In the wake of unprecedented workforce cuts at the FDA, former Commissioner Scott Gottlieb and an unnamed former CBER director spoke to analysts about potential implications for drug review timelines and agency morale.
As the FDA faces an uncertain future following massive workforce cuts enacted by Health and Human Services Secretary Robert F. Kennedy Jr., two former agency officials are speaking out, expressing concern over potential drug review delays while also seeking to reassure anxious stakeholders about the state of the FDA.
Echoing the words of former FDA Commissioner Robert Califf, an unnamed former Center for Biologics Evaluation and Research (CBER) director expressed to BMO Capital Markets that “FDA no longer is as we know it and the changes we see publicly/externally may just be the tip of the iceberg,” according to an investor note from the firm early Wednesday morning (emphasis theirs). The former CBER director, who resigned from their role last month, went on to caution that the recent layoffs of 3,500 staffers “could be disruptive to FDA’s functions across various departments/divisions,” according to BMO.
The former director also spoke to the potential for drug review delays, saying this is a likely outcome that would probably start being felt next year and into 2027. The former FDA official added that despite the layoffs, review teams will likely try to meet typical performance goals of 10 months for a standard review and six months for a priority review—“given their strong commitment to bringing medicines to patients,” BMO wrote. The unnamed individual also noted that new tools could help the reduced staff to conduct reviews more efficiently.
Meanwhile, in a call with Leerink Partners analysts, Scott Gottlieb, who served as FDA commissioner from May 2017 to April 2019, discussed the influence of Kennedy, noting that he has impacted FDA communications and other actions, such as the delayed decision on full approval of Novavax’s COVID-19 vaccine, which was due on April 1. Gottlieb noted the “unprecedented nature” of this situation, according to a Leerink note sent to investors on Wednesday.
BMO’s unnamed expert also “cited uncertainty around potential political involvement of the new leadership in the decision-making process, that could increase the necessary timelines/evidence for approval and/or lead to increased” numbers of refusal to file responses and complete response letters, the analysts wrote.
In a letter sent to Senate Health, Education, Labor, and Pensions Committee Chair Sen. Bill Cassidy (R-LA) earlier this month, biopharma executives, patient advocates and investors said they are already feeling the regulatory impact of the unprecedented cuts. “The companies that happen to be engaging with the FDA right now are our leading indicators—and some of us have already encountered regulatory difficulties that we believe are the consequences of the FDA’s loss of experienced staff,” read the letter, which was organized by the advocacy group No Patient Left Behind.
Despite these concerns, Gottlieb expressed to Leerink that he is not “overly worried about the FDA missing a significant number of PDUFA deadlines,” but that he does anticipate that disruptions at the agency “will diminish both the frequency and quality of interactions between the FDA and biopharma companies,” the analysts summarized.
FDA staff are also contending with “declining morale,” Gottlieb noted during his call with Leerink. Morale was already low in the face of the unprecedented workforce cuts, and the situation was made all the worse when, in a visit to the FDA campus last Friday, Kennedy accused the agency’s remaining employees of being the biopharma industry’s “sock puppet.”
“RFK Jr.’s denigration of FDA during his meeting with employees on April 11 . . . is unfortunate for staff and culture,” Leerink wrote of Gottlieb’s position.
Still, both ex-FDA officials offered positive sentiments. While fears were raised last week that the FDA’s Prescription Drug User Fee Act (PDUFA) program—which funds nearly half of the agency’s operating budget—could be threatened by the cuts, Gottlieb expects Congress to support user fees, Leerink said. The ex-CBER director agreed, according to BMO.
