Exclusive: FDA fires most negotiators for pharma user fee talks, sources say
Source: Reuters
April 17, 2025 6:02 PM EDT Updated 3 hours ago
LONDON/WASHINGTON, April 17 (Reuters) - The U.S. Food and Drug Administration's mass layoffs included senior negotiators in talks with the pharmaceutical industry over renewing the user fee programs that fund the regulator's drug review system, six sources familiar with the matter said. The firings of most of the negotiators and their project managers throw into disarray the complex process of reauthorizing the agreements, overseen by Congress, under which big pharma and generic drug companies pay for the FDA's review of their products, several experts said.
The experts and sources said the loss of those FDA employees jeopardizes the agency's preparations for the looming reauthorization process for the program that funds its budget for one of its core functions, reviewing drug products that can be life-saving and approving treatments that are safe and effective.
Pharma and medical device companies build their business models on the predictability provided in the user fee agreements, in which the FDA commits to complete new drug reviews within either 10 months or 6 months depending on whether it is a standard or priority application, experts say. Among the 15 people fired were the head negotiator and deputy head negotiator for one of the user fee agreements, three of the sources said. All requested anonymity to discuss internal FDA matters that have not been reported previously.
The U.S. Department of Health and Human Services, which has been handling media enquiries for the FDA, did not immediately respond to a request for comment. The user fee negotiations include setting the terms of how the regulator interacts with companies during product approvals. Their results feed into recommendations that guide Congress' reauthorizations of the program.
The layoffs of experienced and senior staff risk giving the upper hand to seasoned industry negotiators at the bargaining table, according to experts. "You can always find a warm body to get into a room with biotech and pharma, but they will get their lunch eaten," said Paul Kim, a health policy lawyer who worked at the FDA to draft the first user fee agreement in 1992 and has worked in Congress and in private practice for industry on every subsequent renewal.
Read more: https://www.reuters.com/business/healthcare-pharmaceuticals/fda-fires-most-negotiators-pharma-user-fee-talks-sources-say-2025-04-17/
There are multiple User Fee programs including PDUFA (Prescription Drug User Fee Act - which was the first in 1992, mentioned in the OP article), and later came MDUFA (Medical Device User Fee Act), and GDUFA (Generic Drug User Fee Act). These are primarily used to "pay for" the FTEs to review applications for new products (or in the case of GDUFA, an ANDA - Abbreviated New Drug Application), so funding for those FTEs for the hours worked don't come out of Budget Authority (appropriated) funds.
It was a GOP "business model for government" thing as a "fee for service". And as an incentive, if the review (with product approved or not) is not completed within the specified time, the firm gets reimbursed their fee payment.
Like everything else they are illegally shutting down, these things were authorized BY LAW. You get rid of that and industry won't get their approvals until years later, which could extend further since they have now pretty much gutted the agency anyway.