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Project Information

Project Information


Ranking FDA Product Categories Based on Health Consequences, Phase II


Project Scope:

This statement of task pertains to the second phase of a two-phase study (see BEST-K-08-03-A). In this phase, an expert committee will refine and test an evidence-based conceptual model to evaluate products and/or product categories addressed by programs of the U.S. Food and Drug Administration (FDA), excluding the tobacco program. The conceptual model and methods will have the capability of evaluating products and/or product categories according to the potential ranges of magnitude of various health consequences to U.S. users of the products at individual and population levels, taking both adverse and beneficial effects into consideration. The committee will consult with FDA to finalize products and /or product categories that are within FDA mandates for human and veterinary drugs, biologics, medical devices, foods, cosmetics, and products that emit radiation. The committee will continue to review selected scientific literature and consult with FDA to determine adverse and beneficial health consequences related to the selected products and/or product categories. It will refine the scientific conceptual model (including specification of attributes) from Phase I and will illustrate potential applications of the model in scenarios developed jointly with the FDA.

In carrying out its task, the committee will include the following activities:

- In selecting products and/or product categories for evaluation, consider products currently in use and near-term future products expected to come under FDA purview (excluding tobacco and tobacco-related products).

- Seek opportunities to assess health consequences in a way that allows results to be compared within and across broad program areas.

- Where data or assessment methods are deficient for evaluating a product and/or product category, identify information needs for addressing key uncertainties and present evaluations.

- Assess the performance of the evidence-based model for evaluating the selected product categories and identify next steps for further refinement of the model.

- In assessing health consequences, consider both the risks and the beneficial aspects of product use, and where applicable and feasible, consider the potential impact on population health if beneficial product use is curtailed through risk reduction strategies.

- In reviewing selected scientific literature, the committee shall consider the scientific literature broadly, to include, as appropriate, social science and economic literature, grey literature, and regulatory policy literature.

The committee will not recommend specific FDA activities or regulatory strategies, because those choices will entail policy judgments that transcend scientific and technologic considerations.

The committee has prepared a brief letter report that describes the conceptual model and methods.

The project is sponsored by the U.S. Department of Health and Human Services.
The approximate start date for the project is June 5, 2008.

Note: The project scope was revised and the final version is shown above(09/28/2009).

Status: Completed

PIN: BEST-K-08-03-B

Project Duration (months): 18 month(s)

RSO: Mantus, Ellen



Geographic Focus:

Committee Membership

Committee Post Date: 03/16/2009

Robert S. Lawrence - (Chair)
Johns Hopkins University

Robert S. Lawrence is The Center for a Livable Future (CLF) professor and director of the CLF in the Department of Environmental Health Sciences, professor of health policy and international health at the Johns Hopkins Bloomberg School of Public Health and professor of medicine at the Johns Hopkins School of Medicine. His expertise and research interests include community and social medicine, human rights, health promotion and disease prevention, evidence-based decision rules for prevention policy, and food security. Dr. Lawrence is a master of the American College of Physicians and a fellow of the American College of Preventive Medicine. He is also a member of the Institute of Medicine and has served on numerous National Academies committees, most recently the Committee on Adolescent Health Care Services and Models of Care for Treatment, Prevention, and Health Development and the Committee to Evaluate Measures of Health Benefits for Environmental, Health, and Safety Regulation. Dr. Lawrence received his MD from Harvard Medical School and trained in internal medicine at the Massachusetts General Hospital.
Jeffrey B. Bender
University of Minnesota, St. Paul

Jeffery B. Bender is an associate professor of veterinary public health for the College of Veterinary Medicine and has an adjunct appoint in the School of Public Health at the University of Minnesota. He currently serves as the Director for the Center for Animal Health and Food Safety. His main research interests are zoonoses and emerging diseases, food safety, and antimicrobial resistance. Dr. Bender teaches courses on veterinary public health, diseases common to humans and animals, factors for the emergence of zoonotic diseases, methods for epidemiologic investigations, and infectious disease surveillance. He has published numerous scientific articles and two book chapters, and he is a diplomate of the American College of Veterinary Preventive Medicine. Dr. Bender received his DVM from the University of Minnesota.
Francisco Diez-Gonzalez
University of Minnesota, St. Paul

