Gottlieb Praises Clinical Trial Initiative; Calls for FDA Career Leadership
Former FDA commissioner Scott Gottlieb is praising the agency's newly announced initiative to accelerate early-stage clinical trials, arguing that the package of reforms could help reverse the migration of Phase 1 studies to overseas markets such as China and Australia. Speaking on CNBC’s Squawk Box, Gottlieb said the agency's 6/22 announcement (see earlier story), which includes a proposed pilot program aimed at shortening the timeline from drug discovery to first-in-human studies, is a "thoughtful" collection of policy changes designed to make it easier for sponsors to launch early clinical research in the U.S.
"One of the big bottlenecks has been getting permission to start a Phase 1 trial here in the United States," Gottlieb said. "A lot of biotech companies are moving their proof-of-concept trials overseas, particularly to China and Australia, because it's much easier to get these trials open there."
According to Gottlieb, many biotechnology companies conduct small early-stage studies abroad to generate initial efficacy signals before returning to the U.S. for larger Phase 2 and Phase 3 trials. He said FDA's reforms could help level the playing field and attract more of that research activity back to the U.S.
The initiative was unveiled as part of a broader HHS effort to strengthen America's position in clinical research and biomedical innovation. FDA said it plans to seek public comment on a pilot program intended to shorten the time required to move from drug identification to first-in-human testing.
Beyond the clinical trial initiative, Gottlieb used the interview to argue that recent improvements at FDA reflect a return to a management structure that relies on experienced career scientists to lead the agency's medical product centers.
Gottlieb, who recently co-authored a commentary in JAMA (see earlier story), said current acting FDA commissioner Kyle Diamantas has restored a model in which career officials oversee the agency's drug, biologics, and device centers. He contrasted that approach with the tenure of former commissioner Marty Makary, whom he criticized for installing political appointees in senior scientific leadership roles.
"These are very difficult jobs inside the agency," Gottlieb said. "There's a very steep learning curve." He noted that FDA medical reviewers often require several years of training before independently handling complex drug applications, arguing that the specialized nature of FDA review work makes it difficult for outside political appointees to effectively manage scientific centers.
He said the agency has recently become more efficient and has avoided some of the controversies that emerged under prior leadership. He also pointed to FDA's reexamination of certain regulatory decisions made during the previous administration, including a recent review involving a diabetes drug developed by Sanofi.
According to Gottlieb, experienced career leaders ultimately make it easier — not harder — for commissioners to advance policy priorities. "What you really want is strong, experienced scientists in those centers that you have a good rapport with, that you can work with, that can get things done," he said.