Reagan-Udall Foundation

The Reagan-Udall Foundation is collaborating with FDA in several high-priority scientific areas identified as part of the agency's innovation strategy. These include food safety, novel approaches in the development of therapies to fight tuberculosis, and methodologies for post-market product surveillance under a program called Innovation in Medical Evidence Development and Surveillance (IMEDS).[1]

Two specific examples:

1) Funded by the Bill & Melinda Gates Foundation, the Reagan-Udall Foundation is an active participant in the Critical Path to TB Drug Regiments (CPTR), a global initiative co-founded by the Bill & Melinda Gates Foundation, the Critical Path Institute, and the TB Alliance in March 2010 to accelerate the development of new tuberculosis (TB) treatment regimens. The Foundation's role is to convene and facilitate collaboration and dialogue between the CPTR team and a broad range of international TB stakeholders including regulatory and academic scientists, drug developers, advocates, and other NGOs, to identify, prioritize and work toward resolving regulatory science issues and challenges.

2) Funded by the Susan G. Komen for the Cure, the Reagan-Udall Foundation is convening a Systems Toxicology Project with the ultimate goal of directly identifying common biological intermediates for toxicity in two classes of oncology drugs, then correlating them to an adverse event. This could enable future research within the drug class to mitigate toxic effects through dosing modification, alternative treatments, or potentially develop a new regulatory tool that would assist in future drug safety evaluation. By having an independent, third party convener, like the Reagan-Udall Foundation, multiple companies can be readily involved, along with toxicologists, oncologists and other scientists from the FDA, National Institutes of Health and academia.

The Reagan-Udall Foundation is managed by June S. Wasser, executive director, and overseen by a 14-member board that includes representatives from (2) patient/consumer advocacy groups, (3) academic research institutions, no more than (4) from the general, pharmaceutical, device, food, cosmetic and biotechnology industries, (1) health care providers and (4) at large representatives with relevant expertise and experience.[2] As required by statute, two leading government scientists - the Commissioner of the FDA and the Director of the National Institutes of Health are ex officio members of the Board. The RUF has numerous provisions in place to protect against conflicts and undue influence. Board members are prohibited from participating in matters in which they have a financial interest and must disclose their financial interest in entities doing business with the Foundation and in entities regulated by the FDA. Additionally, conflicts protections are required for each individual project the Foundation undertakes. All projects are reviewed by the Board of Directors and are subject to an independent review.

Finally, the Foundation is prohibited from participating in regulatory matters or offering advice to FDA on policy matters.

• Regulatory Science
• Sentinel Initiative
• Real word evidence
• Food and Drug Administration
• Food and Drug Administration Amendments Act of 2007
• Mark McClellan
• Ellen V. Sigal
• Tachi Yamada
• Phillip Allen Sharp
• Diana Zuckerman

• https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm109029.htm
• http://www.FDA.gov
• FDA Regulatory Science White Paper
• 2010 IOM Meeting on Regulatory Science
• Possible Role for RUF discussed in NEJM
• Comments on RUF Bylaws as Posted on the Federal Register Form by FasterCures