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:
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