by Ria Eapen, NCL Health Policy Associate
Two Fridays ago, I attended a Food and Drug Administration briefing on the Reagan-Udall Foundation following the much-awaited release of the names of the Foundation’s board members earlier that day. The briefing was led by Dr. Janet Woodcock, FDA Deputy Commissioner and Chief Medical Officer, and participants at the briefing included representatives from patient and consumer advocacy groups.
The Reagan-Udall Foundation was created under Title VI of the recently enacted Food and Drug Administration Amendments Act of 2007, which was signed into law by President Bush on September 27. It’s the new private and independent nonprofit organization created to advance the FDA’s mission to speed up the development of new drug, food, and cosmetic products, and to make sure they’re as safe as possible. The creation of the foundation is part of FDA’s efforts to revamp how agency-regulated products are developed, manufactured, and evaluated for safety and effectiveness, as well as to help private and public stakeholders collaborate on the priorities identified in FDA’s Critical Path reports. The board is made up of 14 members, including four from industry, three from academic research, two from patient or consumer advocacy groups, and four at-large representatives. NCL and other consumer groups strongly supported the decision to include representation of patient or consumer advocacy groups on the board, and we voiced our concern during the nomination process that those nominated may not be conflict-free (i.e., have no financial conflicts of interest or ties to industry) or truly represent the public’s interest in medical research.Participants at the briefing additionally expressed concern over what projects the Foundation would focus on, how those projects would be selected, what would be produced from the projects, and whether the Foundation would be able to dedicate time towards projects on rare diseases that do not typically receive as much attention or funding.