Q&A on the President’s FY 21 budget request and the priorities of key House appropriators
Q: Is the proposed increase in the House bill $247 million or $257 million?
A: FDA’s budget has two components: most of the money is Salary and Expenses (S&E) and a very small amount goes to Buildings and Facilities (B&F). The B&F number has been the same $12 million for several years; all increases have been to Salary & Expenses. For FY 22, the Biden administration proposed an increase for B&F and the House followed, albeit with a smaller increase. Thus, under the House bill, BA S&E is proposed to increase about $247 million and BA B&F is proposed to increase about $10 million. The two combined equal the Subcommittee’s announced $257 million increase for FY 22 above FY 21 funding levels.
Q: How much CURES program monies are proposed for FY 22 and why is it always stated separately from the BA appropriations?
A: The monies for CURES programs comes from “savings from mandated spending.” CURES program monies are not BA or user fees. The Appropriations Committees put the monies in a separate section that comes after the FDA appropriation. The Committees sum the monies for FDA, then state CURES as additional. For FY 22, the maximum authorized for FDA CURES is $50 million, down from $70 million in FY 21. This reflects that the CURES funding is for 10-years and that the annual amount peaks and then starts decreasing. FY 22 is the first year of the decline. The administration requested the full amount; the House concurs, and we expect that Senate will, as well.
Q: What are the key priorities in the House bill as reflected in statements from Chairs DeLauro and Bishop and Ranking Members Granger and Fortenberry?
A: Committee Chair DeLauro: As recent food contamination incidents have underscored, the need to ensure our nation’s food supply is safe is paramount. With $256 million for the Food and Drug Administration, this bill prioritizes FDA’s work to maintain food safety, specifically by targeting the Agency’s work to prevent and respond to foodborne illness outbreaks. It supports a new FDA initiative to reduce heavy metals that have been identified in baby foods.
A: Committee Ranking Member Granger: We are too reliant on imported medical products. The FDA must help to create a regulatory environment where manufacturers of medical equipment and pharmaceuticals come back to the United States. I am encouraged that the bill includes funds for unannounced inspections of drug manufacturing plants around the world, more must be done.
A: Subcommittee Chair Bishop: There is an increase of $72 million to address the opioid crisis, rare cancers, and resume unannounced in-person inspections in the two largest foreign drug manufacturing countries. It also includes a $65 million increase to avoid or more quickly respond to food outbreaks and address heavy metals in baby food.
A: Subcommittee Ranking Member Fortenberry: We have to accelerate generic drug approvals to bring the cost of drugs down. I am happy to see more resources in this bill for unannounced inspections in China and India.
Editorial Note: The Analysis and Commentary section is written by Steven Grossman, Executive Director of the Alliance for a Stronger FDA.
