More than a year after DOGE implemented sweeping job cuts and an early retirement option that paved the way for thousands of additional premature departures, top jobs at the FDA are still filled by temps and less experienced personnel.
But there is hope among industry experts that normalcy may soon return to the agency — at least in the form of more stable leadership.
The agency has been roiled by a revolving door in its leadership, including the May departure of FDA Commissioner Dr. Martin Makary. The agency is now led by an acting commissioner, Kyle Diamantas, who is generally well-liked, according to Elizabeth Jungman, partner at Hogan Lovells Cadwalader.
Meanwhile, two key drug divisions — the Center for Biologics Evaluation and Research, and the Center for Drug Evaluation and Research — have both seen rapid director turnover, including twice-ousted former CBER director Dr. Vinay Prasad, who most recently departed following controversial decisions involving specialty drug and vaccine review. Temporary leaders at the drug divisions, Karim Mikhail at CBER, and Dr. Michael Davis at CDER, are also reportedly in good graces with FDA staff and industry leaders, at least for now.
“On the drug and biologic side, we're really seeing the pendulum swinging back pretty quickly toward more regular order,” Jungman said. “There’s definitely a return of power and decision-making to the divisions.”
But it’s not clear whether the temporary leaders will last or when permanent successors could be named for those positions.
“What I'm hearing anecdotally is that the plan is to nominate a commissioner, a CDER director and a CBER director as a package,” Jungman said. “We will see whether that actually happens or not, but it wouldn't be terribly surprising.”
As the FDA awaits answers about its future leadership, agency employees are forced to contend with swirling questions around the FDA’s long-term priorities, policies and ability to meet workforce demands.
A change in policy direction?
It’s unclear how the evolving leadership picture will affect policy-making going forward, especially because many recent agency initiatives have been announced through less traditional and durable formats, such as fact sheets, journal articles and press releases, instead of traditional guidance documents, Jungman said.
“It's hard when you're advising a company, or when a company is trying to make a decision about a development program, to know whether something that's in a New England Journal of Medicine article is real [policy], or whether that's a couple of senior leaders' opinions,” Jungman said. Pharma companies often take a wait-and-see approach as a result.
Despite the changes, it’s likely that some priorities, such as a desire to accelerate early-stage clinical trials to help the U.S. compete with countries like China, will outlast the current leadership. A push to incorporate AI at the FDA will also probably be durable, said Jodi Scott, partner at Hogan Lovells Cadwalader.
“They're using it to help them manage their workloads. We’re seeing it in inspections,” Scott said, noting that AI is often more reliably flagging problematic files than a human auditor.
But other initiatives may go by the wayside, such as the Commissioner’s National Priority Voucher Program, which accelerates review for chosen drugs and has been critiqued as political, according to Jungman.
“I won't be surprised to see kind of significant structural changes to something like that, if it even survives,” she said.
Ultimately, the hope is that the current trend toward a more traditional FDA will continue.
“I think the industry would like to see people in those [leadership] positions who are going to create that kind of stability and predictability, as opposed to the volatility that we've seen over the course of the last year,” Jungman said.
Short staffing, high pressure
The FDA has struggled with not only retaining leaders, but also with short staffing. The agency was hit hard by DOGE cuts, and is facing an experience gap, thanks, in part, to an early retirement program last spring that allowed people with qualifying years of service to access their pensions, Jungman said. Many department managers with decades of experience opted to leave the agency as a result.
“Those are the people who have the expertise and the competence to be flexible, to be creative, to take risks, [and] to really help figure out a path forward for an application that perhaps doesn't fit well into a previous mold,” Jungman said. “I think it’s an enormous loss.”
The FDA is now looking to fill some 2,200 open positions. While agency roles have historically been lower-paying than comparable industry jobs, they’ve typically attracted experts for their prestige and stability, Jungman said. But amid the recent uncertainty, those jobs might not be viewed as being as stable as they once were.
“Anecdotally, what I'm hearing from hiring managers is that they just don't have the same applicant pool that they used to have,” Jungman said.
As a result, FDA staff sometimes struggle under heavier workloads.
“Staff are overworked and have sometimes been asked to take on areas that are outside of their core expertise,” Jungman said.“We're seeing places where you maybe can't assume that the person on the other end of an interaction with the agency has the same expertise as the person you might have been dealing with a couple of years ago.”
Companies interfacing with the less tenured staff report sometimes receiving seemingly off-target questions during reviews that might not have surfaced under more experienced personnel, Scott said.
While drug approvals appear to be keeping pace with prior years, Jungman said she wonders if the staffing pressures are impacting other work, such as the rate of complete response letters.
Staff members are typically under heavy pressure not to miss goal dates, and issuing a CRL could be a means to buy more review time.
“From at least my experience inside the agency, it is sometimes easier to get to no than to get to yes,” Jungman said.
