Dr. Scott Gottlieb on Novo Nordisk vs. Hims & Hers: We have a drug approval process for a reason

Speakers

Dr. Scott Gottlieb — Former FDA Commissioner; Board Member (Pfizer, Illumina, UnitedHealth); Partner at NEA (Venture Capital)

Summary

The FDA and DOJ are cracking down on Hims & Hers for attempting to sell an unapproved oral GLP-1 drug, signaling a high regulatory moat for weight-loss incumbents.
Hims & Hers is unlikely to secure legitimate pharmaceutical partnerships due to a reputation for "pushing the line" on compliance, unlike competitors such as Ro.
Venture capital funding for new vaccine development (e.g., Epstein-Barr, Lyme) is drying up due to a hostile regulatory environment and rising anti-vaccine sentiment.

Trade Ideas

Ticker	Direction	Speaker	Thesis	Time
HIMS	AVOID	Dr. Scott Gottlieb Former FDA Commissioner; Board Member (Pfizer, Illumina, UnitedHealth); Partner at NEA (Venture Capital)	Hims & Hers attempted to launch a compounded oral GLP-1 using a "liposomal" delivery system to bypass Novo Nordisk's patents. The FDA immediately referred the case to the DOJ, and Hims withdrew the product. Gottlieb argues this wasn't just compounding; by creating a new delivery mechanism to survive stomach acid, Hims effectively created an "unapproved new drug" which requires years of trials. The immediate referral to the DOJ (rather than a standard FDA warning letter) suggests regulators were preparing for a seizure or injunction. The Department of Health and Human Services (HHS) General Counsel made a rare, direct referral to the DOJ before the FDA even took enforcement action. Hims could pivot to standard compounding, though Gottlieb believes their reputation is damaged.	0:13
LLY /NVO	LONG	Dr. Scott Gottlieb Former FDA Commissioner; Board Member (Pfizer, Illumina, UnitedHealth); Partner at NEA (Venture Capital)	Novo Nordisk (NVO) and Eli Lilly (LLY) retain tight control over the GLP-1 market. Novo specifically spent ~$1.8B to acquire the "SNAC" technology that allows their oral drug to survive stomach acid. The regulatory crackdown on Hims validates the "moat" around Big Pharma's IP. While compounding exists, the incumbents will only partner with "compliant" telehealth platforms (like Ro) that respect regulatory boundaries, freezing out aggressive actors like Hims. Novo's patent on the absorption technology prevents generic oral versions from working effectively without infringing IP or triggering FDA "new drug" rules. Continued compounding of the injectable versions (which is legally distinct from the oral pill issue).	5:09
VACCINE R&D /BIOTECH/VACCINE DEVELOPERS	AVOID	Dr. Scott Gottlieb Former FDA Commissioner; Board Member (Pfizer, Illumina, UnitedHealth); Partner at NEA (Venture Capital)	Investment capital is fleeing the vaccine research sector. Gottlieb notes that research into vaccines for Epstein-Barr Virus (EBV), MS, and cancer prevention is being pulled back. The political and regulatory environment has become hostile. It is increasingly difficult to get vaccines through the FDA due to policy changes, and even if approved, the CDC is showing reluctance to recommend them due to anti-vaccine sentiment. Gottlieb states that as a Venture Capital partner, he sees it is "very hard to get a new vaccine program funded" right now. A shift in political sentiment or a new public health crisis forcing a regulatory pivot.	—