FDA Proposes Removing Gender References From Regulations

The U.S. Food and Drug Administration issued a proposed rule this week to remove references to “gender” from its regulations. The agency cited instructions in a 2025 executive order from President Trump as the administration emphasizes biological sex across federal government policies and practices.

The proposal has prompted concerns about possible unintended consequences for research on gender minority populations. Some legal experts said the change could affect how drugs are tested or who is represented in clinical trials, particularly groups that have been traditionally underrepresented in research.

Abortion Pill Access Case Louisiana asked the U.S.

Supreme Court to prevent abortion pills from being prescribed through telemedicine and distributed by mail. The Republican-led state is seeking to overturn a 2023 federal rule that expanded access to the medication. In a filing, the state attorney general asked the justices to deny emergency requests by two manufacturers of the abortion pill.

The manufacturers had sought to lift a lower court’s decision that narrowed access by blocking the regulation nationwide while the state’s legal challenge proceeds. The regulation for the medication, called mifepristone, was issued by the FDA. The state said the rule has allowed medication abortions to increase despite Louisiana’s near-total ban on abortion.

The FDA is also advancing a program for one-day inspections as part of efforts to streamline regulatory reviews. Details of the initiative remain under discussion as the agency evaluates its implementation across different product categories. The proposal on gender references forms part of broader policy shifts following the 2025 executive order.

The FDA has not yet finalized the rule and will accept public comments before any changes take effect.