FDA panel calls to loosen restrictions on testosterone replacement therapy

An FDA panel advocated for regulatory changes to make testosterone replacement therapy, or TRT, more accessible, including changing product labels.

A Food and Drug Administration panel on Wednesday advocated for regulatory changes that would make testosterone medications more widely accessible, including removing their classification as controlled substances and changing product labels to expand eligibility.

The 13-person panel — composed primarily of urologists and federal health officials — gave a resounding endorsement of testosterone replacement therapy, a treatment for men whose bodies don’t produce enough of the hormone. The experts said the therapy, known informally as TRT, has been underutilized due to outdated concerns about risks of prostate cancer, stroke and heart disease.

“Testosterone is still regulated as if it were a dangerous, performance-enhancing drug from the athletic doping scandals of the 1980s. And because of this outdated classification, many physicians fear prescribing it or even screening for it,” said Dr. Helen Bernie, an associate professor of urology at the Indiana University School of Medicine, who was one of the panelists.

The panel was part of a series that the FDA rolled out earlier this year. In each, the agency convenes medical experts for roundtable discussions that can give clues about regulatory changes the FDA might pursue. Three months after a similar panel on hormone replacement therapy for menopausal women, for example, the FDA announced that it was removing a black box warning from the medications.

On Wednesday, several panelists suggested that the FDA should expand its approval of TRT drugs to include men with low testosterone levels and any related symptoms, in accordance with guidelines from the American Urological Association. So far, the FDA has only approved forms of TRT — including gels, pills, patches and injections — for men who have both low testosterone and an associated medical condition, such as a genetic disorder that prevents the testicles from producing the hormone.