Francisco Diez-Gonzalez is an associate professor in the Department of Food Science and Nutrition at the University of Minnesota. His research expertise is in the areas of food safety microbiology, foodborne pathogens, safety of fresh fruits and vegetables, pre-harvest control of pathogenic E. coli, bioterrorism agents, and safety of organic food. Dr. Diez-Gonzalez teaches
courses in Food Safety and Food Microbiology. He has served on the University of Minnesota Institutional Biosafety Committee, and he has advised both undergraduate and graduate students.
He is also the recipient of the New Career Excellence Award for the College of Human Ecology at the University of Minnesota. He is member of the editorial board of Journal of Food Protection and Food Analytical Methods. Dr. Diez-Gonzalez received his PhD in food science from Cornell University.

Kathryn M. Edwards
Vanderbilt University School of Medicine

Kathryn M. Edwards is Sarah H. Sell Chair in Pediatrics and the director of the Vanderbilt Vaccine Research Program at Vanderbilt University Medical Center. Her research interests focus on the evaluation of vaccines for the prevention of infectious diseases in adults and children. She is a fellow of the Infectious Diseases Society of America and the American Academy of Pediatrics. Dr. Edwards has previously served as a member of the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention and the Vaccines and Related Biological Products Advisory Committee of the Food and Drug Administration. She is a member of the Institute of Medicine and has also served as a member of the National Academies Committee to Assess the Safety and Efficacy of the Anthrax Vaccine. Dr. Edwards received her MD from the University of Iowa College of Medicine.
Susan S. Ellenberg
University of Pennsylvania School of Medicine

Susan S. Ellenberg is professor of biostatistics and associate dean for clinical research at the University of Pennsylvania School of Medicine. Her research interests focus on issues related to the design and analysis of clinical trials and on the assessment of medical product safety. Dr. Ellenberg is associate editor of Clinical Trials and the Journal of the National Cancer Institute. She is a fellow of the American Statistical Association, the Society for Clinical Trials, and the American Association for the Advancement of Science. She has also served as a member of the National Academies Planning Committee for The IOM Drug Safety Report: Resource Implications, the Committee on the Assessment of the U.S. Drug Safety System, and the Committee on Applied and Theoretical Statistics. Dr. Ellenberg received her PhD in mathematical statistics from George Washington University.
Paul S. Fischbeck
Carnegie Mellon University

Paul S. Fischbeck is professor of social and decision sciences, professor of engineering and public policy, and director of the Center for the Study and Improvement of Regulation at Carnegie Mellon University. His research focuses on the quantification and communication of uncertainty, including theoretical improvements to decision analysis and numerous applied real world problems. Dr. Fischbeck has written extensively on various applications of decision and risk analysis methods and has won several awards from the Institute of Operations Research and Management Sciences. He has served on several National Research Council committees, including the Committee on Marine Salvage Response Capability: A Workshop and the Committee on Risk Assessment and Management of Marine Systems. Dr. Fischbeck received a PhD in industrial engineering and engineering management from Stanford University.
Karen E. Jenni
Insight Decisions, LLC

Karen E. Jenni is president of Insight Decisions LLC, focusing on the application of decision analysis methods to energy and environmental policy issues. Much of that work emphasizes the assessment, quantification, and modeling of a variety of risks, leading to recommendations about productive areas for applied research and effective risk management strategies. Recent public sector projects include participation in a probabilistic volcanic hazard analysis for the Yucca Mountain region, and a multi-disciplinary study on Selenium mobilization from large scale ground disturbances, transport through environmental media, and the potential effects on biota. She served as a consultant to the National Academies Committee on the Prospective Evaluation of Applied Energy Research and Development at Department of Energy (Phase 2). Dr. Jenni earned a PhD in engineering and public policy from Carnegie Mellon University.


