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Institute of Medicine (US) Forum on Drug Discovery, Development, and Translation. Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary. Washington (DC): National Academies Press (US); 2011.

Cover of Building a National Framework for the Establishment of Regulatory Science for Drug Development

Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary.

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Regulatory agencies worldwide are tasked with a difficult mandate to provide large populations with efficient access to drugs that are both safe and effective. They must also balance this task while adapting to new technologies in medicine and information technology. These demands are further complicated by the increasing globalization of drug development and regulatory relationships. These challenges, along with problems with contaminated supplies, serious adverse events, and other compounding issues that accompany changes in administration, contribute to the overburdening of a regulatory system whose resources have not increased along with its demands. We urgently need to ensure that our regulatory bodies have the autonomy, resources, and scientific support needed to function effectively to promote public health and safety.

The U.S. Food and Drug Administration (FDA) is a science-based agency responsible for regulating 80 percent of Americans’ consumable goods and a quarter of the U.S. economy. It is imperative that every one of FDA’s regulatory decisions be based on the best scientific evidence. Unfortunately, this has not always been possible due to several factors, including—but not limited to—inadequate human capital, leadership support, and funding. Above all, a weakening science base at the agency has threatened its ability to support its core regulatory functions and decisions. FDA needs to resolve this gap between scientific and regulatory decision making to ensure continuity of its duties in an environment of heightened public scrutiny on drug safety and rapid scientific advancements.

The public increasingly recognizes the importance of regulatory science. The notion of basing regulatory decisions on the best scientific knowledge available is not new, but never before have funds been deliberately appropriated for the accomplishment of this task. FDA’s 2011 budget proposal includes $25 million specifically allocated to the building of a regulatory science infrastructure at the agency. In anticipation of this event and as an acknowledgment of the “reform-ready” political atmosphere, the Institute of Medicine’s Forum on Drug Discovery, Development, and Translation held a public workshop with the following goals in mind:

  • Establish a clear definition of regulatory science, and engage the public and the policy community in a discussion of its challenges and opportunities.
  • Increase awareness of inadequate funding for regulatory science and the impact on the development of new therapies on patients.
  • Articulate priorities and strategies for building or rebuilding the infrastructure for regulatory science.

The one-day workshop featured leaders from government, such as Representative Rosa DeLauro (D-CT); Department of Health and Human Services Deputy Secretary, William Corr; and FDA Commissioner, Margaret Hamburg. Speakers from academia, industry, and patient advocacy groups provided a variety of perspectives and illuminated examples of the urgent need of a regulatory science infrastructure. Leaders in emerging technologies, such as genomics, biostatistics, and information technology—whose fields of study are influenced daily by regulatory decisions—deliberated on potential consequences arising from the failure to establish a robust scientific base at the agency level. In addition, moderated panels considered mechanisms for building a regulatory science infrastructure at FDA, analyzed existing implementation models, and posed strategies for engaging the public and policy makers.

This was a timely workshop that provided a valuable opportunity to bring together a diverse group for thoughtful discussion about improving drug development and strengthening regulatory science. I would like to thank all of the individuals—speakers, moderators, and panelists—who contributed to and participated in the workshop. In particular, I would like to thank a small team of participants in the workshop who spent many hours in advance of the workshop discussing the merits of Centers of Excellence in Regulatory Science and the critical characteristics of these centers including: K. Ahlport, M. Anderson, L. Benet, R. Califf, G. FitzGerald, S. Kim, J. Kramer, R. Nerem, D. Nordenberg, M. Osterholm, K. Schneeman, J. Shoemaker, E. Sigal, N. Sung, and J. Tobias. I would also like to thank the members of the Forum and Forum staff for their dedication and commitment to developing and executing this workshop.

Gail H. Cassell, Co-Chair

Forum on Drug Discovery, Development, and Translation

Copyright © 2011, National Academy of Sciences.
Bookshelf ID: NBK54403


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