Alliance's "Ask" for FY 22: Member Input Is Requested

As described in last week’s Analysis and Commentary, the Alliance usually develops its “ask” after the release of the President’s Budget. That doesn’t work in the first year of a new Administration, when the budget request is likely to be delayed for both substantive and political reasons. As a result, the Alliance is likely to be talking with Congress about FDA’s needs before President Biden releases either a “skinny” or full budget request.Below are some possible themes and initiatives that the Alliance may want to consider advancing for FY 22. We hope this will stimulate Alliance members to tell us what they consider the most important FDA funding priorities -- whether discussed below or derived from your own experiences and thinking. Alliance members are encouraged to send their thoughts, preferably by February 22, to Steven Grossman at the Alliance.

“Growing Responsibilities Require a Budget That Grows”

The last year has further demonstrated the importance of FDA and its central role in our nation’s public and personal health. The agency oversees products that represent 20% of all consumer spending ($2.6 trillion) and touch Americans multiple times each day. In addressing the pandemic and in its many other responsibilities, the FDA’s mission continues to grow, while its vital activities have become more complex and require greater sophistication and expertise to complete. More resources will be needed in FY 22 for FDA to sustain and expand its current efforts, address the backlog of assignments, improve efficiency, and reinforce the core agency strength of science-based decision-making.Completing the job of making FDA into a modern 21st Century regulatory agency will require substantial new investments in the agency to improve resiliency, strengthen its workforce, and prepare for the next pandemic. Specifically, 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 product 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, real-world evidence, and other new technologies.In considering the nature and shape of the Alliance’s FY 22 “ask,” Alliance staff have culled five areas where additional support (funding and personnel) can be justified as needed investments in FDA. Each area is relevant to both food safety and medical products, though often in different ways. Whether these themes or some completely different set become part of our ask, we will need to flesh out each of them with additional detail and specifics that Alliance members can share with us.

1. Shortening Supply Lines/Advanced Manufacturing. Reflect lessons learned in the pandemic on both food and medical products; reinforce the move towards "Buy American;" reflect best technology -- block chain, continuous manufacturing; continue to build upon and expand the scope of an investment made by Congress a few years ago in advanced manufacturing of medical products.
2. Safety Product Tracking/Counterfeiting/Standards of Identity/Agro and Bioterrorism. Safe outcomes are not an accident, but rather the combination of good planning, clear implementation, vigilance, and flexibility.
3. Regulatory Science. The more complicated and scientifically sophisticated the world of food and drugs becomes, the more it requires tools and metrics that support regulatory judgments. This includes artificial intelligence, new food assays, more aggressive development of validated endpoints, etc. FDA moved quickly to respond to pandemic needs. How might lessons learned from the pandemic response be applied to other areas?
4. Building Expertise to Match New Science. For example: “How can FDA evaluate a product built around block chain unless it has its own experts?” In addition, the expertise gained from personnel detailed to COVID work needs to be integrated back into the agency’s overall mission.
5. Integrated Knowledge Management Systems That Promote More Efficient and More Effective Efforts by FDA. The five FDA centers operate with multiple legacy platforms that do not talk to each other. This forces humans to collate and disburse information and insights that can be accomplished better with integrated platforms. Those platforms can also provide insight from “big data,” which cannot be done solely by humans.

Please send comments to Steven Grossman. Tell us what you think should be the priorities for FDA funding in FY 22. Don’t limit yourself to this text and list.Editorial note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.