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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