FY 21 Appropriations Provisions and COVID-19 Relief / Stimulus Provisions Related to FDA

FY 21 Appropriations:

The House and Senate have released the text and managers agreement for FY 21 (full-year) appropriations. The House and Senate are expected to vote tonight or, at latest, by tomorrow. It is expected that President Trump will sign the legislation.

Under the final bill, FDA will see a net increase of $42.250 million. The increases are detailed in the explanatory text (here) and also pages 53 to 61 (here). Note that the net increase is derived from $45.250 million in new programming less a $3 million offset from one-time FY 20 money from a machine-learning pilot program.

The increase is apportioned: $22 million for medical products programs, $15.250 million for food safety, and $8 million for cross-cutting initiatives.

Medical Products ($22 million)

• Modernizing Influenza Vaccines. FDA requested 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. FY 21 FINAL: $5 million.
• Transform Medical Device Safety, Cybersecurity, Review, and Innovation. 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. FY 21 FINAL: $9 million.
• Compounding. The FY 2021 Budget request was for $4.5 million to 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. FY 21 FINAL: $2 million.
• Also, Congress appropriated $3.5 million for a foreign inspection pilot and $2.5 million for rare cancer therapeutics.

Food Safety ($15.250 million)

• Strengthening Response Capabilities for Foodborne Outbreaks. Additional funding of $1.2 million was requested to expand CFSAN's ability to ensure that contaminated food is detected and removed from the marketplace as quickly as possible. FY 21 FINAL: $1 million.
• Cannabis and Cannabis Derivatives. FDA requested 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 was to 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. FY 21 FINAL: $5 million.
• Also, Congress appropriated $6 million for a Shrimp Import Inspection Pilot Program; $1.25 million for Allergen Labeling; $1 million for Cosmetics; and $1 million for the National Antimicrobial Resistance Monitoring System.

Cross-Cutting (MP and FS) ($8 million)

• Artificial Intelligence and Other Emerging Technologies (Food Safety and Medical Products). FDA requested 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. FY 21 FINAL: $7 million.
• Also, Congress appropriated $1 million for the Office of Chief Counsel.

COVID-19 Relief/Stimulus Legislation:

The following text was derived from a section-by-section analysis (here) provided by the House.

Agriculture-Rural Development-FDA

Food and Drug Administration – $55 million for continued work on FDA efforts to facilitate the development and review, both pre-market and post-market, of medical countermeasures, devices, therapies, and vaccines to combat the coronavirus. In addition, funds will support medical product supply chain monitoring and other public health research and response investments.

If you have questions, please contact the Alliance for a Stronger FDA’s Steven Grossman at sgrossman@strengthenfda.org.