Public Citizen v. Food and Drug Administration (Aricept 23 mg)

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 requesting that the FDA withdraw from the market Aricept 23 mg tablets and add a label to the lower dose forms of Aricept and generic donepezil warning of the increased toxicity associated with higher doses. 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 complaint, and on the day that FDA’s Answer would have been due, FDA issued a decision on Public Citizen’s petition. We then dismissed the case.