WASHINGTON — A new report from the National Research Council lays out a framework for the U.S. Food and Drug Administration to systematically evaluate and compare the public health consequences of its decisions concerning a wide variety of products. Moreover, the risk-assessment framework provides a common internal language to discuss potential options and draws extensively on well-vetted risk literature to define the relevant health dimensions for FDA decision making.
FDA must make decisions daily, from determining whether a certain drug should be approved to deciding what resources should be allocated for inspections of food production facilities, the report says. The committee that wrote the report said the framework is intended to complement, rather than replace, other risk-based approaches at FDA and is designed to serve as a general guide while providing consistent risk information to support a variety of decisions.
The new framework, while easily articulated, would require FDA to invest thought and effort to implement properly. It consists of three steps: careful definition of the decision options, estimation or characterization of the public health consequences of each option, and structured comparison of the consequences to inform decision makers and the public.
The committee applied the risk-characterization framework to four hypothetical case studies: deciding whether to withdraw a vaccine from the market, evaluating the potential public health consequences of foodborne illness, helping determine testing priorities for a laboratory, and choosing whether to improve existing surveillance of two medical devices. For each, the committee illustrated how its framework could be applied; defined the specific options to be compared; developed a risk-attribute table to characterize the public health consequences of alternative decisions; and illustrated how the risk characterizations could be used to compare the specific decision options.
The committee recognized that precise predictions of different consequences may be difficult to develop in cases where data are lacking or scientists are uncomfortable making the necessary judgments. However, decisions in which risk information could be valuable are made regularly. The committee recommended that FDA use experts who are trained in and comfortable with decision analysis, risk assessment, risk management, and specifically the assessment of uncertainties to facilitate the use of the framework.
The study was sponsored by the U.S. Department of Health and Human Services. The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council make up the National Academies. They are independent, nonprofit institutions that provide science, technology, and health policy advice under an 1863 congressional charter. Committee members, who serve pro bono as volunteers, are chosen by the Academies for each study based on their expertise and experience and must satisfy the Academies’ conflict-of-interest standards. The resulting consensus reports undergo external peer review before completion. For more information, visit http://national-academies.org/studycommitteprocess.pdf. A committee roster follows.
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Pre-publication copies of A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration are available from the National Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at http://www.nap.edu. Reporters may obtain a copy from the Office of News and Public Information (contacts listed above).
NATIONAL RESEARCH COUNCIL
Division of Behavioral and Social Sciences and Education
Division on Earth and Life Studies
and
INSTITUTE OF MEDICINE
Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II
Robert S. Lawrence (chair)1 Professor of Environmental Health Sciences, Health Policy, and International Health;
Director
Center for a Livable Future
Bloomberg School of Public Health; and
Professor
School of Medicine
Johns Hopkins University
Baltimore
Jeffery B. Bender
Associate Professor, and
Director
Center for Animal Health and Food Safety
University of Minnesota
St. Paul
Francisco Diez-Gonzalez
Associate Professor
Department of Food Science and Nutrition
University of Minnesota
St. Paul
Kathryn M. Edwards1
Sarah H. Sell Chair in Pediatrics, and
Director
Vanderbilt Vaccine Research Program
School of Medicine
Vanderbilt University
Nashville, Tenn.
Susan S. Ellenberg
Professor of Biostatistics and Associate Dean
for Clinical Research
School of Medicine
University of Pennsylvania
Philadelphia
Paul S. Fischbeck
Director
Center for the Study and Improvement of Regulation
Department of Social and Decision Sciences
Carnegie Mellon University
Pittsburgh
Karen E. Jenni
Principal
Insight Decisions LLC
Denver
Helen H. Jensen
Professor of Economics, and
Head
Food and Nutrition Policy Division
Center for Agricultural and Rural Development
Iowa State University
Ames
L. Robin Keller
Professor of Operations and Decision
Technologies
Paul Merage School of Business
University of California
Irvine
James D. McKean
Associate Director
Iowa Pork Industry Center
College of Veterinary Medicine
Iowa State University
Ames
David O. Meltzer
Associate Professor
Department of Medicine, and
Associate Faculty Member
Harris School and Department of Economics
University of Chicago
Chicago
Sanford A. Miller
Senior Fellow
Joint Institute for Food Safety and Applied Nutrition
University of Maryland
College Park
Richard Platt
Professor and Chair
Department of Ambulatory Care and
Prevention
Harvard Medical School
Boston
John T. Watson2
Professor of Bioengineering
University of California
San Diego
STAFF
Ellen Mantus
Study Director
1 Member, Institute of Medicine
2 Member, National Academy of Engineering