Helen H. Jensen
Iowa State University

Helen H. Jensen is a professor of economics and head of the Food and Nutrition Policy Division of the Center for Agricultural and Rural Development at Iowa State University. Her research areas are food and nutrition policy, analysis of food consumption behavior, economics of food safety, and health risk assessment. Dr. Jensen is currently on the board of directors of the American Agricultural Economics Association and the Council on Food, Agricultural and Resource Economics, and is on the editorial board of Food Economics. She has served on U.S. Department of Agriculture expert review panels, including the Panel on Measuring Food Security in the United States and the Panel on the Health Eating Index. She has also served on several National Academies committees and is currently a member of the Committee on Nutrition Standards for National School Lunch and Breakfast Programs. Dr. Jensen received her PhD in agricultural economics from the University of Wisconsin, Madison.
L. R. Keller
University of California, Irvine

L. Robin Keller is a professor of operations and decision technologies at the University of California, Irvine. Her research interests are in decision analysis, risk analysis, creative problem structuring, and behavioral decision theory. She is the editor-in-chief of Decision Analysis. Dr. Keller has served as program director for the Decision, Risk, and Management Science Program of the U.S. National Science Foundation, and she has conducted studies with the U.S. Environmental Protection Agency and the Department of Energy. She has served as a member of the National Research Council (NRC) Committee to Assess the Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident, and she is currently a member of the NRC’s U.S. National Committee for the International Institute for Applied Systems Analysis. Dr. Keller received her PhD from the University of California, Los Angeles.
James D. McKean
Iowa State University

James D. McKean is an extension veterinarian and professor in the Department of Veterinary Diagnostic and Production Animal Medicine and associate director of the Iowa Pork Industry Center at Iowa State University. His areas of interest include the assessment and prevention of chemical and drug residues in feed and food animals, quality assurance, food safety, food law, pseudorabies control, and animal welfare and well-being. At Iowa State University’s Food Safety Consortium, his research involves sulfamethazine depletion in market-weight swine, medical and feed management for sulfamethazine, and comparing sulfamethazine depletion with sulfamethazine activity from previous experiments. Dr. McKean has previously served on several national committees for governmental policy development, including the Swine Futures Team, the Taskforce on the Future of FSIS Veterinarians, and as chair of the AASV Pork Safety Committee. He has also served as a member of the National Research Council Committee on Implications of Dioxin in the Food Supply. Dr. McKean earned a JD from Drake University and a DVM from the University of Illinois.
David O. Meltzer
The University of Chicago

David O. Meltzer is an associate professor in the Department of Medicine, chief of the Section of Hospital Medicine, and an associated faculty member in both the Harris School and the Department of Economics at the University of Chicago. He is also director of the Center for Health and the Social Sciences and co-director of the Program on Outcomes Research Training. Dr. Meltzer’s research explores problems in health economics and public policy, with a focus on theoretical foundations of medical cost-effectiveness analysis and the effects of managed care and medical specialization on the cost and quality of care. He is the recipient of numerous awards, including the National Institute of Health Medical Scientist Training Program Fellowship, the National Science Foundation Graduate Fellowship in Economics, and the Lee Lusted Prize of the Society for Medical Decision Making. He is also the immediate past president of the Society of Medical Deicison Making. Dr. Meltzer has served on several National Academies committees, most recently the Committee on the Assessment of the U.S. Drug Safety System and the Committee on Establishing a National Cord Blood Stem Cell Bank Program. He received both his MD and PhD in economics from the University of Chicago.
Sanford A. Miller
University of Maryland, College Park

Sanford A. Miller is a senior fellow at the Joint Institute for Food Safety and Applied Nutrition at the University of Maryland. He was named professor and dean emeritus of the Graduate School of Biomedical Sciences at the University of Texas Health Science Center in December 2000, after serving as dean from 1987 to 2000. He was formerly the director of the Center for Food Safety and Applied Nutrition at the Food and Drug Administration. Dr. Miller has served on many national and international government and professional society advisory committees, including the National Advisory Environmental Health Sciences Council of the National Institutes of Health and the Joint World Health Organization / United Nations Food and Agricultural Organization Expert Advisory Panel on Food Safety. He is currently serving as a member of the National Academies Food and Nutrition Board; the Committee for the Review of Food Safety and Defense Risk Assessments, Analyses, and Data; and as chair of the Committee on Use of Process Indicators for Risk Ranking Processing and Slaughtering Establishments in FSIS Public Health Risk-Based Inspection System. Dr. Miller received his PhD in physiology and biochemistry from Rutgers, The State University of New Jersey, New Brunswick.
Richard Platt
Harvard Medical School

