April Fool’s Day was a difficult day for many FDA employees, because that was when many of them found out they were let go as they attempted to enter FDA’s White Oak HQ by swiping their badges at the entry gates. With many significant Offices and Division cuts, there are questions of how those cuts will impact operations such as the drug/device/biologics and biosimilar review and approval process.
In addition, since many of the staffing cuts were in the communication and policy groups, both the FDA and industry folks are wondering how, and in what manner are those functions going operate if they are centralized in the Department of Health and Human Services (HHS). Industry will obviously want to know how these cuts are going to impact communication and policy development and guidance, both inside and outside of the Agency. The apparent lack of transparency of how the FDA will interact with HHS in assuring that these functions are well defined will cause almost as much angst as the trimming of the workforce has already.
With the User Fee (UFA) negotiations coming up soon and many of the senior staff that have been involved in the previous negotiations now gone from the Agency, the industry is obviously concerned about the loss of Agency historical experience and how that might impact the process.
Operational issues (like how are the outstanding consultations issued to different Agency review divisions from other FDA components going to be handled moving forward) are concerning industry, as many of the staff that have previously handled these internal consultations are now gone. Policy issues that may be necessary to resolve issues impacting pending or approved applications will need to be coordinated and, with so many of the policy folks being dismissed, how and who will be charged with evaluation and resolution of those issues is unclear. Will it be at the Agency or in another centralized policy role within HHS? I am not sure anyone at the FDA can answer that question today.
With regard to prescription drug advertising, an area of particular interest to Secretary Kennedy, who has stated his preference that DTC ads for prescription drugs be banned, how will this be handled at FDA, since, simultaneous to Kennedy’s confirmation, DOGE made significant staffing cuts in that very division, the result of which will dramatically decrease the oversight of DTC advertising by the remaining staff, who are charged with reviewing those DTC ads and all advertising for violations, and initiating corrective or enforcement action. While that seems kind of counterintuitive, perhaps this is an indication that the Administration may be planning to take broader action against prescription drug DTC advertising, in general.
Many of these are, of course, operational issues that can be dealt with, but the lack of transparency and of a clear picture of the impact of the staffing cuts that were made and of what comes next is worrisome to both industry and the FDA. In addition, one must remember that Congress has passed many legislative initiatives over the last five years that placed additional reporting and operational responsibilities on most FDA components. Those additional incremental requirements placed on the Agency will exacerbate the impact of the recent staff reductions, as there is no relief from those statutory mandated requirements.
We are already seeing the impacts of the staff cuts in OGD, as there have not been any reported new ANDA original application approvals posted on the daily FDA webpage since March 27th. Supplemental application approvals are appearing, but for full approvals there is an extra step required, maybe the person who handled that extra step was RIFed on Monday!
The staffing cuts including forced and voluntary exits, especially of senior officials with years of experience in the drug review and approval process and will certainly have a negative impact on the institutional knowledge base that is essential for the proper training of the newer hires and hamper consistent decision making.
With former FDA Commissioners Califf, Gottlieb, and McClellan all expressing worry about the impact the reorganization and staffing cuts may have on FDA’s ability to meet its User Fee dates and other responsibilities, certainly, I for one share many of the same concerns. Let’s hope that over the next few weeks or months there will be more transparency regarding how the Agency will be able to provide the same level of services with fewer people.
