Ending the Pill Penalty on 9/13, Tariffs & FDA Rare Disease Guidance | Making Medicine

In this week’s episode, John Stanford reflects on Incubate’s own holiday, September 13th (9/13), and the ongoing fight to end the pill penalty through the EPIC Act. He also covers the latest developments on tariffs, HHS hearings, FDA’s new rare disease principles, and the future of the SBIR program. We close with new research on how the IRA is affecting biotech investment.What are your thoughts on the pill penalty?Do you think FDA’s new rare disease guidance will accelerate innovation?If you're new to the Making Medicine Podcast, we're happy you're here! Follow us for more:https://x.com/MakingMedPodhttps://www.instagram.com/makingmedicinepod/https://www.linkedin.com/showcase/making-medicine-podcast/about/?viewAsMember=trueTimestamps:0:00 Welcome to Making Medicine0:32 9/13 and the pill penalty explained1:37 Incubate’s advocacy: EPIC Act and campaigns2:31 Life Science Investment Tracker: discontinued drugs & programs3:02 Trump tariffs and pharmaceutical exemptions4:06 Japan deal and Most Favored Nation strategy4:22 RFK Jr. Senate hearing on vaccines, IRA, and drug pricing5:37 The trap of list prices in policy debates5:39 FDA’s new Rare Disease Evidence Principles (RDEP)6:34 Why clarity matters for rare disease companies6:36 SBIR program renewal and uncertainty ahead7:09 NPC survey on the IRA’s impact on investment7:51 Closing thoughts & call to actionWe’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.