FDA user fee deal facing deadline

As the Marketletter was going to press, the renewal of the 1992 Prescription Drug User Fee Act was facing a crucial deadline. On September 21, if both chambers of the US Congress had failed to come to an agreement on a common text, the Food and Drug Administration would have to issue redundancy notices to those of its staff that are employed to review drug applications.

With Democrats controlling both the House of Representatives and the Senate, any delays are likely to be procedural, with other legislation competing for lawmakers' attention. On September 19, the House approved its final text of the 2007 PDUFA (HR 3580) by an overwhelming 405 votes to seven.

Provided time could be found for a Senate vote, passage would therefore seem to be guaranteed. According to the Wall Street Journal, the remaining stumbling block appears to be the attempt by some groups to weaken or scrap the FDA's pre-emption role in terms of drug safety warnings. The agency, with strong Republican party support, has argued that drugmakers are not required to warn patients about a potential risk if the FDA has determined that such action was not required (Marketletter September 3).