Court dismisses part of lawsuit against FDA over Provenge

WASHINGTON CareToLive, a nonprofit advocacy group, has had two parts of a lawsuit it filed against the Food and Drug Administration dismissed by a federal judge.

The lawsuit is in relation to the FDA’s decision to delay the approval of Dendreon’s prostate cancer vaccine Provenge. The FDA is requesting more efficacy data on the drug, despite a previous 13-4 vote on its effectiveness and a 17-0 vote on the safety of the drug by the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee.

In its suit, CareToLive alleges that the director of the Center for Drug Evaluation and Research’s Office of Oncology Drug Products, Richard Pazdur, pressured committee members to deny due process for Provenge’s biologic license application. Pazdur also deliberately placed two oncologists he knew would vote against Provenge on the committee prior to the vote, the complaint says.

The FDA is still reviewing Provenge’s application and may ultimately approve it, which would render the plaintiff’s claims moot, U.S. District Court for the Southern District of Ohio Judge Gregory Frost said. CareToLive failed to support the claim that a complete response letter from the FDA constitutes final agency action.

Because the action is not final, the court could only issue a remand to the FDA to continue its review of Provenge’s BLA, which would not speed patients’ access to the drug, the judge said.

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