Seife was seeking to obtain documents from the FDA related to its approval of a controversial drug – Exondys 51 – created by pharmaceutical company Sarepta. The

Seife was seeking to obtain documents from the FDA related to its approval of a controversial drug – Exondys 51 – created by pharmaceutical company Sarepta. The FDA largely rejected Seife’s request for information pertaining to the drug’s approval, asserting that the clinical trial data and other information he sought could be withheld under Exemption 4 since Sarepta considered it confidential. While ultimately affirming the FDA’s decision to withhold much of the information, the 2nd Circuit rejected its contention that information can be withheld under Exemption 4 simply by virtue of its being confidential. [..] The email posed a simple inquiry – “lawsuit?” – as a possible way to promote transparency for clinical trial data in the wake of multiple scandals involving drugs that turned out to be less safe and effective than suggested by the analysis of the confidential trial data conducted by the pharmaceutical companies themselves. It beggars belief that any clinical trial data used for FDA approval can remain confidential. That the safety analysis is conducted by the same companies hoping to sell the drugs makes this utterly farcical. It's good the lawsuit managed to slightly increase transparency, but my God, what a small victory...