Ep. 100: A Conversation with Dr. Ruwart: The Lost Innovation Cost of the FDA. скачать в хорошем качестве

Ep. 100: A Conversation with Dr. Ruwart: The Lost Innovation Cost of the FDA.

What if our biggest medical breakthroughs never made it to patients, not because they failed, but because they never stood a chance? 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