Nonprofit sues FDA to force Provenge approval

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A nonprofit patient advocacy group has filed suit against the FDA in an Ohio federal court seeking to overturn the agency's decision earlier this year to not approve Dendreon's prostate cancer vaccine Provenge.

The lawsuit, filed by Ohio-based Care to Live, which includes some Dendreon investors, alleges that the FDA in May failed to follow an advisory committee recommendation to approve Provenge and instead asked the company for more information.

The group argues that Provenge's Biologics License Application approval was derailed by Richard Pazdur, director of the FDA drug center's oncologic drugs division, as part of a bureaucratic turf battle with the FDA's biologics center over who would control all oncology therapies.

It charges that this led him to place two conflicted panel members on an advisory committee that reviewed the drug.

The suit also alleges that FDA commissioner Andrew von Eschenbach was in support of an earlier biologics center recommendation to approve Provenge, but instead gave in to Pazdur's demands after he “executed a successful coup d'etat.”

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