Fraud & Abuse in The Sale and Marketing of Drugs

Monday, April 07, 2008

About

Federal and state enforcement activity for fraud and abuse in the sale and marketing of drugs has reached an all-time high. The current climate of multi-million dollar fines and massive settlements sharpens the need for ensuring that a company’s compliance and training policies utilize the best available practices to effectively combat the significant risks involved in the sale and marketing of drugs.

However, implementing these policies is a tremendous challenge. First, companies must stay within the bounds of lawful scientific exchange with respect to off-label communications. Second, new disclosure requirements and enforcement actions at the state level increase the legal burden for manufacturers. Third, distribution of scientific information, educational programs, payments to consultants, and international operations trigger escalating scrutiny by regulators.

In addition, proposed new disclosure requirements for payments to physicians form a potential obstacle in creating a strategy to manage the payments. Further, substantial modifications to the federal False Claims Act (the “False Claims Act Correction Act of 2007”) can impact your strategy with respect to whistleblower suits. And Medicare Part D and new OIG strategic priorities present additional fraud implications for which you must be prepared.

The American Conference Institute has specifically designed this publication from the 8th 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 drug companies today, along with practical strategies for tackling these challenges.

Contents & Contributors

About

Federal and state enforcement activity for fraud and abuse in the sale and marketing of drugs has reached an all-time high. The current climate of multi-million dollar fines and massive settlements sharpens the need for ensuring that a company’s compliance and training policies utilize the best available practices to effectively combat the significant risks involved in the sale and marketing of drugs.

However, implementing these policies is a tremendous challenge. First, companies must stay within the bounds of lawful scientific exchange with respect to off-label communications. Second, new disclosure requirements and enforcement actions at the state level increase the legal burden for manufacturers. Third, distribution of scientific information, educational programs, payments to consultants, and international operations trigger escalating scrutiny by regulators.

In addition, proposed new disclosure requirements for payments to physicians form a potential obstacle in creating a strategy to manage the payments. Further, substantial modifications to the federal False Claims Act (the “False Claims Act Correction Act of 2007”) can impact your strategy with respect to whistleblower suits. And Medicare Part D and new OIG strategic priorities present additional fraud implications for which you must be prepared.

The American Conference Institute has specifically designed this publication from the 8th 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 drug companies today, along with practical strategies for tackling these challenges.

Contents & Contributors

THE ’08 FRAUD AND ABUSE LANDSCAPE: NAVIGATING THE VARIABLES, OBSTACLES, AND INTRICACIES IN REASSESSING AND REFINING COMPLIANCE PROGRAMS
Karen Lowney, Cephalon, Inc. (Frazer, PA)
Alison M. Duncan, Porter Wright Morris & Arthur (Washington, DC)
Sue Seferian, Johnson & Johnson

OPERATION CHARLATANS - COUNTERFEIT PHARMACEUTICAL DRUGS CASE STUDY
Samuel J. Louis, Southern District of Texas (Houston, TX)

INCORPORATING LESSONS LEARNED FROM RECENT SETTLEMENTS INTO RISK MITIGATION STRATEGY
Mark J. Wanda, Sepracor Inc. (Marlborough, MA)

OFF LABEL PROMOTION: INCORPORATING LESSONS LEARNED FROM RECENT SETTLEMENTS INTO RISK MITIGATION STRATEGY
Ellen L. Janos, Mintz Levin Cohn Ferris Glovsky and Popeo (Boston, MA)

OFF-LABEL PROMOTION: INCORPORATING LESSONS LEARNED FROM RECENT SETTLEMENTS INTO RISK MITIGATION STRATEGY
Robin Abrams, Purdue Pharma (Stamford, CT)

SOME CONSIDERATIONS FOR DEVELOPING AN EFFECTIVE COMPLIANCE PROGRAM FOR PHARMACEUTICAL SALES PERSONNEL
Kelly Freeman, Eli Lilly and Company (Indianapolis, IN)

BUSINESS ETHICS & COMPLIANCE OFFICER ORGANON USA INC., A PART OF SCHERING-PLOUGH CORPORATION
Retta M. Riordan, Organon, a part of Schering-Plough Corporation (Roseland, NJ)

COMPLIANCE BY FIELD-BASED SALES REPRESENTATIVES
Lisa C. Dykstra, Morgan, Lewis & Bockius LLP (Philadelphia, PA)

AVOIDING KICKBACK ALLEGATIONS RELATED TO THIRD-PARTY EDUCATIONAL ACTIVITIES
Rachel Abramovitz, Taro Pharmaceuticals U.S.A., Inc. (Hawthorne, NY)

AVOIDING KICKBACK ALLEGATIONS RELATED TO THIRD PARTY EDUCATIONAL ACTIVITIES
Kenneth J. Yood, Fulbright & Jaworksi L.L.P. (Los Angeles, CA)

FACTORING NEW STATE ENFORCEMENT PRIORITIES INTO THE FRAUD AND ABUSE ANALYSIS
Mark S. Thomas, Florida Agency for Health Care Administration (Tallahassee, FL)

BEST PRACTICES ON HANDLING DIVERGENT STATE REPORTING REQUIREMENTS
Robert S. Salcido, Akin Gump Strauss Hauer & Feld LLP (Washington, DC)

Larri A. Short, Arent Fox LLP (Washington, DC)

CONDUCTING EFFECTIVE INTERNAL INVESTIGATIONS IN RESPONSE TO CURRENT FRAUD AND ABUSE ENFORCEMENT PRIORITIES AND INITIATIVES
Keir N. Dougall, Katten Muchin Rosenman LLP (New York, NY)
Elizabeth I. Hack, McDermott Will & Emery LLP (Washington, DC)

COOPERATION DURING A GOVERNMENT INVESTIGATION: THE PRACTICAL IMPACT OF THE MCNULTY MEMORANDUM ON PRIVILEGE WAIVERS
Simone E. Ross, Covington & Burling LLP (Washington, DC)

RESOLVING ETHICAL CONCERNS AND PRESERVING ATTORNEY-CLIENT PRIVILEGE
Carrie Valiant, Epstein Becker & Green, P.C. (Washington, DC)

COMPLIANCE PROGRAMS TO MINIMIZE FRAUD & ABUSE OUTSIDE OF THE UNITED STATES
Daniel T. Kessler, Wyeth Pharmaceuticals (Madison, NJ)

IMPACT OF THE FOREIGN CORRUPT PRACTICES ACT (FCPA) ON THE SALE AND MARKETING OF DRUGS
Roscoe C. Howard, Jr., Troutman Sanders, LLP (Washington, DC)

RE-EXAMINING COMPLIANCE PROGRAMS IN LIGHT OF MEDICARE PART D: COMPLYING WITH MEDICARE PART D
Neville M. Bilimoria, Duane Morris LLP (Chicago, IL)

RE-EXAMINING PHARMACEUTICAL MANUFACTURERS COMPLIANCE PROGRAMS IN LIGHT OF MEDICARE PART D
Marci Handler, Epstein Becker & Green, P.C. (Washington, DC)



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