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Group pushes for FDA to allow transgender hormones

The efforts to approve hormone procedures come as multiple conservative states restrict or prohibit the practices, noting the irreversible physical harm rendered to patients and the biological impossibility of changing individual sex.

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Substances purporting to switch the gender of an individual have long been considered off-label, meaning that the federal health agency has not officially approved them for medical use. File Image.

Activists launched a nonprofit to seek Food and Drug Administration approval for transgender hormone procedures, a move which would potentially circumvent state bans on the practices.

 

The Research Institute for Gender Therapeutics, an organization founded to “bring clinical treatment of gender diverse individuals into standard medical practice,” proposed a clinical trial for a form of estrogen called estradiol in a recent meeting with the FDA. Substances purporting to switch the gender of an individual have long been considered off-label, meaning that the federal health agency has not officially approved them for medical use.

 

 

“Important work has been done previously to establish hormone medications as safe and effective for gender affirming care,” Research Institute for Gender Therapeutics said in a press release. “We are seeking formal FDA approval to support these life-saving treatments and protect healthcare access for the underserved gender diverse population.”

 

The efforts to formally approve transgender hormone procedures come as multiple conservative states restrict or prohibit the practices, noting the irreversible physical harm rendered to patients and the biological impossibility of changing individual sex.

 

 

Entities such as the American Medical Association and the Endocrine Society have affirmed the notion that physicians should “speak out in support” of “gender-affirming care for transgender and gender-diverse individuals.” The latter claimed that “political attacks” on the procedures are improper and vowed to “work at the federal and state level with legislators and regulators” in order to oppose criminal penalties for physicians and parents who push the treatments.

 

The Research Institute for Gender Therapeutics additionally noted that “gender incongruence is associated with mental health concerns such as depression, psychological distress, and suicidal ideation and attempts.” Yet critics of the procedures note that mortality rates surge between ten and fifteen years after surgical interventions, especially as a result of various complications from the procedures and increased rates of suicide, realities which the Centers for Medicare and Medicaid Services acknowledged under the Obama administration.

 

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