The Senate passed legislation on Thursday that would reauthorize the Food and Drug Administration’s user fee programs as part of a continuing resolution to prevent a government shutdown. The resolution was supported by 72 senators, while 25 voted against. The measure needed 60 votes to pass the Senate, The Washington Post reported.
House Republican leaders are urging their members to vote against the continuing resolution, while Democratic leaders say they can muster a majority vote in the chamber.
The user fees bill would fund programs the FDA uses to fund its review of 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.
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 should help 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.
