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.
The memorandum states that consistent with the administration’s policy objectives, the Civil Division will prioritize investigations of entities connected to gender transition care, including pharmaceutical companies that manufacture drugs used in such care.3 The Civil Division states that its enforcement efforts “will include, but will not be limited to, possible violations of the Food, Drug, and Cosmetic Act [FDCA] and other laws by (1) pharmaceutical companies that manufacture drugs used in connection with so-called gender transition and (2) dealers such as online pharmacies suspected of illegally selling such drugs.”4 Notably, the memorandum refers only to “drugs used in connection with” gender transition care — not drugs indicated or approved for use in gender transition care — which leaves open the possibility of enforcement action against pharmaceutical companies whose drugs are used off-label for this purpose. Healthcare providers frequently use Food and Drug Administration (FDA)–approved drugs off-label in gender transition care as part of the practice of medicine. For example, drugs prescribed as puberty blockers in gender transition care may be FDA-approved for other indications, including treatment of endometriosis, prostate cancer, and precocious puberty.5
The Civil Division also announced plans to leverage the False Claims Act in enforcement efforts against doctors and hospitals involved in gender transition care. The memorandum states that the Civil Division will “aggressively pursue claims under the False Claims Act against health care providers that bill the federal government for impermissible services,” such as “providers that attempt to evade state bans on gender dysphoria treatments by knowingly submitting claims to Medicaid with false diagnosis codes.”6
The administration had previously expressed an interest in enforcement action in this area. The June 2025 memorandum cites President Donald Trump’s prior executive orders related to the topic of gender transition care,7 including the January 28, 2025, executive order Protecting Children from Chemical and Surgical Mutilation, which directed the Attorney General to “prioritize investigations and take appropriate action to end deception of consumers, fraud, and violations of the Food, Drug, and Cosmetic Act.”8 The memorandum also cites an April 22, 2025, memorandum from Attorney General Pam Bondi directing the Civil Division, among other things, to “undertake appropriate investigations of any violations of the Food, Drug, and Cosmetic Act by manufacturers and distributors engaged in misbranding by making false claims about the on- or off-label use of puberty blockers, sex hormones, or any other drug” used in gender transition care.9 According to that April 2025 memorandum, “[e]ven if otherwise truthful, the promotion of off-label uses of hormones — including through informal campaigns like those conducted by sales reps or under the guise of sponsored continuing medical education courses — run afoul of the FDA’s prohibitions on misbranding and mislabeling.”10
The June 2025 memorandum is the latest in a series of signals that DOJ may take enforcement action against pharmaceutical companies under the FDCA in connection with the use of the companies’ drugs in gender transition care. It remains unclear how soon industry may begin to see signs of enforcement consistent with this memorandum or what strategies and theories the DOJ may use in its investigation and enforcement efforts. It would not be surprising to see “industry sweep” information requests forthcoming. To prepare, manufacturers and distributors should take proactive measures through counsel to assess their marketing and promotional programs around such hormonal products.
1 Memorandum from Brett A. Shumate, Assistant Attorney General, U.S. Department of Justice Civil Division, to All Civil Division Employees, at 1 (June 11, 2025) (Civil Division Memorandum).
2 Courtney Bublé, Senate Confirms Brett Shumate to Head DOJ Civil Division, LAW360 (June 9, 2025), https://www.law360.com/articles/2350773/senate-confirms-brett-shumate-to-head-doj-civil-division.
3 Civil Division Memorandum at 2.
4 Id. at 2-3.
5 Casey Parks, Puberty Blockers, Hormones: What to Know About Gender Care for Minors, WASH. POST (Dec. 3, 2024), https://www.washingtonpost.com/health/2024/12/03/gender-trans-hormones-kids-health/.
6 Civil Division Memorandum at 3.
7 See Exec. Order No. 14,168, Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government, 90 Fed. Reg. 8615 (Jan. 30, 2025); Exec. Order No. 14,187, Protecting Children from Chemical and Surgical Mutilation, 90 Fed. Reg. 8771 (Feb. 3, 2025).
8 90 Fed. Reg. at 8772-73.
9 Memorandum from Pam Bondi, Attorney General, U.S. Department of Justice, to Select Component Heads, at 4 (Apr. 22, 2025), https://www.justice.gov/ag/media/1402396/dl.
10 Id.
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