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News from the National Academies

Date:  May 9, 2011

 

FOR IMMEDIATE RELEASE

 

FDA Could Analyze Public Health Consequences of Its Decisions Better

With an Overall Risk-Characterization Framework

 

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.

 

 

Contacts: 

Jennifer Walsh, Media Relations Officer

Shaquanna Shields, Media Relations Assistant

Office of News and Public Information

202-334-2138; e-mail news@nas.edu

 

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).

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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