FDA user fee reauthorization added to bill to prevent government shutdown

Sen. Richard Burr (R-N.C.) on Thursday said the five-year reauthorization of the Food and Drug Administration’s (FDA) user fee program will be included in the stopgap spending bill meant to prevent a government shutdown.

Burr, who is the ranking member of the Senate Committee on Health, Education, Labor and Pensions (HELP), told reporters that the reauthorization would be part of the short-term continuing resolution. The FDA user fee authorization is renewed every five years and is set to expire at the end of September.

FDA user fees are collected from drug and medical device companies to fund and expedite the agency’s review of products. Every five years, Congress must vote to reauthorize the FDA’s authority to collect user fees. The last time this reauthorization was passed was in 2017, with an overwhelming majority of the Senate voting in favor of the legislation.

A senior GOP committee aide confirmed to The Hill that the measure is included in the stopgap spending bill, adding that conversations on FDA user fees are still “ongoing.”

An aide for Sen. Patty Murray (D-Wash.), chairwoman of the HELP committee, said, “Senator Murray has reached a deal on a practically clean reauthorization that ensures congressional inaction won’t force FDA to send out pink slips along with some additional policies.”

The House passed an FDA user fee package in June with added provisions such as diversifying clinical trial participation. Burr later introduced a “clean” user fee package in the Senate that left out what he referred to as “harmful additions.”

The aide for Murray said on Thursday, “Even after we have addressed this immediate challenge before the looming deadline, she believes we can’t, and she won’t, stop pushing for the kind of reforms families need to see from the drug industry and this critical agency.”

Congress must pass a funding bill by Oct. 1 to avoid a government shutdown. While Congress has missed the deadline to reauthorize the FDA user fees in the past, the head of the FDA warned this year that if reauthorization isn’t passed, then the agency will have to carry out furloughs.

In a July memo to FDA staff, FDA Commissioner Robert Califf said, “Delayed reauthorization would place important public health efforts at risk, including our ability to ensure access to updated COVID-19 vaccines and therapeutics, confronting emerging diseases, monitor the safety of marketed products, ensure the safety of patients enrolled in clinical trials, and review the applications for treatments for life-threatening diseases with unmet medical needs.”

In his memo, Califf estimated that there was enough carryover funding to last only five weeks into the new fiscal year.