Reagan-Udall Foundation Builds Portfolio of Drug Regulatory and Safety Projects

Established by Congress to channel outside resources to collaborative projects designed to advance science and FDA’s mission, the Reagan-Udall Foundation for the FDA (RUF) is overcoming initial roadblocks and gaining support from a range of public and private organizations. The goal is to form precompetitive collaborations to devise better methods for assessing drug safety and to improve the use of Big Data in developing and evaluating medical products.

A lead RUF project funded by the Bill & Melinda Gates Foundation addresses challenges in developing multi-drug regimens to treat tuberculosis. Gates renewed its support for the Critical Path to Tuberculosis Drug Regimens (CPTR) initiative in 2015, which began in 2011 as a collaboration with the Critical Path Institute and the Global Alliance for TB Development as part of its program to halt the spread of drug-resistant TB strains. This project addresses regulatory challenges to TB research and development and supports the evaluation of regulatory issues related to the development of combination TB treatments.

RUF’s Innovation in Medical Evidence Development and Surveillance (IMEDS) program is exploring ways to improve the evaluation of medical product safety by querying large data sets, with a focus on making FDA’s Sentinel system better able to detect serious safety problems more quickly. Priorities are to address bias in observational studies, better understand the limitations of the data, and provide investigators with access to de-identified healthcare data and computing resources through the IMEDS Research Laboratory.

A new project funded by the Patient-Centered Outcomes Research Institute (PCORI) will help train and educate patient advocates on issues related to biomedical research and medical treatment. This Big Data for Patients (BD4P) initiative supports a lead PCORI goal of helping patient and consumer populations understand PCORI research programs. In announcing this training and education program in July 2015, RUF executive director Jane Reese-Coulbourne acknowledged the need to make data science “less intimidating for patients” so they will be better equipped “to actively engage in the design, conduct, and application of research.”

Developing methods for better evaluating drug safety is the goal of RUF’s PredicTox program, which brings together a number of organizations developing tools to better predict adverse events, such as cardio dysfunction. The foundation emphasizes the importance of data sharing among public and private researchers and aims to facilitate this through by a common data platform and data-use agreements.

RUF is looking to do more related to food safety, as area of growing importance for FDA.  Although the foundation was established in 2007, government funding to support the operation was blocked until 2012 due to concerns among some members of Congress that pharma companies would use RUF as a “backdoor” way to influence FDA regulatory decisions. Support from Gates for the TB project expanded its capacity and credibility, and Congress has continued to appropriate overhead funding, providing a basis for building its annual budget up to about $6.5 million from a mix of public and private sources. 

As with all federal agencies, FDA cannot accept private sector donations, an issue that is even more delicate for an organization that regulates private industry. RUF functions similar to the foundation for the National Institutes of Health (NIH), which channels resources to support collaborations on basic and translational research at the NIH.  A sign of the times is that the 21^st Century Cures legislation moving through Congress includes some uncontroversial provisions to improve the foundation’s governance and management.