[Source: Health and Life Sciences Law Daily, August 1, 2007]
The Seattle Times (8/1, Gonzalez) reports, "A patient-advocacy group sued U.S. Food and Drug Administration officials Monday for withholding approval" of Dendreon's Provenge (sipuleucel-T) in May. The plaintiffs "say the spurned drug is safe and effective, and claim the denial was the capricious outcome of political infighting within the agency. The lawsuit (pdf), filed by Dublin, Ohio-based nonprofit Care to Live in federal court in Columbus, also accuses the agency of ignoring conflict-of-interest issues with some medical advisers chosen to review the therapy."
BusinessWeek (8/1, Arnst) reports that the lawsuit "marks the latest salvo in an acrimonious campaign to gain access to the Dendreon vaccine after the FDA concluded in May that existing data did not warrant approval." The lawsuit names FDA Commissioner Dr. Andrew von Eschenbach, HHS Secretary Michael Leavitt, and Dr. Richard Pazdur, director of the FDA's Office of Oncology Drug Products. Also named is "Dr. Howard Scher, one of the four members of the FDA advisory panel to vote against recommending Provenge for approval." The "Care To Live suit follows a more sweeping action taken by another patient advocacy group, the Abigail Alliance for Better Access to Developmental Drugs, which is suing for broader access to experimental drugs. That lawsuit is currently being considered by the federal circuit court in Washington, D.C," and if the "Abigail Alliance prevails, it could establish a constitutional right to experimental drugs."
