Congress has passed legislation on Friday that would reauthorize the Food and Drug Administration’s user fee programs, as part of a continuing resolution to prevent a government shutdown that would have started at midnight. The measure now goes to President Biden for signature.
The House of Representatives approved the measure in a 230-201 vote, with only 10 Republicans supporting it, Politico reported. The measure funds the government until Dec. 16. On Thursday, it passed the Senate, with 72 senators approving the measure, while 25 voted against, The Washington Post reported.
The user fees bill will fund programs the FDA uses to review medical devices, pharmaceuticals and other products by collecting fees from their manufacturers and other companies. In exchange, the agency committed to performance goals, which set how much time it should take to review product submissions.
“It means that we will not need to begin the notification process for user fee-funded staff,” FDA Commissioner Robert M. Califf said on Twitter of the House vote.
Before the House acted, the leader of the Medical Device Manufacturers Association, Mark Leahey, applauded the Senate’s passage of the resolution, saying in an emailed statement that it “ensures that patients and providers can continue to benefit from the development of lifesaving and life-changing technologies.”
From 2023 to 2027, the bill would allow the FDA to collect $1.78 billion to $1.9 billion in user fees specifically for medical devices. The agreement also sets minimum hiring goals for the agency that are linked to the amount of fees it can collect. In 2023, the FDA plans to hire 144 people, according to a commitment letter it shared earlier this year.
The House passed a bipartisan user fees bill in June, but it got held up in the Senate, where legislators debated sweeping riders, including one that would restructure how diagnostics are regulated. One rider that is likely to be discussed when a permanent funding bill is debated is the VALID Act, which would create a new risk-based framework for all diagnostics and give the FDA authority to regulate lab-developed tests.
As the Sept. 30 date to reauthorize the agreements drew close, the FDA warned it would have to start furloughing staff if Congress missed its deadline. A late agreement between the Senate Committee on Health, Education, Labor and Pensions and the House Energy and Commerce Committee helped avert that scenario.
On Monday, leaders of both committees confirmed that none of the amendments would be included in the bill that was attached to the continuing resolution. However, both said they plan to discuss including the provisions in a permanent funding bill later this year.
This article has been updated to include the vote by the House of Representatives, as well as a comment from FDA Commissioner Dr. Robert M. Califf
