Ep. 100: A Conversation with Dr. Mary Ruwart: The Lost Innovation Cost of the FDA, and How Founders Can Reclaim the Right to Build
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Ep. 100: A Conversation with Dr. Mary Ruwart: The Lost Innovation Cost of the FDA, and How Founders Can Reclaim the Right to Build
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Niklas sits down with biomedical researcher and libertarian author Mary Ruwart (Death by Regulation) to dissect how decades of FDA rules derailed innovation, extended timelines from 4 to 14 years, and quietly reshaped the entire pharma industry, from discovery to delivery.
Together, they unpack:
* The pivotal moments: 1962’s Kefeuver-Harris amendments and 1992’s PDUFA and how they changed the game
* Why the system now favors chronic medication over simpler or even one-shot cures
* How off-label use and underground networks (like HIV buyers clubs) filled the gaps left by regulation
* What the rollback of “Chevron Deference” means and why this may be the biggest opening in decades
* How “statistical significance” became a misleading gold standard
* Why founders still building in the U.S. need to understand the incentives behind drug lag, suppression of short-term treatments, and the quiet cartelization of Big Pharma
* What it means to build around, beyond or outside the FDA: from Montana to Próspera
More about Mary’s work:
* Mary’s X
* Wiki
* Amazon Books
Explore Infinita City:
* Explore the Archive: The Infinita City Times
* Visit Infinita City
* Join the Builders’ Hub on Telegram
* Follow Infinita City on X
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