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 The experts said the therapy, known informally as TRT, has been underutilized due to outdated concerns about risks of prostate cancer, stroke and heart disease.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 And because of this outdated classification, many physicians fear prescribing it or even screening for it,” said Dr.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.
“Given the label restriction, one can make the argument that thousands of patients in need of testosterone therapy have been and are being deprived of it,” said Dr. John Mulhall, a panelist and urologic surgeon at Memorial Sloan Kettering Cancer Center.
Testosterone therapy has soared in popularity in the last five or so years — in large part among young men who have turned to it for unapproved uses such as increasing muscle mass. The medication is widely promoted on social media for this purpose.
“It’s not that there is an increase in the prevalence of testosterone deficiency,” said Dr. Bobby Najari, a urologist at NYU Langone Health, who was not part of Wednesday’s discussion. “I think it’s an increase in the demand for a drug that can make it easier to have physiques that we see in superhero movies.”
Some wellness clinics and “longevity centers” also offer TRT as a purported way to slow the effects of aging, though the FDA has not approved it for that purpose. The agency cautioned in February that the safety and benefits of this use have not been established.
Now-Health Secretary Robert F. Kennedy Jr. told Newsmax in 2023 that he was taking testosterone replacement at the time as part of an “anti-aging protocol.”
Typically, men’s testosterone levels decline about 1% per year starting in their 30s or 40s. Levels aren’t considered low until they reach a certain threshold. After that point, some men experience short-term symptoms such as fatigue, low sex drive and erectile dysfunction, as well as long-term ones like osteoporosis.
The panel included little discussion of the drawbacks of TRT, such as an elevated risk of blood clots. TRT can also shut down sperm production, so doctors don’t recommend it to men trying to have children.
“If they take it long enough, and they’re rendered infertile, it may not be reversible,” said Dr. Marc Goldstein, surgeon-in-chief of male reproductive medicine and surgery at Weill Cornell Medicine, who wasn’t on the panel.
Not all cases of low testosterone need to be treated with TRT, he added — some can be addressed through weight loss or an outpatient surgery to remove swollen veins in the scrotum called varicoceles.
Najari, meanwhile, said it’s important to manage expectations about how much TRT can do.
“A small group of men don’t feel any change at all,” he said. “On the other end of that curve, a small group of men say, ‘I feel so much better. This really changed my life.’ And then the majority of men say, ‘I feel a little bit better.’”
The panelists on Wednesday argued that the Drug Enforcement Administration should remove its designation of testosterone as a Schedule 3 drug — the same category that the drug ketamine is in.
Dr. Landon Trost, a panelist and the director of the Male Fertility and Peyronie’s Clinic in Orem, Utah, said that because prescriptions for Schedule 3 drugs must be carefully tracked, physicians may be hesitant to give them and some pharmacies may choose not to carry the drugs or limit their volume.
“Because of that, you get these pop-up T clinics and other things that will fill that gap, whereas normally the patient would be going to their primary care physician, 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 not incorporating a diversity of viewpoints or thoroughly screening panelists for conflicts of interest.
Some experts have also expressed concern that the format may be taking the place of a more formal review process and that panelists are picked to support changes that Kennedy favors. The American College of Obstetricians and Gynecologists, for example, said that a panel on antidepressant use during pregnancy was “alarmingly unbalanced.”
FDA Commissioner Marty Makary pushed back against that line of criticism on Wednesday.
“The FDA today is making it clear that we want to learn more about this topic. We don’t have preconceived ideas. We are not promoting any medical recommendation or any product,” he said.
Several panelists noted that doctors’ understanding of testosterone therapy has changed over the last several decades. Although the FDA had previously identified reports of strokes and heart attacks in patients taking the hormone, a large clinical trial launched in 2018 did not find those risks.
In light of the trial results, the FDA in February recommended removing a warning about an increased risk of cardiovascular issues from testosterone products. However, the agency said the products must add a warning about increased blood pressure based on the results of other safety studies.
