THE FDA ALLIANCE www.StrengthenFDA.org

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THE FDA ALLIANCEwww.StrengthenFDA.org

• Education and Advocacy to
• Increase the Appropriated Resources
• Available to FDA
• For more information or Updated
• to join the FDA Alliance APRIL 16, 2006
• info_at_StrengthenFDA.org
• [phone]

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FDAs Goals Americas Needs

• Streamline development and speed approval of
  safe/effective human drugs, biologics, devices,
  veterinary medicines
• Harness the latest drug and device safety tools
  in both pre- and post-market settings
• Increase FDAs capacity to assure a safe food
  supply and to provide consumers with sound
  nutrition information
• Assure a better informed consumer

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Advocacy for FDA Resources

• Private organizations support many agencies of
  government, e.g. NIH and its Institutes
• The FDA Alliance is a newly-created Maryland
  corporation that will be run by a board of
  directors using a coalition-model
• Free-standing entity, positions/policies set by
  board and members no hidden agendas
• Advocate for increased appropriations, more
  manpower, enhanced personnel recruitment

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Why Now?

• Maintain credibility
• Build public trust and support
• FDA receives minimal new , each year, yet
• Costs increase
• Missions evolve
• Science expands
• Inflation erodes
• Assure an FDA that is sized and modernized to
  meet its mandate in the 21st century

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Mission

• Educate the public
• Focus national attention on the need for a strong
  FDA
• Ensure Congressional action to increase
  appropriated funds for the FDA

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Objectives

• Advocate to the public and the media and before
  Congress and OMB for increased appropriated
  resources for FDA
• Become a year-round resource on FDA budget,
  manpower and infrastructure needs
• Unite organizations, grassroots and media to
  support resources for FDA and its vital role
• Assure support for FDAs continuing mission as a
  scientifically-based regulatory agency

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Scope

• Seek public and media support for increased
  appropriations, agency-wide and by function
• No Alliance position on earmarks/user fee levels
• Advocate increases in budget FTE ceilings to
  support manpower needs
• Recognize need for appropriations for IT and
  other infrastructure improvements
• Target budget and appropriations committees,
  Congressional leadership secondary focus on
  authorization committees

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Governance

• Coalition of groups and individuals consumers,
  patients, agricultural and health organizations,
  professional groups, companies, associations, law
  firms, academia, consultants, FDA alumni and
  other individuals
• Coalition positions generated by membership and
  elected leadership, supported by staff
• Focus on budgetary, not policy, issues
• FDA Alliance organized as a 501(c)(4) to enable
  public education and advocacy activities

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FDA Alternative Budget

• Congress sees OMB minimal increase budget
  request as accurate baseline
• FDA Alliance offers Congress an alternative
  budget baseline for FDA
• Alternative budget grounded in public need/good
  regulatory science
• FDA Alliance budget recommendations by Center and
  major functions, not by programs
• No earmarks or policy directives
• No hidden agendas

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FDA Alternative Budget, cont.

• Budget recommendations constructed by
  knowledgeable Center teams
• --Alliance members --FDA alumni --Budget
  experts
• to assure credible numbers
• Series of short meetings to develop consensus
  recommendations for FY 2007 appropriations
• Broader, more encompassing preparation and
  process for FY 2008 and later years
• NOTE FDA employees cannot participate in
  Alliance activities

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2006 Core Program

• Organize FDA Alliance and recruit members
• Initial outreach to public, media and Congress
• Message need for increased FDA funding
• Series of short meetings of Alliance members to
  develop consensus recommendations for FY 2007
  appropriations
• Informal briefings of media and Hill as
  alternative budget is being formed

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2006 Core Program, CONT.