Richard Platt is professor and chair of the Department of Ambulatory Care and Prevention and a professor of medicine at the Harvard Medical School. His research focuses on the safety and effectiveness of marketed drugs and vaccines, and on infectious diseases in the community and hospital settings. Dr. Platt is the former chair of the Food and Drug Administration Drug Safety and Risk Management Advisory Committee. He is a member of the Advisory Panel for Research of the Association of American Medical Colleges and has chaired the executive committee of the HMO Research Network, the Epidemiology and Disease Control study section of the National Institutes of Health, and the steering committee of the Centers for Disease Control and Prevention's Office of Health Care Partnerships. He has also served on several National Academies committees and is currently a member of the Roundtable on Evidence-Based Medicine. Dr. Platt received his MD from Harvard Medical School.
John T. Watson
University of California, San Diego

John T. Watson is a professor of bioengineering at the University of California, San Diego. Formerly, he was director of clinical and molecular medicine of the National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH) and contributed a total of 27 years of service to NIH. Dr. Watson is a mechanical engineer and physiologist who is interested in finding ways to reduce the time it takes medical technology to move from a concept into the clinic. His areas of research include heart failure, medical implant design and science, and biomaterials. Dr. Watson is a founding fellow and former President of the American Institute of Medical and Biological Engineering and has received numerous honors, including a member of the Greatest Engineering Achievements of the 20th Century selection committee, and invitations to be a member of the Japanese Kyoto Prize nominating committee, and the National Academy of Engineering Draper Prize selection committee. He is a member of the National Academy of Engineering and has participated in several National Research Council activities, including as a speaker at a Workshop on Innovation and Invention in Medical Devices and as a member of the Committee to Develop a Research Agenda for Test Methods and Models to Simulate Accelerated Aging of Infrastructure Materials. Dr. Watson earned a PhD from the University of Texas Southwestern Medical Center at Dallas.

Disclosure of Conflicts of Interest

<br>
Disclosure of Conflict of Interest: David O. Meltzer

In accordance with Section 15 of the Federal Advisory Act, the “Academy shall make its best efforts to ensure that no individual appointed to serve on [a] committee has a conflict of interest that is relevant to the functions to be performed, unless such conflict is promptly and publicly disclosed and the Academy determines that the conflict is unavoidable.” A conflict of interest refers to an interest, ordinarily financial, of an individual that could be directly affected by the work of the committee. As specified in the Academy's policy and procedures (http://www.nationalacademies.org/coi/index.html), an objective determination is made for each provisionally appointed committee member whether or not a conflict of interest exists given the facts of the individual's financial and other interests and the task being undertaken by the committee. A determination of a conflict of interest for an individual is not an assessment of that individual's actual behavior or character or ability to act objectively despite the conflicting interest.

We have concluded that for the committee to accomplish the tasks for which it was established its membership must include, among others, at least one person who has expertise in medical cost-effectiveness analysis in the context of the pharmaceutical industry. To meet the need for this expertise and experience, Dr. David O. Meltzer is proposed for appointment to the committee even though we have concluded that he has a potential conflict of interest because he is currently engaged in consulting for companies that develop products that could be regulated by FDA.

As his biographical summary makes clear, Dr. Meltzer is a nationally recognized expert on health economics and public policy, specifically the theoretical foundations of medical cost-effectiveness analysis and the effects of different factors on the cost of quality of care. He has extensive experience in the use of medical cost-effectiveness analysis in the pharmaceutical industry and his expertise provides a critical viewpoint that complements the comparative risk analysis and decision analysis experts on the committee. This combined expertise is essential for the refinement and application that will occur to the conceptual model during phase II of this study. We believe that Dr. Meltzer can serve effectively as a member of the committee and that the committee can produce an objective report, taking into account the composition of the committee, the work to be performed, and the procedures to be followed in completing the work.

After an extensive search, we have been unable to find another individual with the equivalent combination of current practical experience and expertise as Dr. Meltzer who does not have a similar conflict of interest. Therefore, we have concluded that this potential conflict is unavoidable.


