Advocates of the drug industry are quietly allying with some of their longtime critics, pushing to split FDA into two agencies, one for food safety and one for medical products, hoping such reorganization will lead to faster approval for new medicines. Drug executives see a chance to speed up approvals that have lagged amid a drought of new products, provided their regulator is no longer distracted by high-profile food-safety breakdowns.
This year, the agency will spend just 73 cents on food safety for every dollar spent on drugs, according to the Institute of Medicine. Last year FDA missed review deadlines on more than 12 drugs, or more than 20% of those received, analysts estimate. The agency’s internal goal is to miss no more than 10%.
—The Atlanta Journal-Constitution, 3/22/09