Alliance for a Stronger FDA -- FY 21 “Ask” and Explanation

“Growing Responsibilities Require a Budget that Grows”The FDA’s mission continues to grow; vital responsibilities have become more sophisticated and complex. Accordingly, the Alliance’s FDA “ask” for FY 21 is for an increase of $120 million in budget authority (BA) above the FY 20 appropriations level. This would bring FDA “salary and expenses” to $3.278 billion. This would be an overall increase of just under 4% compared to the FY 20 enacted levels and an increase of $72 million over the Administration FY 21 request. Funding under 21st Century Cures, $70 million, is additional.The agency needs an increased budget, more scientific and technical staff, and better analytical tools to support scientific-based decision-making and innovation in both food safety and medical products activities.

• In food safety, this means use of artificial intelligence, whole genome sequencing, culture-independent diagnostic testing, and enhanced electronic record-keeping.
• In medical products, this means new tools to evaluate medical products that incorporate cell and gene therapy, digital health, artificial intelligence, and real-world evidence and other new technologies.

Food Safety -- In FY 20, Congress committed more than $1.4 billion in BA funding to food safety, nutrition, cosmetics, dietary supplements, animal foods, and other food elements of FDA’s mission.  For FY 21 for food safety programs, the Alliance is recommending a $50 million increase in BA program funding (or $41.6 million more than the President’s request for food safety programs). We urge Congress to consider:

• More robust and rapid FSMA implementation, including increased cooperation with states, finalization of guidances including traceability, and a focus on produce safety, import safety, and training/education;
• Enhanced funding of systems for surveillance of foodborne illness and outbreak response;
• Upgrades to the public health laboratories network;
• Strengthening the scientific capabilities of CFSAN, CVM, and NCTR.

Funding should also be considered for: FDA’s recall initiative, nutrition education, safety of cosmetics and dietary supplements, antimicrobial resistance, CBD, and standards of identity/food labeling and product claims.Medical Products -- In FY 20, Congress committed nearly $1.7 billion in BA funding to support drug, devices, biologics, and other medical product elements of FDA’s mission. For FY 21 for medical products, the Alliance is recommending a $70 million increase in BA program funding ($39.9 million more than the President’s request for medical products programs). We urge Congress to consider:

• Addressing the shortage of agency staff and expertise in (1) new high-growth scientific areas, notably the dramatic increase in products being developed with gene and cell therapy and (2) new technology-driven challenges, such as cybersecurity, artificial intelligence, digital health, and blockchain;
• Expanding the FDA’s ability to respond to public health emergencies, including coordinated efforts to speed development of diagnostics, therapeutics, and vaccines for viral and other emerging threats to public health;
• Strengthening FDA ability to address the safety of imported medical products and APIs;
• Renewing and expanding initiatives first funded in FY 19, including innovative initiatives in advanced manufacturing, outsourcing, real world evidence, compounding, generics and rare diseases.
• Strengthening the scientific capabilities of CDER, CBER, CDRH, CVM, and NCF.

Funding should also be considered for: integrated knowledge management systems to support medical device and biologics; and efforts to develop and integrate interoperable data systems.Editorial note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.