<p>Niklas sits down with biomedical researcher and libertarian author Mary Ruwart (<em>Death by Regulation</em>) 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.</p><p>Together, they unpack:</p><p>* The pivotal moments: 1962’s Kefeuver-Harris amendments and 1992’s PDUFA and how they changed the game</p><p>* Why the system now favors chronic medication over simpler or even one-shot cures</p><p>* How off-label use and underground networks (like HIV buyers clubs) filled the gaps left by regulation</p><p>* What the rollback of “Chevron Deference” means and why this may be the biggest opening in decades</p><p>* How “statistical significance” became a misleading gold standard</p><p>* 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</p><p>* What it means to build around, beyond or outside the FDA: from Montana to Próspera</p><p></p><p><strong>More about Mary’s work:</strong></p><p>* <a target="_blank" href="https://x.com/MaryRuwart">Mary’s X</a></p><p>* <a target="_blank" href="https://es.wikipedia.org/wiki/Mary_Ruwart">Wiki</a></p><p>* <a target="_blank" href="https://www.amazon.com/stores/Mary-J.-Ruwart/author/B001KC8O7S?ref=ap_rdr&#38;isDramIntegrated=true&#38;shoppingPortalEnabled=true&#38;ccs_id=62588392-7afb-4487-b5cd-31044d771c86">Amazon Books</a></p><p><strong>Explore Infinita City:</strong></p><p>* <a target="_blank" href="https://www.infinita.city/times">Explore the Archive: The Infinita City Times</a></p><p>* <a target="_blank" href="https://www.infinita.city">Visit Infinita City</a></p><p>* <a target="_blank" href="https://www.infinita.city/builders-hub">Join the Builders’ Hub on Telegram</a></p><p>* <a target="_blank" href="https://x.com/InfinitaCity">Follow Infinita City on X</a></p> <br/><br/>This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit <a href="https://www.infinitacitytimes.com?utm_medium=podcast&#38;utm_campaign=CTA_1">www.infinitacitytimes.com</a>