Frequently Asked Questions About the Reagan-Udall Foundation
1. What is the Reagan-Udall Foundation for the FDA?
The Reagan-Udall Foundation is a private and independent nonprofit organization that advances the mission of the Food and Drug Administration (FDA) to modernize medical, veterinary, food, food ingredient, and cosmetic product development; accelerate innovation; and enhance product safety.
The Foundation was created through bi-partisan action in Congress in the FDA Amendments Act of 2007. Many members on both sides of the aisle believed that the Foundation was needed for a critical role at this time of rapid scientific progress and innovation in such areas as genomics and proteomics, information technology, and other technologies that could protect and improve the health of Americans.
The Foundation supports activities that promote better science and better technical capabilities that can advance the FDA’s mission. The Foundation does not advise the FDA on regulations or approvals. In its unique statutory role, it creates and facilitates public-private partnerships, which include all stakeholders — patient groups, academia, government, health care providers, industry and others – seeking to develop better science and evidence.
View the FDA’s Fact Sheet on the Foundation.
2. What are the reasons for creating the Reagan-Udall Foundation with the FDA as an active partner?
As a regulator, the FDA should not conduct stakeholder collaborations when the scientific information produced may come to the Agency for evaluation. Rather, the FDA’s role is to evaluate this scientific information along with all of the other scientific information it considers, from public and private sources, in fulfilling its mission. However, FDA experts have many insights about the most important gaps in the science available to support the FDA’s mission. To help fill these gaps, the Foundation can organize complex scientific collaborations that need a neutral third party to convene the participants, negotiate complex working and data sharing agreements, and help resolve disputes among participants.
In the end, the goal is to produce better science that can be used by the FDA and the public and private sector on issues that are important to FDA, and thus to the American public. Congress recognized that the Reagan-Udall Foundation could help advance this critical but unmet goal.
3. What are some examples of Reagan-Udall Foundation projects?
The Reagan-Udall Foundation for the FDA leads projects to improve the science, analytic evidence, and scientific capacity for supporting the mission of the FDA. For details on current projects and work in development, see here.
4. Why does the Reagan-Udall Foundation convene Public-Private Partnerships?
The Reagan-Udall Foundation was created to develop scientific evidence and technical expertise that is too complex and expensive for one group to accomplish. The Reagan-Udall Foundation will conduct activities that can only be accomplished through partnerships of multiple stakeholders, including patient groups, government, academia, and industry. The Foundation works hard to get balanced input from all stakeholders. This along with a proactive system of disclosure requirements and on-going transparency will ensure that there will be no undue influence by any one sector or group.
5. How does the Reagan-Udall Foundation determine its priorities?
All of the Foundation’s projects and programs must be approved by the Board of Directors and the FDA Commissioner before they are undertaken.
The Foundation takes guidance from the FDA on the important scientific issues that FDA feels are inadequately addressed. As part of its innovation strategy, the FDA has identified several high-priority scientific areas that FDA would like to engage in with the Foundation, such as exploring opportunities in the areas of food safety, novel approaches for developing therapies to fight TB, and methods to enhance the FDA’s ability to use clinical data sets for active post-market product surveillance.
6. How is the Reagan-Udall Foundation funded?
The Reagan-Udall Foundation is supported by both public and private funds. When Congress created the Foundation, it authorized transfers of FDA funds to the Foundation for general operations in the amount of $500,000-$1,250,000 annually. Prior to 2012, no funds were appropriated for the Foundation. Projects can be funded by grants and charitable giving. These contributions are integral to helping the Foundation fulfill its mission. All contributions are reviewed by the Executive Director and the Board of Directors, including for possible and potential conflicts of interest. The Foundation maintains discretion to accept or refuse contributions.
7. How does the Reagan-Udall Foundation protect against conflicts of interest and undue influence?
The Reagan-Udall Foundation has numerous provisions in place to protect against conflicts of interest and undue influence. For example, Board members are prohibited from participating in Foundation matters in which they (or close relatives or entities in which they have an interest) have a financial interest and must disclose their financial interests in entities doing business with the Foundation and in entities regulated by the FDA, and their involvement in entities with interests that may conflict with the Foundation’s best interests.
Similarly, annual financial disclosures submitted by Foundation employees and Board members are reviewed by the Foundation’s Outside Counsel, who is responsible for identifying conflicts and determining what actions are necessary to ensure that an employee or director does not participate in matters in which such a conflict would or could exist. Regulated industry representation on the Board is limited to four of the fourteen voting members.
All projects must be reviewed and approved by the Board and can be subject to independent peer review. Finally, the Foundation is prohibited from participating in regulatory matters or offering advice to FDA on policy matters. The Reagan-Udall Foundation does not advise the FDA on regulatory or other decisions. Rather, the scientific and technical information developed by the Foundation go into the public domain, where they can be used by the FDA and others.
8. How does the Reagan-Udall Foundation maintain transparency?
The Foundation is committed to transparency and is in the process of posting critical information on its web site: As the website is built out further and as new projects are considered, the Foundation will continue to post additional information. Please check back for new information.