About this episode
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 PrósperaMore about Mary’s work:* Mary’s X* Wiki* Amazon BooksExplore Infinita City:* Explore the Archive: The Infinita City Times* Visit Infinita City* Join the Builders’ Hub on Telegram* Follow Infinita City on X This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit www.infinitacitytimes.com
