An FDA advisory panel has recommended easing restrictions on testosterone replacement therapy, including removing the hormone’s designation as a controlled substance and expanding eligibility for treatment.
During a public meeting Dec. 10, the 13-member panel consisting of urologists and federal health officials characterized testosterone therapy as underutilized and overly regulated due to outdated safety concerns. Panelists urged the FDA to align labeling with American Urological Association guidelines, which support therapy for men experiencing low testosterone and related symptoms, and not just those with underlying medical conditions.
Testosterone is currently regulated as a Schedule III controlled substance, the same category as ketamine. Panelists said this classification restricts access, deters primary care physicians from prescribing the therapy and has contributed to the rise of unregulated “T clinics.”
Testosterone levels typically decline about 1% per year beginning in a man’s 30s or 40s. While some men report improvements in fatigue and sexual function with treatment, the panel acknowledged risks such as elevated blood pressure, blood clots and infertility.
The FDA previously cited stroke and heart attack risks, but a large 2018 clinical trial found no such connection. In February, the agency recommended removing cardiovascular warnings from product labels and adding warnings about blood pressure instead.
The discussion mirrors recent FDA action on hormone therapy for menopausal women. In November, the agency began working with manufacturers to remove boxed warnings from those therapies after a July advisory panel and public comment period. Officials said the warnings were based on outdated data from an early 2000s study.
