SUMMARY

This article discusses the often misinterpreted "safe harbor" and whether MSLs enjoy such protection when disseminating off-label information. Where, if anywhere, does the law ascribe "safe harbor" surrounding verbal and written dissemination of off-label use for a drug? Ironically, the term "safe harbor" is not found in FDAMA document. If a pharmaceutical employee works within the boundaries specified by what is collectively identified as "safe harbor," the company is safe. If the employee's actions fall outside the box, it is fair game. This does not mean it is illegal per se.

Topics covered include:

• Deconstructing “Safe Harbor”
• Compliance Programs are Useless Without Enforcement at Both the Corporate Level and Field Level
• Effective Compliance Requires Leadership, Not Lip-Service
• Helpful Links to more information

More than ever, it is important to educate physicians about new drugs and to keep this education separate from the marketing function of the company yet aligned with commercial goals.

This Special Supplement to Pharma Markeing News is critical reading for pharmaceutical companies and physician education service providers wishing to understand the new roles of key opinion leader physicians (KOLs) and medical science liaisons (MSLs) in the physician education process.

TABLE OF CONTENTS