Fraud and Abuse In The Sale and Marketing of Drugs

Wednesday, October 24, 2007

About

Ensure your organization's compliance strategies can withstand today's increased government scrutiny.

According to the most recent statistics released by the Department of Health and Human Services and the Department of Justice the government more than doubled its recovery of funds in judgments and settlements against healthcare companies in fiscal 2005. As the government intensifies enforcement for drug marketing cases, it is expected that the amounts will only continue to increase.

Know the current hot areas of enforcement!

increasingly, standard sales and marketing activities are triggering enforcement actions. Distribution of scientific information, educational programs, the use of consultants and international operations are now subject to escalating strict scrutiny by federal regulators. In addition, Medicare Part D presents additional fraud implications for which you must be prepared. Understanding these most recent areas of government focus, as well as the key terms and conditions of recent settlements, is paramount in developing corporate policies that protect against future fraud claims.

Develop effective compliance programs to prevent fraud and abuse allegation.

With the myriad ways that organizations can be charged with fraudulent marketing activities, a well-defined and developed compliance program is mandatory. But having a program is not sufficient - you need to ensure that the appropriate monitoring of policies is occurring to ensure the program's effectiveness.

With all of this in mind, the American Conference Institute has developed this publication from the 7th National Forum on Fraud & Abuse in the Sale and Marketing of Drugs to provide you with a sophisticated and comprehensive understanding of the most difficult and costly issues facing companies today, along with practical strategies for tackling these challenges.

Contents & Contributors

About

Ensure your organization's compliance strategies can withstand today's increased government scrutiny.

According to the most recent statistics released by the Department of Health and Human Services and the Department of Justice the government more than doubled its recovery of funds in judgments and settlements against healthcare companies in fiscal 2005. As the government intensifies enforcement for drug marketing cases, it is expected that the amounts will only continue to increase.

Know the current hot areas of enforcement!

increasingly, standard sales and marketing activities are triggering enforcement actions. Distribution of scientific information, educational programs, the use of consultants and international operations are now subject to escalating strict scrutiny by federal regulators. In addition, Medicare Part D presents additional fraud implications for which you must be prepared. Understanding these most recent areas of government focus, as well as the key terms and conditions of recent settlements, is paramount in developing corporate policies that protect against future fraud claims.

Develop effective compliance programs to prevent fraud and abuse allegation.

With the myriad ways that organizations can be charged with fraudulent marketing activities, a well-defined and developed compliance program is mandatory. But having a program is not sufficient - you need to ensure that the appropriate monitoring of policies is occurring to ensure the program's effectiveness.

With all of this in mind, the American Conference Institute has developed this publication from the 7th National Forum on Fraud & Abuse in the Sale and Marketing of Drugs to provide you with a sophisticated and comprehensive understanding of the most difficult and costly issues facing companies today, along with practical strategies for tackling these challenges.

Contents & Contributors

MINIMIZING EXPOSURE FROM OFF-LABEL PROMOTION CLAIMS: STATE ENFORCEMENT TRENDS
Anne M. Murphy, Holland & Knight LLP (Chicago, IL)

MINIMIZING EXPOSURE FROM OFF-LABEL PROMOTION CLAIMS - THE PERSPECTIVE FROM IN-HOUSE COUNSEL
Howard L. Dorfman, Bayer Healthcare LLC (West Haven, CT)

OFF-LABEL PROMOTION: CURRENT TRENDS IN FEDERAL ENFORCEMENT
Stephen P. Anthony, Covington & Burling LLP (Washington, DC)

DIVERGENT STATE REPORTING REQUIREMENTS
Retta M. Riordan, Organon USA Inc. (Philadelphia, PA)

DIVERGENT STATE REPORTING REQUIREMENTS: COMBATING FRAUD AND ABUSE ALLEGATIONS
Joseph W. Metro, Reed Smith LLP (Washington, DC)

LESSONS LEARNED FROM RECENT SETTLEMENTS
Kenneth Barker, FTI Consulting (Washington, DC)
David T. Shapiro, Pepper Hamilton LLP (Philadelphia, PA)
(Former DOJ Trial Attorney in the Civil Fraud Section)

DEFENDING AGAINST FALSE CLAIMS LITIGATION: THE CURRENT PHARMA LANDSCAPE
Laurence J. Freedman, Patton Boggs LLP (Washington, DC)
Michael L. Koon, Shook, Hardy & Bacon LLP (Kansas City, MO)
Stephen J. Immelt, Hogan & Hartson LLP (Baltimore, MD)

AUDITING AND MONITORING COMPLIANCE PROGRAMS FOR OPTIMAL EFFECTIVENESS
Michael J. Morgan, Eli Lilly and Company (Indianapolis, IN)
Trudy J. Seeley, Sanofi-Aventis, (Bridgewater, NJ)
Gregory Mayes, ImClone Systems Incorporated (Branchburg, NJ)
Wendy C. Goldstein, Epstein Becker & Green P.C. (New York, NY)

COMPLIANCE MONITORING AND AUDITING
Michael J. Morgan, Eli Lilly and Company (Indianapolis, IN)

PROTECTING ATTORNEY-CLIENT PRIVILEGE AND ETHICALLY REPRESENTING CLIENTS FACED WITH FRAUD AND ABUSE ALLEGATIONS
Sheila Finnegan, Mayer Brown LLP (Chicago, IL)
Keir N. Dougall, Katten Muchin Rosenman LLP (New York, NY)
David H. Resnicoff, Baxter International Inc. (Deerfield, IL)
CURRENT LEGAL/REGULATORY ISSUES CONCERNING THIRD-PARTY EDUCATIONAL ACTIVITIES
Geoffrey Levitt, Wyeth Pharmaceuticals (Collegeville, PA)

FUNDING THIRD-PARTY EDUCATIONAL ACTIVITIES
Anna L. Spencer, Sidley Austin LLP (Washington, DC)

DIRECTING NON-U.S. BASED OPERATIONS ON GLOBAL FRAUD & ABUSE RISKS
David M. Ryan, Nixon Peabody LLP (Boston, MA)

CALCULATING THE FAIR MARKET VALUE OF CONSULTANTS TO AVOID THE APPEARANCE OF IMPROPRIETY
Charlene A. Gallagher, Wyeth Pharmaceuticals (Collegeville, PA)

HOW TO EFFECTIVELY MONITOR SALES FORCE COMPLIANCE
Shannon Thyme Klinger, Barr Laboratories (Woodcliff Lake, NJ)

TAKING OWNERSHIP OF COMPLIANCE
Scot Steinheiser, Astellas US LLC (Deerfield, IL)

SALES AND MARKETING ISSUES IN PHARMACEUTICAL LITIGATION
Joseph K. Hetrick, Esq., Dechert LLP (Philadelphia, PA)



DOCUMENT TYPES: PRESENTATIONS AVAILABLE: 0