FDA Panel Calls for Expanded Access

• 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.

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.

• testicular dysfunction
• pituitary disorders
• hypothalamic disease

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.

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 are testosterone-deficient,” Mauvais-Jarvis continued.

The FDA panel’s recommendations follow revisions to TRT safety warnings issued earlier this year.

In February 2025, the FDA recommended changes to TRT labeling to remove a black-box warning related to the increased risk of cardiovascular disease. The FDA first implemented the boxed warning in 2015.

The decision followed the results of the TRAVERSE trial, a large randomized, placebo-controlled trial, the results of which were published in NEJM in 2023. That study found that in males with hypogonadism and preexisting or high risk of CVD, TRT was not associated with a higher rate of heart attack or stroke than placebo.

Concerns about an increased risk of prostate cancer have also been reevaluated in recent years, with many experts concluding that the risk has likely been overstated.

“The bottom line is no, testosterone does not increase the risk of prostate cancer,” Mauvais-Jarvis said.

The results of a Harvard-led trial, published in JAMA Network Open in 2023, generally support this assertion. The study, which involved more than 5,000 males, concluded that among middle-aged and older males with hypogonadism — excluding those at high risk for prostate cancer — there was no significant difference in prostate cancer incidence between patients receiving TRT and those receiving placebo.

“In the last several years, new data from large trials have emerged that warrant an update to the known risks of T therapy. Several concerns regarding cardiovascular risks and prostate cancer risk have largely been disproven in the latest trials,” said Michael Eisenberg, MD, a professor of urology at Stanford University who has no association with the FDA panel.

Despite these findings, TRT is not risk-free and is still associated with side effects, including:

However, recent data on the two biggest concerns related to TRT suggest that proponents argue that for many males, the benefits far outweigh the risks.

Testosterone has a wide range of effects on the body. Potential health benefits include:

• muscle gain
• prevention of muscle wasting
• maintaining bone density
• improving sex drive
• fat loss

“People who have low testosterone have a major risk of mortality. It’s the best biological marker of poor health,” said Mauvais-Jarvis.

The FDA panel was also critical of testosterone’s placement as a Schedule III controlled substance, where it is classified alongside codeine, an opioid, and ketamine, a dissociative anesthetic.

Scheduled drugs are tracked by the DEA and state-run prescription monitoring databases, which some physicians and pharmacies say have made them more cautious about prescribing or dispensing these medications.

“Such a designation places a burden on both the patient and provider. Without the same level of concern as other medications in this category, this seems an appropriate step to ease treatment for hypogonadism,” said Eisenberg.

Testosterone’s classification as a controlled substance has, in some experts’ opinions, contributed to the rise of testosterone prescribing via telehealth platforms and “optimization” clinics — some of which may have dubious prescribing patterns or financial incentives

“If you remove it from Schedule III, then doctors won’t be afraid. I believe you’ll have more patients going through appropriate channels to get TRT, because urologists, endocrinologists, people qualified in sexual medicine will be prescribing it,” Mauvais-Jarvis said.

However, not all experts agreed on this point.

“I don’t understand how rescheduling it and making it easier to prescribe gets it into the hands of endocrinologists and urologists, as opposed to any anti-aging or longevity clinic that can write a prescription,” said Philip Werthman, MD, a board certified urologist and director of the Center for Male Reproductive Medicine and Vasectomy Reversal in Los Angeles. He has no association with the FDA panel.

Werthman expressed serious concerns that rescheduling testosterone might, in fact, lead to more illicit use, not less.

“I see the other end of the stick, which is the guy who comes in in his thirties with his wife, and they’ve been trying to have a baby for a year, and no one told him it will make him sterile,” he told Healthline. “That’s where the harm is.”