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Public Citizen v. Food and Drug Administration (Proton Pump Inhibitors)

This case was filed under the Food, Drug, and Cosmetic Act (FDCA) and the Administrative Procedure Act (APA) to compel the FDA to act on Public Citizen’s petition seeking black box warnings about four serious adverse effects and additional safety-related information on the labeling of proton pump inhibitor drugs. After we filed suit, the agency responded to the petition and we dismissed the case.