With physicians and hospitals offering only lukewarm support to proposed FDA reforms of its drug safety policy and communications with the public and providers, Congress is likely to push ahead with plans of its own to regulate the agency, experts say. Physician groups like the AMA and Medical Group Management Association said they were pleased with the FDA's plans to notify physicians more quickly about drug safety concerns, though as MGMA president noted, the FDA still has little authority to force pharmas to do post-approval research on drugs. (This is probably the point at which legislators will be jumping in.)
Ultimately, advocacy group Public Citizen summed up much of the public response, arguing that FDA's proposals were appropriate, but "generally weak," focused mostly on follow-up study, panels and the like rather than concrete action plans, said Peter Lurie, deputy director for its Health Research Group. This sets the stage for Congress to take its own shots, observers like Lurie suggest.
To get more background on the response to FDA reforms:
- read this piece from Modern Healthcare