Published April 7, 2025
On April 7, 2025, EPPC Administrative Accountability Project Director Rachel N. Morrison submitted two public comments in response to draft guidances proposed by the Food and Drug Administration (FDA) at the beginning of January. The first comment addressed draft guidance on the “study of sex differences in the clinical evaluation of medical products’ and the second comment addressed draft guidance on the “evaluation of sex-specific and gender-specific data in medical device clinical studies.”
Morrison’s comments supported the importance of studying sex differences and evaluating sex-specific data because “biological and physiological differences between males and females could impact efficacy and safety.” This information “is necessary for a woman to fully appreciate the benefits and risks and make informed decisions about her health.”
Her comments also drew the FDA’s attention to ways that the draft guidances’ discussions of sex and gender are inaccurate and conflict with President Trump’s executive orders and Department of Health and Human Services guidance. She urged the FDA to carefully examine its draft guidances in light of President Trump’s executive orders and HHS guidance, concluding that the FDA should not finalize the guidances without appropriate revisions.
Rachel N. Morrison is a Fellow at the Ethics and Public Policy Center, where she directs EPPC’s Administrative State Accountability Project. An attorney, her legal and policy work focuses on religious liberty, health care rights of conscience, the right to life, nondiscrimination, and civil rights.
