House Would Slow US FDA Budget Authority Increases In FY 2021
Executive Summary
After two years of significant growth in non-user fee funds, House appropriators offer FDA a more modest increase for FY 2021.
House appropriators called for another increase in non-user fee funding for the US Food and Drug Administration in fiscal year 2021, but not as lavish as the previous two fiscal years, suggesting a flatter budget may be coming.
The agency would receive $3.2bn in non-user fee dollars, also known as budget authority, in the FY 2021 Agriculture, Rural Development, FDA and Related Agencies appropriations bill that the associated House subcommittee approved on 6 July.
The bill moved to the full committee by voice vote and without any amendments offered, although there were warnings from Republicans of provisions that may be problematic, such as one designating veterans health care funding as an emergency in order to allow increased spending in other areas. Several Republicans said such a move was not part of the 2019 budget agreement.
A full House Appropriations Committee mark-up of the legislation is scheduled for 9 July.
The FDA budget authority total would be a $40.8m increase over the FY 2020 appropriations legislation enacted in December 2019. The agency also would receive an additional $78m in user fee revenue, a nearly 3% increase compared to FY 2020.
The boost in budget authority is lower than seen in previous years, a signal that at least for now that committee priorities may be shifting. In fact, the House bill offers a lower budget authority total than the House Appropriations Committee initially proposed for FY 2020.
House appropriators in May 2019 gave the FDA $3.25bn in budget authority for FY 2020. Following negotiations with the Senate and White House, that figure was reduced to $3.16bn upon enactment. (Also see "US FDA Gets Another Appropriations Increase In FY 2020 House Bill" - Pink Sheet, 22 May, 2019.)
After three years of slower growth (FY 2016-FY 2018), non-user fee dollars began to flow to the agency in greater numbers in the last two years. Appropriators gave the FDA a $268.6m increase in budget authority in FY 2019 and then a $91m increase in FY 2020. (See chart below.)
The latest House bill likely is a starting point for negotiations, which may mean the budget authority total will decrease in order to reach an agreement with Senate Republicans and President Trump. Overall, the FDA budget would increase about 2% over FY 2020, from $5.77bn to $5.89bn, under the House bill.
That bottom line total is lower than the president’s budget request ($6.2bn). However, the administration’s proposed increase was almost entirely driven by user fees, including through creation of new fees. The Trump administration proposed a $25.4m increase in budget authority and about $240m increase in user fee revenue. (Also see "Trump Budget Would Remove Tobacco From FDA, Increase Dependency On User Fees" - Pink Sheet, 10 Feb, 2020.)
CDER, CDRH Would Receive More Of The Increase Than FY 2020
Under the House bill, the budget authority funding includes targeted increases to advance new influenza vaccine manufacturing technology, food and medical product safety, as well as help create a framework for cannabidiol (CBD) regulation, according to a bill summary.
Nearly half of the increase in combined user fee and budget authority funds, 49.7%, would go to the Center for Drug Evaluation and Research. Another 24.9% of the increase would go to the Center for Devices and Radiological Health.
House appropriators did not reduce any product centers’ funding, but did not increase the appropriation for the National Center for Toxicological Research. Money paid to the federal government for building maintenance and other activities, known as General Services Administration (GSA) rent, would decrease 1.5% in the bill.
Cures Funding To Begin Its Decline
The FDA also is poised to receive $70m as part of the 21st Century Cures Act, which can be used for patient-focused drug development, biomarker qualification, and other activities.
Although a nice supplement to the agency budget, annual allocations from the Cures Act will decline in FY 2021 after peaking at $75m in FY 2020. In FY 2022, the total will drop to $50m, where it will remain until FY 2025. That year, the agency will receive $55m, the final installment of a $500m allocation over nine years. (Also see "US FDA Getting More Money Up Front Under Cures Bill Revisions" - Pink Sheet, 30 Nov, 2016.)
A second Cures bill is in development, and some early ideas include additional FDA funding for complex clinical trial design and patient-focused drug development grants. Reimbursement and some coronavirus-related issues were an early focus of the effort. (Also see "Cures 2.0 May Get Fast Tracked Due To COVID-19" - Pink Sheet, 29 Apr, 2020.)