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Public Citizen v. Food and Drug Administration (propoxyphene)

Topic(s): Foods, Drugs, Medical Devices, and Dietary Supplements
Date Of Involvement: 06/19/2008

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Description:

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 a phased withdrawal of the painkiller propoxyphene (Darvon) and all propoxyphene-containing products such as Darvocet. We alleged that FDA's failure to act on Public Citizen's petition constituted agency action unlawfully withheld or unreasonably delayed, and we sought an order directing FDA to act on the petition. On July 7, 2009, in response to our lawsuit, FDA issued a decision on Public Citizen's petition, and we dismissed the case as moot.