FDA panel urges easier access to testosterone therapy for men

Exactly a month after it announced the removal of black box warning labels on estrogen therapy products used in menopause, the Food and Drugs Administration hosted an expert panel to discuss the other sexual hormone with a potentially outdated black box: testosterone. 

Nine experts, including academics, clinicians, and the CEO of a pharmaceutical startup focused on testosterone products, delivered lectures and answered questions highlighting the importance of testosterone as a marker of broader male health. They also promoted increased engagement with its therapeutic value and recommended changes in labeling and substance control. 

In introducing the panel, FDA Commissioner Martin Makary noted that estrogen and testosterone therapy share similarities — including outdated beliefs about their safety — and important differences. “There are far fewer research studies demonstrating the … potential benefits of testosterone therapy. They are emerging,” he said.