Protecting Patients Initiative (+$364 million) recommends new user fees to support FDA generic drug activities and to support development and review of biosimilar biological products.