Public Citizen Health Research Group v. Food and Drug Administration

704 F.2d 1280 (1983)

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Public Citizen Health Research Group v. Food and Drug Administration

United States Court of Appeals for the District of Columbia Circuit
704 F.2d 1280 (1983)

Facts

As required by the Food and Drug Administration (FDA) (defendant), manufacturers of intraocular lenses (IOLs) submitted certain information relating to their clinical tests and studies of IOLs to the FDA. The information included summaries of patients’ adverse reactions as the manufacturers had attempted to produce safe and effective IOLs. The information was confidential to each manufacturer, and manufacturers conducted clinical trials to produce viable commercial products. Subsequently, the Public Citizen Health Research Group (the advocacy group) (plaintiff) requested the manufacturers’ information from the FDA under the Freedom of Information Act (FOIA). The FDA refused to produce the information under exemption 4 of FOIA, which allowed withholding of records on matters related to trade secrets and confidential commercial information. The advocacy group sued the FDA to obtain disclosure. On summary judgment, the district court ruled in favor of the FDA, based in part on finding that the manufacturers’ submitted information was trade secret. The advocacy group appealed.

Rule of Law

Issue

Holding and Reasoning (Edwards, J.)

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