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December 10, 2025
4 min read
Key takeaways:
- An FDA expert panel on testosterone therapy supported loosening restrictions on which men can receive it.
- The panel also called for removing testosterone from the list of controlled substances.
An FDA expert panel on testosterone therapy for men expressed interest in expanding the indication for testosterone therapy, eliminating some of its contraindications and removing its status as a Schedule III controlled substance.
“Testosterone deficiency is an important medical condition that adversely affects a man’s health, quality of life and risk of mortality,” Mohit Khera, MD, MBA, MPH, professor of urology at Baylor College of Medicine and co-moderator of the panel discussion, said during the hearing. “Large randomized controlled trials and observational studies have demonstrated the safety and multiple clinical benefits of testosterone therapy. Current FDA prostate warnings and contraindications are not supported by contemporary evidence and should be removed. Testosterone should not be treated as a controlled substance. Its current scheduling creates unnecessary barriers for patients and providers. Men who have signs and symptoms of testosterone deficiency along with documented low testosterone levels may be candidates for treatment regardless of the underlying cause. There is no scientific basis for excluding age-related hypogonadism from treatment eligibility. Doing so only prevents affected men from accessing therapies that could significantly improve their quality of life.”
An FDA expert panel on testosterone therapy for men expressed interest in expanding the indication for testosterone therapy.
Adrian S. Dobs, MD, MHS, director of Johns Hopkins Clinical Research Network and professor of medicine and oncology at the Johns Hopkins University School of Medicinedivision of endocrinology, diabetes and metabolism, told Healio that she had a “very positive” reaction to the panel meeting.
Adrian S. Dobs
“Some very important concepts were brought out, and I am very pleased that the government is thinking in terms of men’s health as an important initiative,” she told Healio.
The panel members said approximately one-third of U.S. men older than 45 years have a testosterone level of less than 300 ng/dL, and 5.6% of American men aged 30 to 79 years have symptoms of comorbidities caused by testosterone deficiency, yet the FDA currently restricts testosterone therapy to patients who have a definitive etiology for their testosterone deficiency related to the testes or the brain, which approximately 90% do not.
Dobs told Healio that “several medical societies and the FDA for too long were fixated on the idea that we needed to have a specific reason for the low testosterone. We oftentimes don’t know the reason. That goes for a lot of diseases, including high blood pressure. But we still know it’s bad to have high blood pressure and we treat it. We often don’t know what’s happening at the level of the hypothalamus or the pituitary gland. Maybe in 10 or 20 years we will know. But in the meantime, if there are some benefits that can be seen by taking testosterone, then I would be an advocate of treating, and I think that’s what was brought out at the meeting.”
Khera said many the FDA’s regulations on testosterone are based on perceptions from decades ago that testosterone was a lifestyle drug that had large potential for abuse and carried risk for cardiovascular disease, prostate cancer and other adverse events. “Today, we know that testosterone is not a carcinogen, it is not a cardiovascular risk factor, it’s not mainly a lifestyle drug,” he said. “What we do know is that testosterone plays a very important role across multiple organ systems throughout the body. In fact, testosterone deficiency negatively impacts health, it reduces quality of life, it increases the risk for mortality. Testosterone therapy offers multiple clinical benefits such as improvements in obesity, diabetes and bone mineral density. Testosterone is one of the best markers of a man’s overall health.”
As Healio previously reported, based on the results of TRAVERSE, a large randomized controlled trial, the FDA in March recommended removing language from the black box warning of all testosterone products that stated testosterone therapy could lead to increased risk for adverse CV outcomes.
Helen L. Bernie, DO, MPH, associate professor of urology and director of the Male Sexual and Reproductive Medicine Program at Indiana University, said despite contemporary studies showing its benefits, “testosterone is still regulated like it’s a dangerous performance-enhancing drug from the athletic doping scandals of the 1980s. Because of this outdated classification, many clinicians fear prescribing it or even screening for it. When men finally get their testosterone checked and it comes back low, they are told there is nothing to do or that [treating it] is unsafe, even when the scientific evidence shows the opposite. And this leaves millions of American men undiagnosed, untreated and at increased risk for preventable disease. We are failing men, not because we lack science, but because we lack the policy, the screening and the permission to use that science. If we want to help American men … we must recognize testosterone deficiency for what it is: a public health issue.”
Testosterone was classified as a Schedule III controlled substance — the same as ketamine and barbiturates — by a law passed in 1990 in response to the doping scandals of the ’80s, Landon Trost, MD, director of the Male Fertility and Peyronie’s Clinic, Laboratory and Procedural Services at Brigham Young University, said during the panel meeting.
But, he said, “there is no evidence to suggest dependency at any physiologic levels with testosterone, in contrast to things like narcotics.”
Testosterone use declined in the first 10 years after the law was passed, but has since exceeded pre-1990 levels, yet men who need testosterone therapy for health reasons have to go through a lot of hurdles to get it, so the law has not achieved what it set out to do and the Schedule III designation for testosterone should be removed, Trost said.
Dobs said she agrees with the call to remove the Schedule III designation. “In some states it is too cumbersome to get, and you need triple the prescription paperwork,” she told Healio. “Many medications are associated with the potential for abuse. Education is important here. We are talking about using testosterone therapy to get men into a normal range. We are not talking about supraphysiological treatments at all. The issue of improving access is an important one.”
She also said she agreed with panelist comments that testosterone is a good marker of health, noting that screening for testosterone levels at a young age “can key a man into the health care system. There are many reasons why men have increased mortality [compared with women], and one is that they don’t go to the doctor and don’t get their cholesterol and glucose tested. Then they show up with heart disease and high blood pressure when it’s many years too late.”
However, there are not enough data to prove that improving testosterone levels reduces mortality, in contrast to, for example, the data showing that improving cholesterol levels reduces mortality, she said.
For more information:
Adrian S. Dobs, MD, MHS, can be reached at adobs@jhu.edu.
Sources/Disclosures
Source:
FDA expert panel on testosterone replacement therapy for men. YouTube. https://www.youtube.com/live/BdAawJmQ9Fs. Published Dec. 10, 2025. Accessed Dec. 10, 2025.
Disclosures:
Bernie, Dobs and Trost report no relevant financial disclosures. Khera reports serving on the steering committee for the TRAVERSE trial funded in part by AbbVie and consulting for Endo Pharmaceuticals, Marius and Verdi.
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