{"id":12870,"date":"2006-01-01T00:00:00","date_gmt":"2006-01-01T00:00:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/uncategorized\/mslq-article02\/"},"modified":"2019-02-26T03:30:22","modified_gmt":"2019-02-26T03:30:22","slug":"mslq-article02","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/mslq-article02\/","title":{"rendered":"Off-Label Information Dissemination, Safe Harbor, and MSLs"},"content":{"rendered":"<p> <b>Affiliate Article:<\/b><br \/>  <b>Off-Label Information Dissemination, Safe Harbor, and MSLs<\/b><br \/> Author: <b>Jane Chin<\/b>, Ph.D., President, Medical Science Liaison Institute, LLC <\/p>\n<p> SUMMARY <\/p>\n<p> This article discusses the often misinterpreted &#8220;safe harbor&#8221; and whether MSLs enjoy such protection when disseminating off-label information. Where, if anywhere, does the law ascribe &#8220;safe harbor&#8221; surrounding verbal and written dissemination of off-label use for a drug? Ironically, the term &#8220;safe harbor&#8221; is not found in FDAMA document. If a pharmaceutical employee works within the boundaries specified by what is collectively identified as &#8220;safe harbor,&#8221; the company is safe. If the employee&#8217;s actions fall outside the box, it is fair game. This does not mean it is illegal per se. <\/p>\n<p> Topics covered include: <\/p>\n<ul type=\"DISC\">\n<li>Deconstructing \u0093Safe Harbor\u0094 <\/li>\n<li>Compliance Programs are Useless Without Enforcement at Both the Corporate Level and Field Level <\/li>\n<li>Effective Compliance Requires Leadership, Not Lip-Service <\/li>\n<li>Helpful Links to more information <\/li>\n<\/ul>\n<p>   <b>Order this article and learn more &#8230; $24.95<\/b><br \/> (Pay online by credit card. 5-page PDF file delivered to you by email, usually within a few minutes)               <\/p>\n<p\/>\n<hr\/>\n<p>  Special Supplement<br \/>  <b>Physician Education<br \/><\/b>Key Opinion Leaders, Medical Science Liaisons, &amp; CME  <br \/><i>A New Addition to the Pharma Marketing News Archives!<\/i>   <\/p>\n<p> <a href=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/news\/PMNSupplementPhysEd.htm\"> <img loading=\"lazy\" decoding=\"async\" alt=\"PhysEd Supplement Cover\" src=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2019\/02\/PhysEdcover.jpg\" width=\"220\" height=\"306\" border=\"1\" hspace=\"10\" align=\"left\"\/><\/a> <b>OVERVIEW<\/b><\/p>\n<p>  It&#8217;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 &#8220;learned intermediaries.&#8221;   <\/p>\n<p> 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.  <\/p>\n<p> This Special Supplement to <i>Pharma Markeing News<\/i> 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.  <br clear=\"all\"\/><\/p>\n<p> <b><a href=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/news\/PMNSupplementPhysEd.htm\">TABLE OF CONTENTS, FIGURES<\/a><\/b><\/p>\n<p> Order and pay for this Special Supplement now using your credit card <\/p>\n<p><b>ONLY $29.95<\/b><br \/>PDF file delivered to you by email (usually within minutes of placing your order):  <\/p>\n<p> <img loading=\"lazy\" decoding=\"async\" alt=\"\" border=\"0\" src=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2006\/01\/pixel.gif\" width=\"1\" height=\"1\"\/> <\/p>\n<p> If you wish to be pay by check or credit card off-line, please use:<br \/><b><a href=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/news\/PMNSuppPhysEdOrderForm.pdf\">Printable Order Form<\/a><\/b>  <\/p>\n","protected":false},"excerpt":{"rendered":"<p>This article discusses the often misinterpreted safe harbor and whether MSLs enjoy such protection when disseminating off-label information.<\/p>\n","protected":false},"author":2,"featured_media":14051,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[6,9],"tags":[],"topic":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.0 - 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