Avoiding Regulatory Scrutiny in the

Sales and Marketing of Medical Devices

Best practices for ensuring safe navigation through an ever-evolving regulatory minefield

Wednesday, November 29, 2006

About

Identify and Avoid Government Enforcement Triggers

Recent subpoenas and claims of reimbursement manipulation, off-label promotion, and unlawful physician kickbacks indicate a new era of heightened scrutiny for the medical device industry and its sales and marketing practices. While the importance of compliance has increased exponentially, navigating the various federal and state regulations, laws, and guidelines that govern device sales and promotion has only become more complex.

You need insights from those who have been through an investigation or whistleblower suit before

The possibility of massive fines and highly publicized and expensive litigation only adds fuel to the fire. Having sound corporate policies in place just isn't enough anymore; you must ensure that everyone involved from sales representatives to distributors follows sound procedures that are well documented.

Deploy, monitor and maintain a truly effective compliance infrastructure

The publication for Avoiding Regulatory Scrutiny in the Sales and Marketing of Medical Devices brings leading in-house counsel, compliance officers, government enforcers, and regulatory practitioners whom provide first-hand, practical, and comprehensive information on:

  • Managing off-label communications to reduce exposure
  • Navigating compliance requirements across state lines
  • Planning, drafting & monitoring the complaint consulting physician agreements
  • Avoiding the hazards of marketing / sales ROI analysis

Contents & Contributors

About

Identify and Avoid Government Enforcement Triggers

Recent subpoenas and claims of reimbursement manipulation, off-label promotion, and unlawful physician kickbacks indicate a new era of heightened scrutiny for the medical device industry and its sales and marketing practices. While the importance of compliance has increased exponentially, navigating the various federal and state regulations, laws, and guidelines that govern device sales and promotion has only become more complex.

You need insights from those who have been through an investigation or whistleblower suit before

The possibility of massive fines and highly publicized and expensive litigation only adds fuel to the fire. Having sound corporate policies in place just isn't enough anymore; you must ensure that everyone involved from sales representatives to distributors follows sound procedures that are well documented.

Deploy, monitor and maintain a truly effective compliance infrastructure

The publication for Avoiding Regulatory Scrutiny in the Sales and Marketing of Medical Devices brings leading in-house counsel, compliance officers, government enforcers, and regulatory practitioners whom provide first-hand, practical, and comprehensive information on:

  • Managing off-label communications to reduce exposure
  • Navigating compliance requirements across state lines
  • Planning, drafting & monitoring the complaint consulting physician agreements
  • Avoiding the hazards of marketing / sales ROI analysis

Contents & Contributors


AVOIDING THE HAZARDS OF MARKETING/SALES ROI ANALYSIS:WHEN "RETURN ON INVESTMENT" BECOMES "RISK OF INCARCERATION"
Thomas S. Schroeder, Faegre & Benson LLP (Minneapolis, MN)

A GAME PLAN FOR RESPONDING TO A SUBPOENA FROM THE GOVERNMENT
R. David Walk, Dechert LLP (Philadelphia, PA)

MANAGING OFF-LABEL COMMUNICATIONS TO REDUCE EXPOSURE
Linda A. Baumann, Arent Fox PLLC (Washington, DC)

MANAGING OFF-LABEL COMMUNICATIONS TO REDUCE EXPOSURE
Stephen J. McConnell, Dechert LLP (Philadelphia, PA)

OVERSEEING CLINICAL TRIALS & POST-MARKET STUDIES WITHOUT RUNNING AFOUL OF FRAUD & ABUSE LAWS
Russell Hayman, McDermott Will & Emery LLP (Los Angeles, CA)

NAVIGATING COMPLIANCE REQUIREMENTS ACROSS STATE LINES
John P. Oroho, Porzio, Bromberg & Newman P.C. (Morristown, NJ)

DIRECT TO CONSUMER ADVERTISING AND MEDICAL DEVICES
Mark T. Piazza, DePuy Orthopaedics, Inc. (Warsaw, IN)

PLANNING, DRAFTING & MONITORING THE COMPLIANT CONSULTING PHYSICIAN AGREEMENTS Teresa I. Ford, Law Offices of Teresa I. Ford, PC (Houston, TX)



DOCUMENT TYPES: PRESENTATIONS AVAILABLE: 0