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:* <a target="_blank" href="https://x.com/MaryRuwart">Mary’s X</a>* <a target="_blank" href="https://es.wikipedia.org/wiki/Mary_Ruwart">Wiki</a>* <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>Explore Infinita City:* <a target="_blank" href="https://www.infinita.city/times">Explore the Archive: The Infinita City Times</a>* <a target="_blank" href="https://www.infinita.city">Visit Infinita City</a>* <a target="_blank" href="https://www.infinita.city/builders-hub">Join the Builders’ Hub on Telegram</a>* <a target="_blank" href="https://x.com/InfinitaCity">Follow Infinita City on X</a> 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>

Podurama

Home

Trending

Personal

Your Podcasts

New Episodes

My Files

Favourite Episodes

Tags (Folders)

Recently Played

Bookmarks

Followed Playlists

Ep. 100: A Conversation with Dr. Mary Ruwart: The Lost Innovation Cost of the FDA, and How Founders Can Reclaim the Right to Build

Stranded Technologies Podcast

AI Chapters

AI Insights

Reviews