Reactions to Industry Pressures and Regulatory Challenges

In Episode 45 of Hims House, hosts Jonathan Stern and Patrick Lester (aka Bayside) welcome Scott Brunner, CEO of the Alliance for Pharmacy Compounding, for a conversation on the future of compounding. They cover the surge in GLP-1 demand, lawsuits involving Eli Lilly and Novo Nordisk, FDA policies, and the regulatory pressures shaping 503A and 503B pharmacies. Brunner also unpacks the challenges around the demonstrably difficult to compound list, compounded hormone therapy, and peptides, while sharing insights into congressional actions and the MAHA movement’s role in protecting patient access to compounded medications.

00:00 - Introduction

01:02 - The Role of the Alliance for Pharmacy Compounding

01:51 - 503Bs Ramping Production? Rumors vs Realities

07:55 - Lawsuits Involving Eli Lilly and Novo Nordisk

11:58 - Patents

15:51 - Policy Negotiations and the MFN Debate

25:06 - Lawmaker Letter to FDA

28:04 - What’s in the APC Blueprint

28:51 - The 5% Rule and MOU Requirements

33:42 - The Demonstrably Difficult to Compound List

41:00 - Compounded Hormone Therapy

43:21 - Peptides