The FDA’s Role in Regulating Access to Gender-Affirming Care Medications

Over the last decade, many states have passed laws seeking to restrict or ban certain medications approved by the United States Food and Drug Administration (FDA). One of the most recent examples: gender-affirming care medications for transgender youth and young adults. As of January 2025, twenty-six states have passed laws banning or restricting the provision of genderaffirming care to minors. Proponents of these laws challenge the procedures and prescription drugs as “experimental,” while critics of these laws characterize both as best-practice medical care. In either case, these laws demonstrate a second-guessing of the FDA’s long-established authority in determining the safety of prescription drugs. Although the FDA does not regulate the practice of medicine, the effect of these healthcare regulations is to limit or prohibit access to FDA-approved medications. This inconsistency raises the question of what the FDA’s role is— and should be—in protecting access to medicines. This Article considers the FDA’s role in securing access to medications, focusing on the case of gender-affirming care medications. In doing so, this Article makes three key contributions. First, this Article provides a comprehensive account of the state laws restricting access to genderaffirming care. Second, this Article analyzes how these state laws interact with federal prescription drug regulation and demonstrates the limitations of FDA authority in preempting state laws on gender-affirming care medications. Third, this Article argues that federal prescription drug regulation must be strengthened in order to protect patients’ equitable access to medicines, including, but not limited to, gender-affirming care medications. Noting the historical role of the FDA in medical care and drug regulations, as well as the federalist implications of expanding this authority, this Article frames the FDA as not only a consumer protection agency, but also as an access to medicines agency. This framework will support the development of reforms centered at the FDA aiming to secure and expand the availability of prescription drugs for patients across the country.