Public Citizen Health Research Group v. FDA (discontinued INDs)

In this Freedom of Information Act case, Public Citizen sought disclosure of safety and effectiveness data from clinical trials for new drugs where the trial was stopped because of health or safety concerns. Sponsors of five drugs intervened in the case to argue that release of the records would cause them substantial competitive harm, although human testing of the drugs had been discontinued because the drugs posed unreasonable risks to the patients. The briefs addressed the application of FOIA exemption 4.

Based on a disclosure mandate in the Food, Drug, and Cosmetic Act and agency regulations that require disclosure of safety and effectiveness data when a drug sponsor has abandoned its efforts to seek approval of a new drug, the district court ordered release of information about three experimental drugs that the manufacturer, Schering, admitted it had no further plans to have its drugs approved for marketing in the United States. The district court found that this disclosure mandate did not apply to two other drugs of Schering and the company HMR, because the companies had not abandoned efforts to seek FDA approval. The FDA and Schering appealed the order requiring disclosure, and Public Citizen appealed the order denying disclosure.

On appeal, the D.C. Circuit the held that the statutory provision requiring disclosure of safety and effectiveness data absent extraordinary circumstances did not apply to investigational new drug applications (INDs), that four of the five INDs at issue were exempt from disclosure as confidential commercial information, and the district court should determine on remand whether any nonexempt portions of the INDs could be segregated for purposes of disclosure. The court held that one of the INDs should be disclosed because Schering failed to show that disclosure would cause it substantial competitive harm.