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MSL Knowledge Series - Dissemination of Off-Label Information and Safe Harbors
Medical Science Liaison Institute (MSL), April 2004, Pages: 8
This article deconstructs a widespread notion of 'safe harbor' in discussing off-label information, and present three critical issues in compliance as identified by medical science liaisons (MSLs).
Quest for “Safe Harbor”
Where, if anywhere, does the law ascribe ‘safe harbor’ surrounding verbal and written dissemination of off-label use for a drug? Based on the general activities of medical science liaisons, the motivation behind the question should be obvious. Dissecting the origins of the term “safe harbor” is an ugly process to wade through, because each section requires you to look up another legal document, but compliance officers and attorneys are probably used to this.
It was found that under United States Code Title 21 Food and Drugs, Chapter 9, Subchapter V, Part D, Section 360aaa (amended by FDAMA's Section 551), 'Requirements for dissemination of treatment information on drugs or devices' contains a safeguard to disseminate written information when the manufacturer fulfills certain requirements to enable distribution of information that is not in the approved labelling of the drug. These requirements have an exception described under Section 557 'Rules of Construction':
Key points from this research:
- There is no 'Safe Harbor' for Medical Science Liaisons
- Compliance Programs are Useless without Enforcement at Both the Corporate Level and Field Level
- Effective Compliance Requires Leadership, Not Lip-Service
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