Reagan-Udall Foundation Receives FDA Funding to Advance Regulatory Science

WASHINGTON, June 13, 2012 /PRNewswire-USNewswire/ -- The Reagan-Udall Foundation for the Food and Drug Administration today announced it has received $900,000 from the FDA to support its FY2012 operations and infrastructure. The Foundation, an independent, non-profit organization, was created by Congress to advance the mission of the FDA through the study and pursuit of regulatory science initiatives.

"This is a critically important milestone for the Reagan-Udall Foundation," said Jane Reese-Coulbourne, M.S. ChE., Executive Director, Reagan-Udall Foundation. "The appropriation, combined with project grants, will put us on the path Congress set before us and help provide the Agency with additional scientific thinking about its ongoing regulatory activities."

The Reagan-Udall Foundation was established with the Food and Drug Administration Amendments Act of 2007 to bring together experts, consumer advocates and research scientists to help develop better scientific evidence relevant to the development and use of medical products, their manufacturing, and the safety of foods, enabling progress on safety and innovation. The law requires FDA to provide between $500,000 and $1.25 million each fiscal year to support the Foundation.

Foundation priorities include exploring opportunities in the areas of food safety, novel approaches for developing therapies to fight tuberculosis, better understanding of cancer drug toxicities, and methods to enhance the FDA's ability to use clinical data sets for active post-market product safety surveillance. Additional areas of focus include scientific capacity building through training and fellowship programs for research scientists.

"Genomic science, biomarker research, and biomedical information technology are examples of areas of rapid scientific progress that have the potential to help improve the safety and effectiveness of FDA-regulated products," said Mark McClellan, M.D., Ph.D., Chair of the Board of Directors for the Reagan-Udall Foundation and former FDA Commissioner. "Turning scientific potential into real evidence and practical scientific capabilities that can be used by FDA and the public requires new collaborations that the Reagan-Udall Foundation was designed to support. The Foundation provides a unique opportunity to bring all parties to the table - patient groups, academia, government entities, and industry - to work together on scientific issues to support the FDA's public health mission."

In 2011, the Foundation was awarded a $1 million grant from the Bill and Melinda Gates Foundation to serve as a facilitator among global tuberculosis stakeholders in the Critical Path to TB Multidrug Regimens Project (CPTR). The Foundation also received a grant from Susan G. Komen for the Cure to support a pilot project to better understand treatment toxicity in a specific cancer population.

"The Reagan-Udall Foundation is an important partner in advancing the FDA's public health mission and embodies the agency's vision for collaborative innovation to address the scientific challenges of the 21st century," said FDA Commissioner Margaret A. Hamburg, M.D. "We are pleased to work with the Foundation on major public health concerns, such as tuberculosis and cancer, and we look forward to future activities that bring the best possible science in support of our regulatory activities."

Stakeholders and other audiences may stay updated on the latest news and developments from the Foundation by visiting http://www.ReaganUdall.org and joining the email subscriber list.

SOURCE Reagan-Udall Foundation