Ep. 100: A Conversation with Dr. Mary Ruwart: The Lost Innovation Cost of the FDA, and How Founders Can Reclaim the Right to Build

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

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* Follow Infinita City on X

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