Post-Finasteride Syndrome Foundation v. FDA

In 2017, the Post-Finasteride Syndrome Foundation (PFSF) submitted a petition to the Food and Drug Administration (FDA) asking the agency to remove the popular hair loss drug, Propecia, from the market due to evidence of serious risk of patient injury, including depression and suicidal ideation. Propecia is the brand-name version of 1mg finasteride. Prescriptions have significantly increased in recent years, as the product and its generic versions are heavily marketed on television and online.

Nearly four years later, the FDA has neither granted nor denied PFSF’s petition. Represented by Public Citizen, PFSF sued the FDA seeking a declaration that the FDA has violated the Administrative Procedure Act by unlawfully withholding action on PFSF’s petition and an order requiring the FDA to act on the petition.