Trump officials push wider access to testosterone therapy
The FDA is considering label changes that could broaden testosterone use for age-related sexual symptoms, as experts warn about overprescribing and fertility risks.
By Sofia Marchetti · World Affairs Correspondent
3 min read
Trump administration health officials are moving to make testosterone therapy easier to prescribe, a shift that could expand access for men with age-related sexual symptoms. The effort comes as recent studies have eased some concerns about heart risks, while medical specialists continue to warn that many prescriptions may not meet guideline standards.
The Associated Press reported that Health Secretary Robert F. Kennedy Jr. and other senior officials support broader access to testosterone, a hormone tied to sex drive, mood and other health factors. Defense Secretary Pete Hegseth said Tuesday that the military would start screening troops for low testosterone and offer treatment to help service members perform at their “absolute best,” according to the AP.
The Food and Drug Administration last year removed a boxed warning about possible heart risks from testosterone pills, gels, injections and patches, citing newer data that did not show an increase in those problems. Last month, the FDA proposed changing prescribing instructions to allow testosterone use for age-related symptoms such as low libido and erectile dysfunction.
Research has shifted the debate
Testosterone was first approved in the 1950s for hypogonadism, a condition involving low hormone levels caused by medical problems affecting the testes or other organs, according to the AP. Current labeling says the drugs are approved for abnormally low testosterone caused by serious medical conditions or injury.
Dr. Shalender Bhasin of Harvard Medical School, who has helped write testosterone guidelines and studies, told the AP that symptoms tied to low testosterone can overlap with ordinary aging in men, creating a risk of misdiagnosis. The Endocrine Society’s guidelines recommend considering therapy for men with symptoms and two blood tests confirming low testosterone.
A recent study by Michigan researchers found that 12% of men who received a testosterone prescription met those Endocrine Society criteria, according to the AP. Dr. Helen Bernie, a urologist and director of sexual health at Indiana University, told the AP that many patients seeking care are men whose symptoms are harming their quality of life.
An FDA-required study published in 2023 followed 5,000 men with a history of heart disease, with half receiving testosterone gel and half receiving a placebo, according to the AP. After two years, researchers found no difference in heart attack, stroke and related events between the groups.
National Institutes of Health studies involving nearly 800 older men found that testosterone therapy improved erectile dysfunction, libido and other sexual measures and had a small effect on mood, according to the AP. Those studies found little or no improvement in fatigue, memory or overall well-being.
Overprescribing remains a concern
Testosterone prescriptions surged in the early 2010s after drug companies spent heavily on television ads for “low T” treatments, according to the AP. By 2013, testosterone products were generating more than $2 billion in annual sales, even though the FDA had not approved them for many advertised symptoms.
In 2015, the FDA required companies to clarify that the drugs were not approved for routine aging-related problems and added a boxed warning about possible heart risks. The agency now says updated evidence supports easing some restrictions.
Bhasin told the AP that the FDA’s proposed label changes are a welcome step, but said more work is needed to define long-term safety and effectiveness. In comments to the FDA, the Endocrine Society recommended studies lasting 15 to 20 years to assess slower-developing risks, including prostate cancer.
Doctors also warn that testosterone can harm fertility. Dr. Justin Dubin, a urologist at Baptist Health Miami Cancer Institute, told the AP that outside testosterone can interrupt signals from the brain to the testes, reducing sperm production.
The AP reported that dietary supplements marketed online as testosterone boosters should be avoided because they are not FDA-approved and probably do not work. Dubin’s 2022 paper found that only one in seven online prescribing companies asked basic screening questions, including whether patients planned to have children, and most lacked a testing threshold for low testosterone.
This story draws on original reporting from Fortune.