This story was updated at 2:30 p.m. ET on Feb. 19.
While the FDA’s diversity guidance for clinical trials has been temporarily restored, the page it is housed on now carries a message from the Trump administration claiming that the guidance “does not reflect biological reality.” In a follow-up on Feb. 19, the Department of Health and Human Services (HHS) outlined plans to restore "the concept of biological truth in federal government."
The HHS release includes definitions of terms relating to President Donald Trump’s Inauguration Day executive order titled “Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government.” Both the executive order and the department’s guidance claim there are only two sexes: male and female.
“This administration is bringing back common sense and restoring biological truth to the federal government,” HHS Secretary Robert F. Kennedy, Jr., said in the release. “The prior administration’s policy of trying to engineer gender ideology into every aspect of public life is over.”
HHS said it is also working to implement policies aimed at "protecting children from chemical and surgical mutilation" and "keeping men out of women’s sports." In tandem, the agency's Office on Women’s Health rolled out a new webpage that includes the administration's definitions and other resources.
“In health care, sex distinctions can influence disease presentation, diagnosis, and treatment differently in females and males,” Dorothy Fink, M.D., deputy assistant secretary for women’s health, said in the release. “HHS recognizes that biological differences between females and males require sex-specific practices in medicine and research to ensure optimal health outcomes.”
The HHS update Wednesday comes after warnings from the Trump administration were posted on several federal health agency sites, including the FDA's diversity guidance for clinical trials.
The draft guidance details diversity action plans for studies that evaluate drugs, devices and other medical products and was taken down after Trump stepped into office last month. The president launched his second term with orders designed to eliminate diversity, equity and inclusion practices across the government.
On Feb. 11, a federal judge ordered the HHS 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 (PDF) was requested by the Doctors for America, an advocacy group designed to prioritize “patients over politics.”
Now, though restored, certain pages come bearing a new message: “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 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 mpox prevention and vaccination, along with the CDC’s information page about health disparities among LGBQ+ youth—a page also now missing the acronym's usual “T” for transgender—among others.
The warning includes language similar to that of Trump’s executive order, which several scientists have spoken out against, 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,” per WHO.
About 2% of people are born with intersex traits—such as sexual anatomy, reproductive organs, hormonal patterns or chromosomal patterns that don’t 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 Jan. 21 statement.