Jun 232025
U.S. DOJ Civil Division to Investigate Possible Violations of the Food, Drug, and Cosmetic Act by Pharmaceutical Firms Manufacturing Drugs Used in Gender Transition Care
On June 11, 2025, the U.S. Department of Justice (DOJ) Civil Division issued a memorandum outlining five Trump administration policy objectives and “direct[ing] Civil Division attorneys to prioritize investigations and enforcement actions advancing these priorities.”1 The memorandum is signed by Assistant Attorney General Brett A. Shumate, who was confirmed by the Senate two days earlier, on June 9, 2025.2 One of the five policy objectives, entitled “Protecting Women and Children,” has potentially significant enforcement implications for pharmaceutical companies whose drugs may be used in gender transition care — even if they are used off-label.