• Launch FDA alternative budget in June 2006
• Media outreach, including editorial boards
• Formal delivery of alternative budget to Budget
  and Appropriations Committees
• Alternative budget sent to all Members of
  Congress
• Education and advocacy to media, key committees,
  OMB after launch of alternative budget
• Planning and early action on FY 2008 cycle in
  Fall 2006 (especially more for budget function
  350, Agriculture programs and FDA)

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2006 Program Add-ons (funds permitting)

• Press conference at National Press Building
• Increased media and other public outreach
• Increased Hill advocacy activities, including
  retained lobbying counsel(s)
• Grassroots-enabled Website
• Increased use of former Commissioners, other key
  endorsers, FDA alumni, budget experts, etc. for
  public appearances
• More support materials in preparation for next
  budget cycle

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Timeline

• Organizational activities members, board, budget
  teams START ASAP
• Initial appropriations committee and media
  outreach by 5/10/06
• Alternative budget launched by 6/15/06
• Ongoing outreach amount, scope and timing
  dependent on available funds
• Begin contact with OMB and Budget Committee about
  FY2008 appropriations by 10/1/06

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Annual Membership Dues

• We seek the broadest representation of
  interests supporting our cause, as well as
  sufficient resources to be effective.
• Non-profit organizations (including research,
  voluntary, advocacy, professional and academic
  groups)
• --250/600/1000 based on size of organization
  and ability to pay
• --Board to review/ratify all non-profit dues
  assignments to assure equitable allocations

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Annual Membership Dues, cont.

• Trade Associations
• --10,000 to 25,000
• --Board to review/ratify all trade association
  dues assignments to assure equitable allocations
• Business and Industry
• --No marketed products 500
• --Less than 500M in sales 3,500
• --500M to 1B in sales 7,000
• --More than 1B in sales 12,000 and up

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Annual Membership Dues, cont.

• Law Firms/Consulting Firms
• --1 or 2 employees 200
• --3 to 10 employees 500
• --11 to 25 employees 2,000
• --26 to 99 employees 5,000
• --100 or more employees 10,000
• Individual memberships 50.
• Former FDA employees are particularly encouraged
  to join.

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ADDITIONAL CONTRIBUTIONS

• Our mission is a difficult one
• The Federal budget is tight
• FDA cannot succeed with small increases each year
• We need to build an effective organization to
  make a difference in FDAs resources and
  capabilities
• Additional contributions are needed/welcomed
• Alliance member efforts supplemented with experts
  in public relations, lobbying, economic research,
  etc.
• Funds are needed for start-up costs, to build
  reserves, and to plan and implement more
  activities

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Contributions and Tax Status

• FDA Alliance expects to be recognized as an
  exempt organization under section 501(c)(4)
• Similar organizations are structured this way
• As a result
• Dues and other membership payments are not
  deductible as charitable contributions for U.S.
  federal income tax purposes, but may be
  deductible as business expenses. The FDA Alliance
  estimates that 60 of the membership dues are not
  deductible as a business expense as a result of
  the Alliances lobbying activities on behalf of
  its members.

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HPS GROUP, LLC

• Created in 2001
• Philosophy Think. Plan. Act.
• HPS mission bring strategic approaches to
  health policy, regulatory, and government
  resource issues
• Steven Grossman, principal of the firm, will
  serve as part-time executive director of the
  Alliance
• Thirty years of DC health policy experience,
  including service in the legislative and
  executive branches

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Initial Board of Directors.

• .who shall act until their successors are duly
  elected and qualified
• Diane Dorman, Vice President, Public Policy,
  National Organization for Rare Disorders
• Nancy Myers, President, Catalyst Healthcare
  Consulting
• Wayne Pines, President, Regulatory Services, APCO
  Worldwide

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FOR MORE INFORMATION

• The FDA Alliance
• PO Box 4305 info_at_StrengthenFDA.org
• Silver Spring [phone]
• MD 20914-4305 [phone]
• Or
• Steven Grossman, President, HPS Group, LLC
• sgrossman_at_hpsgroup.com, [phone]
• Diane Dorman, Vice President, Public Policy,
  National Organization for Rare Disorders,
  ddorman_at_rarediseases.org, [phone]