With drug pricing almost done, Congress looks to wrap up FDA user fee legislation
The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.
FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”
That means Congress has a tiny cushion of about a month, until Nov. 4, to get its act together.
Right now, there are vast differences between the House-passed version of the bill from early June, and the Senate’s previously introduced version, which it has yet to vote on. While there are differences between the two versions, on major issues like the regulation of IVDs and cosmetics, both the House and Senate agree that accelerated approval pathway reforms should be added to the user fee deals.
But industry and others are making the case for not going too far with those reforms, especially as accelerated approvals have helped many cancer patients access treatments earlier than they otherwise would have.
Amgen researchers recently published a paper explaining, “Over the 30-year history of the accelerated approval program, there have been relatively few delinquent cases or dangling approvals. Legislative or other changes to the program should be based on cumulative experience, not outliers.”
North Carolina Republican and Senate health committee ranking member Richard Burr last month introduced a blank version of the user fee legislation as an attempt to start over without any of the policy riders that made it out of the committee, like the accelerated approval pathway changes that would allow the FDA to require companies to begin postmarketing studies before granting the sped-up approvals.
But it remains unclear how Congress will move.
Califf added that if the FDA has “reasonable assurance from Congress that they will act in time to allow us to continue collecting fees after September 30th, then we will not need to begin the notification process for PDUFA-funded staff.”
But in the meantime, the FDA will have to prepare and FDAers are already expending time and resources for that doomsday scenario, even if it remains unlikely.