The FDA is requesting a budget of $4.5 billion to protect and promote the public health as part of the president’s fiscal year 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.
“These are austere budget times, and the FDA budget request reflects this reality,” said Margaret A. Hamburg, M.D., commissioner of food and drugs. “Our budget increases are targeted to strategic areas that will help speed the availability of new medical products, address the challenges of increased globalization and allow FDA to fulfill its public health duties more efficiently. With FDA-regulated products accounting for about a quarter of each dollar that Americans spend, these budget priorities will benefit patients and consumers and strengthen our economy.”
Highlights of the FDA FY 2013 budget include: