Pending FOIA Case Has Major Implications For Trial Data Disclosure

In a case with major implications for what kinds of clinical trial information can be made public, HHS and Sarepta Pharmaceuticals are asking a federal appeals court to uphold a lower court decision that FDA does not have to disclose confidential clinical trial information on Sarepta’s Duchenne muscular dystrophy drug, Exondys 51. HHS and Sarepta argue the information sought by the plaintiff, journalism professor Charles Seife, is confidential commercial information that FDA is not allowed to release under the Freedom...