The FDA Is Finally Talking About Testosterone in Women
Sep 24, 2026
[Special bonus episode in reaction to the FDA addressing testosterone use in women.] For eighty years, clinicians have been using testosterone to treat women. There is still no FDA-approved testosterone product for women in the United States. In September, the FDA convened a public workshop to examine that gap. In this conversation, recorded in the days beforehand, Dr. Terri sits down with Dr. Cassie Smith, MD, a dual board-certified endocrinologist and the founder of Modern Endocrine in Oklahoma City. Dr. Cassie trained at the Harold Hamm Diabetes Center and spent years running pharmaceutical clinical trials before building a telehealth practice that now serves patients across 45 states. She has seen the approval process from the inside, and she has opinions about it. Together they take on what the hearing might actually accomplish, why the approval gap has persisted this long, and what it costs the women sitting in their exam rooms. They get into the money: why a hormone that pulls patients off statins, blood pressure medication, and antidepressants is not an attractive product to develop. They get into the paperwork: why testosterone sits on the controlled-substance schedule alongside opioids, what that does to access, and why a patient who forgets her prescription on vacation simply goes without. And they get into the part neither of them can let go of — that the people writing these rules have never spent a day in a clinic watching what happens when you get a woman's hormones right. What you'll discover Why 2026 became the year women's health finally got regulatory attention — 00;06;17 What the absence of an FDA-approved product actually does to patients and prescribers — 00;07;21 What clinicians were already doing with testosterone in the 1940s — 00;12;18 How a lab "reference range" gets set, and why normal and healthy are not the same thing — 00;16;53 The risk that a badly dosed product sets the whole conversation back a decade — 00;18;34 Where medical freedom ends and regulatory overreach begins — 00;24;41 How testosterone ended up on the controlled-substance schedule in the first place — 00;31;10 What a DEA license, 46 state databases, and one forgotten prescription look like from the prescriber's side — 00;34;47 The symptoms of testosterone deficiency that start showing up as early as 30 — 00;47;04 Whether either of them is actually optimistic about change — 00;49;10 Two clinicians, one hormone, and a regulatory system that has not caught up to its own evidence.