The draft guidance details diversity action plans for studies that evaluate drugs, medical devices, and other medical products, and was taken down after President Donald Trump stepped into office last month (January 2025). The president launched his second term with orders designed to eliminate diversity, equity and inclusion practices, plus another order entitled “Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government”.
On 11 FEB 2025, a federal judge ordered the Department of Health and Human Services to begin restoring health information web pages and public health data sets that were pulled down to comply with the executive orders. The temporary restraining order was requested by the Doctors for America, an advocacy group designed to prioritize “patients over politics.”
Now, while the FDA diversity guidance has returned to the site, it is accompanied by a message from the Trump administration that acknowledges the court order as the reason for the restoration. “Any information on this page promoting gender ideology is extremely inaccurate and disconnected from the immutable biological reality that there are two sexes, male and female,” the post reads.
“The Trump Administration rejects gender ideology and condemns the harms it causes to children, by promoting their chemical and surgical mutilation, and to women, by depriving them of their dignity, safety, well-being, and opportunities,” the message continues. “This page does not reflect biological reality and therefore the Administration and this Department reject it.”
The same message can be found on pages for the Centers for Disease Control and Prevention’s (CDC’s) interim-clinical considerations for m-pox prevention and vaccination along with the CDC’s information page about health disparities among LGBQ (lesbian, gay, bisexual, and queer) youth, among others.
The warning includes language similar to that of Trump’s executive order that outlines his plan to use “clear and accurate language and policies that recognize women are biologically female, and men are biologically male.” Several scientists have spoken out against the executive order, arguing that it defies research.
Gender — identifying as a woman, for example — is a social construct encompassing characteristics that can vary between societies and change over time, according to the World Health Organization (WHO). “Gender interacts with but is different from sex, which refers to the different biological and physiological characteristics of females, males and intersex persons,” the WHO says.
About 2% of people are born with intersex traits — such as sexual anatomy, reproductive organs, hormonal patterns or chromosomal patterns, that do not fit into the typical binary framework — according to the United Nations Human Rights office.
Trump’s executive order “attempts to erase the existence of transgender and intersex people in order to further the administration’s own ideological agenda, which is grounded not in science but rather in a regressive and discriminatory worldview,” intersex advocacy group interAct wrote in a 21 JAN 2025 statement.
REFERENCE: Fierce BioTech; 18 FEB 2025; Gabrielle Masson