July 18, 2022 – With just days left before a deadline to send layoff notices to thousands of Food and Drug Administration (FDA) staff, legislation to reauthorize prescription drug user fees – which fund half of the FDA’s budget – has not yet been passed.
Although Congress is well aware of both the Sept. 30 deadline for the expiration of current user fees and the Aug. 1 deadline by which the FDA would need to issue 60-day layoff notices to staff whose positions are funded by those fees, there has been little success in reconciling differences between the House bill (Food and Drug Amendments of 2022 (FDA22)) and the Senate bill (Food and Drug Administration Safety and Landmark Advancements Act (FDASLA)). At issue are add-on provisions that go beyond the user fees to address infant formula shortages, clinical trial diversity, intellectual property, drug importation, dietary supplements, and other issues championed by various members of the House and Senate committees.
The House passed its version of the legislation in early June; the vote of 392-28 reflected strong bipartisan support. The Senate HELP committee voted its version out of committee (13-9) a week later, adding provisions on regulation of laboratory tests, provisions intended to improve supplies of infant formula, and other topics.
Leaders of the relevant committees in both chambers are digging in their heels. Last week, the chair and ranking member of the House Energy and Commerce Committee, Reps. Frank Pallone (D-N.J.) and Cathy McMorris Rodgers (R-Wash.), squarely blamed the Senate for the logjam.
Meanwhile, HELP Committee Chair Patty Murray (D-Wash.) reiterated her support for the Senate version. In a July 14 statement, she said she and ranking member Sen. Richard Burr (R-N.C.) “have spent months negotiating bipartisan policies that will keep families safe, support innovation, bring down drug prices, and much, much, more. People want us to get this done – all of it.” Addressing the Aug. 1 FDA layoff notice deadline, Murray said that “pink slips are unacceptable to me, and they should be unacceptable to all of us – that is why it makes absolutely no sense to back out of bipartisan negotiations now.”
Last week, Burr, himself a sponsor of one of the controversial add-on provisions concerning laboratory test regulation, introduced a stripped-down version of the user fee bill – the Food and Drug Administration Simple Reauthorization Act – that he says is the best path forward. “Everyone seems to want to blame me for holding up user fees. I don’t want to hold it up,” Burr told POLITICO. “I’m ready to go, let’s do it. I’m willing to throw everything overboard to make sure this program continues. Now I’ll see if my colleagues are willing to do the same.”
Industry’s and FDA’s worries over potential FDA layoff notices may work in favor of Burr’s “clean” bill. FDA Commissioner Robert Califf, M.D., last week told the Alliance for a Stronger FDA that further delays in reauthorizing user fees could have a negative impact on both recruiting and morale, especially at a time when the agency’s resources already are stretched thin, according to Regulatory Focus.
“We’re in the period of the ‘Great Resignation,’” Califf said. “Who wants to work in an organization if you’re afraid that these jobs are not even going to exist in the next short period of time? We really need to avoid that,” Califf said.
“Even more than in prior reauthorization cycles, some members of Congress have tried to shoehorn their pet ideas into the must-pass user fee legislation,” said Coalition for Healthcare Communication Executive Director Jon Bigelow. “This year, the number of off-topic provisions plus the general gridlock in Congress have endangered passage of the basic user fees that nearly all members support. It’s time to stop holding the FDA – and a large proportion of its staff – hostage,” he said. “The FDA can’t operate efficiently and solve its recruiting and staffing issues if the agency can’t count on its funding.”