An FDA Reviewer Exodus on the Horizon: Gottlieb
FDA is likely to see up to a 25%, if not greater, reviewer exodus over the coming months as about 600 reviewers have currently recused themselves from working on product evaluations while they look for employment in industry or outside of the federal government. “These are people who are looking to leave the agency,” former FDA commissioner Scott Gottlieb told CNBC’s Squawk Box earlier this week.“So there’s an expectation that there's going to be a lot of voluntary departures from the agency over the course of the summer.”
The upcoming departures coupled with the reduction-in-force cuts and ongoing voluntary retirements paint a stark picture of FDA in disarray. Gottlieb says biotech companies are already not receiving the same level of interaction with the agency that they previously expected. For example, companies that seek meetings with FDA are receiving written responses instead for policy clarifications, he said. “That’s not good for small biotech companies that need that engagement with the agency, that have complex development pathways or not as much experience, and that’s starting to impact development programs.”
In looking at the first quarter, there have only been nine drug approvals at FDA, Gottlieb said. That’s a low not seen since Covid-19. There are about 75 drugs slated for approval this year, “but so far, you’ve seen the agency fall behind on some of that work,” he said. On the bright side, Gottlieb said there’s a lot of “resiliency built into the agency, and so I think that they're going to find ways to try to work more efficiently, by not having the meetings and as much engagement, and focusing more on the review activities.”
However, looking on the horizon, Gottlieb cautioned that HHS’ leadership is pushing a reorganization plan that would consolidate all the medical product and scientific Centers into one big review function to reduce headcount. “I think that will have a very dramatic and traumatic impact on the agency if they go forward,” he said.
The HHS reorganization is also looking to separate things like the compliance functions from the scientific review functions and consolidating these to reduce headcounts, according to Gottlieb. “There are very good reasons why you want the compliance function, for example, closely integrated with the scientific review staff, because the scientific review staff understands the sort of nature of a problem that arises in a post-market setting, say, a drug side effect, and they can direct the compliance function to take appropriate action,” he explained. “So you don't want to separate those two scientific functions because it might look like redundancies to have a compliance and a review team within each center.”