Speakers from the patient community, such as Ellen Sigal of Friends of Cancer Research and Margaret Anderson of FasterCures, highlighted the importance of public policy advocates as the ultimate catalysts for political reform. The final workshop session examined ways to interact with the public policy community, gain its support, and mitigate the unique challenges faced in the process.


Steven Grossman, founder of Alliance for a Stronger FDA, highlighted three principal challenges that hinder engagement of the public policy community in support for enhanced regulatory science at FDA: funding, policy development, and communication.

  • Funding—Fully 80 percent of FDA’s budget goes to personnel costs. Grossman expressed concern that—despite the increase in FDA’s appropriated budget for 2011—the agency faces an unprecedented need for scientific research combined with increased expectations. Given the fixed expenses required to run the agency, little funding will remain for new initiatives.

  • Policy development—In policy development, there is often a demand for fast results; however, building a regulatory science infrastructure will require a significant investment of resources and time. Strong leadership and a clearly articulated implementation process must be communicated to policy makers at the outset to prevent a loss of support, said Grossman. He also suggested that the move to build a regulatory science infrastructure at FDA should remain independent of user fees and other potential funding sources that could be perceived as posing a conflict of interest.

  • Communication—A common theme underlying public policy challenges is the importance of communication and education. FDA will need to build an understanding of regulatory science among the public and policy makers, remarked Grossman, as well as those directly partnering with the agency.


Mary Woolley, President, Research!America, presented the results of a survey conducted by her organization (Research!America, 2010) as context for the actions needed to energize the public policy community to support the development of a regulatory science infrastructure at FDA. Woolley noted that public sentiment is dynamic and is driven by emotion,

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