The Androgen Society made history last week as three of the field's most distinguished leaders—Dr. Mohit Khera, Dr. Marty Miner, and Dr. Abe Morgentaler—participated in a groundbreaking FDA panel that could fundamentally transform testosterone therapy access and patient care.
This pivotal panel addressed critical barriers that have long hindered optimal patient treatment, with key recommendations presented to the FDA:
Panel Recommendations:
- Eliminate the "age-related" restriction – Many medical conditions are “age-related” in that they become more prevalent with aging, including hypertension, heart disease, and most adult cancers. These conditions are treated to improve health. The same should be true for testosterone deficiency.
- Remove testosterone from the list of controlled substances – No other hormone is controlled. This step will reduce barriers to testosterone therapy access
- Raise treatment threshold to 350 ng/dL – Allow therapy initiation at this level when accompanied by clinical signs and symptoms
- Remove prostate cancer warnings from labeling – Reflecting current evidence and eliminating outdated concerns that prevent appropriate care
This event represents a watershed moment in our field's efforts to advance evidence-based care and remove regulatory obstacles that have prevented countless men from accessing appropriate treatment.
The Androgen Society remains committed to advocating for policies that prioritize patient health and reflect the latest scientific evidence in men's health.
