The Senate Committee on Appropriations on Tuesday released draft legislation proposing $3.21 billion in discretionary funding for the US Food and Drug Administration for FY2021, closely matching the amount the agency would receive under the minibus passed in the House in July.
In total, the draft bill would set FDA’s total FY2021 funding, including user fees, at $5.88 billion.
Due to inaction on appropriations bills in the Senate before the start of the fiscal year on 1 October 2020, FDA is currently being funded at FY2020 levels under the short-term continuing resolution that expires on 11 December. (RELATED: $3.2 billion FDA budget clears US House, Regulatory Focus 27 July 2020).
As with the House bill, the draft Senate legislation would provide FDA with $40 million in additional funding over the FY2020 enacted level and would release an additional $70 million in 21st Century Cures Act funds.
To avoid a government shutdown, the appropriations bills must be passed before the current continuing resolution expires or the House and Senate must pass another continuing resolution.
According to the explanatory statement released alongside the draft bill, the committee says that much of the net increase in funding will go to medical product and food safety activities, including $12.5 million for medical device and cyber review innovation activities, $8.25 million for artificial intelligence and emerging technologies, $7.25 million for infrastructure improvements, $5 million for influence vaccine activities, $5 million for cannabis and cannabis derivatives and $2 million toward compounding activities.
Both Senate and House bills fall short of the $6.2 billion in total funding FDA sought in its proposed budget for FY2021. (RELATED: Trump’s 2021 budget request seeks modest funding increase for FDA, Regulatory Focus 10 February 2020).
“By and large, these bills are the product of bipartisan cooperation among members of the committee. As negotiations with the House begin in earnest, I look forward to working with Chairwoman [Nita] Lowey [D-NY], Vice Chairman [Patrick] Leahy [D-VT] and Ranking Member [Kay] Granger [R-FL] to resolve our differences in a bipartisan manner,” said Committee Chairman Richard Shelby (R-AL).
However, Leahy said he is “disappointed that the majority chose to cancel committee mark ups of the FY 2021 bills and that the bills were not considered by the full Senate,” though he said the release of the bills will help to move the appropriations process forward.