Barclay P. Butler
Deputy Commissioner for Operations & Chief Operating Officer, Food and Drug Administration
Barclay Butler’s latest achievement is applying the lessons he learned while leading the consolidation of Army, Navy and Air Force hospitals into the Defense Health Agency to designing and launching FDA’s new shared services operating model.
“Our single vision in the COO’s office is to remove administrative burdens from the reviewers, inspectors, and investigators by providing them with effective and efficient shared services covering finance, human resources, facilities, IT, contracting, grants, FOIA, and more, by which we can improve on the time and cost of reviews and inspections, bring more products to the American public, while assuring we meet the FDA mission to protect the public health and preserve the national security,” Butler said.
Why Watch
Through 2025, Butler’s team will focus on building and training the shared service providers that support FDA centers, offices and programs. Their goal is to remove administrative burdens from the drug, biologics, medical device, tobacco and food review teams; ensure a safe food supply; keep inspectors and investigators in the field; and give FDA staff more time to carry out their mission of protecting public health and national security.
As one of the largest operational divisions within the Department of Health and Human Services, FDA is fully aligned with the efficient use of taxpayer-funded resources. It has exceeded the administration’s resourcing goals while continuing to fulfill its critical mission on behalf of the American public.
“We also have to modernize,” said Dr. Marty Makary, FDA commissioner. “On day one of me being on the job, I actively began an effort to organize to use AI for our scientific reviewers to make their jobs easier. Well, two weeks ago, we just announced our first AI-assisted review with the latest generation AI technology. One reviewer said that what normally took him two to three days, the AI did in six minutes. … The goal is to reduce the paperwork burden of reviewers, which is tremendous, so that we can deliver more cures and meaningful treatments to the American people faster.”
Fun Fact: Butler is an avid sailor who spends his vacations chartering bareboats along the U.S. East Coast and in the British Virgin Islands. He’s also a member of American Legion Riders, riding his Harley-Davidson in parades with three large flags mounted on the back and helping raise money for local charities.