1. The Policy-Making Process ESD 11 December 8, 2000

2. Problem Definition Policies and Methods of Analysis Stake- holders/ Politics History of the Issue Policy Formulation “What can we do?” Policy Implementation “How do we make it work”

3. Implementation Impediments Tactical Plan Identify Issues Stakeholder Frames Problem Definition Policy Instruments Cast of Characters Identify the Options Analytic Methods Analyst's Frame Historical Why, How Current Conditions Decision Makers Influence Brokers Definition of Needed Change Definition of Options &Means Definition of Constituency Definition of Strategy Evaluation of The Policy-Making Process Analysis Formulation Identification of Impediments Negotiations RegulationLegislation Enforcement

4. Problem Definition u Issue Identification and Knowledge Base –Lung and heart disease »Evidence u 400,000 + deaths per year attributable to Tobacco –Addiction »Young smokers »Intentional nicotine blending –Industry knowledge »When (early) »What (everything) u Current Conditions –Political and Popular movement against tobacco –Increasing fear of Cancer

5. Definition of Needed Change u Kessler Proposal –Prohibit sales to < 18 yr olds –Prohibit sales in vending machines –Prohibit free samples –Prohibit brand name advertising at sporting events –Prohibit advertising on clothing, tote bags, etc –Prohibit any advertising within 1000 feet of a school –Require any advertising to be black and white text –Make distributors responsible for under age sales –Create a $150 million fund for anti-smoking

6. Policy Instruments u Analyst’s frame –Federal and State Public Health official u Analytic methods available –Epidemiology »Health Causation: Hypothesis u “If you are a smoker you have a higher than normal probability you will die of respiratory cancer or heart disease” »Economic Costs: Hypothesis u “Smoking is a societal ill. Persons who smoke place an unacceptably high burden on society in terms of loss of productivity and increased medical care requirements” u Rationale for Action –FDA job description »Interpretation or fact?

7. Definition of the Means u Legal -- State and Federal Courts u Administrative -- Issue regulatory orders –Assume the authority exists u Legislative -- Propose a change in the law u Negotiation -- Bring all the parties to the table u Political -- Create an alliance with the President u Press -- Feed the media with consumable science u Inertia -- do nothing and let the process go forward on its own momentum

8. Cast of Characters u On side of greater regulation –Stakeholders »Health Community »Families of dead and dying smokers »Academic / Scientific Community (truth …) »Some members of Congress u Tax revenues –Decision makers »Some members of Congress –Influence Brokers »The President »Ex senator Goldwater u Why? Bastion of the ultra conservative right

9. Cast of Characters u On side of the Tobacco Industry –Stakeholders »Tobacco Companies »Smokers (tax) »Advertising Companies »Convenience Store Owners »Billboard Owners »Some members of Congress u Tobacco States u Contributions –Decision makers »Some members of Congress –Influence Brokers »Some members of Congress »Specific members of the Scientific Community

10. Definition of Constituency u Health Community u Attorneys General u Plaintiff’s Bar (?) u Families of dead and dying smokers u Academic / Scientific Community u Some members of Congress interested in increased tax revenues u

11. Definition / Evaluation of Impediments u Tobacco $ and legal expertise u Insufficient funds u Ability to remain at FDA –Kessler specifically u Congressional resistance u Legal / administrative basis for position –FDA does / does not have the authority

12. Development of Strategy u Attack the industry from as many sides as possible –Continuous harassment u Move as though the agency has the authority and the resources to enforce it –Force them onto your playing field u Develop a coherent policy position on actions required of the industry –“Get them down and then kick them while they are down”

13. Tactical Plan u Define required response by industry and assure that their actions are monitorable and enforceable within the resource base (or expected resource base) of the Agency u Support (intellectually not financially) plaintiff suits against the industry u Provide information to the media u Sway the influence brokers, particularly the President

14. Negotiation / Regulation / Legislation u Negotiate –Move toward most acceptable position with industry u Legislation –Write / assist in writing any required change in laws u Regulation –Write the rules to be implemented and be certain that they are enforceable

15. Enforcement u If all in the industry were to get together and not perform as agreed –Anti-Trust – Triple damages! –RICOH (anti racketeering) –Further control as a “drug” u Single Player –Fines (large) –Imprisonment of executives (unpleasant)

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