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Public Citizen v. Food and Drug Administration (FDA) (Fluoroquinolone)

Topic(s): Foods, Drugs, Medical Devices, and Dietary Supplements
Status: closed open
Date Of Involvement: 01/03/2008

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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 adequate warnings about the risk of tendon injury associated with fluoroquinolone antibiotics. 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.

After Public Citizen filed its motion for summary judgment, and one day before FDA’s response was due, FDA issued a decision on Public Citizen’s petition, requiring manufacturers of fluoroquinolones to add a black box warning to their labels and to issue a Medication Guide to fully advise patients of the risk of tendon problems associated with fluoroquinolones. The parties then stipulated to dismissal of the case.