{"id":3158,"date":"2016-03-01T00:00:00","date_gmt":"2016-03-01T00:00:00","guid":{"rendered":"http:\/\/www.pharma-mkting.comindex.php\/2016\/03\/01\/pmn1502-article03\/"},"modified":"2019-02-06T02:36:10","modified_gmt":"2019-02-06T02:36:10","slug":"pmn1502-article03","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn1502-article03\/","title":{"rendered":"Brave New World of Off-Label Marketing: After the Fire Comes the Flood"},"content":{"rendered":"<p>Brave New World of Off-Label Marketing        After the Fire Comes the Flood<br \/><img loading=\"lazy\" decoding=\"async\" src=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2016\/05\/OffLabel-Fire-then-flood.jpg\" alt=\"Fire, Then Flood\" width=\"300\" height=\"293\" align=\"right\" hspace=\"7\" vspace=\"5\"\/>FDA&#8217;s authority to prevent or even regulate off-label promotion by pharmaceutical companies is dwindling. After losing to Amarin in court, FDA suffered another setback when it settled a case with Pacira Pharmaceuticals. In both cases, the plaintiffs argued that off-label marketing was protected free speech as long as the information was truthful and not misleading. While the FDA still insists it has the ultimate authority to decide what is and is not truthful, other entities have claimed a stake in the debate.<\/p>\n<p>This article summarizes various scenarios for how the FDA, courts, and independent 3rd-parties may influence off-label drug promotion in the future.<\/p>\n<p><b>Topics (partial list)<\/b>:<\/p>\n<ul>\n<li>Avoiding Off-Label Chaos<\/li>\n<li>External Entity Review<\/li>\n<li>Judicial Off-Label Activism<\/li>\n<li>Crying Fire!<\/li>\n<li>Figure: Drug ADEs and Off-Label vs. On-Label Prescribing<\/li>\n<li>The Coming Flood<\/li>\n<\/ul>\n<p>Download the full article (PDF file) here:<br \/><a style=\"color: #993300;\" track=\"on\" shape=\"rect\" href=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/news\/pmnews1502-article03.pdf\" linktype=\"link\">www.pharma-mkting.com\/news\/pmnews1502-article03.pdf<\/a><\/p>\n<p\/>\n<hr\/>\n<p> <a href=\"http:\/\/www.scoop.it\/t\/pharmaguy-s-take-on-drug-industry-news\/p\/4061041651\/2016\/03\/11\/fda-may-soon-be-replaced-by-judicial-off-label-activism\">FDA May Soon Be Replaced by Judicial Off-Label Activism<\/a>    <\/p>\n<p>PMN1502-03<br \/>Issue: Vol. 15, No. 2: March 2016<\/p>\n<p\/><b>Find other articles in related Topic Areas:<\/b> <\/p>\n<ul>\n<li><a href=\"http:\/\/www.news.pharma-mkting.com\/PMNphysMktingReprints.htm\">Physician Marketing &amp; Promotion<\/a><\/li>\n<li><a href=\"http:\/\/www.news.pharma-mkting.com\/PMNsfeReprints.htm\">Sales Force Effectiveness<\/a><\/li>\n<li><a href=\"http:\/\/www.news.pharma-mkting.com\/PMNRegComplianceReprints.htm\">Regulatory Compliance<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>This article summarizes various scenarios for how the FDA, courts, and independent 3rd-parties may influence off-label drug promotion in the future.<\/p>\n","protected":false},"author":2,"featured_media":13101,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[65,6,15],"tags":[],"topic":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.0 - 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