Question: Relying on the Freedom of Information Act FOIA Public Citizen

Relying on the Freedom of Information Act (FOIA), Public Citizen Health Research Group asked the Food and Drug Administration (FDA) for documents relating to drug applications that had been abandoned for health or safety reasons. When the FDA denied this request, Public Citizen sued in federal court. Schering Corporation, which had submitted five investigational new drug applications (INDs) of the sort requested by Public Citizen, intervened as a defendant. The FDA and Schering contended that certain documents in the five INDs contained confidential commercial information and could therefore be withheld under Exemption 4 of the FOIA. Public Citizen argued that disclosure would prevent other drug companies "from repeating Schering's mistakes, thereby avoiding risk to human health." In addition, Public Citizen argued that under Exemption 4, the court should gauge whether the competitive harm done to the sponsor of an IND by the public disclosure of confidential information is outweighed by the strong public interest in safeguarding the health of human trial participants. Were Public Citizen's arguments regarding Exemption 4 legally correct? Were the requested documents subject to being withheld under Exemption 4?

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  • CreatedJuly 16, 2014
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