FDA Obesity Working Group

1
FDA Obesity Working Group

• Alan Rulis, Ph.D.
• FDA Public Meeting on Obesity
• October 23, 2003

2
Obesity Working Group

• Charge to Form Working Group August 11, 2003
• Action Plan to Commissioner - February 2004
• OWG Membership
• Dr Lester Crawford, Deputy FDA Commissioner
  Chair
• Mr Joseph Levitt, Director, CFSAN Vice Chair

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OWG Members

• Pat Kuntze, Sr. Advisor for Consumer Affairs,
  OER/OC -Exec. Asst.
• Pete Salsbury, Acting Director, Executive
  Operations Staff, OCD/CFSAN - Exec. Sec.
• Alan Rulis, Senior Advisor for Applied Nutrition,
  OCD/CFSAN
• Susan Bond, Special Assistant to the Deputy
  Commissioner/OC
• Donna Robie Howard, Special Assistant to Senior
  Advisor for Applied Nutrition, CFSAN
• Christine Taylor, Director, Office of Nutritional
  Products, Labeling, and Dietary Supplements/CFSAN

4
OWG Members

• Elizabeth Yetley, Lead Scientist for
  Nutrition/CFSAN
• Kathy Ellwood, Director, Div. of Nutrition
  Programs and Labeling, ONPLDS/CFSAN
• David Acheson, Chief Medical Officer, CFSAN
• Richard Williams, Director, Div. of Market
  Studies, OSAS/CFSAN
• David Orloff, Director, Div. of Metabolic and
  Endocrinologic Drugs, CDER
• Jonca Bull, Director, Office of Drug Evaluation
  V, CDER

5
OWG Members

• Peter Pitts, Associate Commissioner for External
  Relations, OC
• Mike Landa, Deputy General Counsel, Office of the
  Chief Counsel
• Tomas Philipson, Senior Economic Advisor to the
  Commissioner, OC
• Serina Vandegrift, Senior Advisor for Policy and
  Operations, OC
• Mary-Lacey Reuther, Special Asst. to the
  Commissioner, OC

6
OWG Adjunct Members

• Virginia Wilkening, Deputy Director, ONPLDS/CFSAN
• Steven Bradbard, Supervisory Psychologist, Div.
  of Market Studies, OSAS/CFSAN
• Lisa Lubin, Consumer Safety Office, OFAS/CFSAN
• Rick Canady, Senior Science Policy Analyst,
  OSCC/OC
• Jeff Shuren, Assistant Commissioner for Policy,
  OPPL/OC
• Susan Bernard, Policy Analyst, OPPL/OC
• Susan Wood, Director, Office of Womens Health,
  OSCC/OC
• Joanne Lupton, Visiting Scholar, CFSAN

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Obesity Working Group

• Clear, Effective Message
• Education Program (to deliver the message)
• Support of the Message
• Food Labels
• Restaurants
• Therapeutic Treatments
• Research Needs
• Stakeholder Investment to Ensure Results

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Obesity Work GroupSubgroups

• Knowledge Base
• Message
• Public Meeting
• Food Labels
• Restaurants/Industry
• Education Program
• Therapeutic Treatment
• Research
• Report Writing

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Knowledge Base Subgroup

• Conduct Interviews and Collect Information on
  Existing and Planned Obesity Related Activities
  Occurring in the United States (Excluding
  Research)
• Assemble a Centralized Repository of the
  Information Gathered
• Report Out to the Full OWG on the Scope/Contents
  of the Repository

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Message Subgroup

• Identify Existing Messages in the Public and
  Private Sector
• Review these Messages for Appropriateness and
  Effectiveness
• Present Options for Consideration of the Full OWG

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Public Meeting Subgroup

• Satisfy All Procedural Elements for Conducting a
  Public Meeting
• Receive Input from Subgroup Leads and Chair/Vice
  Chair of OWG for Questions/Issues to be Addressed
  at Public Meeting
• Plan Outreach for the Public Meeting, Including
  the Media
• Provide a Report(s) to the Full OWG on the Public
  Meeting

12
Food Labels Subgroup

• Examine Existing Statutory Framework for Labeling
  vis a vis Reducing Obesity and Preventing Weight
  Gain
• Consider Outcome of November 20 DHHS/FDA Workshop
  on Food Labels/Weight Loss
• Provide Recommendations to the Full OWG on
  Approaches for Using Food Labels to Convey
  Obesity Reduction Messages

13
Restaurant/Industry Subgroup

• Pursue Dialogue with Restaurant Industry/Trade
  Associations on Current, Planned, and Potential
  Obesity/Nutrition Initiatives
• Provide Input to the Obesity Knowledge Subgroup
  and OWG at Large on Findings from such Dialogue
• Develop Recommendations on Approaches to
  Encourage the Restaurant Industry to take
  Appropriate Steps to Address the Obesity Epidemic

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Restaurant/Industry Subgroup

• Consider Outcome of November 20 HHS/FDA Workshop
  on Food Labels/Weight Loss
• Focus on Packaging and Labeling
• Funded by DHHS/ASPE
• Report to the Full OWG on the Subgroup
  Recommendations

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Education Program Subgroup

• Explore and Develop Answers to the Following
  Questions Concerning an Education/Outreach
  Program to Deliver FDAs Message(s) on Obesity
• What are the Target Populations for the Education
  Program?
• What are the most effective modes for delivering
  the program?
• How do we know the message(s) will be received?
• How would we evaluate whether the education
  program/message will be effective?

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Education Program Subgroup

• Work with DHHS to Determine how FDAs Obesity
  Outreach/Education Efforts Fit in the Larger
  Context of DHHS Efforts
• Provide Recommendations to the Full OWG for
  Creating/Constructing a Program(s) to Deliver
  FDAs Obesity Message(s)

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Therapeutic Treatment Subgroup

• Gather Information on Existing Therapeutics for
  Obesity Treatment (Including Drugs, Devices, and
  other Medical Interventions) and Real or
  Perceived Barriers to Development of New, or
  Enhanced Therapeutics
• Make Recommendations to the Full OWG on
  Therapeutic Needs and Ways to Encourage
  Development of New or Enhanced Therapeutics

18
Research Subgroup

• Identify Existing Research as Well as Research
  Gaps on Obesity (Including, but not Limited to,
  the Development of Healthier Foods and a better
  Understanding of Consumer Behavior and
  Motivation)
• Present Recommendations to the Full OWG on Areas
  for Expanded and/or New Research Pertinent to the
  Charge of the OWG and how to Facilitate that
  Research

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Report Writing Subgroup

• Solicit Input from OWG, Subgroups, Stakeholders
  and through Public Meetings as Material for the
  Final Report
• Prepare the Final Report of the OWG