AXIOS December 15, 2023
Maya Goldman

An effort to get the Food and Drug Administration’s approval of hormone therapies for gender-affirming treatment could help preserve patients’ access to the therapies as states restrict them.

The big picture: For years, transgender patients have received hormone therapies “off label” — a common medical practice in which doctors prescribe treatments for a use the agency hasn’t approved.

  • A small nonprofit formed this year with the goal of obtaining FDA approval of the drugs for gender-affirming care believes the agency’s formal OK could strengthen legal protections for the treatments and boost insurance coverage.

Catch up quick: Estrogen and testosterone therapies have been approved by the FDA for other purposes. For instance, estrogen is approved as a hormone replacement...

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Topics: FDA, Govt Agencies, Patient / Consumer, Provider
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