FDA budget aims for "strong, smart" regulator

Drugs finished second--behind food and feed, but ahead of new cigarette and tobacco controls--in funding requests in the FDA's 2011 budget request. Some $100.8 million is designated for traditional drug regulation in the "Protecting Patients Initiative," while $25 million is asked for efforts to advance regulatory science.

In a conference call yesterday, FDA Commissioner Margaret Hamburg gave a broad-strokes outline of the total $4.03-billion FDA budget proposal--a 23 percent increase over the agency's current $3.28 billion budget.

"The FY 2011 resources will strengthen our ability to act as a strong and smart regulator," says Hamburg. The request aims to fund efforts to improve medical product safety, protect patients, and modernize FDA regulatory science to advance public health, she adds.

The $25-million, 50-person regulatory science initiative is a nod toward FDA catch-up with the "extraordinary investments" over the last two decades that have led to "revolutionary advances in the life and biomedical sciences," according to an announcement. It will help the agency "strengthen its core scientific capacity" and "identify improved pathways to product development and approval for new technologies."  

- see the FDA announcement
- here's the 600+-page budget document

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