towards an industry advisory group an open round-table conversation 19 may 2009

Towards an Industry Advisory GroupAn Open Round-Table Conversation

19 May 2009

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Towards an Industry Advisory Group – An Open Round-Table Conversation

Faced with the product design, manufacturing, marketing and sales restrictions and requirement as well as new reporting and documentation requirements to be mandated under a new regulatory regime, what should companies be doing now to prepare their organizations and their consumers?

ConfidentialDo not copy or reproduce without express written permission of Foresight Group, LLC (Foresight). For more information, contact Foresight at [email protected]. Or visit our website: www.foresight-grp.com c

Purpose & Objectives of Today’s Discussion

Facilitate preliminary discussion of guiding principles for the tobacco industry as it enters a new era of regulation

Encourage active participation and presentation of differing viewpoints

Lay groundwork for future discussions and industry actions

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Ultimately, agreement on a set of actionable guiding principles will allow the tobacco industry to better adapt and respond to the challenges of a new and ever-evolving regulatory environment.


Panel Members

Name Affiliation

Farrell Delman (moderator) Tobacco Merchants Association

Terry Gallagher Smoker Friendly

Bill Greiwe Cheyenne Tobacco

Bill Godshall Smokefree Pennsylvania

Brian Haynes Troutman Sanders

John Lauterbach Lauterbach & Associates

John Manthei Latham Watkins

David O’Reilly BAT

Adrian Payne Tobacco Horizons

Roger Penn Mane France

Jamie Portnoff Foresight Group

Jim Starkey Tobacco Merchants Association

Jim Swauger RAI

Lyle Smith DLC Services

Uwe Trinks Foresight Group


What Companies Should be Doing Now

Required actions can be organized in three major categories:

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The following slides will examine these topics in more detail


“Regulatory Response”

FDA and other health authorities will publish proposed regulations and guidelines and solicit stakeholder feedback

Stakeholders, including tobacco manufacturers, will have the opportunity to provide written responses to the health authorities

Tobacco can chose to either respond using the pharma industry approach or take an alternative approach

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Traditional Pharma approach - Each individual manufacturer develops their own interpretation/application of the proposed rules, and submits their own written response to health authorities

Alternative approach – Single task force composed of representatives from all manufacturers collectively discuss proposed rules and potential implications for industry, and coordinate a single written response to health authorities


“Regulatory Affairs Strategy” (1)

Waxman Bill includes requirement for initial and periodic registration of new and existing individual tobacco products and their ingredients, including a description of tobacco, substances, compounds, and additives, including nicotine content and smoke constituents, by brand and sub-brand

Documents that relate to health, toxicological, behavioral, or physiologic effects of current or future tobacco products, their constituents (including smoke constituents), ingredients, components, and additives would also require submission to health authorities

In order to bring a “modified risk product” to market, a detailed product application will need to be submitted; following approval, the applicant will need to conduct post-marketing surveillance

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Each tobacco manufacturer will need to evaluate how proposed regulations will impact their overall product strategies in both the near- and long-term



Specific regulatory strategies will need to be developed, and these should take into account:

Current regulatory landscape Anticipated future regulatory landscape Emerging public policies Available regulatory pathways for approval Achievable commercial claims/target labeling Potential regulatory and/or product risks Possibility of accelerated development or exclusivity

Industry will need to anticipate how the new regulatory environment will impact timelines to:

Bring a new or modified product to market Efficiently and accurately register existing products with FDA

Is all required information available to fulfill this requirement? Can planned product launches continue to market on schedule?

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Stakeholders in establishment of regulatory affairs strategy: Regulatory affairs Clinical development Pharmacovigilance/drug safety Pre-clinical Sales/Marketing Manufacturing

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“Regulatory Readiness” (1) Industry needs to assess their organizational, functional and technical needs

following interpretation of proposed regulations New technical solutions will be required for:

Safety reporting - for adverse events reported by consumers Product complaint tracking/investigation – for product complaints reported by

consumers Product registration information- to manage information communicated to health

authorities Corrective action/Preventative action tracking

Existing technical solutions will need to undergo a functional technical assessment

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Traditional Pharma approach - Each individual manufacturer performs their own assessment and buys/builds their own technical solutions

Alternative approach - Industry performs collective assessment and establishes “global” technical industry standards and “industry technical solutions” that do not constitute a competitive advantage


“Regulatory Readiness” (2)

Functional areas will need to be established and/or enhanced: Manufacturing Clinical development Pharmacovigilance Regulatory Affairs

Tobacco manufacturers should be prepared to comply with: Good Clinical Practices Good Manufacturing Practices Good Pharmacovigilance Practices

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“Regulatory Readiness” – Pharma Experience

Pharma has had mixed success with the collective approach, due to several factors: Pharma can be “slow–moving” with regard to adopting new approaches Efforts to work collaboratively were initiated after each manufacturer

already began to work independently Successful efforts to date have had a tremendously positive impact

on business efficiencies

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