FDA Drug Labeling Changes Spark Concerns Over Impact of Trump-Era Gender Policy on HIV Prevention & Treatment
Washington, D.C. – Recent decisions by the Food and Drug Governance (FDA) and the Department of Health and Human Services (HHS) regarding HIV prevention and treatment guidelines are raising alarms among public health advocates, who point to a potential link with the Trump administration’s 2020 Executive Order directing agencies to curtail the promotion of “gender ideology.” The changes, including the omission of specific guidance for transgender individuals in the labeling for the new PrEP drug lenacapavir and the removal of detailed information on providing antiretrovirals to transgender people from HHS treatment guidelines, are prompting fears of reduced access to vital healthcare and potential setbacks in the fight against HIV.
The final drug label for lenacapavir, approved for HIV prevention, states “there were no clinically important differences in the pharmacokinetics of lenacapavir based on…gender identity.” This contrasts with the CDC’s 2021 PrEP guidelines, released before the drug’s approval, which did include a section addressing PrEP for transgender people. Similarly, the World Health Organization (WHO) guidelines for lenacapavir identify gender diverse people as a key population and offer prescribing guidance for those also undergoing gender-affirming hormone therapy.
Experts worry the FDA’s omission could discourage prescribing among healthcare providers less familiar with PrEP or transgender healthcare needs. This concern is heightened by a previous instance where the PrEP drug emtricitabine/tenofovir alafenamide was initially not approved for individuals engaging in “receptive vaginal sex” due to a lack of effectiveness data in that population – a key factor that drove the more inclusive trial design and broad approval of lenacapavir.
Further fueling these concerns is the recent,quiet removal of detailed information on providing antiretrovirals to transgender people for HIV treatment from the HHS clinical guidelines,occurring sometime between March and April 2025.
These actions are widely seen as aligning with the administration’s stance on sex and gender, stemming from the Executive Order instructing agencies to “remove all statements, policies, regulations, forms, communications, or other internal and external messages that promote or otherwise inculcate gender ideology.”
Public health officials warn that limiting access to complete treatment and prevention information could have significant consequences. HIV is a lifelong chronic condition requiring treatment, and can be deadly if left untreated. Reduced access to care could also strain private and public budgets, given the estimated lifetime cost of HIV treatment in the United States exceeding $1 million per person, according to a recent study published in PubMed.