Cracking open FDA

A window has opened in Washington for reformers from both parties to revamp FDA's oversight of medical products, but the opening is narrow and will slam shut quickly. Reform proposals will be adopted only if they are highly specific and if they can attract assent, if not endorsement, from Democrats and Republicans, FDA, patient groups and regulated industry.

The opening exists because Congress must reauthorize drug and medical device user fees. PDUFA and the Medical Device User Fee and Modernization Act (MDUFMA) expire on Sept. 30, 2012. But to avoid eviscerating FDA's ability to review medical products, the reauthorization legislation must be enacted by about July 1...