FDA panel calls to loosen restrictions on testosterone replacement therapy

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

The 13-person panel — made up mostly of urologists and federal health officials — gave resounding support for testosterone replacement therapy, a treatment for men whose bodies don’t produce enough of the hormone. Experts said the therapy, known informally as TRT, was underused because of outdated concerns about the risks of prostate cancer, stroke and heart disease.

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 And because of this outdated classification, many doctors fear prescribing it or even testing for it,” said Dr.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

The panel was part of a series launched by the FDA earlier this year. In each, the agency convenes medical experts for roundtable discussions that can provide clues about regulatory changes the FDA might undertake. Three months after a similar panel on hormone replacement therapy for postmenopausal women, for example, the FDA announced it was removing the black box warning on the drugs.

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

“Given the label restrictions, it can be argued that thousands of patients in need of testosterone treatment have been and are being deprived of it,” said Dr. John Mulhall, panelist and urologic surgeon at Memorial Sloan Kettering Cancer Center.

Testosterone therapy has grown in popularity over the past five years, largely among young men who have turned to it for unapproved uses such as increasing muscle mass. The drug is widely promoted for this purpose on social media.

“This is not an increase in the prevalence of testosterone deficiency,” said Dr. Bobby Najari, a urologist at NYU Langone Health, who was not involved in Wednesday’s discussion. “I think this is an increase in demand for a drug that can make it easier to achieve the physique you see in superhero movies.”

Some wellness clinics and “longevity centers” also offer TRT as a purported way to slow the effects of aging, although the FDA has not approved it for this purpose. The agency warned in February that the safety and benefits of this use had not been established.

Current Secretary of Health Robert F. Kennedy Jr. told Newsmax in 2023 that he was taking testosterone replacement as part of an “anti-aging protocol” at the time.

Typically, men’s testosterone levels decline by about 1% per year starting in their 30s or 40s. Levels are not considered low until they reach a certain threshold. After this point, some men experience short-term symptoms such as fatigue, low libido and erectile dysfunction, as well as long-term symptoms like osteoporosis.

The panel discussed little about the downsides of TRT, such as a high risk of blood clots. TRT can also stop sperm production, which is why doctors don’t recommend it for men trying to have children.

“If they take it long enough and they become infertile, it might not be reversible,” said Dr. Marc Goldstein, surgeon-in-chief of male reproductive medicine and surgery at Weill Cornell Medicine, who was not on the panel.

Not all cases of low testosterone need to be treated with TRT, he added: Some can be treated with weight loss or outpatient surgery to remove swollen veins in the scrotum called varicoceles.

Najari, meanwhile, said it’s important to manage expectations about what TRT can do.

“A small group of men don’t feel any change,” he said. “At the other end of the curve, a small group of men are saying, ‘I feel so much better. This has truly changed my life.’ And then the majority of men say, “I feel a little better.” »

Panelists argued Wednesday that the Drug Enforcement Administration should remove testosterone’s designation as a Schedule 3 drug — the same category in which the drug ketamine falls.

Dr. Landon Trost, panel member and director of the Peyronie and Male Fertility Clinic in Orem, Utah, said that because prescriptions for Schedule 3 drugs must be carefully tracked, doctors may be hesitant to give them and some pharmacies may choose not to carry the drugs or limit their volume.

“For that reason, you’re getting these pop-up T clinics and other things that will fill that gap, when normally the patient would go to their primary care doctor, their urologist, their endocrinologist,” Trost said.

The FDA says the broader goal of these panels is to “modernize regulatory oversight,” but some public health experts have criticized them for failing to incorporate a diversity of viewpoints or carefully screen panel members for conflicts of interest.

Some experts also expressed concern that the format could replace a more formal review process and that panelists would be chosen to support changes favored by Kennedy. The American College of Obstetricians and Gynecologists, for example, said a panel on antidepressant use during pregnancy was “alarming and unbalanced.”

On Wednesday, FDA Commissioner Marty Makary pushed back against that line of criticism.

“The FDA is making clear today that we are interested in learning more about this topic. We have no preconceived ideas. We are not promoting any medical recommendation or product,” he said.

Several panelists noted that doctors’ understanding of testosterone treatment has changed over the past several decades. Although the FDA has previously identified reports of strokes and heart attacks in patients taking the hormone, a large clinical trial launched in 2018 did not reveal these risks.

In light of the trial results, the FDA recommended in February removing the warning about an increased risk of cardiovascular problems from testosterone products. However, the agency said products must add a warning about increasing blood pressure, based on the results of other safety studies.