Planning for the FDA's overhaul

Just about everybody agrees that the FDA needs a safety overhaul--including Commissioner Andrew von Eschenbach, who recently admitted [1] the agency is in crisis. The agency itself drafted a five-year plan that would channel user fees into more safety evaluators, epidemiologists, regulatory project managers, and risk experts, all to beef up post-marketing drug-safety oversight. In addition to new staff, the plan calls for technology and communications systems, plus two or three years of intense staff training.

Meanwhile, Rep. John Dingell [2] has been working on a plan of his own. According to Congressional Quarterly, Dingell would expand the FDA's regulatory authority by funding a team of full-time overseas inspectors [3]. He'd require drugs, devices, and food products to be labeled according to country of origin. He'd levy new user fees to pay for spot checks at overseas plants and U.S. ports. Sweeping change is absolutely necessary, Dingell tells CQ, saying that the agency doesn't have "the vaguest idea who's producing these things, whether they're safe or not, whether they're using good manufacturing practices or not...or anything else that might relate to seeing to it that the safety of the American people is attended to." Ouch.

- read the Dingell item [4] at Pharmalot
- see a summary [5] of the FDA plan at FDANews
- check out the FDA's plan draft [6] (.pdf)

ALSO: The San Jose Mercury News' editorial board says the FDA should be embarrassed by its lack of attention to the ingredients in prescription drugs--and that its laissez-faire foreign inspections make its refusal to import cheaper prescription meds (for "safety reasons") into "hypocrisy." Report [7]

Related Articles:
FDA chief admits need for funding, reform. Report [1]
FDA can't guarantee drug safety. Report [8]
FDA wants satellite offices overseas. Report [3]
FDA badly needs more money, staff. Report [9]