Lawmakers Call for Investigation Into FDA's Provenge Decision

Several members of Congress are calling on the House Energy and Commerce Committee to investigate why the FDA did not approve Dendreon’s prostate cancer vaccine Provenge.

Conflicts of interest on an FDA advisory committee could have contributed to the agency’s decision, Reps. Mike Michaud (D-Maine), Dan Burton (R-Ind.) and Tim Ryan (D-Ohio) said. “There are reasons to believe that serious ethics rules were violated by two FDA advisory panel members in their decision and that these violations played a role in the subsequent FDA decision to not approve Provenge at this time,” a letter from the lawmakers said.

Earlier this year, the FDA requested more efficacy data for Provenge despite a positive vote from its Cellular, Tissues and Gene Therapies Advisory Committee. The additional clinical trials the FDA requested will not be completed until 2010, the lawmakers said.

The committee voted 13–4 that Provenge was effective and 17–0 that it was safe. However, some cancer experts sent written requests to the agency asking that Provenge not be approved.

One of the committee members who voted against Provenge is the lead investigator for a competing cancer drug made by Novacea. The FDA should not be appointing scientists who are testing a rival drug for another company to an advisory committee, Michaud said, adding that the FDA can and should eliminate conflicts of interest in its advisory committee members to restore public confidence in the agency.