Two months after being rejected by the a federal appeals court, a group of prostate cancer patients and investors have asked the US Supreme Court to allow them to proceed with a lawsuit against the FDA over its handling of the Provenge prostate cancer vaccine.
They filed their case last year, after the agency unexpectedly rejected the recommendation of its advisory committee, causing considerable controversy. The lawsuit alleged undisclosed conflicts of interest by two FDA advisory committee members, who wrote FDA officials to urge a go-slow approach, and Byzantine agency politics involving the head of the oncology drugs office.
The US Court of Appeals for the Sixth Circuit in Cincinnati rejected arguments that judicial review was required because of a lack of transparency and accountability in the way the FDA decided to delay approval for the vaccine, which is being developed by Dendreon. Here's the petition filed with the US Supreme Court.