FDA Says It's Time to Ease Restrictions on Testosterone Replacement Therapy

on PinterestAn FDA panel has called for an easing of restrictions on testosterone replacement therapy (TRT).

on PinterestAn FDA panel has called for an easing of restrictions on testosterone replacement therapy (TRT). Image Credit: Malorny/Getty Images

• A Food and Drug Administration (FDA) expert panel is urging loosened restrictions and expanded access to testosterone replacement therapy (TRT).
• The recommendations follow new large clinical trials suggesting TRT does not raise heart attack, stroke, or prostate cancer risk in appropriately selected males.
• If adopted, the changes could make TRT more accessible for millions of males, but also raise new questions about oversight and prescribing practices.

An FDA expert panel that convened this month has called for loosening regulations and expanding access to testosterone replacement therapy.

FDA Commissioner Martin Makary signaled that the agency would be open to such revisions.

Just one month after the FDA removed black box warnings for menopausal hormone replacement therapy (HRT), they are now eyeing regulatory changes to testosterone replacement therapy (TRT).

The 13-member panel expressed strong support for TRT, arguing that the therapy could benefit a broader group of individuals than those currently covered by its approved indications.

“We are failing men,” Helen L. Bernie, DO, a urologist at Indiana University and member of the expert panel, said during the hearing.

“If we want to improve the health of American men, if we want to close the mortality gap, we must recognize testosterone deficiency for what it is: a public health issue,” Bernie continued.

Current uses for TRT

TRT is only approved for low testosterone (hypogonadism) associated with specific medical causes, such as:

• testicular dysfunction
• pituitary disorders
• hypothalamic disease

TRT is not approved for age-related testosterone deficiency, which occurs naturally as males get older.

The FDA’s indications are misaligned with guidance from professional groups such as the American Urological Association, which recommends considering testosterone therapy in males with confirmed low testosterone levels and clinical symptoms.

In addition to limited clinical indications, TRT has historically been underutilized amid concerns about a purported increased risk of cardiovascular disease and prostate cancer. But panelists argued that such claims are no longer accurate in light of recent trial data.

TRT has also been heavily scrutinized because of its association with performance-enhancing drug use and high-profile doping scandals in the 1980s and 1990s, a legacy reflected in testosterone’s current classification as a Schedule III controlled substance.

New FDA recommendations

The expert panel recommended sweeping regulatory changes for TRT, including:

• expanding FDA-approved indications to include age-related low testosterone
• removing its Schedule III controlled substance designation

The panel also made clinical recommendations, including an emphasis on routine screening for low testosterone, similar to lipid panels and other commonly ordered blood tests.

Franck Mauvais-Jarvis, MD, PhD, a professor of medicine at Tulane University and director of the VA hormone therapy clinic at New Orleans Medical Center, said that he unequivocally supported the panel’s recommendations. He has no association with the FDA panel.

“I completely agree with them,” he told Healthline.

“They wanted to show that testosterone deficiency is no longer part of this prehistoric paradigm wherein only men with testicular pathology or genetic cause have testosterone deficiency. In 2025, with the increased prevalence of obesity, metabolic disease, and sedentary behavior, a lot of people

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