President Barack Obama proposed Thursday to give the FDA a budget of $3.2 billion to protect and promote the public health as part of the administration's fiscal year (FY) 2010 budget--reflecting a 19 percent increase over the agency's current budget allocation.
The FY 2010 request, which covers the period of Oct. 1, 2009, through Sept. 30, 2010, includes increases of $295.2 million in budget authority, $215.4 million in industry user fees and $166.4 million to monitor the safety of medical devices.
The FDA budget proposes two initiatives for FY 2010: Protecting America's Food Supply and Safer Medical Products. It also includes increases for current user fees and for infrastructure to support critical agency operations.
The FDA is also proposing four new user fees to facilitate review of generic drugs, register and inspect food manufacturing and processing facilities, reinspect facilities that fail to meet Good Manufacturing Practices and other safety requirements, and issue export certifications for food and feed.
"This historic increase in the FDA's budget is a great investment in public health," said Joshua Sharfstein, MD, acting commissioner of food and drugs.
The FDA's key proposed budget increases include:
- Safer Medical Products ($166.4 million) - This effort provides targeted resources to improve the safety of human and animal drugs, medical devices, vaccines, blood, and other medical products. It will allow the FDA to strengthen safety and security of the supply chain for medical products. The initiative also includes $46.6 million in new user fees for generic drug review and new fees to reinspect medical product facilities that fail to meet safety standards.
- Current Law User Fees ($74.4 million) - In addition to the new user fees proposed for FY 2010, the FDA request also includes inflationary and other authorized increases for fees that support FDA review of applications for new human drugs (+$67.5 million), animal drugs (+$2.3 million), and medical devices (+$4.5 million).
- Follow-on Biologics & Drug Importation ($5 million) - Within the Safer Medical Products initiative, the budget proposes a new authority for the FDA to approve follow-on biologics through a regulatory pathway that protects patient safety and promotes innovation, and includes $5 million for the FDA to develop policies to allow Americans to buy drugs approved in other countries.