FDA's Marty Makary: Everything should be over-the-counter unless it's unsafe or requires monitoring
Speakers
Summary
- GLP-1 Crackdown: The FDA is actively cracking down on "mass compounding" of GLP-1s now that shortages are resolving. Makary explicitly mentions sending a warning letter to Hims & Hers (HIMS) for violating marketing and compounding guidance.
- Moderna Setback: Makary defends the FDA's "refusal to file" letter regarding Moderna's mRNA flu vaccine, citing "substandard care" in the control group for seniors. He emphasizes that established seasonal flu shots are the standard of care.
- PBM Reform: The administration views PBM "spread pricing" (marking up drugs 10x-100x) as price gouging and intends to enforce transparency, which threatens the traditional PBM business model.
- OTC Push: A major 2026 goal is moving safe prescription drugs (e.g., vaginal estrogen, nausea meds) to Over-The-Counter status to lower prices and bypass insurance middlemen.
- US vs. China Biotech: The FDA aims to drastically reduce the "pre-IND" timeline (currently 520 days) to compete with China's speed (200 days) in initiating Phase 1 clinical trials.
Trade Ideas
Makary notes that GLP-1 shortages are ending and emphasizes that compounders should be getting APIs directly from the patent holders (Novo Nordisk and Eli Lilly) to "play by the rules." The regulatory crackdown on "grey market" compounders eliminates low-cost competition. As the FDA forces the market back toward approved products and authorized supply chains, volume and pricing power return to the IP owners. LONG as the regulatory moat is re-established. Continued supply chain constraints or political pressure on list prices.
Makary defends the FDA's "refusal to file" decision on Moderna's flu vaccine, stating the trial used "substandard of care" (no flu shot) for the control group of seniors, rather than the existing effective flu shot. This indicates the FDA will hold mRNA platforms to rigorous traditional standards rather than granting the emergency leeway seen during COVID. It signals delays and higher hurdles for Moderna's non-COVID pipeline. AVOID until regulatory pathway clarifies. Moderna could rapidly redesign trials or produce overwhelming data that satisfies the FDA.
Marty Makary
FDA Commissioner
Makary explicitly confirms the FDA sent Hims & Hers a warning letter in September regarding their marketing claims and compounding practices. He states the FDA is "serious about cracking down on mass marketing claims" and unapproved APIs now that shortages are ending. HIMS has relied heavily on compounded GLP-1s for recent growth. An active FDA crackdown targeting them by name suggests significant regulatory risk to this revenue stream. SHORT due to heightened regulatory enforcement and the end of the shortage exemptions that allowed their business model to thrive. HIMS may successfully pivot to branded partnerships or the FDA enforcement may be slower than anticipated.
