FDA Highlights Testosterone Crisis in Cisgender Men Amid Declining Levels

The U.S. Food and Drug Administration recently convened an expert panel to address declining testosterone levels in cisgender men, describing it as a public health crisis warranting broader access to replacement therapy. FDA Commissioner Martin Makary highlighted this issue in an interview, noting that testosterone levels have declined in men and emphasizing the need for treatments to mitigate associated health risks. The panel, held on December 10, 2025, focused on testosterone replacement therapy for men experiencing low levels due to medical conditions like hypogonadism. Makary told NPR's Morning Edition that low testosterone is believed to contribute to symptoms such as fatigue and reduced energy, advocating for reduced stigma in accessing these therapies at pharmacies.

Testosterone replacement is FDA-approved specifically for cisgender men with low levels caused by disorders of the testicles, pituitary gland, or hypothalamus, such as genetic issues or damage from chemotherapy. However, the agency has updated labeling as recently as February 28, 2025, removing certain cardiovascular risk warnings from product boxed warnings based on clinical trial data showing no increased risk of heart attack or stroke compared to placebo, while adding notes on blood pressure risks. This shift reflects evolving evidence on safety for approved uses.

Reports indicate the FDA is pushing for deregulation of testosterone, a controlled substance, to allow cisgender men easier pharmacy access without stigma. This enthusiasm for testosterone in treating cisgender men's health issues stands in contrast to stricter oversight for off-label uses, including hormone therapy for transgender people seeking gender-affirming care. Transgender advocates have long noted that while testosterone is readily prescribed for cisgender men with age-related declines or symptoms like low energy, access for transgender men and nonbinary individuals is often more restricted and stigmatized.

The FDA's historical stance clarifies that benefits and safety are not established for low testosterone due solely to aging in cisgender men, yet recent discussions suggest a pivot toward promoting awareness and access. Diagnosis requires lab confirmation of low levels on at least two mornings, but data shows some prescriptions occur without such testing. The public is encouraged to submit comments via docket FDA-2025-N-6743 on the expert panel's recommendations.

LGBTQ+ organizations express concern that expanding access for cisgender men could further highlight disparities in hormone therapy availability for transgender people. Transgender men, who use testosterone as part of gender-affirming care, often face barriers like insurance denials or requirements for extensive mental health evaluations, unlike cisgender men seeking it for hypogonadism. Advocates argue for inclusive policies that affirm transgender identities while ensuring safe access for all who medically need it.

Groups like the Human Rights Campaign have historically called for equitable healthcare, noting that gender-affirming care, including testosterone for transgender individuals, is supported by major medical associations as safe and effective when medically necessary. The FDA's focus on cisgender men underscores the need for parallel efforts to destigmatize and streamline access for transgender communities.

This FDA initiative could lead to updated guidelines, potentially increasing prescriptions for millions of cisgender men affected by declining levels. Natural age-related drops occur, but whether replacement is always beneficial remains under study. For transgender people, consistent access to testosterone supports mental health and quality of life, with studies affirming its role in alleviating gender dysphoria.

The panel's outcomes may influence policy, with the FDA seeking public input to balance benefits, risks, and access across demographics. Healthcare providers are urged to confirm diagnoses rigorously before prescribing. As discussions continue, inclusive approaches will be key to addressing hormone therapy needs for cisgender men, transgender men, and all gender-diverse individuals.