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

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Making Medicine

Incubate Coalition

50 episodes

4 days ago

There's a scientific breakthrough in your medicine cabinet. But how did it get there?

At a time when medicines are helping us all live longer and healthier lives, this podcast will explore where these taken-for-granted miracles come from, how many of them almost never happened, where the life science ecosystem is taking us next, and most importantly, what it means for patients.

From chance meetings that led to new ideas, to risky investments that never pay off, hear from the people behind today's and tomorrow's treatments, vaccines, technologies, devices, and yes, cures.

In this golden age of health discovery and innovation fueled by record breaking investment in the life sciences, we'll bring guests who really understand what it means to be Making Medicine.

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

Making Medicine

8 minutes

2 months ago

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?
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Timestamps:
0:00 Welcome to Making Medicine
0:32 9/13 and the pill penalty explained
1:37 Incubate’s advocacy: EPIC Act and campaigns
2:31 Life Science Investment Tracker: discontinued drugs & programs
3:02 Trump tariffs and pharmaceutical exemptions
4:06 Japan deal and Most Favored Nation strategy
4:22 RFK Jr. Senate hearing on vaccines, IRA, and drug pricing
5:37 The trap of list prices in policy debates
5:39 FDA’s new Rare Disease Evidence Principles (RDEP)
6:34 Why clarity matters for rare disease companies
6:36 SBIR program renewal and uncertainty ahead
7:09 NPC survey on the IRA’s impact on investment
7:51 Closing thoughts & call to action

We’re reporting on the headlines, not making medical recommendations. For personal health questions, always consult a doctor.