The FDA is seeking feedback on whether — and how — to expand the number of men prescribed testosterone treatment.

FDA Commissioner Marty Makary, MD, MPH, recently held a public forum which was streamed on the FDA’s YouTube channel. In his opening comments, Makary raised questions about the Drug Enforcement Administration (DEA)’s Schedule III designation of the hormone. This designation adds legal, documentation, and practice requirements, that can create greater administrative burden and potentially discouraging clinicians from prescribing.

The DEA’s caution about testosterone stems from concerns that arose in the 1990s and 2000s about athletes misusing it, Makary said.

“That may be true, but maybe it is also a time to revisit the scheduling of testosterone, given the potential clinical benefits and the barrier that that scheduling may present,” he continued.

While setting DEA policy falls outside of the FDA’s jurisdiction, Makary signaled a willingness to revise his agency’s policies on testosterone.

Comments on testosterone replacement therapy (TRT) are being accepted online through February 9, 2026. Comments will be gathered in a docket, a public record, which allows people to see what others’ views are on the topic.

The agency stated that “any potential updates to testosterone labeling, including revisions to approved indications, will undergo the FDA’s standard rigorous review process.”

Among the questions posed by the FDA in the docket are:

• “What are the biggest opportunities to improve education of providers and patients concerning the prescription of TRT?”
• “How could interested parties — including, but not limited to, drug developers, healthcare providers, patients, consumers, and retailers — work together to further identify therapeutic uses of TRT and generate evidence supporting the safety and efficacy of these uses?”

At the meeting, Makary noted there are parallels with the FDA’s November decision to remove most black box warnings from products containing estrogen and progestogen. The decision was part of a campaign to promote wider use of hormone replacement therapies (HRTs) in older women.

In the same vein as HRT for women, Makary said that “dogma” about testosterone risks may be curtailing its use in men.

“There are far fewer research studies demonstrating the detailed benefits or potential benefits of testosterone therapy,” he said, but “the data are emerging.”

The meeting highlighted the views of scientists and one pharmaceutical company leader who advocated for greater use of testosterone.

Some Concerns About the Presentation of TRAVERSE

The current panel approach is a departure from the formal FDA advisory committee meetings used previously.

Some experts have expressed concern about the change. For example, Adriane Fugh-Berman, MD, professor in the Departments of Pharmacology and Physiology and Family Medicine at Georgetown University Medical Center (GUMC), in Washington, DC, told Medscape Medical News that she had concerns about the discussion about the results of the TRAVERSE study, a key testosterone study.

The FDA selected Mohit Khera, MD, MBA, MPH, professor of urology at Baylor College of Medicine, Houston, and one of the study authors, to speak about its results. In response to an FDA directive to resolve conflicting evidence about cardiovascular risks, the TRAVERSE trial was conducted by a consortium of five manufacturers of testosterone replacement products, led by AbbVie.

The results showed that TRT does not appear to raise the risk for adverse cardiac events among middle-aged and older men with hypogonadism at high risk for heart disease.

These findings add to the body of evidence supporting wider use of testosterone, said Khera, who confirmed that he has been a consultant for AbbVie and other companies.

“Today we know that testosterone is not a carcinogen. It is not a cardiovascular risk factor. It’s not mainly a lifestyle drug,” Khera said, “We do know that testosterone plays a very important role across multiple organ systems throughout the body.”

In February 2025, the FDA announced some changes to testosterone product labels to reflect the TRAVERSE findings in addition to other research.

In a statement, Fugh-Berman, who also is the director of PharmedOut, a watchdog project at GUMC that studies pharmaceutical marketing, agreed that the TRAVERSE results were “reassuring about cardiovascular risks in a highly selected, carefully monitored population of men who received transdermal testosterone gel bringing their testosterone levels only to normal levels.”

But she added that the presentation at the FDA meeting skipped over important concerns, some of which had been highlighted in an editorial that accompanied the 2023 publication of TRAVERSE results in The New England Journal of Medicine.

“In TRAVERSE, no cardiovascular benefit was found,” Fugh-Berman wrote. “In addition, testosterone did not prevent progression from prediabetes to diabetes and did not improve blood sugar in diabetics. Other studies have found an increase in cardiovascular events. These data need to be analyzed as a whole.”

Steven Nissen, MD, senior author of the TRAVERSE study and chief academic officer at the Heart and Vascular Institute at the Cleveland Clinic in Cleveland, also urged caution about applying its results more broadly.

“The men in our trial were carefully selected based on low testosterone and symptoms. They were titrated to achieve appropriate blood levels of testosterone. I worry about how men may be selected and monitored in clinical practice,” said Nissen.

Industry Included in Meeting Despite Previous Policy

The FDA’s decision to include Shalin Shah, CEO of Marius Pharmaceuticals, in the meeting also drew criticism.

At the meeting, Shah proposed more government action is needed to increase insurance coverage of screening for low testosterone. He suggested that the US Preventive Services Task Force review the evidence on testosterone screening and then give it a strong recommendation.

“Most men struggle with their doctors to get a simple testosterone level done,” said Shah. “And while there’s a good case for screening all men, we should certainly be screening men with any metabolic dysfunction.”

Khera reported being a consultant for Verity, Marius Pharmaceuticals, Endo, Besins, AbbVie, and Tolmar. He served as investigator for the TRAVERSE trial as did Nissen. Both had also participated in studies unrelated to testosterone.

Fugh-Berman reported serving as a paid expert witness in litigation regarding pharmaceutical and medical device marketing practices, including being retained briefly for attorneys in a testosterone multidistrict litigation case.

Kerry Dooley Young is a freelance journalist based in Washington, DC. She has covered medical research and healthcare policy for more than 20 years.