FDA Drug Labeling โขChanges Spark โขConcerns Over โImpact of Trump-Era Gender Policy on HIV Prevention & Treatment
Washington, D.C. – Recent โขdecisionsโ by the Food and Drug Governance (FDA) and the Department โof Health and Human Services (HHS) regarding HIV prevention and treatment guidelines areโ raising alarmsโค among public health advocates, who point to โขa โpotential link with the Trumpโค administration’s 2020 Executive Order โฃdirecting agencies to โcurtail the โpromotion of “gender ideology.” The changes, including the omission of specific guidance for transgender โคindividuals in the labeling for the new PrEP drug lenacapavir and theโฃ removal of detailed information on โคproviding antiretrovirals to transgenderโค people โfrom HHS treatment guidelines, are โprompting fears of reduced access toโ vital healthcare โขand potential setbacks in the fight against HIV.
The final drug label for lenacapavir, approved for HIV prevention, statesโ “there were no clinically โคimportant โdifferences inโ the pharmacokinetics ofโข lenacapavir based onโฆgender identity.” This contrasts with the CDC’s โ2021 PrEP guidelines, released before the drug’s approval, which did include a section addressing PrEP for transgender people. Similarly, the World Health Organization (WHO) guidelinesโ for lenacapavir identify gender diverse people as a keyโข population and offer prescribing guidance for those alsoโ undergoing gender-affirming hormone therapy.
Experts worry the FDA’s โคomission could discourage prescribing among healthcare providers less familiar with PrEP or transgender healthcare needs. Thisโฃ concern is heightened by a previous instance where the PrEP drug emtricitabine/tenofovir alafenamide was initially not approved forโข individualsโ engaging in “receptive vaginal sex”โ due to a lack of effectiveness data in that populationโค – a key factor that drove the โคmoreโข inclusive trial designโฃ and broad approval of lenacapavir.
Further fueling these concerns is the recent,quiet โremovalโ of detailed information on providing antiretrovirals to transgender people for HIV treatmentโค from the โขHHS clinical guidelines,occurring sometime betweenโข March and โคApril 2025.
These actionsโ are โwidely โseen as โขaligning with the administration’s stance on sex and gender, stemming from the Executive Order instructing โฃagencies โto “remove all statements, policies,โ regulations, โฃforms, โขcommunications, orโฃ other internal and external messages that promote or otherwise inculcate gender ideology.”
Public health officialsโค warn that limiting accessโข to complete treatment and prevention information โขcould have significant consequences. HIV is a โขlifelong chronic conditionโ requiring treatment, and can be deadly if leftโข untreated. Reduced access to care could also strainโค private and public budgets, given the estimatedโ lifetime cost of HIV treatment in the United States exceeding $1 million per person, according to a recent study โpublished in PubMed.