Newswise — Silver Spring, Maryland — Helen Barney, MD, MPH, assistant professor of urology at Indiana University School of Medicine, will participate in the U.S. Food and Drug Administration’s Expert Panel on Testosterone Replacement Therapy and Men’s Health on Wednesday, December 10th. Bernie’s role on the committee is as a clinical expert on men’s reproductive health, which is the focus of both her clinical practice and academic research. She is available to comment on panels and related topics regarding men’s health.
“This panel represents a very important step forward for men’s health,” Barney said. “Testosterone is not a lifestyle drug; it is a biomarker and therapeutic tool that has significant effects on mortality, cardiometabolic health, athletic performance, cognition, and overall well-being.”
Barney, director of the Male Reproductive Medicine Program and Andrology Fellowship at the IU School of Medicine, is an authority on a variety of men’s health issues, including testosterone deficiency, erectile dysfunction, Peyronie’s disease, and male infertility. The FDA panel, which will be streamed live on YouTube starting Wednesday at 1 p.m., will be comprised of about a dozen experts from a variety of medical and pharmaceutical fields. The FDA is considering how to regulate the treatment, testosterone replacement therapy. It is used in men who have low energy, mood, and sex drive due to low testosterone levels. Low testosterone levels are also associated with cardiovascular disease, metabolic disease, diabetes, osteoporosis and fracture risk, anemia, frailty, and increased all-cause mortality. Men are rarely tested for low testosterone, and doctors are often not trained on how to recognize and treat the symptoms. The main goal of the committee is to implement testosterone therapy. It will help inform regulatory understanding and future policy discussions in the broader context of men’s health, preventive medicine, and public health. Increasing education and resources about men’s health is another goal. This panel follows a similar discussion on female hormones recently led by the FDA.
Bernie said it was an honor to serve on such an important committee.
“I am grateful for the opportunity to contribute to this national conversation and advocate for evidence-based, patient-centered recommendations that will shape the future of care for millions of men,” she said.
About Indiana University School of Medicine
IU School of Medicine is the largest medical school in the United States and annually ranked among the nation’s top medical schools by U.S. News & World Report. The school offers quality medical education, access to cutting-edge medical research, and a rich campus life in nine Indiana cities, including rural and urban areas consistently recognized for their livability. IU School of Medicine ranks 13th among all public medical schools in the country for National Institutes of Health funding in 2024, according to the Blue Ridge Medical Research Institute.
For more news, visit the IU School of Medicine newsroom: medicine.iu.edu/news
