FDA panel calls for easing restrictions on testosterone replacement therapy for men

A panel convened by the US Food and Drug Administration (FDA) on Thursday recommended easing restrictions on testosterone replacement therapy (TRT) for men. Currently, FDA labeling states that this drug should only be used if a man has low testosterone due to a specific medical condition, such as hypogonadism. The panel also suggested removing the classification of these therapies as controlled substances, arguing that the current restrictions are compromising men's health.

The panel, which was composed of urologists and federal health officials, stated that low testosterone is a significant biomarker for men’s health. However, it is not effectively used as a screening tool. The panel attributed this limited usage to common misconceptions that TRT can lead to prostate cancer, stroke, and heart disease.

Panel members also noted a disconnect between the FDA’s stance on TRT therapy and the recommendations from professional medical societies that support broader use of these products.

During the meeting, FDA Commissioner Marty Makary highlighted the similarities between this meeting and previous discussions regarding hormone replacement therapies (HRTs) for women. Last month, Makary and Robert F. Kennedy Jr., the Secretary of the Department of Health and Human Services (HHS), announced the removal of boxed warnings on these therapies. (RELATED: FDA to remove boxed warnings from hormone therapies for menopause, Regulatory Focus 10 November 2025)

In announcing the rollback of the warning on HRTs for menopausal women, Makary said the move was aimed at “clearing up 22 years of misconceptions” related to HRT and the risk of cardiovascular issues and cancer. He said that a similar scenario is at work regarding TRT therapy for men.

Makary noted that despite the health benefits of TRT, many men with low testosterone levels are not receiving this treatment. He referenced a study indicating that more than one-third of men over 45 have low testosterone levels, defined as less than 300 ng/dL (nanograms per deciliter). This condition can lead to various health issues, including decreased libido and depression. One reason some people hesitate to seek treatment is that testosterone is classified as a controlled substance.

Makary said the underutilization of TRT began in the 1990s, following allegations that some Olympic athletes were using testosterone for doping purposes. Yet he said that the benefits of TRT outweigh the risks and suggests it may be time to reconsider testosterone's classification as a controlled substance.

During his remarks, Makary also announced a request for information from stakeholders to share their perspectives on testosterone replacement therapy for men. The deadline for providing comment is 9 February 2026.

The panel agreed with Makary’s sentiments. Mohit Khera, a professor of urology at the Baylor College of Medicine, explained that there have been "decades of misconceptions" surrounding TRT. This began to change with the Traverse trials, which studied older men with heart disease. The findings, confirmed in 2023, demonstrated the safety of testosterone therapy concerning cardiovascular events, strokes, and mortality.

“Today we know that it is not a life cycle drug but plays a vital role in men’s health,” he said.

Yet Khera said that only 5-20% of men who suffer from low TRT seek therapy, due to the misperception among providers and the lack of awareness of the benefits of TRT therapy. “TRT deficiency is associated with poor overall health in men and men with low testosterone are more likely to have cardiovascular disease and diabetes.”

He added that there is a “regulatory disconnect” concerning testosterone replacement therapy (TRT). While the FDA's labeling indicates that TRT should only be used by men with specific medical conditions, this perspective contradicts that of many professional societies, which advocate for broader applications of testosterone.

Helen Bernie, an associate professor of urology at the Indiana University School of Medicine, said that testosterone is a critical biomarker. “Testosterone therapy is not a lifestyle drug. It is a cornerstone for preventive health,” she said.

Bernie stated that the absence of clear policy guidelines is hindering men's access to this treatment and that men should be screened for the condition just like they are screened for conditions like diabetes.

John Mulhall, a surgeon and urologist at the Sloan Kettering Cancer Center, agreed with his colleagues that many men who need TRT are being denied necessary treatment. He noted that many family doctors refuse to prescribe TRT to patients with low testosterone because they do not meet the labeling requirements. The current labeling for this therapy, he argued, is “not fit for purpose.”

Mulhall said that testosterone deficiency is recognized as being associated with a “constellation of medical conditions” such as osteopenia and cardiovascular problems.

Michael Davis, the deputy director of FDA’s Center for Drug Evaluation and Research (CDER), said that more studies are needed to suggest expanding these treatments beyond the current labeling for hypogonadism. “The regulatory pathway for TRT is well established for classic hypogonadism, but expanding its use into broader populations presents scientific and regulatory challenges.”

Davis added that “for any proposed labeling expansion, FDA expects a clear scientific justification for the expansion, not just the classic hypogonadism.”

The meeting was held as an expert panel discussion, rather than in a traditional advisory committee setting. Several news outlets have reported on the FDA’s recent spate of expert panel meetings, which, unlike traditional advisory committees, do not require the same level of scrutiny when selecting members. The expert panels also do not have to provide briefing documents for public scrutiny or give the same level of notice for public engagement. (RELATED: This Week at FDA: Expert panels draw criticism, HHS seeks to define ultra-processed foods, Regulatory Focus 25 July 2025).

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FDA panel calls for easing restrictions on testosterone replacement therapy for men

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