FDA Takes Steps to Expand Testosterone for Men’s Libido

Heralding a “step forward on testosterone therapy for men,” the FDA announced an initiative to support a potential new indication of low libido in men due to idiopathic hypogonadism.

The FDA will encourage drug companies with existing approved indications for testosterone replacement therapy (TRT) to contact the agency about the potential new indication.

“New and emerging data suggest there may be an opportunity to help men suffering from symptoms that significantly affect quality of life,” said FDA Commissioner Marty Makary, MD, MPH, in a statement. “We are eager to work with sponsors to further evaluate this potential new use while upholding our rigorous standards for safety and effectiveness.”

Currently, the only FDA-approved indications for TRT pertain to men with hypogonadism related to structural or genetic causes. Late last year an expert panel convened by the FDA called on the agency to expand indications for TRT and to drop testosterone’s classification as a schedule III controlled substance, which originated with the Anabolic Steroids Control Act of 1990.

During the expert panel meeting, Mohit Khera, MD, MPH, of Baylor College of Medicine in Houston, noted that testosterone’s standing with the FDA puts the agency at odds with professional medical societies, such as the American Urological Association and the Endocrine Society. Both groups’ clinical guidelines for TRT have a broader scope of clinical indications.

Another panel participant, John Mulhall, MD, of Memorial Sloan Kettering Cancer Center in New York City, said almost half of the men with diagnosed testosterone deficiency in his clinical practice “do not technically meet the label requirements” when starting TRT.

Early last year, the FDA took a step toward relaxing regulation of TRT by removing a boxed warning about a risk of heart attack and stroke from product labeling. A warning about a potential risk of high blood pressure remained.

TRT continues to stoke controversy, both professionally and socially. As evidenced by comments during the expert panel meeting, some urologists think indications for TRT are too narrow and that the therapy is overregulated. Others have expressed concern that some clinicians are too quick to prescribe the hormonal therapy for men complaining of fatigue, low energy, diminished libido, or erectile dysfunction. One urologist who declined to be interviewed for this story referred to TRT as “a bit messy.”

The term “low T” caught on quickly with direct-to-consumer advertising for TRT. In particular, online purveyors of TRT have attracted scrutiny for questionable business and medical practices, including prescribing the hormone for “undercover” patients who had normal testosterone levels. A more recent examination of telehealth sites that promised a cure for “male menopause” added to the perception of unsavory business and medical practices.

The FDA set an April 30 deadline for companies to contact the agency about filing a supplemental New Drug Application for approved testosterone products. The FDA emphasized that “any approval for a new indication would require demonstration of substantial evidence of effectiveness and that the benefits outweigh the risks for the intended population.”