Should Testosterone Replacement Therapy Be Less Regulated?
From MedCity Pivot by Breaking Media
February 22, 2026 · 23 min · Episode 78
About this episode
This episode discusses the regulation of Testosterone Replacement Therapy and its implications for patient care.
EPISODE SUMMARY In this episode, Arundhati Parmar interviews Shalin Shah, CEO of Marius Pharmaceuticals, about Testosterone Replacement Therapy (TRT) and the long-standing regulatory classification that places testosterone as a Schedule III controlled substance. Shah explains that testosterone was scheduled in 1990 following Olympic doping scandals — despite opposition at the time from the FDA, DEA, and the American Medical Association. More than 30 years later, he argues that the regulatory framework no longer reflects current clinical evidence and may be doing more harm than good. The conversation explores: The scientific evidence surrounding cardiovascular and prostate safety The differences between injectable and oral testosterone therapies The stigma and logistical barriers created by controlled substance status How GLP-1 drugs intersect with hormone health and muscle preservation The possibility of expanding testosterone therapy access to women Whether the current regulatory environment may revisit testosterone scheduling At its core, this episode examines whether testosterone is being regulated based on outdated controversy rather than modern clinical science — and what…
People in this episode
Host: Arundhati Parmar
Guest: Shalin Shah
Topics covered
- Testosterone Replacement Therapy
- regulation
- hormone therapy
- clinical evidence
- healthcare access
Keywords
- Testosterone Replacement Therapy
- TRT regulation
- Schedule III classification
- controlled substances
- hormone therapy
Mentioned in this episode
Organizations: Marius Pharmaceuticals, FDA, DEA, American Medical Association
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