FDA Panel Pushes to Expand Access to Testosterone Therapy—Here's What Changed

A Food and Drug Administration (FDA) expert panel is calling for major changes to testosterone replacement therapy (TRT) regulations, arguing that current restrictions are outdated and preventing millions of men from accessing potentially life-saving treatment. The 13-member panel convened in December 2025 to address growing evidence that testosterone therapy is safer than previously believed and could benefit far more men than current guidelines allow.

What Specific Changes Are Experts Recommending?

The panel made sweeping recommendations to modernize testosterone therapy access. Currently, TRT is only approved for men with low testosterone caused by specific medical conditions like testicular dysfunction or pituitary disorders—not for the age-related testosterone decline that affects millions of men naturally.

• Expanded Indications: Remove restrictions limiting TRT to specific medical causes and include age-related testosterone deficiency
• Controlled Substance Reclassification: Remove testosterone's Schedule III controlled substance designation, which creates unnecessary barriers to care
• Routine Screening: Implement regular testosterone testing as a standard health biomarker, similar to cholesterol panels
• Updated Safety Warnings: Remove outdated prostate cancer warnings that aren't supported by current evidence

"If you knew that there was a simple test that could help identify a man at risk for cardiovascular disease, diabetes, or osteoporosis, if you knew it could help prevent your husband or your father or your son from premature death, wouldn't you want that test to be part of routine care?" said Helen L. Bernie, DO, a urologist at Indiana University and panel member.

Why Are Current Restrictions Considered Outdated?

The push for change follows landmark research that challenged long-held safety concerns. The TRAVERSE trial, the largest randomized controlled study on testosterone to date, included 5,246 men aged 45 to 80 years with preexisting or high cardiovascular disease risk. Results showed that major adverse cardiovascular events occurred in 7.0% of men taking testosterone versus 7.3% taking placebo—essentially no difference.

This evidence led the FDA to remove black box warnings about cardiovascular risks from testosterone products in February 2025. Now experts argue the same outdated thinking applies to prostate cancer warnings. "Today, we know that testosterone is not a carcinogen. It is not a cardiovascular risk factor," explained Mohit Khera, MD, a professor of urology at Baylor College of Medicine who investigated the TRAVERSE trial.

How Many Men Could Benefit From Expanded Access?

According to the Journal of Clinical Endocrinology and Metabolism, 5.6% of men aged 30 to 79 have low testosterone and symptoms—representing millions of American men who could potentially benefit from treatment. However, current FDA labeling conflicts with professional medical guidelines, creating confusion for both patients and doctors.

The American Urological Association and Endocrine Society recommend testosterone therapy for men with both symptoms of low testosterone and confirmed low morning testosterone levels, regardless of the underlying cause. This broader approach differs significantly from the FDA's narrow approval criteria.

"We are failing men not because we lack science, but because we lack the policy, the screening and the permission to use that science," Bernie concluded during the panel discussion. The testosterone classification as a Schedule III controlled substance stems from the Anabolic Steroids Control Act of 1990, which was driven more by political concerns about performance-enhancing drug abuse than medical evidence about legitimate therapeutic use.

FDA Commissioner Martin Makary signaled openness to these changes, comparing the current situation to the recent removal of black box warnings for women's hormone replacement therapy. The agency's willingness to reconsider testosterone regulations suggests significant policy changes could be coming for men's health treatment options.