FDA’s ‘Gender’ Change Carries Drug Trials, Tobacco Policy Impact

The Food and Drug Administration’s proposal to remove references to “gender” across its regulations sparked concerns about unintended consequences into research on gender minority populations.

The FDA issued its proposed rule this week, citing instructions laid out in a 2025 executive order from President Donald Trump, as the administration emphasizes “biological sex” across federal government policies and practices.

The Trump administration has supercharged efforts to signal there are only two biological sexes, and has spent the first year and a half targeting gender-related policies expanded by the Biden administration related to health, education, and justice.

The FDA said the policy is unlikely to change much, stating the proposal “does not impact industry practice” and they “do not anticipate any measurable change in industry.”

But some legal experts see potential for broader impacts on how drugs are tested or who is represented in clinical trials, especially among groups that are traditionally underrepresented in research.

“It seems to be mostly, even with their own kind of telling of it, a little bit of political theater or compliance with the executive order,” said I. Glenn Cohen, professor and faculty director for the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School. “I’m not sure whether they’re right that there’s not going to be any effects.”

He said it was not clear to him what the agency’s compelling reason was to make the change, what was problematic about its existing structure, or how often gender is used rather than sex in drug approvals and labels.

“I would expect their analysis to explain more about what the legal landscape and current usage looks like,” said Cohen.

Possible Effects

The proposal also raised questions about how the changes could affect drug interactions, clinical trial ethics, and tobacco marketing.

The regulation could affect the FDA’s institutional review boards (IRBs), which are authorized to monitor, modify or disapprove of research involving human subjects to protect their safety and well being.

If the only operative question for the composition of an IRB is sex, it would mean the FDA would not have to consider gender identity, and it would lose out on representation of nonbinary, transgender, and intersex individuals, said Elana Redfield, federal policy director at the Williams Institute at the UCLA School of Law.

The FDA’s premarket tobacco product application process requires evaluating a product to make sure it doesn’t increase public harm, including toward vulnerable populations such as veterans, those in rural areas, or people of certain races.

The rule would change the definition of vulnerable populations to remove “sexual or gender minorities.”

“They’ve not only taken out the consideration of trans people, but they’re also now not considering LGBTQ, queer people in general, to fall under the definition of vulnerable populations and the tobacco part,” said Andrew A. Ortiz, senior policy attorney at the Transgender Law Center.

“There’s a documented history of them targeting queer communities, and so I would like to hope that we’re not in a time where this gets removed and then they’re instantly back and trying to do that thing because they don’t feel like they have to report on it anymore.”

It’s also unclear how the change would affect drug trials and how drug interactions may affect transgender individuals differently.

“If we’re not collecting data or we don’t know what the outcome is, there can be assumptions or misinformation or underinformation can be spread in a community that ends up having a negative impact on folks as a whole,” said Ortiz.

It might also have consequences for adverse action reporting, he said.

There could be adverse reactions that are not reported or are inaccurately reported because they only occur in a subpopulation in relation to other drugs. Without that clarity, Ortiz said, this could be understood as a one-off reaction as opposed to something likely to reoccur with a subpopulation.

Broader Look

Redfield said this type of change is more common in the sub-regulatory environment where agencies have more leeway to make changes. The federal government has already been substituting “sex” for “gender” in forms, surveys, and administrative processes.

The Office of Information and Regulatory Affairs did not respond to a request for comment on how many agencies have adopted similar proposals.

“There’s something somewhat mundane about what’s happening, which is that it’s kind of going through and making these subtle changes throughout the language that don’t appear to carry a lot of weight,” said Redfield.

But if you look at them in total, she said, “what you see is this government-wide effort to eradicate any mention of or recognition of transgender, nonbinary, and intersex people. And that itself is a much bigger problem than a particular agency.”