The BioCentury Show Ep. 103 - Kolchinsky: FDA Conservatism, MFN and IRA Are Slowing Drug Development
20 snips
Feb 18, 2026 
Peter Kolchinsky, managing partner and co-founder of RA Capital and outspoken biotech investor and policy advocate. He warns that FDA staffing and conservatism are slowing U.S. trials and pushing early-stage work overseas. He dives into MFN and drug pricing risks, offers a targeted MFN pilot idea, and urges stronger industry advocacy and international R&D collaboration while protecting manufacturing.
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Parallel-Track Early Trials Outside U.S.
- Do run early-stage trials outside the U.S. when possible to avoid FDA review delays and staffing issues.
- Use countries like Australia or the U.K. to parallel-track phase I/II work and buy time before U.S. submissions.
MFN Risks Shrinking Global Drug Value
- MFN-style policies can shrink ex-US revenue and reduce a drug's global NPV by about 20–30%.
- That lower global value makes ex-US partnerships less attractive and could reduce launches abroad.
Contract Protect Ex‑US Pricing Control
- Do include contract clauses in ex‑US partnerships that preserve control over ex‑US pricing or allow taking back rights.
- Bake price-control or reversion mechanisms into partner agreements to prepare for future MFN rules.
