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 had neither granted nor denied PFSF’s petition. Represented by Public Citizen, PFSF sued the FDA under the Administrative Procedure Act alleging that the FDA had unlawfully withheld action on PFSF’s petition and seeking an order requiring the FDA to act on the petition.

In response to the lawsuit, the FDA issued a decision on the petition, which it granted in part and denied in part.