FDA citizen petitions 'abused' by drug firms

A bipartisan attack on the alleged abuse of "citizen petitions" to the US Food and Drug Administration by research-based drug companies, claims that a new loophole has been found by some firms to prevent or delay competition from generic drugmakers.

According to figures compiled by US Senator Debbie Stabenow (Democrat, Michigan) and published recently in the Washington Post newspaper, the FDA has rejected 20 out of 21 citizen petitions filed by branded drugmakers since 2003. The number of petitions has escalated from 90 in 1999 to 170 under review at present. Sen Stabenow has proposed legislation with former Senate majority leader Trent Lott (Republican, Mississippi) that would restrict drugmakers' ability to employ this device. Both face re-election in November, with Sen Stabenow under pressure in what is thought to be a close race.

The FDA informed the Washington Post that about 30% of the petitions are challenges to marketing applications by generic manufacturers. A petition filed by Canadian drugmaker Biovail, which has delayed approval of an application by US specialty drugmaker Impax Laboratories to produce a generic version of the antidpressant Wellbutrin XL (bupropion HCl), has prompted the two Senators to write in protest to the FDA's acting Commissioner, Andrew von Eschenbach, claiming that US patients are losing $37.0 million per month through lack of competition.