Gottlieb TV Appearance Endorses Overton FDA Nomination
On the eve of FDA commissioner-nominee Heidi Overton’s Senate confirmation hearing, Former FDA head Scott Gottlieb appeared on CNBC to offer his ringing endorsement of President Trump’s pick to lead the agency. Gottlieb cited as being positive her White House experience, relationships with administration officials, and her potential role in restoring stability to an FDA that has experienced substantial staff turnover.
In the CNBC interview, Gottlieb said her experience working on FDA-related policy at the White House could help the agency advance its priorities while addressing staffing shortages and maintaining continuity in its drug review operations.
Gottlieb’s television appearance comes the day after he and former FDA commissioner Mark McClellan co-authored an article endorsing Overton's nomination. “I think she has experience that could be very effective for the agency coming out of the White House,” Gottlieb said. “Those relationships, I think, are going to be very important in terms of moving policy on behalf of the agency.”
Gottlieb said FDA officials who have worked with Overton believe she supported the agency on important policy decisions. He also pointed to recent decisions to make career Center directors permanent (see story), including leadership positions overseeing drugs, biologics and tobacco, as steps toward preserving institutional continuity. Although Gottlieb said he believed Overton may have played a role in those decisions, he did not provide direct evidence of her involvement.
Gottlieb said Overton is likely to face direct questions about the administration's vaccine policies, particularly a recent White House executive order addressing the measles, mumps and rubella (MMR) vaccine. He identified Sen. Bill Cassidy (R-LA) as a vocal lawmaker expected to press Overton on the issue.
Gottlieb said Overton's involvement in developing the executive order has been the subject of speculation, but he suggested the policy reflected the direction of the president and administration leadership rather than necessarily Overton's personal views. He said the confirmation hearing would provide an opportunity for senators to establish her own position on vaccination. “I don't perceive her as someone who's anti-vax in any sense,” Gottlieb said, adding that he expected her to answer questions about the administration's vaccine policies directly.
Gottlieb also discussed FDA's efforts to rebuild its workforce following substantial personnel losses, saying acting commissioner Kyle Diamantas has focused on restoring senior leadership and hiring additional drug reviewers. One obstacle, Gottlieb acknowledged, is that the agency has lost many of the human resources personnel responsible for recruiting and onboarding new employees. “The HR function has been substantially reduced, and it's just giving them challenges trying to onboard new people into the agency,” he said.
Gottlieb said the agency has not yet experienced a dramatic deterioration in its drug review function despite losing thousands of employees, including senior scientific and regulatory personnel. However, he cautioned that the effects of those departures could become more pronounced over time. He expects rebuilding the workforce to remain a priority under Overton if she is confirmed.
Gottlieb also outlined a potential regulatory reform aimed at accelerating the initiation of Phase 1 clinical trials in the United States and addressing increasing competition from China in early-stage drug development. He said Chinese drug developers can move investigational products into first-in-human studies more quickly and at lower cost, allowing them to evaluate more compounds and establish proof of concept earlier in the development process.
Gottlieb suggested that one way to improve FDA's efficiency would be to reorganize its pharmacology and toxicology review functions, which evaluate the preclinical evidence supporting investigational new drug applications. Under his proposal, pharmacology and toxicology groups would be moved out of individual drug review divisions and consolidated into a separate office dedicated to preclinical development. The change, he said, could provide more consistent supervision of preclinical reviews and improve the efficiency of decisions allowing investigational products to proceed into human testing.
Gottlieb noted that FDA previously established separate offices for other scientific disciplines supporting drug review, creating a matrix organizational structure during McClellan's tenure as commissioner in the early 2000s. Pharmacology and toxicology groups, however, remained within individual review divisions. "I think one thing you could do is pull them out and create a separate office," Gottlieb said.
He characterized the proposal as an opportunity to improve oversight of preclinical development and reduce regulatory bottlenecks that may contribute to companies conducting early clinical studies outside the United States.
Gottlieb said Overton has already been involved in policy work addressing early drug development during her tenure at the White House and expressed his expectation that the issue would remain a focus if she assumes leadership of the FDA.