October 5, 2026

ARPA-H's SURPASS Program

WASHINGTON, D.C. – Faster access to effective treatments is a goal every physician shares. But speed must never come at the expense of knowing whether a drug is safe. The Department of Health and Human Services' SURPASS (Simulation-augmented Real-time Platform Adaptive Seamless trials) program was announced just after confirmation hearings for a permanent Food and Drug Administration (FDA) Commissioner. The SURPASS program is the centerpiece initiative which seeks to build perpetual, adaptive platform trials using predictive computational models, shared control groups, and AI-driven operations. This program by itself raises serious concerns for patient safety, and taken together with FDA proposals to shorten trials and alter standards of proof of benefit, is a revolutionary change in drug approval. 

Specific concerns raised by the SURPASS program involve fundamental questions on the capacity of the FDA to fulfill its mission to approve drugs that are proven to be safe and effective.Safety signals, especially rare or delayed ones, depend on observing real patients. Substituting in silico information for human control data, or enrolling fewer participants, risks missing harms until a drug is widely used. Without clearly defined evidentiary standards set in advance, decisions about when models may stand in for human data could be shaped by political priorities rather than science.

The decision process has not been transparent, and the mechanisms in SURPASS are likewise shrouded in uncertainty.The public has not been told how much funding is involved, how models will be validated, or how AI systems handling safety reporting will be audited. The FDA Task Force firmly believes that proprietary algorithms which cannot be parsed and analyzed for legitimacy must not become incorporated into drug approval.We have concerns about the adequacy of data in this program. Continuously adapting designs complicate interpretation, and regulators and clinicians need clear, reproducible evidence to make confident decisions.

Doctors for America urges ARPA-H and FDA to publish validation criteria, require independent review, and preserve human-derived evidence as the foundation of approval. Making this vital information transparent is an important step towards putting patients over politics.

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About Doctors for America:

Doctors for America (DFA) is a national nonprofit that mobilizes over 40,000 physicians and medical trainees to advocate for policies that improve the health of patients and communities. Through advocacy training and action at the state and federal levels, DFA works to expand access to affordable care, strengthen community health and prevention, and advance health justice and equity. We do not accept funding from pharmaceutical, insurance, or for-profit health care entities, ensuring our work remains fiercely independent and patient-centered. DFA puts patients over politics–and over profits. Find out more at doctorsforamerica.org and on X @drsforamerica or Bluesky drsforamerica.bsky.social.

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