Excerpts from the Alliance’s Testimony to the House Appropriations Committee’s Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies.
The full testimony is here.
The Alliance strongly supports the Administration’s budget authority (BA) request of $3.653 billion for fiscal year (FY) 2023. This provides for an increase of $318 million in BA salary and expenses (S&E) and an increase of $18 million in BA buildings and facilities (B&F). We also support the proposed no-year money requests for pandemic response ($1.6 billion) and the Cancer Moonshot ($20 million). We urge Congress to adopt these proposed funding levels.
Our request for FY 23 funding focuses exclusively on appropriations that come from monies paid by taxpayers (BA) and intentionally does not include user fees and mandated funding (e.g., Cures monies transferred from National Institutes of Health). However, we urge Congress to fully fund those programs, as well.
Background
Completing the job of making FDA into a modern 21st Century regulatory agency will require substantial new investments. The agency needs an increased budget, more scientific and technical staff, and better analytical tools that support science-based decision-making and keep up with innovation in both food and medical products.
The growing complexity of science, interwoven with new innovative technology is a challenge across the agency. In food safety, this means the use of artificial intelligence, whole genome sequencing, and enhanced electronic recordkeeping that will contribute to a safer food supply. 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.
Consistent with that, FDA needs to attract and retain specialized personnel that are experts in increasingly complex fields such as artificial intelligence, genomics, diagnostics, digital technology, cybersecurity, blockchain, advanced manufacturing, robotics, and whole genome sequencing.
Specific Programs and Initiatives
We see specific programs and initiatives where additional investment in FDA would add to the value of the agency’s activities on behalf of the American public:
Food Safety – For FY 23, we urge Congress to consider:
More robust and rapid Food Safety Modernization Act (FSMA) implementation, including increased cooperation with states, finalization of guidances, and a focus on produce safety, import safety, and training/education;
Enhanced funding of systems for surveillance of foodborne illnesses and outbreak response;
Upgrades to the public health laboratories network;
Strengthening the scientific capabilities of the Center for Food Safety and Applied Nutrition (CFSAN), the Center for Veterinary Medicine (CVM), and the National Center for Toxicological Research (NCTR); and
Starting the development and implementation of initiatives contained in the agency’s New Era of Smarter Food Safety.
Funding should also be considered for: FDA’s recall initiatives, nutrition education, safety of cosmetics and dietary supplements, antimicrobial resistance, CBD, and standards of identity/food labeling and product claims.
Medical Products – For FY 23, 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 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 API’s;
Renewing and expanding initiatives first funded in prior years, including innovative initiatives in advanced manufacturing, outsourcing, real-world evidence, compounding, generics, and rare diseases; and
Strengthening the scientific capabilities of the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), CVM, and NCTR.
Funding should also be considered for integrated knowledge management systems to support medical devices and biologics, and efforts to develop and integrate interoperable data systems.
Conclusion
In conclusion, we urge Congress to recognize the multiple opportunities for FDA to be a more effective protector of the public health, as well as a fair and efficient regulator. We are at a point where additional investment in FDA will result in substantial added value to the American public.
Editorial Note: The week’s Analysis and Commentary section was written by the Alliance’s Executive Director, Steven Grossman.
