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In recent years, governing bodies in many national and international settings have sought to mandate the consideration of gender and sex as important determinants of health in biomedical research. Since research regulations represent an important means by which certain accounts of embodied difference become institutionalized, this paper considers how the National Institutes of Health (NIH) in the United States has come to endorse an approach to gender and sex inclusion that constructs sex as binary, biological, and more fundamental to health outcomes than gender, as epitomized by the recent Sex as a Biological Variable (SABV) policies for preclinical research. In showing how this policy trajectory emerged over time in ways that were contested and by no means inevitable, I show how the more complex accounts of gender and sex, such as those promoted by scholars aligned with Feminist Science Studies and feminist biology, were rendered marginal by NIH policy-makers. Drawing on textual materials from 1996 to 2016 and semi-structured interviews with key stakeholders, this qualitative study uncovers the cumulative institutional processes that excluded alternative epistemologies of gender and sex and allowed the NIH to legitimately move towards a narrowly defined inclusion agenda. I argue that attending to institutional dynamics serves as a critical and timely extension of feminist critiques of science and medicine, not only since the current inclusion agenda of the NIH may do little to address the specific health concerns of men and women, but also because it may inadvertently undermine the institutional recognition and acceptance of non-binary, genderqueer, and trans embodiments.