Recently, a senior Republican committee aide revealed to the media Endpoints News that although policy negotiations including additional provisions (accelerated approval of reforms, etc.) are still ongoing, at least Congress has reached an agreement on the reauthorization of the PDUFA Act and will Incorporated into continuing resolutions of Congress. The ongoing resolution or short-term spending bill needs to be finalized by the end of next week, but at least the pending bill, PDUFA, is finally moving forward.
The Prescription Drug User Fee Act (PDUFA) was enacted by the U.S. Congress in 1992 to authorize the FDA to collect fees from drug developers to expedite the review and approval of drug marketing applications. The FDA will set an approval deadline for each application, namely the PDUFA date. Before this time, the FDA must make a review decision on the applied drug—approval, disapproval, and supplementary information before considering whether to approve or not.
PDUFA needs to be reauthorized every 5 years, and it was updated in 1997, 2002, 2007, 2012 and 2017, and September 30 this year is the node that expires in 5 years.
In fiscal 2021, 46 percent of the FDA’s $6.1 billion total budget comes from PDUFA, which covers the salaries of more than 18,000 full-time employees. If Congress doesn’t re-approve the FDA’s current funding package this month, those wage budgets that run under the PDUFA program could be the first to be affected.
FDA Commissioner Robert M. Califf previously said that if Congress doesn’t live up to its commitments, the PDUFA date is about to expire and more than 3,500 employees whose salaries come from PDUFA funding will be affected. If employees are forced out of work, the FDA’s Center for Drug Evaluation and Research (CDER) will have fewer than 1,000 employees, and its Center for Biologics Evaluation and Research (CBER) will have about half its staff. If funding is not authorized, FDA will need to initiate a notification process to inform employees of PDUFA-funded employees of upcoming layoffs or furloughs.
In a July 2022 memo to FDA staff, Robert M. Calif stated: “We continue to communicate to Congress the urgency of timely reauthorization of PDUFA. If we have reasonable assurance from Congress, allow us to continue beyond September 30. Charge a fee, then we won’t need to start notifying employees of PDUFA funding. We’re trying to get that assurance from Congress, and I’m optimistic they won’t let our program expire.”
It has previously been reported that if the PDUFA Act does not pass, the FDA may have to tap the reserve funds to ensure that the normal operation of the FDA and drug review continue for another month or so.
“Senator Murray has negotiated a reauthorization agreement on this sparsely funded PDUFA Act to ensure that Congressional inaction does not force FDA to issue a termination notice,” an assistant to Senate Health Committee Chairman Murray told Endpoints via email. Some additional policies. But even if we address this urgent challenge by the looming deadline, she doesn’t think we can and she will not stop pushing for reforms in the pharmaceutical industry and the key agency, the FDA.”