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FDA Can Withhold Muscular Dystrophy Treatment Study Records

Aug. 5, 2022, 6:05 PM

A science journalist can’t access the redacted portions of documents submitted to the FDA relating to the accelerated approval of Sarepta Therapeutics Inc’s. drug for treating Duchenne muscular dystrophy, the Second Circuit affirmed Friday.

Releasing the documents would harm Sarepta’s business so an exemption to the Freedom of Information Act applies, the US Court of Appeals for the Second Circuit said. And there’s no carevout for cases where disclosure would serve public health, Judge Denny Chin wrote for the court.

The FDA granted accelerated approval for Sarepta’s treatment for DMD, a fatal disease, after an outpouring of public support for ...