Sen. Richard Burr, RN.C., said Thursday that a five-year reauthorization of the Food and Drug Administration’s (FDA) user fee program would be included in a temporary spending bill to prevent a government shutdown. .
Barr, a senior member of the Senate Health, Education, Labor and Pensions Committee (HELP), told reporters the reauthorization would be part of a short-term continuation resolution. is renewed every five years and expires at the end of September.
FDA user fees are collected from pharmaceutical and medical device companies to fund and facilitate product review by the FDA. Congress must vote every five years to reauthorize FDA’s authority to collect user fees. This reauthorization was last passed in 2017, when an overwhelming majority of the Senate voted in favor of the bill.
A senior Republican commission aide confirmed to The Hill that the action is included in the makeshift spending bill, adding that conversations about the FDA’s user fees are still “ongoing.”
Senator Patty Murray (D-Washington), chairman of the Senate HELP Committee, said: Use some additional policies. “
The House of Representatives passed the FDA royalties package in June, adding provisions such as diversifying participation in clinical trials.the bar later “Clean” usage fee package in the Senate that ruled out what he called a “harmful addition.”
Murray’s aide said Thursday: this important institution. “
Congress has until October 1st to pass a funding bill to avoid a government shutdown. Congress has passed the deadline to reauthorize the FDA’s user fees, but this year the FDA’s chief warned that if the reauthorization is not passed, the agency will have to implement a furlough.
and July memo FDA Commissioner Robert Calif told FDA staff: Confirm the safety of patients enrolled in clinical trials and consider applications for the treatment of life-threatening diseases with unmet medical needs. “
In the memo, Calif estimates that he has enough carryover funds to last just five weeks into the new fiscal year.
