Yesterday’s purge of thousands of HHS workers has left many wondering how federal health agencies will function without a substantial portion of the workforce. The answer will likely take time to reveal itself, but if the “chaotic” start to Robert F. Kennedy Jr.’s restructuring plan is any indication, pharma has plenty of reasons to worry.

Changes to staff involved in user fee negotiations could hit the industry particularly hard. Specifically, there were “major impacts” felt on teams who handle PDUFA, MDUFA, BsUFA and GDUFA according to Alec Gaffney, vice president of regulatory policy and intelligence at Politico’s AgencyIQ, who added that the situation leaves “major questions about who will represent the FDA at these negotiations.” 

Getting a clear picture of the totality of the layoffs has been difficult with no information coming directly from HHS on which staff were impacted. But today, we’re looking at what we know about how these changes have shaken up leadership ranks at the FDA and who’s been given the boot by the agency. 

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