Main Recommendations From Dec 10, 2025:
The 13-person panel (primarily urologists and federal health officials) made several major recommendations:
1. Remove Schedule III Classification Panelists argued that testosterone's classification as a Schedule III controlled substance creates unnecessary barriers to care and is based on outdated concerns from 1980s athletic doping scandals rather than current medical evidence
NBC News Urology Times.
2. Expand FDA Approval The panel suggested expanding approval to include men with low testosterone levels and any related symptoms, aligning with American
Urological Association guidelines
NBC News. Currently, the FDA only approves TRT for men with both low testosterone AND an associated medical condition.
3. Remove Prostate Cancer Warnings Experts argued that current warning labels and contraindications for prostate cancer are not supported by contemporary evidence and should be removed
Urology Times.
Key Context
This panel follows a similar format to the menopausal hormone therapy panel from three months earlier, after which the FDA removed black box warnings from those medications
NBC News. The FDA already decided in February 2025 to remove the black box warning related to cardiovascular risks, based on the TRAVERSE trial
Urology Times.
Panel Members
The panel included notable experts like Dr.
Mohit Khera from Baylor, Dr. Landon Trost, Dr. Helen Bernie from Indiana University, and Shalin Shah (CEO of Marius Pharmaceuticals), moderated by HHS Assistant Secretary Dr. Brian Christine.
The FDA has opened a public docket for comments and data submission. This appears to be part of the FDA's broader effort to "modernize regulatory oversight" of hormone therapies.
www.federalregister.gov
