FDA could analyze public health consequences of its decisions better

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.


Jennifer Walsh, Media Relations Officer

Shaquanna Shields, Media Relations Assistant

Office of News and Public Information

202-334-2138; e-mail [email protected]

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).


Division of Behavioral and Social Sciences and Education
Division on Earth and Life Studies



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;


Center for a Livable Future

Bloomberg School of Public Health; and


School of Medicine

Johns Hopkins University


Jeffery B. Bender

Associate Professor, and


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


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


Paul S. Fischbeck


Center for the Study and Improvement of Regulation

Department of Social and Decision Sciences

Carnegie Mellon University


Karen E. Jenni


Insight Decisions LLC


Helen H. Jensen

Professor of Economics, and


Food and Nutrition Policy Division

Center for Agricultural and Rural Development

Iowa State University


L. Robin Keller

Professor of Operations and Decision


Paul Merage School of Business

University of California


James D. McKean

Associate Director

Iowa Pork Industry Center

College of Veterinary Medicine

Iowa State University


David O. Meltzer

Associate Professor

Department of Medicine, and

Associate Faculty Member

Harris School and Department of Economics

University of 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


Harvard Medical School


John T. Watson2

Professor of Bioengineering

University of California

San Diego


Ellen Mantus

Study Director

1 Member, Institute of Medicine

2 Member, National Academy of Engineering

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