Off-Label Information Dissemination, Safe Harbor, and MSLs
Author: Jane Chin, Ph.D., President, Medical Science Liaison Institute, LLC
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
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Key Opinion Leaders, Medical Science Liaisons, & CME
A New Addition to the Pharma Marketing News Archives!
It’s a new era for pharmaceutical company support of physician education. New guidelines and regulations from various governmental and non-governmental regulatory bodies have come into play during the past few years. The second event defining this new era was the withdrawal of Vioxx from the market in 2004 and the subsequent re-emergence of the importance of physicians as “learned intermediaries.”
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.
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