US Congress holds back from Provenge probe

The US House of Representatives' Committee on Energy and Commerce, which oversees the Food and Drug Administration, will not hold hearings into the agency's recent decision to reject marketing approval for Seattle-based Dendreon's oncology drug Provenge (sipuleucel-T; Marketletters passim). The controversial FDA decision led to death threats against dissenting members of the agency's own review committee, and an investigation by the Securities and Exchange Committee is also underway.

Two members of the Cellular, Tissue and Gene Therapies Advisory Committee who declared a potential conflict of interest were allowed to participate in the vote: Maha Hussein of the University of Michigan and Howard Sher of the Memorial Sloan-Kettering Cancer Center in New York. They were among the four members of the panel to vote against approving Provenge. Despite a 17-0 vote on safety and a 13-4 vote on efficacy by the advisory committee, the FDA rejected the drug's application in May last year.

Rep John Dingell (Democrat, Michigan) who chairs the HCEC and Frank Pallone (Democrat, New Jersey) who chairs the Subcommittee on Health, rejected a request by three colleagues for hearings on the case, arguing that the FDA has not yet made a final decision on the prostate cancer vaccine.