{"id":3162,"date":"2016-09-01T00:00:00","date_gmt":"2016-09-01T00:00:00","guid":{"rendered":"http:\/\/www.pharma-mkting.comindex.php\/2016\/09\/01\/pmn1504-article01\/"},"modified":"2019-02-06T02:36:11","modified_gmt":"2019-02-06T02:36:11","slug":"pmn1504-article01","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn1504-article01\/","title":{"rendered":"Off-Label DTC Advertising: Will FDA Be Forced to Allow It?"},"content":{"rendered":"<p>Off-Label DTC Advertising        Will FDA Be Forced to Allow It?<br \/><img loading=\"lazy\" decoding=\"async\" src=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2016\/09\/GandpaSimpson-v-TV-Off-Label-DTC.jpg\" width=\"300\" height=\"225\" align=\"right\" hspace=\"7\" vspace=\"5\"\/>In what has been described as a &#8220;surprise move&#8221; (see below) the FDA recently published a Federal Register notice announcing that it will hold a 2-day public hearing November 9-10, 2016, to obtain input on issues related to off-label communications by manufacturers regarding FDA-regulated drugs and medical devices. FDA says it is &#8220;engaged in a comprehensive review of its regulations and policies governing firms&#8217; communications about unapproved uses of approved\/ cleared medical products, and the input from this meeting will inform FDA&#8217;s policy development in this area.&#8221;<\/p>\n<p> What&#8217;s even more surprising is that FDA is asking questions about off-label direct-to-consumer (DTC) and direct-to-patient communications in addition to the typical questions about such promotions directed at physicians. <\/p>\n<p>This article summarizes the First Amendment assault on FDA&#8217;s ability to regulate off-label communications.<\/p>\n<p><b>Topics (partial list)<\/b>:<\/p>\n<ul>\n<li>A Brief History of Off-Label Promotion<\/li>\n<li>Chart: 25 Years of Pharma Criminal and Civil Penalties<\/li>\n<li>First Amendment Challenges<\/li>\n<li>Is the Battle Lost?<\/li>\n<li>A Slippery Slope<\/li>\n<li>Cancer Off-Label DTC May Be First Case?<\/li>\n<li>Has It Already Happened?<\/li>\n<li>Duke Chimes in on Off-Label Drug Promotion<\/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\/pmnews1504-article01.pdf\" linktype=\"link\">www.pharma-mkting.com\/news\/pmnews1504-article01.pdf<\/a> <\/p>\n<hr\/>\n<p> <a href=\"http:\/\/www.scoop.it\/t\/pharmaguyevents\/p\/4068481517\/2016\/09\/01\/in-a-surprise-move-fda-will-hold-a-public-meeting-to-review-off-label-marketing\">In a Surprise Move, FDA Will Hold a Public Meeting to Review Off-label Marketing<\/a>    <\/p>\n<p>PMN1504-01<br \/>Issue: Vol. 15, No. 4: September 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\/PMNDTCReprints.htm\">Direct-to-Consumer (DTC) Advertising &amp; Marketing<\/a><\/li>\n<li><a href=\"http:\/\/www.news.pharma-mkting.com\/PMNpatedReprints.htm\">Patient Education<\/a><\/li>\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\/PMNRegComplianceReprints.htm\">Regulatory Compliance<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>This article summarizes the First Amendment assault on FDA&#8217;s ability to regulate off-label communications.<\/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 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Off-Label DTC Advertising: Will FDA Be Forced to Allow It? 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