Alliance "Hill Day": April 28 and 29

When the Alliance and its members participate in a “virtual Hill day” on April 28 and 29, the following is the hand-out we will be using. It makes the case for a large investment in FDA in FY 22 but defers making a specific “ask” until the President’s Budget Request is submitted to Congress. The strength of our case for increased FDA funding is enhanced when we have many different stakeholders with the common message: FDA needs greater investment to stay ahead of its growing responsibilities and broadening mission. To join our Hill Day activities, contact Reed Diskey and let him know your availability.

FDA and the FY22 Appropriations CycleThe Alliance for a Stronger FDA--April 2021“Growing Responsibilities Require a Budget That Grows”

FDA’s jurisdiction includes responsibility for 70% of the food supply and the entirety of drugs, medical devices, biologics, vaccines, diagnostics, veterinary food and medicine, dietary supplements, and cosmetics. Altogether, the agency oversees products that represent 20% of all consumer spending ($2.6 trillion) and touch Americans multiple times each day.No federal agency’s mission and responsibilities are more affected by changes in science, technology, innovation, and social trends than the FDA. This past year has further demonstrated the central role of the agency in our nation’s public and personal health, as well as its ability to respond to national crises.Thanks to Congressional appropriators, FDA has received much-needed funding over the last decade. However, the FDA’s mission continues to grow, and its vital activities have become more complex and require greater sophistication and expertise to complete. Rapid acceleration of science and technology creates both new challenges and new opportunities.Completing the job of making FDA into a modern 21^st 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 scientific-based decision-making and keep up with innovation in both food and medical products. FDA has released a Technology Modernization Action Plan and a Data Modernization Action Plan, both in need of substantial new funding.Because FDA’s funding needs are growing so rapidly and the dynamic nature of the agency’s mission is accelerating, the Alliance has chosen not to formulate a specific “ask” prior to release of the President’s Budget Request.Until that occurs, Alliance staff have identified six key areas where FDA and the American people would benefit from investments in the agency. Each area is relevant to both food safety and medical products.

1. Shortening Supply Lines/Advanced Manufacturing
2. Product Safety and Tracking
3. Regulatory Science
4. Building Expertise to Match New Science
5. Modernization of FDA’s Data Infrastructure and Technological Capacity
6. Public Health Priorities, including nutrition

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.When we have the President’s Budget Request, we will analyze it and determine the amounts the Alliance will recommend for specific priorities.Editorial Note: The Analysis and Commentary section is written by Steven Grossman, Executive Director of the Alliance for a Stronger FDA.