Kolchinsky: Policy constraints holding back biomedical innovation

RA Capital’s Peter Kolchinsky on FDA, MFN, IRA and more, on The BioCentury Show

In a candid interview with BioCentury, RA Capital Managing Partner Peter Kolchinsky warned that staffing losses and growing conservatism at FDA are slowing drug development and pushing companies to launch early-stage trials outside the U.S.

Kolchinsky said sponsors should now assume “a three-month minimum delay for even the best drugs,” arguing that capacity constraints at the agency are reshaping development strategies. He told BioCentury he is increasingly advising companies to consider Australia or the U.K. for first-in-human studies when feasible.

Kolchinsky also raised concerns about U.S. policy headwinds, including most-favored-nation (MFN) pricing proposals and the Inflation Reduction Act’s “pill penalty,” and criticized the biopharma sector for being too “genteel” in its advocacy. Kolchinsky discussed his decision to speak publicly about regulatory and political issues, including immigration, and reflected on China’s expanding role in the global life sciences innovation ecosystem.