Dive Brief:
- In the event of a government shutdown, the Food and Drug Administration would be able to continue with product reviews thanks to funding from user fee programs and COVID-19 relief efforts.
- Congress must pass spending bills that can be signed into law before midnight Saturday to avoid a partial government shutdown.
- The FDA would have to immediately furlough 19% of staff in a shutdown, according to a contingency plan posted by the agency. The agency said activities funded by carryover user fee funding — including regulating drugs, biosimilars and medical devices — will continue.
Dive Insight:
The U.S. Senate reached a bipartisan agreement Wednesday on a short-term spending bill, which would continue funding at current levels through mid-November, but U.S. House Speaker Kevin McCarthy, R-Calif., has rejected it, the Washington Post reported. As a potential shutdown looms, the FDA will be among the least affected agencies in the healthcare sector, keeping 81% of its staff while the Centers for Medicare and Medicaid Services faces deeper staffing cuts, analysts at TD Cowen wrote in a research note.
Nearly two-thirds of the FDA’s staff will continue to be funded through user fee carryover balances or COVID appropriations. Another 17% of staff have positions deemed necessary for the safety of human life or protection of property and are not subject to furloughs.
Last year, Congress passed a user fees provision that increased the amount the FDA can collect from medical device companies to $1.78 billion over five years from 2023 to 2027, or $1.9 billion if the agency meets certain performance goals.
A “significantly higher proportion” of FDA staff would be able to keep working compared with the last major shutdown in early 2019, when the agency retained about 60% of its staff, the analysts wrote.