US Congress demands FDA Provenge review

Several US Representatives have demanded that the House Energy and Commerce Committee should investigate the Food and Drug Administration's decision not to approve US biotechnology firm Denreon's prostate cancer vaccine Provenge (sipuleucel-T; Marketletters passim). The call was made by a bipartisan group of members of the House of Representatives, Dan Burton (Republican, Indiana), Mike Michaud (Democrat, Maine) and Tim Ryan (Democrat, Ohio). There have been persistent claims of potential conflicts of interest by some members of the FDA committee which considered the application.

At the meeting of the FDA's Office of Cellular, Tissue and Gene Therapies Advisory Committee, the vote on Provenge's safety was carried 17 votes to nil, and on the drug's efficacy by 13 to four. However, written submissions from cancer experts to the federal government agency opposed Provenge's clearance. A decision was taken to delay approval until data from a clinical trial scheduled to end in 2010 can be analysed.

Following the meeting, two members were reported to have received death threats and to require personal protection. However, Rep Michaud, in a letter to the House committee, claimed that one of the scientists voting against the Dendreon product is the lead investigator for Asentar (DN-101) from rival USA-based biopharmaceutical firm Novacea (Marketletters passim).