3rd National Forum

Fraud and Abuse in the Sales and Marketing of Drugs and Medical Devices

The Latest Information from the Front Lines on Current and Emerging Enforcement Hot Spots and Practical Compliance Strategies

Wednesday, March 05, 2003

About

ARE YOU SURE YOUR COMPANY'S FRAUD AND ABUSE COMPLIANCE STRATEGY CAN WITHSTAND TODAY'S ENFORCEMENT SCRUTINY?

The staggering TAP settlement of October 2001 was by no means the end of the story. Rather, it marked the beginning of a more aggressive enforcement era in the pharmaceutical and medical device arena.

With the dust barely settled from the TAP, Bayer and Pfizer settlements, more companies are under investigation for promotion practices and alleged pricing irregularities. Enforcers are employing innovative means to include companies in the ever-widening net of prosecution, from consumer fraud to conspiracy to defraud to false claims. The industry is facing significant pressure to implement, maintain and monitor effective, comprehensive and appropriate compliance strategies. It is clear that no pharmaceutical or device manufacturer will remain a leader without effective in-house compliance policies and a comprehensive understanding of current enforcement activity and allegations.

In this volatile arena, even the most sophisticated corporate counsel, sales and marketing executive and compliance officer needs an up-to-the minute understanding of the latest developments…and a forecast for what tomorrow's enforcement agenda holds. American Conference Institute's Third National Forum on Fraud and Abuse in the Sales and Marketing of Drugs and Medical Devices materials will provide you with a sophisticated and comprehensive overview of the most difficult, pressing and costly issues, including effective compliance - from the front lines.
The faculty included prosecutors in the most active jurisdictions who will provide timely and critical insight on current civil and criminal theories, how to avoid the microscope of enforcement and emerging trends.
In-house counsel from Pfizer, Pharmacia, Wyeth, Boehringer Ingelheim and Sanofi-Synthelabo also shared their experiences in creating and maintaining effective compliance strategies.

And that's not all! Along with the key prosecutors and in-house counsel, expert outside attorneys offered practical tips and insights on the hottest issues for today…and tomorrow, including:
  • Tactics from the trenches - the lessons of TAP and Bayer
  • Comprehensive overview of the latest enforcement
    activity… and forecast for tomorrow
  • Critical preventive techniques to minimize
    civil exposures to criminal investigations
  • Pricing: avoiding the pitfalls that lead to allegations of fraud
  • Implementing and maintaining compliance guidelines
  • When is a physician a bona fide consultant?
  • The next generation of enforcement: relationships
    with pharmacies, PBMs and researchers
  • The impact of the OIG and PhRMA guidelines on generic companies
  • Practical considerations in using advisory opinions

Contents & Contributors

About

ARE YOU SURE YOUR COMPANY'S FRAUD AND ABUSE COMPLIANCE STRATEGY CAN WITHSTAND TODAY'S ENFORCEMENT SCRUTINY?

The staggering TAP settlement of October 2001 was by no means the end of the story. Rather, it marked the beginning of a more aggressive enforcement era in the pharmaceutical and medical device arena.

With the dust barely settled from the TAP, Bayer and Pfizer settlements, more companies are under investigation for promotion practices and alleged pricing irregularities. Enforcers are employing innovative means to include companies in the ever-widening net of prosecution, from consumer fraud to conspiracy to defraud to false claims. The industry is facing significant pressure to implement, maintain and monitor effective, comprehensive and appropriate compliance strategies. It is clear that no pharmaceutical or device manufacturer will remain a leader without effective in-house compliance policies and a comprehensive understanding of current enforcement activity and allegations.

In this volatile arena, even the most sophisticated corporate counsel, sales and marketing executive and compliance officer needs an up-to-the minute understanding of the latest developments…and a forecast for what tomorrow's enforcement agenda holds. American Conference Institute's Third National Forum on Fraud and Abuse in the Sales and Marketing of Drugs and Medical Devices materials will provide you with a sophisticated and comprehensive overview of the most difficult, pressing and costly issues, including effective compliance - from the front lines.
The faculty included prosecutors in the most active jurisdictions who will provide timely and critical insight on current civil and criminal theories, how to avoid the microscope of enforcement and emerging trends.
In-house counsel from Pfizer, Pharmacia, Wyeth, Boehringer Ingelheim and Sanofi-Synthelabo also shared their experiences in creating and maintaining effective compliance strategies.

And that's not all! Along with the key prosecutors and in-house counsel, expert outside attorneys offered practical tips and insights on the hottest issues for today…and tomorrow, including:
  • Tactics from the trenches - the lessons of TAP and Bayer
  • Comprehensive overview of the latest enforcement
    activity… and forecast for tomorrow
  • Critical preventive techniques to minimize
    civil exposures to criminal investigations
  • Pricing: avoiding the pitfalls that lead to allegations of fraud
  • Implementing and maintaining compliance guidelines
  • When is a physician a bona fide consultant?
  • The next generation of enforcement: relationships
    with pharmacies, PBMs and researchers
  • The impact of the OIG and PhRMA guidelines on generic companies
  • Practical considerations in using advisory opinions

Contents & Contributors

KEY EVENTS, 2002
Ann E. Lewis, Pfizer, Inc.
Ethan Posner, Covington & Burling

FROM TAP TO TODAY: LESSONS LEARNED
Paul E. Kalb, Sidley Austin Brown & Wood
Harvey A. Yampolsky, Arent Fox Kintner Plotkin & Kahn PLLC

CRITICAL ROADMAP TO THE OIG AND THE PhRMA GUIDELINES
Lori G. Baer, Alston & Bird LLP
Christiana P. Callahan, Alston & Bird LLP

THE FINAL OIG GUIDELINES AND THE PhRMA GUIDELINES: STRATEGIES FOR GETTING YOUR COMPLIANCE PROGRAM TO BE WHERE IT SHOULD BE
Robert B. Ramsey, III, Buchanan Ingersoll, P.C.

THE MARKETING IMPERATIVE
W. Charles Lucas, Pharmacia Corporation

HOUSE CALL: PhRMA CODE AND THE AMA GUIDELINES
Joseph McMenamin, M.D., J.D., McGuire Woods

A HISTORY OF MEDICARE/AWP REIMBURSEMENT
Ethan Posner, Covington & Burling
Mark H. Lynch, Covington & Burling
Frederick G. Herold, Dechert

LITIGATION AND ENFORCEMENT UPDATE
Ellyn Sternfield, Oregon DOJ Medicaid Fraud Unit
David Waterbury, Washington Attorney General's Office

WHAT TO DO BEFORE THE GOVERNMENT KNOCKS ON YOUR DOOR: PREVENTIVE TECHNIQUES TO MINIMIZE DAMAGES FROM A CRIMINAL INVESTIGATION
Carolyn McElroy, Mintz Levin Cohn Ferris Glovsky & Popeo
Howard J. Young, Sonnenschein Nath & Rosenthal

CRITICAL CONSIDERATIONS IN USING ADVISORY OPINIONS
Robert Homchick, Davis Wright Tremaine LLP

ISSUES ARISING IN THE CONTEXT OF RESEARCH
Ann E. Lewis, Pfizer, Inc.

CAUGHT IN THE WEB? HOW OIG AND PHRMA GUIDELINES AFFECT GENERIC DRUG COMPANIES
Joseph Hetrick, Dechert
James Berger, Dechert


DOCUMENT TYPES: PRESENTATIONS AVAILABLE: 0