The Department of Health and Human Services has upped its budget request for fiscal year 2009 with an additional $275 million for the FDA to back import-safety and food-protection programs, in efforts to deal with the mushrooming global economy.
Among the provisions is $65 million to modernize the agency’s information technology infrastructure.
Under the FDA Amendments Act of 2007, the agency would conduct safety surveillance to identify early signs of adverse events linked to medical products, and implement new requirements related to clinical trials and pediatric drugs and devices. It would establish unique-device identifiers to track devices, facilitate device recalls, support inventory management during disasters and responses to terrorism events, and conduct more import exams and foreign and domestic inspections of medical-product manufacturers.
A $100 million increase for the FDA’s medical-product programs would help ensure the safety and effectiveness of medical products, from product development and pre-approval testing, through approval, and post-approval safety surveillance.
The increase brings the Administration’s total proposed increase in the FDA‘s budget for FY 2009 to $404.7 million—a 17.8% rise in funding from fiscal year 2008.