Expert Call: FDA Lawyer's Thoughts On GLP-1 Shortage
Notes from our conversation with an FDA lawyer with >40 years of experience
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***Apologies for the back-to-back HIMS GLP-1 update but we share our notebook as we update it with notes/ideas/etc. There is one last broader report we’ll send out that we’ve been working on but excluding a random encounter, we should be back to sharing new updates/ideas with you all soon.***
Discussion Notes
On Friday, January 31st, 2025, we spoke with a lawyer regarding the FDA shortage around GLP-1s and what their take was on the situation. For legal reasons, we have not included their name but have included their background for context on the knowledge and expertise they bring.
Worked at the FDA for ~15 years dealing with various regulatory issues affecting prescription and OTC pharmaceuticals, medical devices, and other biologics.
They’ve spent the last ~25 years handling FDA-related regulatory and litigation issues ranging from DOJ and DEA inquiries to most recently, the tele/digital health space.
We have to paraphrase here without giving too much but basically, they’re very well-informed and knowledgeable. Below are the notes from our discussion today.
**Please note that this is not a transcription! It’s our notes that we’ve summarized only.
So aside from the research we’ve put out recently (below), we wanted to get a sanity check on the situation and get their thoughts on what’s happening. When it came to the general compounding of GLP-1s, broadly speaking, they were concerned about the situation, and when it came to what happens after a shortage, they had choice words as well.
We’ve bucketed our notes from the call into 2 main categories and a few subcategories for clarity and organization.