Disclosure of Conflict of Interest: Susan S. Ellenberg

In accordance with Section 15 of the Federal Advisory Act, the “Academy shall make its best efforts to ensure that no individual appointed to serve on [a] committee has a conflict of interest that is relevant to the functions to be performed, unless such conflict is promptly and publicly disclosed and the Academy determines that the conflict is unavoidable.” A conflict of interest refers to an interest, ordinarily financial, of an individual that could be directly affected by the work of the committee. As specified in the Academy's policy and procedures (http://www.nationalacademies.org/coi/index.html), an objective determination is made for each provisionally appointed committee member whether or not a conflict of interest exists given the facts of the individual's financial and other interests and the task being undertaken by the committee. A determination of a conflict of interest for an individual is not an assessment of that individual's actual behavior or character or ability to act objectively despite the conflicting interest.

We have concluded that for the committee to accomplish the tasks for which it was established its membership must include, among others, at least one person who has expertise in biostatistical analyses related to the design and analysis of clinical trials and the assessment of medical product safety and who has experience with FDA and the pharmaceutical industry. To meet the need for this expertise and experience, Dr. Susan S. Ellenberg is proposed for appointment to the committee even though we have concluded that she has a potential conflict of interest because she is currently engaged in consulting for companies that develop products that could be regulated by FDA.

As her biographical summary makes clear, Dr. Ellenberg is a nationally recognized expert in the field of biostatistics and is an expert on issues related to the design and analysis of clinical trials and the assessment of medical product safety. This expertise, together with her previous position at the Center for Biologics Evaluation and Research at FDA and her work with the pharmaceutical industry, provides the committee with a unique perspective that has assisted the committee during phase I and will be essential to its work through phase II. We believe that Dr. Ellenberg can serve effectively as a member of the committee and that the committee can produce an objective report, taking into account the composition of the committee, the work to be performed, and the procedures to be followed in completing the work.

After an extensive search, we have been unable to find another individual with the equivalent combination of current practical experience and expertise as Dr. Ellenberg who does not have a similar conflict of interest. Therefore, we have concluded that this potential conflict is unavoidable.

Events



Location:

Keck Center
500 5th St NW, Washington, DC 20001
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Nola Golson
Contact Email:  pgolson@nas.edu
Contact Phone:  202-334-1669

Agenda
This meeting will be closed in its entirety.
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Robert Lawrence (chair)
Francisco Diez-Gonzalez
Kathryn Edwards (via teleconference)
Susan Ellenberg
Paul Fischbeck
Karen Jenni
Helen Jensen
Robin Keller
David Meltzer
Sanford Miller
John Watson (via teleconference)

The following topics were discussed in the closed sessions:

1) Committee’s draft report
2) Conclusions and recommendations
3) Deadlines and schedule for report review

The following materials (written documents) were made available to the committee in the closed sessions:

11. FDA. 2010. Information requested from the committee on medical devices, received July 14, 2010.

Date of posting of Closed Session Summary:
July 26, 2010
Publication(s) resulting from the event:

-


Location:

Keck Center
500 5th St NW, Washington, DC 20001
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Nola Golson
Contact Email:  pgolson@nas.edu
Contact Phone:  202.334.1669

Agenda
This meeting will be closed in its entirety.
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Robert Lawrence (chair)
Francisco Diez-Gonzalez
Kathryn Edwards
Susan Ellenberg
Paul Fischbeck
Karen Jenni
Helen Jensen
Robin Keller
James McKean
David Meltzer
Sanford Miller
Richard Platt (via teleconference)
John Watson

The following topics were discussed in the closed sessions:

1) Draft materials developed by committee members.
2) Conclusions and recommendations.
3) Additional materials and information needed to finalize the draft report.
4) Meeting schedule and deadlines for committee assignments.

The following materials (written documents) were made available to the committee in the closed sessions:

FDA. 2010. Response to committee request for data. E-mail received from Kathleen Koehler on May, 13, 2010.

FDA. 2010. Response to committee request for data. E-mail with attachment received from Kathleen Koehler on May 25, 2010.

FDA. 2010. Response to committee request for data. E-mail received from Kathleen Koehler on June 1, 2010.

Date of posting of Closed Session Summary:
July 26, 2010
Publication(s) resulting from the event:

-


Location:

Keck Center
500 5th St NW, Washington, DC 20001
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Heidi Murray-Smith
Contact Email:  hmurray-smith@nas.edu
Contact Phone:  202-334-1434

Agenda
This meeting will be closed in its entirety.
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Robert Lawrence (chair)
Jeffrey Bender
Francisco Diez-Gonzalez
Kathryn Edwards
Susan Ellenberg
Paul Fischbeck
Karen Jenni
Helen Jensen
Robin Keller
James McKean
David Meltzer (via teleconference)
Sanford Miller
John Watson


The following topics were discussed in the closed sessions:

1) Draft materials developed by committee members.
2) Content and organization of the committee’s final report.
3) Preliminary conclusions and recommendations.
4) The schedule for committee meetings and deadlines for committee
assignments.

