DOJ and Texas AG Announce First Settlement in National Investigation of Gender-Affirming Care for Minors
On May 15, 2026, the U.S. Department of Justice and the Texas Attorney General announced the first publicly disclosed settlement arising from the federal government’s nationwide investigation into gender-affirming care for minors. The resolution with Texas Children’s Hospital reflects a coordinated federal-state enforcement approach grounded in False Claims Act (“FCA”) and Federal Food, Drug, and Cosmetic Act (“FDCA”) theories, alongside significant non-monetary remedies extending beyond traditional healthcare fraud settlements. In addition to a substantial monetary payment, the agreements impose operational, clinical, and governance-related obligations that may signal how enforcement authorities intend to pursue similar matters going forward.
This blog post examines the settlement terms, the broader federal policy and enforcement framework underlying the investigation, and the implications for healthcare providers and life sciences companies navigating areas of aligned federal and state enforcement focus. Click to read more about the resolution and what it may signal for future DOJ and state attorney general enforcement activity.
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.
