Last week, Do No Harm submitted to the U.S. Food and Drug Administration a comment in support of a proposed rule replacing “gender” with “sex” — or removing “gender” altogether — throughout Title 21 of the Code of Federal Regulations.
The proposed change follows the directive of Executive Order 14168, “Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government,” issued on January 20, 2025.
It also aligns with scientific evidence.
Per the executive order: “[E]very agency … shall use the term ‘sex’ and not ‘gender’ in all applicable Federal policies and documents.”
This is important because sex (not “gender”) is a primary variable that affects pharmacokinetics — i.e., the movement of drugs through the body. Clinical studies, prescription labeling, and adverse-event reporting can all be compromised when differences between the two sexes — men and women — are improperly indicated or not taken into account.
At stake here is women’s health. The safety and efficacy of medical treatments should not be sacrificed in furtherance of gender ideologies.
Please read the full comment here or below.
