There's a testosterone crisis, the FDA says - for cisgender men

"For too long, hormone therapy has been inaccessible for cisgender men who need it - or so said clinicians, professors and a pharmaceutical CEO gathered this week by the Food and Drug Administration (FDA). Testosterone, a controlled substance, should be deregulated and patients should be able to access it at pharmacies without stigma, they said. Low testosterone in men is not just a cosmetic issue, they claimed - it's an American health crisis."

"Experts at Wednesday's FDA panel presented a unified and mostly rosy view of testosterone, praising it as the answer to common ailments that follow men as they age: weight gain, loss of muscle mass and exhaustion. Their need for more testosterone is dire, the panel claimed, to prevent disease and premature death. Millions of men are at risk of low testosterone and aren't being screened for it, they said."

"Not all medical experts agree on these broad claims, and some criticized the FDA panel for lacking key context about the risks of taking testosterone. Regardless, FDA Commissioner Dr. Marty Makary made it clear that the agency is interested in revisiting testosterone's current label as a drug with a higher risk of abuse and physical dependence. With that label comes restrictions on refillsand penalties for possessing it without a prescription."

An FDA convening of clinicians, professors and a pharmaceutical CEO argued that testosterone therapy for cisgender men is underused and should be deregulated so patients can obtain it at pharmacies without stigma. Panelists described low testosterone as linked to weight gain, muscle loss, exhaustion, increased disease risk and premature death, and warned that millions of men are not being screened. Some medical experts criticized the panel for omitting risk context. FDA Commissioner Marty Makary signaled interest in revisiting the drug's controlled-substance label, which imposes refill restrictions and penalties for possession without a prescription. Trans advocates have previously sought looser restrictions for gender-affirming care.

Read at Advocate.com