Ex-VA Secretary: Tap VA to Win Biotech Race With China
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- China has pulled ahead of the U.S. in key biotech measures, now conducting more early-stage clinical trials than the United States and capturing nearly half of global pharmaceutical licensing activity by dollar amount in 2025, according to the piece.
- The bipartisan National Security Commission on Emerging Biotechnology has warned that the U.S. risks losing its biotechnology advantage entirely if it fails to act, with Shulkin comparing the moment to the Sputnik-era space competition.
- The Department of Veterans Affairs cares for more than 9 million enrolled veterans, operates the nation's largest integrated health care system, and maintains one of the most robust longitudinal electronic health record databases — positioning it as a potential platform for adaptive clinical trials and real-time evidence generation.
- HHS recently launched Operation Trialblazer, a department-wide initiative uniting the FDA, NIH, the National Center for Advancing Translational Sciences, the National Cancer Institute, the Office of the National Coordinator for Health IT, ARPA-H, and the HHS Inspector General to modernize and accelerate American clinical research.
- The FDA has announced policies intended to cut the time from drug discovery to first-in-human studies and clarified that, in appropriate circumstances, a single high-quality late-stage study supported by confirmatory evidence may provide sufficient evidence of effectiveness.
- Shulkin proposes linking HHS, the VA, and the Department of Defense into a coordinated clinical research strategy, arguing the VA could serve as the equivalent of DARPA for clinical research — accelerating discoveries that strengthen both health outcomes and America's strategic position.
- David Shulkin, M.D., the ninth Secretary of Veterans Affairs under the Trump administration and former undersecretary for health under Obama, authored the opinion piece.
Why it matters: Shulkin's proposal would fold the VA into HHS's new Operation Trialblazer alongside the FDA, NIH, and DOD, creating a coordinated clinical research engine anchored by 9 million enrolled veterans that, he argues, China cannot easily replicate — making regulatory adaptation speed the decisive factor in whether the U.S. retains its biotech edge.
