Recent reductions in force (RIFs) and leadership changes at FDA are already affecting key agency functions—and as the administration plans a broader reorganization, the impact will likely grow. One area drawing increasing attention is how these changes will affect the drug development and review process.
As reported by the Wall Street Journal last week, reviews of both innovative and follow-on drugs have been caught in a traffic jam, largely due to a leadership vacuum at the Center for Drug Evaluation and Research (CDER). Senior officials have left, others haven't been replaced, and internal morale is reportedly "a work in progress"—a euphemism that, frankly, isn't very euphemistic. That's all bad news if your timeline depends on FDA sticking to theirs.
The Prescription Drug User Fee Act (PDUFA) sets specific deadlines for FDA to act on applications—typically ten months from the date FDA files the application for standard review and six months for priority review. These timelines are sacred to both R&D teams and Wall Street, and historically, FDA has a solid track record. According to the agency's own performance reports, FDA has earned an "A" over the past five years, even reaching or exceeding 97% of its review goals for 11 of 12 submission types in 2023.
But, in recent weeks, concerns have mounted that deadlines may slip. While we haven't seen much slow-down yet in our work at HPM, we are aware of some applications that appear to be idling. A recent Bloomberg Law report noted that staff cuts have left reviewers juggling multiple roles, including some filling in for departed senior leaders while still covering their own work, all without the help of RIFed support staff. One reviewer described the situation as "chaotic," and another simply said, "We don't have the bandwidth."
If you were hoping for signs of stabilization, other recent headlines suggest more turbulence. Reuters reports that FDA recently dismissed most of its user fee negotiators—just as the next PDUFA and GDUFA reauthorization cycles begin. These are the professionals responsible for negotiating how the agency gets funded. Swapping out experienced negotiators at the start of high stakes talks raises legitimate concerns about whether FDA is prepared for the administrative heavy lifting ahead. While a fresh perspective can be valuable, in this case, the agency may be refreshing its roster right into a disadvantage.
Like the WSJ, we believe the impacts of such drastic staff cuts are a near certainty, but we are also cautious not to attribute every delay or unanswered email to the RIF and leadership changes. Some regulatory actions or inactions like the three cited in the WSJ article may not be attributable to anything other than the machinations of a large agency and are of the sort that have plagued clients for years. FDA's failure to respond to a substantive question in two weeks' time is hardly cause for concern, the proximity to the RIFs notwithstanding. Exercising a keen eye to discern which actions or inactions are actually being caused by the recent events may aid us in being more effective at combating them.
For companies with pending or planned NDAs or BLAs, this environment calls for both defensive and offensive strategies. First, it's wise to build in more time for FDA review—even if your data look great and your application is buttoned-up. That's especially true for applications involving advisory committees, REMS evaluations, or pre-approval inspections. Second, clarity and focus in your pre-submission meetings are more critical than ever. These interactions—already short and highly structured—may now be your best shot at aligning with a stretched agency. And finally, if your business strategy hinges on hitting a PDUFA date, consider engaging regulatory counsel early to spot red flags well in advance. In this climate, getting the first cycle right isn't just about speed, it's potentially about survival.
In recent interviews, FDA Commissioner Dr. Marty Makary emphasized that no scientists or reviewers were affected by the RIFs, stating that the layoffs targeted administrative and support roles. He's also committed to ensuring that remaining scientific staff have the tools they need. But it's fair to say the full impact on remaining reviewers—now operating without both senior leadership and support infrastructure—has yet to be fully realized.
We'll be back with more on this.
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