staff turnover have increasingly hampered the agency’s ability to fulfill its regulatory mission.

As discussed in this introduction, there has been much discussion regarding the urgency of evolving FDA to a robust and autonomous agency that has capacity to bridge gaps in knowledge and resources so that safe, effective drugs can be delivered to patients. Only recently, however, have funds been requested specifically for the task of fortifying the science base behind FDA’s regulatory actions (FDA, 2010a).


In its 2007 report The Future of Drug Safety: Promoting and Protecting the Health of the Public (IOM, 2007), the Institute of Medicine (IOM) identified the need for an improved science base for drug evaluation within FDA, including both internal resources and extramural funding for collaboration with academia. In that same year, the FDA Science Board,4 at the request of Congress, reported on the agency’s need for an enhanced science base, including infrastructure development, multisector collaboration, and an expanded workforce capable of addressing the rapidly evolving science of drug discovery and development. In 2008, the IOM Forum on Drug Discovery, Development, and Translation held a public workshop to explore the science of drug regulation, focusing on the gap between leading-edge technologies of drug development and FDA’s capacity to adapt its process of regulatory evaluation to these technologies (IOM, 2008). Together, the results of these efforts suggest a widening gap between scientific developments in areas relevant to FDA’s mission and its ability to address these innovations, as well as a lack of understanding among the public, policy makers, and the agency of what is required to fill this gap.

To address these concerns, the IOM Drug Forum convened a public workshop on February 26, 2010, to examine the state of the science of drug regulation and consider approaches for enhancing the scientific basis of regulatory decision making. The workshop provided an opportunity to explore the concept of regulatory science, examine how it can be used to improve regulatory decision making, and consider alterna-


The FDA Science Board is an advisory committee with the following mission: “The Board shall provide advice primarily to the Commissioner and other appropriate officials on specific complex and technical issues as well as, emerging issues within the scientific community, in industry and academia. Additionally, the Board will provide advice to the Agency on keeping pace with technical and scientific evolutions in the fields of regulatory science, or formulating an appropriate research agendas; upgrading its scientific and research facilities to keep pace with these changes. It will also provide the means for critical review of Agency sponsored intramural and extramural scientific research programs” (FDA, 2010b).

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