PRESS RELEASE: FDA Seeks Nominations for Reagan-Udall Foundation

FDA Seeks Nominations for Reagan-Udall Foundation

Foundation part of new FDA law

The U.S. Food and Drug Administration is seeking nominations from patient and consumer advocacy groups, professional scientific and medical societies, and industry trade organizations to serve on the board of directors of the newly created Reagan-Udall Foundation.

Title VI of the recently enacted Food and Drug Administration Amendments Act of 2007 created the foundation to advance the mission of FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.

The foundation will be a private, independent, nonprofit entity. The statute calls for a diverse 14-member board: four representatives from the general pharmaceutical, device, food, cosmetic and biotechnology industries; three representatives from academic research organizations; two representatives from patient or consumer advocacy groups; one member representing health care providers; and, four at-large representatives with expertise or experience relevant to the purpose of the Reagan-Udall Foundation.

"A concerted effort by government, industry and academia is needed to modernize the scientific tools used to develop products and to monitor their safety once they go to market," said Commissioner of Food and Drugs Andrew C. von Eschenbach. "We are looking forward to foundation candidates who will work with us to embrace the transformational nature of future efforts to protect and promote the public health."

The foundation will identify unmet scientific needs in the development, manufacture, and evaluation of the safety and effectiveness of FDA regulated products, including post-market evaluation, and establish scientific projects and programs to address those needs. It will help accomplish the scientific work the FDA needs to support its regulatory mission. The foundation will be an important vehicle for private and public stakeholders to collaborate to address the priorities and opportunities identified in FDA's Critical Path reports, and to help modernize the product evaluation sciences.

FDA, the National Institutes of Health, Centers for Disease Control and Prevention, and the Agency for Healthcare Research and Quality have 30 days to appoint the foundation's board of directors. FDA will handle the submission process. Nine members are to be appointed from a list of candidates provided by the National Academy of Sciences. Five members are to be appointed from lists of candidates submitted by organizations mentioned above.

Interested persons may submit nominations by facsimile to Lisa Rovin or Nancy Stanisic at 301-443-9718, or by e-mail to [email protected]. All nominations must be received on or before Oct. 15, 2007.

This notice requests nominations "provided by patient and consumer advocacy groups, professional scientific and medical societies, and industry trade organizations" as specified in section 770(d)(1)(C)(i).  Note that the statute does not provide for nominations by individuals, corporations, or organizations that are not "patient and consumer advocacy groups, professional scientific and medical societies, and industry trade organizations.

Suggested Articles

Cedrik Britten, M.D., becomes the biotech’s new chief medical officer to help run its adoptive cell therapy and TCR bispecifics platform.

Five Prime Therapeutics’ clinical development lead is hoping for a more stable time at new employer Spectrum Pharma.

The update comes as Gilead closes in on a FDA approval that will position it to compete with JAK inhibitors sold by AbbVie, Eli Lilly and Pfizer.