Federal science-based agencies had actually done a reasonable job at resisting gender madness through the late 2010s, some peak years those were. It makes sense, places like the Food and Drug Administration (FDA) had long been issuing guidance on sex differences with respect to matters of life and death. Clinical trails and the devices and drugs they assess are, at their best, gold standard experimental work involving human participants; there isn’t a terrible amount of room for religious nonsense. I’d often point to such technocratic agencies in the past to show transactivists their pseudo scientific ideas could not be found in places where you found adults doing serious work.
But then…take a look at a recent draft of an FDA document on sex differences (“Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies”). This passage, inserted near the end of Biden’s term, occurs right after the short introduction and is trans all over:
Use of the term male and female versus man and woman depends upon whether biological or psychosocial factors are under study.For purposes of this document, the terms male and female are used in the context of sex.
I mean…ok. Using male and female consistently in this context is fine…but they are synonyms for man/woman. Why would psychosocial factors imply the need for a different set of words (that are synonyms)?
The terms man, woman, nonbinary and/or transgender are used in the context of gender. In this document, when both sex and gender are relevant to the study, the terms male/man, female/woman, and/or other participants may be used and such usage indicates male and/or man, female and/or woman, and/or other participants. While sex and gender are distinct, they are interrelated and are not necessarily mutually exclusive. Sex and gender and their interactions may drive epigenetic influences and resultant physiologic reactions, influence etiology and presentation of disease, and affect treatment outcomes.
What the holy hell. Why would anyone believe this?
For the purposes of this guidance: Sex is a biological construct based on anatomical, physiological, hormonal, and genetic (chromosomal) traits. Sex is generally assigned based on anatomy at birth and is usually categorized as female or male, but variations occur. Variations of sex refers to differences in sex development (DSD) or intersex traits. Gender is a multidimensional construct that encompasses how an individual self-identifies. Gender may be described across a continuum, may be nonbinary, and may change over the course of a lifetime. Gender may or may not correspond to a person’s sex assigned at birth.
So sex is now “assigned” (not determined, not observed)…and apparently not before birth. Doesn’t the FDA regulate tests and devices that are used for Non-Invasive Prenatal Testing (NIPT) and sonography that are routinely applied in pregnancies and reliably tell us the sex of the baby before birth? What are you smoking FDA? Have you thought of regulating it?
Footnote 10 launders the idea of gender through the NIH:
For more information, please see National Institutes of Health (NIH) Sex and Gender Minority Research Office, available at https://dpcpsi.nih.gov/sgmro.
But it is “gender” that is multi dimensional now, not sex. The NIH, at the time, said that sex is multi dimensional…
None of this is coherent. None of this is scientific.
At the time of writing, I can’t see the original or corrected version on the FDA site itself.