Brief of Public Health and Health Law Scholars In Re: 2025 Subpoena to Children’s National Hospital

The Department of Justice has subpoenaed hospitals providing gender-affirming care to minors on a theory that mischaracterizes the Federal Food, Drug, and Cosmetic Act, treating physicians’ off-label prescribing as a potential basis for civil or criminal liability when Congress, the courts, the FDA, and the Department itself have long understood the Act to regulate manufacturers and distributors rather than individual clinical decisions.The amici, represented by Harvard Law School’s Center for Health Law and Policy Innovation, warn that accepting the Department’s theory would leave no legal protection for off-label prescribing generally and would let federal officials use investigative powers to chill medical practice disfavored by the sitting administration.