Concerns rise that Congress may miss budget, user fee renewal deadlines

Regulatory NewsRegulatory News
| 21 July 2022 | By Ferdous Al-Faruque 

With just over two months to go, it’s increasingly looking like Congress is going to miss its deadlines to pass a final US Food and Drug Administration appropriations bill and a user fee reauthorization bill.
On 20 June, Democrats in the US House passed a $400 billion “minibus” appropriations bill in a 220-207 vote that largely split down party lines. That means it’s now up to the Senate to pass a similar bill, but lawmakers in the upper chamber haven’t even publicly presented their budget bill, with the 30 September deadline quickly approaching.
The House bill includes $341 million increase over last year’s budget for the FDA, which Steven Grossman, executive director at the Alliance for a Stronger FDA, calls a monumental step forward. He notes that there’s still a possibility that the Senate proposes a draft budget bill of their own later this month that would allow lawmakers to pass a final bill before the September deadline.
“Otherwise, Congress will need to pass a Continuing Resolution,” said Grossman. “If so, starting 1 October, FDA would only be able to spend up to the current year’s level. The size of the increase proposed by the House reflects the gap that would occur under a CR’s level funding. That would continue until appropriations bills are passed, presumably after the election.”
The FDA’s budget isn’t the only thing at stake in September. The agency is also hoping to see its user fee programs reauthorized after years of negotiations with industry. Without, renewing the user fee bills, the agency warns it may have to set in motion mass lay-offs and slow product reviews. (RELATED: Califf: ‘Enormous’ implications for FDA if user fee programs are not reauthorized, Regulatory Focus 12 July 2022)
“On the medical products side, this is a very significant part of funding and basically we’d have to lay people off,” warned FDA Commissioner Robert Califf during a meeting with the Alliance for a Stronger FDA last week. “We’re in the period of the ‘Great Resignation’ … 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.”
“If the user fees are not funded, we’ll review products as quickly as we can, but the timelines go away and the commitment to the timelines goes away,” he added.
Califf said medical industries are expanding and becoming more complex globally, and without significantly increased funding to handle the growing workload, he warned the agency will be limited in its ability to get products to patients.
Grossman says that while the passage of the appropriations bill and the user fee reauthorization bill may seem similar, they are not.
"For the appropriations, there is no agreement on top-line spending. Until you have an agreement on top-line spending, then none of the 12 [appropriations] subcommittees know precisely how much money they have available to spend," he said. On the other hand, he says the main hold-ups with the user fee reauthorization bill are riders that affect the FDA but are not directly related to user fees such as the VALID Act and provisions that affect rare disease research and dietary supplements.
Senate Health, Education, Labor and Pensions (HELP) committee Ranking Member Richard Burr (R-NC) recently introduced a “clean reauthorization” bill that strips out several riders from the Senate user fee reauthorization bill. So far, it’s gotten a thumbs-down from Democrats in the committee and from the leaders of the House Energy & Commerce committee. (RELATED: Burr introduces stripped-down user fee bill, Regulatory Focus 14 July 2022)
"On the appropriations process, yes it's political because federal spending is a party-line issue," Grossman added. "So far, the user fee is not a political issue, it's a disagreement among members of Congress and not along party lines.”
An industry source with knowledge of the negotiations on the Hill told Regulatory Focus they think there isn’t enough time to pass an appropriations bill or a user fee reauthorization bill by 30 September. They say it’s most likely a continuing resolution will keep the FDA funded until a bill is eventually passed toward the end of the year.
As for user fee funding, the source argues the agency should have enough carry-over funding from the various user fee streams to allow it to keep staff employed until the end of the year when again they expect a user fee reauthorization bill will be passed.
"I don't think you're going to see any resolution until after Labor Day,” they said. “Once you look at the dynamics, you do see a path forward."


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