Editor’s note: The Alliance for a Stronger FDA recently offered this analysis of the Food and Drug Administration’s FY 2021 funding.
The current fiscal year (FY) 2021 Continuing Resolution runs through Dec. 11. So either (1) action on funding bills will be completed by that date, (2) another short term Continuing Resolution (CR) could be passed to allow additional time to finish the FY 2021 package, or (3) a longer term CR will be adopted to take us into early next year and a new Congress and Administration. Ultimately, if these all fail, there could be a full-year CR, under which FDA would receive flat-funding based on the FY 2020 levels.
The President’s FY 2021 budget request, the House-passed bill, and the Senate’s new proposed bill have 1. similar funding levels and 2. a common core of initiatives for FDA to carry out in the new fiscal year. If, as we expect, the agency receives about a $40 million increase for FY 2021, there are six programs most likely to receive that funding.
On pages 10-17 of the FY 2021 Congressional Justification for FDA (see document here; our analysis here), the current Administration proposed the following program initiatives, which total $43 million (net of proposed cost savings that Congress does not usually accept):
- Artificial Intelligence and Other Emerging Technologies (Food Safety and Medical Products) (+$10.2M) FDA requests a total of $10.2 million across CDRH ($5M), ORA ($2.1M), CFSAN ($1.6M), and FDA HQ ($1.5M) for AI and other emerging technologies. Senate: +$8.25 million; House supports, no amount specified.
- Strengthening Response Capabilities for Foodborne Outbreaks: (+$1.2 million) Additional funding will expand the Center for Food Safety and Applied Nutrition’s (CFSAN) ability to ensure that contaminated food is detected and removed from the marketplace as quickly as possible. Senate: +$1 million House +$1.24 million
- Cannabis and Cannabis Derivatives (+$5.0 million) FDA requests a total of $5 million across ORA ($2.0M), CFSAN ($2.0M), FDA HQ ($0.5M), and CVM ($0.5M). This new funding will enable FDA to continue regulating the usage of cannabis-derived substances, such as cannabidiol (CBD), in FDA-regulated products such as dietary supplements and when used as unapproved food and feed additives. Senate +$5 million; House: $ 5 million
- Modernizing Influenza Vaccines (+$5.0 million) FDA requests a total of $5 million across CDER ($0.5M), CBER ($2.0M), CDRH ($0.5M), Headquarters ($2.0M) to help make the U.S. influenza vaccine supply more robust, secure, and nimble to combat seasonal influenza epidemics and potential influenza pandemics. Senate: +$5 million; House supports, no amount specified.
- Transform Medical Device Safety, Cybersecurity, Review, and Innovation (+$18.0 million) FDA requests $18 million to build an integrated knowledge management system and portal for medical devices using modern, agile information technology systems with secure data storage. Senate: +$12.5; House supports, no amount specified.
- Compounding (+$4.5 million) The FY 2021 Budget request will allow FDA to continue oversight of human drug compounding by strengthening the scientific framework, bolstering existing and new regulatory compliance initiatives, and expanding policy development to support the needs of the compounding program. Senate +$2 million; House supports, no amount specified.
The Senate bill also includes $7.25 million for infrastructure improvements at FDA. Presumably, this matches the president’s request for monies to support repairs, improvements, operations, maintenance, and utilities at FDA owned sites, including infrastructure improvements at White Oak to improve capacity and reliability. The Administration had proposed to pay for these activities from budget savings, while the Senate would appropriate the funds. The Senate bill also provides $2 million for the Office of General Counsel, but the subcommittee’s explanatory statement does not address the purposes of these funds.
In addition, as part of “Report Language,” the House provided greater clarity on funding for a few programs. The House bill provides an increase of $1.5 million to CFSAN for work related to allergen labeling. Also included is $1 million for FDA’s Office of Minority Health and Health Equity to engage in community-based education on the dangers of cosmetics containing dangerous levels of mercury and hydroquinone, notably in skin-lightening products. The House also directed that $500,000 in existing National Center for Toxicological Research funding be directed toward research to improve the understanding of biofilms and the regulatory science of biofilms associated with FDA work on medical devices.
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