The following materials (written documents) were made available to the committee in the closed sessions:

None.

Date of posting of Closed Session Summary:
April 27, 2010
Publication(s) resulting from the event:

-


Location:

National Academy of Sciences Building
2101 Constitution Ave NW, Washington, DC 20418
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Nola Golson
Contact Email:  pgolson@gmail.com
Contact Phone:  202.334.1669

Agenda
NATIONAL RESEARCH COUNCIL
COMMITTEE ON RANKING FDA PRODUCT CATEGORIES BASED ON HEALTH CONSEQUENCES, PHASE II

Public Meeting: February 3, 2010
National Academy of Sciences, Lecture Room
2101 Constitution Avenue, NW
Washington, DC 20418

PUBLIC AGENDA


1:00 PM
Purpose of Public Session and Introduction of Committee Members
Robert Lawrence
Chair, Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II

1:10 PM
The Revised Task and How FDA Plans to Use the Committee’s Model
Malcolm Bertoni
Assistant Commissioner for Planning, FDA

1:30 PM
Scenarios Related to Food Safety
Donald Kautter
Deputy Director, Office of Compliance, Center for Food Safety and Applied Nutrition, FDA

2:00 PM
Scenarios Related to Drug Safety
H. Gregg Claycamp
Director, Division of Compliance Risk Management and Surveillance; Associate Director for Risk Analysis and Strategic Policy Assessment, Office of Compliance, Center for Drug Evaluation and Research, FDA

2:30 PM
Scenarios Related to Vaccine Safety
Richard Diamond
Special Assistant to the Center Director, Center for Biologics Evaluation and Research, FDA

3:00 PM
BREAK

3:15 PM
Scenarios Related to Animal Feed and Drug Safety
Barry Hooberman
Risk Analyst and Toxicologist, Center for Veterinary Medicine, FDA

3:45 PM
Scenarios Related to Medical Devices
Ann Ferriter
Senior Program Analyst, Division of Risk Management Operations, Office of Compliance, Center for Devices and Radiological Health, FDA

4:15 PM
Scenarios that Cut across Categories
Steve Solomon
Deputy Associate Commissioner for Regulatory Affairs, Compliance Policy, Office of Regulatory Affairs, FDA

4:45 PM
Open Microphone – Comments from the Audience

5:00 PM
ADJOURN PUBLIC SESSION


Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Robert Lawrence (chair)
Jeffrey Bender
Francisco Diez-Gonzalez
Kathryn Edwards
Susan Ellenberg
Paul Fischbeck
Karen Jenni
Helen Jensen
Robin Keller
Sanford Miller
John Watson (via teleconference)


The following topics were discussed in the closed sessions:

1) Scenarios provided by the U.S. Food and Drug Administration.
2) Information provided at the public session.
3) Content and organization of the committee’s final report.
4) The schedule for workshops and committee meetings.


The following materials (written documents) were made available to the committee in the closed sessions:

2. FDA. 2009. Public Health Risk/Benefit Decision Scenarios for the National Academy of Sciences Committee. December 3, 2009.

3. FDA. 2009. Public Health Risk/Benefit Decision Scenarios for the National Academy of Sciences Committee: Second Submission. December 16, 2009.

4. FDA. 2010. Public Health Risk/Benefit Decision Scenarios for the National Academy of Sciences Committee: Scenarios Relevant to Medical Devices. January 26, 2010.

5. FDA. 2010. Public Health Risk/Benefit Decision Scenarios for the National Academy of Sciences Committee: Comprehensive List. January 26, 2010.

6. FDA. 2010. Public Health Risk/Benefit Decision Scenarios for the National Academy of Sciences Committee: Final Submission. February 3, 2010.

7. FDA 2010. Opening Remarks by Malcolm J. Bertoni, Assistant Commissioner for Planning, U.S. Food and Drug Administration, at public session of Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II. Washington, DC. February 3, 2010.


