A Food and Drug Administration panel on Wednesday advocated for legislative changes that would make testosterone drugs more accessible, including ending their classification as controlled substances and changing product labels to expand eligibility.
The 13-member panel, made up mostly of urologists and federal health officials, strongly backed testosterone replacement therapy, a treatment for men whose bodies don't produce enough of the hormone. Experts said the therapy, known informally as TRT, is underused due to lingering concerns about the risks of prostate cancer, stroke and cardiovascular disease. heart disease.
“Testosterone is still regulated as if it were a dangerous performance-enhancing drug following the sports doping scandals of the 1980s. And because of this outdated classification, many doctors are afraid to prescribe it or even test for it,” said Dr. Helen Burney, an assistant professor of urology at Indiana University School of Medicine, who was one of the panelists.
The panel was part of a series the FDA introduced earlier this year. In each case, the agency convenes medical experts for roundtable discussions that can provide insight into regulatory changes the FDA might undertake. For example, three months after a similar panel on hormone replacement therapy for menopausal women, the FDA announced that removing black box warnings from medications.
On Wednesday, several panelists suggested that the FDA expand its approval of TRT drugs to include men with low testosterone and any associated symptoms, in line with American Urological Association guidelines. Currently, the FDA has only approved forms of TRT, including gels, tablets, patches and injections, for men who have low testosterone levels and underlying conditions, such as a genetic disorder that prevents the testicles from producing the hormone.
“Given the limitations of the label, it could be argued that thousands of patients who need testosterone therapy have been and continue to be denied it,” said Dr. John Mulhall, a panelist and urologic surgeon at Memorial Sloan Kettering Cancer Center.
The popularity of testosterone therapy has risen sharply over the past five years or so – mainly among young people who have turned to it for unapproved purposes, such as increasing muscle mass. For this purpose, the drug is widely advertised on social networks.
“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 involved in Wednesday's discussion. “I think this is an increase in demand for a drug that can make it easier to achieve the physiques we 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. Agency warned in February that the safety and benefit of such use have not been established.
The current Secretary of Health is Robert F. Kennedy, Jr. told Newsmax in 2023 that he was taking testosterone replacement therapy 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 and 40s. Levels are not considered low until they reach a certain threshold. After this, some men experience short-term symptoms such as fatigue, low sex drive and erectile dysfunction, as well as long-term symptoms such as osteoporosis.
There was little discussion at the panel about the disadvantages of TRT, such as the increased risk of blood clots. TRT can also stop sperm production, so doctors don't recommend it for men planning to have children.
“If they continue this long enough and become infertile, it may be irreversible,” said Dr. Mark Goldstein, surgeon-in-chief of male reproductive medicine and surgery at Weill Cornell Medicine, who was not on the panel.
He added that not all cases of low testosterone need to be treated with TRT—some can be addressed with weight loss or outpatient surgery to remove swollen veins in the scrotum called varicoceles.
Nadjari, meanwhile, said it's important to manage expectations about how much TRT can do.
“A small group of men feel no change at all,” he said. “At the other end of that curve, a small group of men are saying, ‘I feel so much better. It really changed my life.” And then most men say: “I feel a little better.”
Panelists said Wednesday that the Drug Enforcement Administration should remove the designation of testosterone as a Schedule 3 drug, the same category in which the drug ketamine falls.
Dr. Landon Trost, a panelist and director of the Male Infertility and Peyronie's Clinic in Orem, Utah, said that because prescriptions for Schedule 3 drugs must be closely tracked, doctors may be hesitant to fill them, and some pharmacies may decide not to carry the drugs or limit their quantities.
“Because of that, you get these pop-up T-clinics and other things that will fill that gap, whereas typically the patient would go to their primary care physician, urologist, endocrinologist,” Trost said.
The FDA says the broader goal of these panels is to “modernize regulatory oversight,” but some public health experts criticized them for failing to consider diversity of viewpoints or carefully screen panelists for conflicts of interest.
Some experts also expressed concern that the format could replace a more formal review process and that commissioners are chosen to support changes that Kennedy supports. The American College of Obstetricians and Gynecologists, for example, said its panel on the use of antidepressants during pregnancy was “alarmingly unbalanced.”
FDA Commissioner Marty Macari pushed back against that line of criticism on Wednesday.
“Today, the FDA is making it clear that we want to learn more about this topic. We have no preconceived ideas. We are not promoting any medical advice or any product,” he said.
Some panelists noted that physicians' understanding of testosterone therapy has changed over the past few decades. Although the FDA has previously reported cases of strokes and heart attacks in patients taking this hormone, large clinical trial launched in 2018, did not find such risks.
In light of the trial results, the FDA recommended in February remove warning about the increased risk of cardiovascular disease due to testosterone products. However, the agency said the products should carry a warning about high blood pressure based on the results of other safety studies.
