Califf seeking Congressional assurance user fees won’t run out

Regulatory NewsRegulatory News | 01 August 2022 |  By 

With only two months to go before user fee legislation runs out and no indication Congress will reauthorize it in time, FDA Commissioner Robert Califf sought to assure agency staff that he is doing his best to get certainty from lawmakers their jobs are not in jeopardy, according to a letter to FDA employees dated 29 July.

“We are continuing to evaluate the situation, and to explore all potential options and scenarios,” said Califf. “Our latest estimates are that we have carryover for [the Prescription Drug User Fee Amendment (PDUFA) program], the user fee program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.
“However, if we have 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,” he added. “We are working to obtain such assurance from Congress, and I am optimistic that they will not allow our programs to expire.”
Califf’s all-staff letter referenced only PDUFA-related reauthorization and staff. The FDA did not get back to Regulatory Focus by press time to elaborate further on how the agency intends to deal with the Medical Device User Fee Amendments (MDUFA) and the Generic Drug User Fee Amendment (GDUFA) programs.
By law, the US Food and Drug Administration must notify user-fee funded staff that they may be laid off 60 days prior to the user fee program running out of money.
One industry source told Regulatory Focus they estimate the agency has enough carryover funds from MDUFA to keep the program afloat at least to the end of December.
While lawmakers have insisted that they will not allow the user fee programs to expire, it looks more and more like Congress does not have time to reauthorize them before their deadlines (Related: User fee reauthorization marches on with first Senate hearing, Regulatory Focus, 5 April, 2022).
During a talk with reporters hosted by the Alliance for Health Policy on 28 July, Califf described the inability of lawmakers as political “brinksmanship” that ultimately hurts the American public as well as FDA staff.
“If the user fees are not enacted, the greatest suffering will be from the American people because our public health mission will be injured if we don't have the money to pay employees,” said Califf. “I think we've been through this sort of a situation before…  [But] I'm optimistic that we'll get through this brinksmanship as sort of the way it's happened before, but you know the consequences on things like new treatments getting assessed with a reasonable timeline would be very difficult.
“Philosophically, I wish the taxpayer paid for all the FDA and there weren't user fees,” he added. “But the reality is, the user fees exert a discipline to the review of applications which allows one to know full well exactly what it takes to assess a new treatment that comes along, and this would be greatly impaired in addition to our other missions.”
Failing to reauthorize the user fee programs also could demoralize current staff and make it harder for the agency to hire new talent, Califf continued.
“We have a number of employees that we're trying to hire,” he told Regulatory Focus. “There are many regulations that cause there to be multiple checks and balances and take time, and we don't want to discourage all the people that are currently looking for jobs that may have other opportunities.”
Califf said that, ultimately, if the hiring process drags on because of lack of user fees, the agency may lose out on hiring much needed new staff which is especially problematic in the midst of “the great resignation.”
“I think [based on past experience], if things drag on into September, we'll start losing steam because we won't have as many people and we won't be hiring in new people,” he said. “And it takes a long time to recover from that in the federal system.”
During his confirmation hearings, Califf highlighted that he is concerned the FDA doesn’t create a conducive environment for people to join the organizations especially as they have to repeatedly face job uncertainties and compete with private sector salaries (Related: Califf wants to create incentives for FDA commissioners to stay longer, Regulatory Focus, 28 April, 2022).
During the Alliance for Health Policy press conference Califf also said that he’s impressed with how the FDA staff have continued to not just do their regular jobs over the past two years of the pandemic but also gone above and beyond to do their part to fight the COVID-19 crisis. He notes that many staff have been working overtime, often on weekends, and have not taken a vacation in the past two years.
“We all have a lot on our plate these days,” he said in his all-staff letter. “Still, I encourage you, to the extent possible, to take some time off during the rest of this summer... While your work is crucial and you're busy, I hope you take some time to rest, unwind, relax and focus on your families and friends.”
While Congress continues to hash out the user fee reauthorization bill, it also hasn’t passed an FDA appropriations bill. Califf, however seems more optimistic that ultimately lawmakers will at least pass a continuing reauthorization bill that will allow the agency to continue paying staff at current budgetary levels (Related: Concerns rise that Congress may miss budget, user fee renewal deadlines, Regulatory Focus, 21 July, 2022).
“It would be unheard of for Congress not to pass some kind of continuing resolution if they're not going to do the full package, and I think everyone at FDA has gotten used to that,” he told Regulatory Focus. “Given all the work that's gone into the specifications in this year and next year's budget, it would be a shame if we’re on continuing resolution. But we can continue our operations, we've shown that before, just not to the same extent on some of the programs that are very high priority.”


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you