Reagan-Udall Foundation for the FDA: Our Work
In 2007, Congress created the Reagan-Udall Foundation for the FDA in response to the FDA’s own “FDA Science and Mission at Risk” report of the Subcommittee on Science and Technology, prepared for the FDA’s Science Board. The report assessed the state of science and technology at the FDA and its ability to support current and future regulatory science needs. The Subcommittee noted that while demands on the FDA had increased due to ongoing scientific innovation, resources had not kept up with the demands and exceeded the FDA’s regulatory scientific capacity. The Subcommittee identified critical needs in the areas of strengthening science capability, capacity and organization, as well as improving information sciences and technology.
The Reagan-Udall Foundation for the FDA (the Foundation) has been asked to undertake a number of important projects to improve the science, analytic evidence, and scientific capacity for supporting the mission of the FDA. The Foundation works to facilitate engagement between FDA and external stakeholders through Public-Private Partnerships. The Foundation’s projects support the FDA while incorporating voices of all stakeholders, including patients and consumer advocates, regulated industry, healthcare providers, academics, and others – with the ultimate goal of improving public health. Current and developing work areas are outlined below.
Big Data for Patients (BD4P) is a training program developed for patients and advocates in the science of big data. This program will provide an introduction to the concepts of big data–what it is, how it is used, who is using it–to empower patients and advocates to more effectively participate in, and contribute to, current data science efforts in health and medicine. Read more about the program here.
The Reagan-Udall Foundation (RUF) for the FDA is a partner in the CPTR Initiative, a global partnership launched by the Bill and Melinda Gates Foundation, the Critical Path Institute, and the TB Alliance to accelerate the development of new tuberculosis (TB) multi-drug regimens. In conjunction with the CPTR team, RUF is proactively bringing together a broad range of international TB stakeholders with diverse perspectives, including: regulators, drug developers, academic scientists, and advocates to identify, prioritize, and work toward resolving regulatory science issues and challenges of drug development and treatments for people with TB. Read more about this project here.
The IMEDS program serves to advance the science and tools necessary to support post-market evidence generation on regulated products and to facilitate utilization of a robust secondary electronic healthcare data platform for generating better evidence on regulated products in the post-market settings. Read more about the program here.
Work in Development
Food Safety Innovation Consortium (FSIC)
The FSIC is a partnership to advance regulatory science in the area of food safety. Creation of the FSIC provides a much-needed venue for fostering collaboration between the FDA, other federal agencies, academia, industry and consumer advocates, with the goal of developing and executing a research agenda with both short-term and long-term priorities focused on shared needs. This initiative would serve to create a home-base to foster innovation and collaboration on food safety issues, with the goal of improving food safety and reducing foodborne illness. Read more about the proposed FSIC here.
Expanded Access (EA) Navigator
The EA Navigator would serve as a coordinated resource for clear information to help patients and healthcare providers navigate the EA request process, also known as compassionate use. The focus of the EA Navigator would be (non-emergency) individual patient access to investigational drugs (“single patient INDs”). Read more about the proposed EA Navigator here.
Regulatory Science Education & Fellowships
This work area aims to address the critical need for strengthening scientific capability and capacity, both within the FDA as well as externally. RUF is currently in the process of defining and developing our regulatory science education agenda. Ultimately, this will include work to foster greater understanding of and expertise in new scientific tools, diagnostics, and manufacturing techniques, and will serve to identify potential barriers to translating basic research into clinical and regulatory practice.