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The Policy-Making Process

ESD 11 December 8, 2000

History of the Issue Policies and Methods of Analysis Policy Formulation What can we do?

Problem Definition

Stakeholders/ Politics

Policy Implementation How do we make it work

The Policy-Making Process

Problem Definition Identify Issues Historical Why, How Current Conditions Policy Instruments Analyst's Frame Analytic Methods Identify the Options Cast of Characters Stakeholder Frames Decision Makers Influence Brokers


Definition of Needed Change

Definition of Options &Means Definition of Strategy

Definition of Constituency

Identification of Impediments
Evaluation of Impediments


Tactical Plan Negotiations Regulation Enforcement


Problem Definition

Identification and Knowledge Base

400,000 +

Lung and heart disease Evidence

deaths per year attributable to Tobacco

Addiction Young smokers Intentional nicotine blending Industry knowledge When (early) What (everything) Current


Political and Popular movement against tobacco Increasing fear of Cancer

Definition of Needed Change



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

Policy Instruments


Federal and State Public Health official

Analytic methods available Epidemiology Health Causation: Hypothesis


you are a smoker you have a higher than normal probability you will die of respiratory cancer or heart disease 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

Economic Costs: Hypothesis



for Action

FDA job description Interpretation or fact?

Definition of the Means


-- State and Federal Courts Administrative -- Issue regulatory orders

Assume the authority exists Legislative

-- Propose a change in the law Negotiation -- Bring all the parties to the table Political -- Create an alliance with the President Press -- Feed the media with consumable science Inertia -- do nothing and let the process go forward on its own momentum

Cast of Characters

side of greater regulation

Stakeholders Health Community Families of dead and dying smokers Academic / Scientific Community (truth ) Some members of Congress


Decision makers Some members of Congress Influence Brokers The President Ex senator Goldwater

Bastion of the ultra conservative right

Cast of Characters

side of the Tobacco Industry

Stakeholders Tobacco Companies Smokers (tax) Advertising Companies Convenience Store Owners Billboard Owners Some members of Congress

States Contributions

Decision makers Some members of Congress Influence Brokers Some members of Congress Specific members of the Scientific Community

Definition of Constituency

Community Attorneys General Plaintiffs Bar (?) Families of dead and dying smokers Academic / Scientific Community Some members of Congress interested in increased tax revenues

Definition / Evaluation of Impediments


$ and legal expertise Insufficient funds Ability to remain at FDA

Kessler specifically Congressional

resistance Legal / administrative basis for position

FDA does / does not have the authority

Development of Strategy

the industry from as many sides as possible

Continuous harassment


as though the agency has the authority and the resources to enforce it
Force them onto your playing field


a coherent policy position on actions required of the industry

Get them down and then kick them while they are down

Tactical Plan

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

Negotiation / Regulation / Legislation

Negotiate Move toward most acceptable position with industry

Legislation Write / assist in writing any required change in laws

Regulation Write the rules to be implemented and be certain that they are enforceable


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



Fines (large) Imprisonment of executives (unpleasant)

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