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.
2027 EXPIRY
The Prescription Drug User Fee Act ( PDUFA) and the Generic Drug User Fee Amendments (GDUFA) programs involved are reauthorized every five years and expire in September 2027.
About 70% of the FDA's drug review budget is funded by the industry fees collected by the agency, through PDUFA. In fiscal year 2024, the FDA collected about $1.4 billion in fees paid by companies for the review of their brand name drugs.
Since mid-2024, staff had been preparing to hold planning meetings in April with industry groups PhRMA and BIO to set the schedule and discuss logistics for formal negotiations slated to begin in September. Those meetings were cancelled, several of the sources said.
PhRMA and BIO did not respond to requests for comment on Thursday.
The dismissed staff were ordered to stop working immediately and had no opportunity to hand over negotiation materials to colleagues, the sources said.
Health Secretary Robert F. Kennedy Jr., who has led the firing of 10,000 workers at federal public health agencies including the FDA, has said the cuts are needed to pare down bureaucracy at the regulator and will improve efficiency.
The FDA also laid off staff responsible for organizing its legally required public meetings, which must be held before the negotiations begin over the agreement renewals, the six sources said.
The meeting for generic drugs was set for June, and the one for prescription drugs for July.
These day-long sessions at FDA headquarters typically draw hundreds from pharma companies, trade groups, patient advocates and the public who suggest priority topics for the reauthorized agreement.
Some of those fired on April 1, including negotiators, also monitored the FDA's progress on commitments under the current user fee programs, like hiring targets, the sources said. Their dismissal has halted work on required reports to Congress, such as the annual PDUFA Performance Report.
"There are no people at the FDA now doing overall tracking and reporting on whether the agency is meeting its required comments under PDUFA and GDUFA," said Janet Woodcock, who was Principal Deputy FDA Commissioner before she retired last year.
"These programs have been hobbled by losing all of their support staff. They are what enable the system to bring safe and effective medicines to the American public."
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.
2027 EXPIRY
The Prescription Drug User Fee Act ( PDUFA) and the Generic Drug User Fee Amendments (GDUFA) programs involved are reauthorized every five years and expire in September 2027.
About 70% of the FDA's drug review budget is funded by the industry fees collected by the agency, through PDUFA. In fiscal year 2024, the FDA collected about $1.4 billion in fees paid by companies for the review of their brand name drugs.
Since mid-2024, staff had been preparing to hold planning meetings in April with industry groups PhRMA and BIO to set the schedule and discuss logistics for formal negotiations slated to begin in September. Those meetings were cancelled, several of the sources said.
PhRMA and BIO did not respond to requests for comment on Thursday.
The dismissed staff were ordered to stop working immediately and had no opportunity to hand over negotiation materials to colleagues, the sources said.
Health Secretary Robert F. Kennedy Jr., who has led the firing of 10,000 workers at federal public health agencies including the FDA, has said the cuts are needed to pare down bureaucracy at the regulator and will improve efficiency.
The FDA also laid off staff responsible for organizing its legally required public meetings, which must be held before the negotiations begin over the agreement renewals, the six sources said.
The meeting for generic drugs was set for June, and the one for prescription drugs for July.
These day-long sessions at FDA headquarters typically draw hundreds from pharma companies, trade groups, patient advocates and the public who suggest priority topics for the reauthorized agreement.
Some of those fired on April 1, including negotiators, also monitored the FDA's progress on commitments under the current user fee programs, like hiring targets, the sources said. Their dismissal has halted work on required reports to Congress, such as the annual PDUFA Performance Report.
"There are no people at the FDA now doing overall tracking and reporting on whether the agency is meeting its required comments under PDUFA and GDUFA," said Janet Woodcock, who was Principal Deputy FDA Commissioner before she retired last year.
"These programs have been hobbled by losing all of their support staff. They are what enable the system to bring safe and effective medicines to the American public."
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