Make the FDA Great Again

Blog post, April 5, 2025. By Joe Lonsdale.

Key Takeaways

• The thesis: regulatory burden — not scientific difficulty — is what threatens American biotech leadership, and China is gaining because its regime is more permissive.
• “Capital is following suit: venture dollars, and strategic acquisitions are pouring into Chinese biotech.”
• Trial design is the specific ask: remote trials, adaptive designs and challenge trials in place of Phase III conventions set in the mid-20th century.
• Manufacturing vulnerability: over 90% of generic injectable drugs are made abroad; he wants domestic capacity rebuilt with equal inspection standards for foreign and US plants.
• Patient access: shift the frame from caution toward transparency and informed choice.

Connections

• Saved into Chips For America - Research because it is the same argument in a different industry — a permitting-and-process critique of American industrial capacity — which is what makes it useful there rather than as a biotech read.
• Sits directly beside the NEPA reporting in that draft: both claim process is the constraint. ⚠️ Both are also advocacy; the draft should mark them as positions, not findings.