TUCSON, Ariz., September 3, 2026 — Critical Path Institute® (C-Path) is deeply saddened to announce the passing of Peter Barton Hutt, a longtime member of C-Path’s Board of Directors, on September 2, 2026.
Peter joined C-Path’s Board in 2015, bringing decades of unparalleled leadership and expertise in food and drug law to the organization’s mission of advancing drug development through science-driven collaboration. Hutt served as Chief Counsel for the U.S. Food and Drug Administration from 1971 to 1975, a tenure during which he helped transform the agency’s approach to regulation and left a lasting imprint on modern food and drug law. His innovative approach to regulation cemented his reputation as a foundational figure in regulatory science. Hutt continued to teach food and drug law at Harvard Law School for more than three decades. Mr. Hutt testified before the U.S. House and Senate more than 100 times, co-authored the leading casebook Food and Drug Law: Cases and Materials, and, over a career spanning more than six decades, served as a principal architect for most major legislation amending the Federal Food, Drug, and Cosmetic Act. He was a longtime member of the Institute of Medicine (now the National Academy of Medicine) and maintained an active legal practice and teaching schedule throughout his final years.
“I had the privilege of knowing Peter for many years, and I can say without exaggeration that few people have shaped the practice of food and drug law, and by extension the course of regulatory science, the way he did,” said Klaus Romero, M.D., M.S., FCP, CEO of C-Path. “Peter brought a rare combination of historical perspective and forward-looking judgment to our Board. He had seen regulatory science evolve across different sectors for over five decades, and he used that experience to help guide C-Path through some of the most important years of our growth, always pushing us to think rigorously about how science and policy intersect. He was generous with his time, sharp in his counsel, and genuinely invested in our mission. We are grateful for everything he gave to this organization, and our thoughts are with his family.”
“Peter Hutt was a towering figure in food and drug law whose influence will be felt for generations. He did more than interpret the laws governing medicines, medical devices, and food, he helped shape the modern regulatory framework itself, while educating and mentoring generations of leaders who would carry that work forward,” said C-Path Board Chairwoman Karen Bernstein, Ph.D. “Peter brought extraordinary intellectual rigor, historical perspective, and a deep commitment to public health to everything he did. C-Path was fortunate to benefit from his wisdom and service on our Board, and we are profoundly grateful for his enduring contributions to our organization, to the FDA, and to the field of regulatory science.”
C-Path extends its deepest condolences to Mr. Hutt’s family, friends, and colleagues during this time of loss.
About Critical Path Institute
Founded in 2005, as a public-private partnership in response to the FDA’s Critical Path Initiative, C-Path’s mission is to lead collaborations that advance better treatments for people worldwide. Globally recognized as a pioneer in accelerating drug development, C-Path has established numerous international consortia, programs and initiatives that currently include more than 1,600 scientists and representatives from government and regulatory agencies, academia, patient organizations, disease foundations and pharmaceutical and biotech companies. With dedicated team members located throughout the world, C-Path’s global headquarters is located in Tucson, Arizona, and C-Path’s Europe subsidiary is headquartered in Amsterdam, Netherlands. For more information, visit c-path.org.
Critical Path Institute is supported by the Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS) and is 43% funded by the FDA/HHS, totaling $20,724,703, and 57% funded by non-government source(s), totaling $27,346,613. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. Government.
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