Hims House

Ep 45 - Scott Brunner on Compounders vs. Big Pharma

12 snips
Sep 9, 2025
Scott Brunner, CEO of the Alliance for Pharmacy Compounding, dives deep into the world of compounding pharmacies. He discusses the struggle between compounding and big pharmaceutical companies, particularly against giants like Eli Lilly and Novo Nordisk. The conversation touches on regulatory challenges, including the 5% rule and a contentious list of hard-to-compound medications. Brunner also highlights the increasing demand for GLP-1 drugs and the implications for patient access, advocating passionately for the future of compounded medications.
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INSIGHT

Legal Limits On 503B GLP-1 Production

  • 503B outsourcing facilities can only legally compound when an FDA-approved drug is on shortage or the API is on the 503B bulks list.
  • Semaglutide and tirzepatide are not on the bulks list and shortages ended, so legal authority for widespread 503B compounding is unclear.
ANECDOTE

Risk-Based Approach Among Bad Actors

  • Scott described a risky mindset in some compounders as a “risk-based approach” meaning "we'll do it until we get caught."
  • He warned this behavior harms the entire compounding industry's reputation.
INSIGHT

Drugmaker Lawsuits Are Diverse And Mixed

  • Lawsuits from Lilly and Novo Nordisk vary: trademark, state deceptive-practice claims, and telehealth allegations are common.
  • Courts so far have often been unsympathetic to drugmakers and have rejected state-law claims preempted by federal law.
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