Indiana University physician joins FDA panel on male hormone therapy

Helen Bernie, DO, MPH, assistant professor of urology at Indiana University School of Medicine, will participate in an expert panel on testosterone replacement therapy and men's health to be held Wednesday, Dec. 10, by the U.S. Food and Drug Administration. Bernie's role on the panel is that of a clinical expert on men's reproductive health, which is the focus of both her practice and academic research. She is available to comment on the panel and related men's health topics.

"This panel represents a critically important step forward for men's health," Bernie said. "Testosterone is not a lifestyle drug - it is a biomarker and therapeutic tool with significant implications for mortality, cardiometabolic health, mobility, cognition, and overall well-being."

• Bernie, director of the Male Sexual & Reproductive Medicine Program and the Andrology Fellowship at IU School of Medicine, is an authority on various men's health issues, including testosterone deficiency, erectile dysfunction, Peyronie's disease and male infertility.
• The FDA panel, which will broadcast live on YouTube at 1 p.m. Wednesday, will consist of about a dozen experts in various medical and pharmaceutical fields.
• The FDA is weighing how to regulate testosterone replacement therapy, a treatment used for men experience low energy, mood and libido due to low testosterone levels.
• Low testosterone is also linked to higher rates of cardiovascular disease, metabolic disease and diabetes, osteoporosis and fracture risk, anemia, frailty and higher all-cause mortality.
• Men are only seldom screened for low testosterone, and physicians often lack training in how to recognize and treat the symptoms.
• A key goal of the panel is to place testosterone therapy in the broader context of men's health, preventive medicine and public health, helping inform regulatory understanding and future policy discussions.
• Increasing education and resources for men's health is another goal.
• The panel follows a similar discussion on women's hormones recently led by the FDA.

Bernie said she was honored to serve on such a consequential panel.

"I am grateful for the opportunity to contribute to this national discussion and to advocate for evidence-based, patient-centered recommendations that will shape the future of care for millions of men," she said.