4th National Forum

Fraud and Abuse in the Sales and Marketing of Drugs

Critical Updates on Enforcement Activity, Civil Liability and Ongoing Compliance Techniques

Monday, October 25, 2004

About

Are You Confident That Your Compliance Practices Can Withstand Ongoing Scrutiny?

Aggressive and rapid enforcement activity continues across the pharmaceutical manufacturing community. Enforcers are more vigilant than ever in attempting to curb questionable sales and marketing practices of pharmaceutical companies. The means employed by enforcers to include companies in the net of prosecution continue to be creative and challenging to defend. Moreover, the plaintiffs' bar has followed in the wake of the criminal prosecutions with civil suits seeking significant damages.

Each company must not only ensure that its fraud and abuse compliance strategy is effective, it must constantly monitor and maintain it in an effort to avoid being caught up in the ever-widening net of prosecution.

As the need for ongoing and bullet-proof compliance techniques increases, even the most sophisticated corporate counsel, sales and marketing executive and compliance officer needs an up-to-the-minute understanding of the latest developments on the enforcement front... and forecast for tomorrow's enforcement agenda. American Conference Institute's Fourth National Forum on Fraud and Abuse in the Sales and Marketing of Drugs will provide you with the most sophisticated and comprehensive understanding of the most difficult and costly issues - from the front lines.

This year's forum features insights from experienced prosecutors from the most active jurisdictions, who will highlight the latest criminal and civil actions…and what you need to learn from those prosecutions to minimize your company's exposure. In-house counsel from Pfizer, Schering, Sanofi and Wyeth share their insights on creating and maintaining effective compliance strategies.

Along with these key prosecutors and in-house counsel, expert outside attorneys will offer practical tactics on the hottest issues for today… and tomorrow, including:

• False Claims Act cases - what attracts government attention and how to avoid it
• Critical insights on policing the sales force and ensuring compliance on an ongoing basis • The impact of the latest enforcement activity on your client
• How will the new Medicare bill impact pricing?
• How will OIG's new jurisdiction over pricing impact pharmaceutical manufacturers?
• CME: Striking the balance between sponsorship and compliance
• How to define a "bona fide consultant"

Contents & Contributors

About

Are You Confident That Your Compliance Practices Can Withstand Ongoing Scrutiny?

Aggressive and rapid enforcement activity continues across the pharmaceutical manufacturing community. Enforcers are more vigilant than ever in attempting to curb questionable sales and marketing practices of pharmaceutical companies. The means employed by enforcers to include companies in the net of prosecution continue to be creative and challenging to defend. Moreover, the plaintiffs' bar has followed in the wake of the criminal prosecutions with civil suits seeking significant damages.

Each company must not only ensure that its fraud and abuse compliance strategy is effective, it must constantly monitor and maintain it in an effort to avoid being caught up in the ever-widening net of prosecution.

As the need for ongoing and bullet-proof compliance techniques increases, even the most sophisticated corporate counsel, sales and marketing executive and compliance officer needs an up-to-the-minute understanding of the latest developments on the enforcement front... and forecast for tomorrow's enforcement agenda. American Conference Institute's Fourth National Forum on Fraud and Abuse in the Sales and Marketing of Drugs will provide you with the most sophisticated and comprehensive understanding of the most difficult and costly issues - from the front lines.

This year's forum features insights from experienced prosecutors from the most active jurisdictions, who will highlight the latest criminal and civil actions…and what you need to learn from those prosecutions to minimize your company's exposure. In-house counsel from Pfizer, Schering, Sanofi and Wyeth share their insights on creating and maintaining effective compliance strategies.

Along with these key prosecutors and in-house counsel, expert outside attorneys will offer practical tactics on the hottest issues for today… and tomorrow, including:

• False Claims Act cases - what attracts government attention and how to avoid it
• Critical insights on policing the sales force and ensuring compliance on an ongoing basis • The impact of the latest enforcement activity on your client
• How will the new Medicare bill impact pricing?
• How will OIG's new jurisdiction over pricing impact pharmaceutical manufacturers?
• CME: Striking the balance between sponsorship and compliance
• How to define a "bona fide consultant"

Contents & Contributors

UPDATE ON OIG ACTIVITY
Robert B. Ramsey, III, Buchanan Ingersoll

DEFENDING NOVEL PRODUCTS LIABILITY CLAIMS BASED ON RECENT LAWSUITS ARISING FROM FRAUD AND ABUSE PROSECUTIONS
Lori Cohen, Alston & Bird LLP
Christiana P. Callahan, Alston & Bird LLP

FALSE CLAIMS ACT RISKS FROM OFF LABEL MARKETING ACTIVITIES
Peter O. Safir, Covington & Burling

TRAINING & POLICING THE SALES REPRESENTATIVES: CREATIVE TACTICS FOR AN EFFECTIVE COMPLIANCE PROGRAM
Linda Pissott Reig, Porzio, Bromberg & Newman, PC
Ana Pierro, Porzio Pharmaceutical Services, LLC

CREATIVE TACTICS FOR AN EFFECTIVE COMPLIANCE PROGRAM
John Oroho, Porzio, Bromberg & Newman, PC

THE IMPACT OF THE MMA ON PRICING
Patrick Morrisey, Sidley Austin Brown & Wood LLP

MMA EFFECT ON PRICING: AN IN-HOUSE PERSPECTIVE
David Ralston, Schering Corporation

PRICING AS DETERMINED BY OIG: WHAT WILL IT MEAN FOR COMPLIANCE AND IMPLEMENTATION?
William Sarraille, Sidley Austin Brown & Wood LLP

BEST PRACTICES FOR USING HEALTH CARE PROFESSIONALS AS CONSULTANTS
Susan Hart-White, Sanofi-Synthelabo
Kenneth J. Yood, Paul Hastings Janofsky and Walker

CME: STRATEGIES FOR EFFECTIVE PROGRAM IMPLEMENTATION
Geoffrey M. Levitt, Wyeth Pharmaceuticals

CONTINUING MEDICAL EDUCATION: THE ROLE OF INDUSTRY IN 2004 AND BEYOND
Marcia J. Coleman, M.D., M.B.A., Wyeth Pharmaceuticals

CONDUCTING AN INTERNAL INVESTIGATION
Richard S. Reig, Proskauer Rose

FROM SALES REPRESENTATIVE TO UPPER MANAGEMENT: STRATEGIES FOR ACHIEVING A CULTURE OF COMPLIANCE WITHIN YOUR COMPANY
Eric Aaronson, Pfizer, Inc.

SELECTED ISSUES: MEDICAL LIAISON FACT PATTERN
Linda Pissott Reig, Porzio, Bromberg & Newman, PC



DOCUMENT TYPES: PRESENTATIONS AVAILABLE: 0