When user fees are added, the agency’s budget increases to $4.5 billion, up from $3.8 billion the previous year. The fees come from the companies that FDA regulates. Pharmaceutical firms pay the majority of these fees, which are used to expedite drug reviews.
The budget proposes seven new user fees, reauthorizes prescription drug and medical device fees that are set to expire in October, and increases existing fees.
Two of the new fees would support key elements of the Food Safety Modernization Act, a landmark food safety bill that was adopted in late 2010 after a string of high profile recalls shook consumer confidence in the nation’s food supply. Those fees would generate $225 million.
A separate fee that would speed the approval of lower cost generic drugs would provide $299 million. Another would be used to bring “biosimilars ” to the U.S. market and provide $20 million. Biosimilars are treatments generally derived from human and animal materials that are used to treat diseases and health conditions.
The budget includes $10 million to boost FDA’s presence in China. Some of that money would be used to hire 19 full-time equivalent staffers to help improve the safety of food and medical products imported from China.
The budget also proposes $24 million for an initiative designed to protect the public against emerging infectious diseases and intentional threats. The proposed funding is up $4 million from the previous year.
The agency is part of the Department of Health and Human Services, which would receive $76.4 billion under the president’s proposal, about even with last year.