Date of posting of Closed Session Summary:
February 16, 2010
Publication(s) resulting from the event:

-


Location:

Keck Center
500 5th St NW, Washington, DC 20001
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Panola Golson
Contact Email:  pgolson@nas.edu
Contact Phone:  (202) 334-1669

Agenda
This meeting was closed in its entirety.
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Robert Lawrence (chair)
Jeffrey Bender
Kathryn Edwards
Paul Fischbeck
Karen Jenni
Helen Jensen
Robin Keller
James McKean
David Meltzer
Sanford Miller
Richard Platt and John Watson.

The following topics were discussed in the closed sessions:

1. Scenarios provided to the committee by FDA.
2. Agenda for February committee meeting.
3. Action items and committee assignments.


The following materials (written documents) were made available to the committee in the closed sessions:

2. FDA. 2009. Public Health Risk/Benefit Decision Scenarios for the National Academy of Sciences Committee. December 3, 2009.

3. FDA. 2009. Public Health Risk/Benefit Decision Scenarios for the National Academy of Sciences Committee: Second Submission. December 16, 2009.



Date of posting of Closed Session Summary:
January 07, 2010
Publication(s) resulting from the event:

-


Location:

Keck Center
500 5th St NW, Washington, DC 20001
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Nola Golson
Contact Email:  pgolson@gmail.com
Contact Phone:  202-334-1669

Agenda
This meeting is closed in its entirety.
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Robert Lawrence (Chair)
Jeffrey Bender
Kathryn Edwards
Susan Ellenberg
Paul Fischbeck
Karen Jenni
Helen Jensen
Robin Keller
Sanford Miller
John Watson

The following topics were discussed in the closed sessions:

1) Revisions to the committee’s statement of task.
2) Agenda for February workshop.
3) Action items and committee assignments.


The following materials (written documents) were made available to the committee in the closed sessions:

None.

Date of posting of Closed Session Summary:
November 10, 2009
Publication(s) resulting from the event:

-


Location:

Keck Center
500 5th St NW, Washington, DC 20001
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Nola Golson
Contact Email:  pgolson@nas.edu
Contact Phone:  202-334-1669

Agenda
The meeting is closed in its entirety.
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Robert Lawrence (chair)
Jeffrey Bender
Francisco Diez-Gonzalez
Kathryn Edwards
Susan Ellenberg
Paul Fischbeck
Karen Jenni
Helen Jensen
Robin Keller
James McKean
David Meltzer
Sanford Miller
Richard Platt (via teleconference)
John Watson


The following topics were discussed in the closed sessions:

1) Components of the committee’s risk-ranking model (product categories and risk attributes).
2) Structure of committee workshops to conduct risk-ranking exercise.
3) Content and organization of the committee’s final report.
4) The schedule for workshops and committee meetings.


The following materials (written documents) were made available to the committee in the closed sessions:

None.

Date of posting of Closed Session Summary:
June 30, 2009
Publication(s) resulting from the event:

-


Location:

Keck Center
500 5th St NW, Washington, DC 20001
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Nola Golson
Contact Email:  pgolson@nas.edu
Contact Phone:  202-334-1669

Agenda
This meeting is closed in its entirety.
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Robert Lawrence (chair)
Jeffrey Bender (via teleconference)
Francisco Diez-Gonzalez
Kathryn Edwards
Susan Ellenberg
Paul Fischbeck
Karen Jenni (via teleconference)
Helen Jensen
Robin Keller
James McKean
David Meltzer (via teleconference)
Sanford Miller
Richard Platt (via teleconference)
John Watson

The following topics were discussed in the closed sessions:

1) Standard NRC discussion of policies, procedures, potential bias and conflict of interest.

2) Committee’s statement of task, approach, and letter report.

3) Agenda for Workshop I at which product categories and risk attributes will be finalized.

4) Schedule for future committee meetings.


The following materials (written documents) were made available to the committee in the closed sessions:

1. FDA. 2009. FDA Comments on NAS “Letter Report on the Development of a Model for Ranking FDA Product Categories on the Basis of Health Risks.” April 3, 2009.

Date of posting of Closed Session Summary:
April 16, 2009
Publication(s) resulting from the event:

-

Publications

  • Publications having no URL can be seen at the Public Access Records Office