FDA Gears Up for Food Safety, Drug Surveillance

The U.S. Food and Drug Administration could get a substantial boost if Congress approves President Barack Obama's 2011 request for a 23% increase over its current budget, to a shade over $4 billion. Most of the increase—$601 million—would come from user fees charged to the drug, device, tobacco, and other companies regulated by FDA, which have supplied FDA with billions of dollars in recent years. Another $146 million would come from the federal government. Like any federal support, the user fee increases require congressional approval.

FDA’s priorities under its new director, Margaret Hamburg, have four headings: The biggest is food safety, garnering an increase of $318 million. Much of that will go towards implementing recommendations from the President’s Food Safety Working Group, created last spring to bolster food safety and make outbreaks of food-borne illnesses less likely. The recommendations include improved the tracing of foods to pinpoint where illnesses like salmonella originated, and more audits and inspections of facilities.

The agency has also been promised an extra $101 million to help improve the safety of drugs, devices, blood, and medical therapies, including efforts to bolster safety of cord blood and human tissue for transplant. Five million dollars is slated to expand postmarketing surveillance of products already approved for sale.

FDA is also seeking $215 million, all in fees from tobacco companies, to help regulate tobacco products, and $25 million for a “new generation of medical technologies,” said Hamburg in a press briefing this afternoon. Those could make it easier for the agency to assess therapies that touch on personalized medicine, nanotechnology, regenerative medicine, and other cutting edge areas.