New Nonprofit Navigates Path To FDA Approval For Transgender Hormone Treatment

Written By BlabberBuzz | Saturday, 16 December 2023 10:15 AM
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New Nonprofit Navigates Path To FDA Approval For Transgender Hormone Treatment

The Research Institute for Gender Therapeutics (RIGT), a nonprofit organization established in 2023, is in discussions with the Food and Drug Administration (FDA) regarding a potential clinical trial aimed at securing federal approval for transgender hormone treatment, as per a recent LinkedIn post by the organization.

RIGT, committed to gaining FDA approval for transgender hormone therapies, submitted a proposal for a clinical trial to the FDA earlier this year. The organization's LinkedIn post stated that the response from the FDA "gives us a pretty clear path to a federal approval for gender-affirming care." The proposed trial would examine the effectiveness of estradiol, a type of estrogen, as a treatment for gender dysphoria. The FDA has suggested the inclusion of participants as young as 13 in the trial, according to the post.

The FDA also recommended that a control group not be included in the potential trial, as stated in the post. In pharmaceutical trials, a control group typically receives a placebo treatment, allowing researchers to compare the effects of the actual treatment with those of the placebo.

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The RIGT press release stated, "Through its discussions with RIGT, FDA has officially recognized the medical appropriateness of a formal development program for gender-affirming care, marking a significant milestone for the gender-diverse community."

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The FDA, when contacted by the Daily Caller News Foundation, stated that it "cannot confirm or deny the existence of a pending product application or discuss the status of a pending application." The agency further added, "In general, our advice provides drug sponsors with various approaches to study design appropriate to assessing their proposed use of the drug both scientifically and ethically."

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Pharmaceutical Technology reports that doctors in several states already prescribe transgender hormones to children "off-label," meaning the hormones are approved for conditions other than gender dysphoria.

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Politico reported that some medical professionals, including Dr. Madeline Deutsch, medical director of the University of California, San Francisco’s Gender Affirming Health Program, and Dr. Meredithe McNamara, assistant professor of pediatrics at Yale School of Medicine, believe that FDA approval for transgender hormone treatments could potentially challenge Republican efforts to prohibit the administration of hormones to children identifying as transgender.

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RIGT also intends to seek FDA approval for transgender testosterone treatments and puberty blockers in the future, according to STAT News.

Two of the three founders of RIGT are pharmaceutical executives, as per the organization's website. The pharmaceutical industry has previously funded research promoting child gender transitions.

In 2022, the market size for transgender hormone therapy was $1.6 billion, as reported by Grand View Research.

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