What Will Actually Get Funded at FDA in FY 21?

The President’s FY 21 budget request, the House-passed bill, and the Senate’s new proposed bill all have a common core of initiatives for FDA to carry out in the new fiscal year. If the agency receives about a $40 million increase, the following programs -- detailed in the President's FY 21 Budget Request here, and in our analysis here -- are the ones most likely to be funded:  

• Artificial Intelligence and Other Emerging Technologies (Food Safety and Medical Products) (+$10.2 million) FDA requests a total of $10.2 million across CDRH ($5 million), ORA ($2.1 million), CFSAN ($1.6 million), and FDA HQ ($1.5 million) 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 CFSAN's 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 ($2.0 million), CFSAN ($2.0 million), FDA HQ ($0.5 million), and CVM ($0.5 million). 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 ($0.5 million), CBER ($2.0 million), CDRH ($0.5 million), and Headquarters ($2.0 million) 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.

Editorial note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.