{"id":5248,"date":"2012-01-26T00:00:00","date_gmt":"2012-01-26T00:00:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/index.php\/2012\/01\/26\/pmn111-article02\/"},"modified":"2019-02-18T20:14:52","modified_gmt":"2019-02-18T20:14:52","slug":"pmn111-article02","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn111-article02\/","title":{"rendered":"FDA Guidance on Responding to Unsolicited Requests for Off-Label Information"},"content":{"rendered":"<p>FDA Guidance on Responding to Unsolicited Requests for Off-Label Information                The Social Media Guidelines Nobody Expected!<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" src=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2019\/02\/LousyFDAGuidance-T-Shirt_200x200.jpg\" alt=\"All I Got Was This Lousy Guidance\" width=\"200\" height=\"200\" border=\"0\" align=\"right\" hspace=\"8\"\/>Two days after Christmas, on December 27, 2011, while most of us were still on vacation, the FDA quietly issued &#8220;Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.&#8221; Section VI. of this guidance addresses responding to unsolicited requests on public forums such as the Internet.<\/p>\n<p>  While this may not be the &#8220;social media&#8221; guidance many people were expecting, it does include guidelines for responding to unsolicited requests for off-label information encountered through &#8220;emerging electronic media.&#8221; <\/p>\n<p>This article takes a closer look at how the off-label guidelines apply to social media such as Youtube, Blogs, and Twitter. <\/p>\n<p>Topics include:        <\/p>\n<ul>\n<li>A Bit of History<\/li>\n<li>Defining &#8220;Off-label&#8221;<\/li>\n<li>What We Expected Was This<\/li>\n<li>In Best Interest of Public Health<\/li>\n<li>Public vs. Private, Solicited vs. Unsolicited<\/li>\n<li>Youtube and Solicited Requests<\/li>\n<li>Blogger Example of &#8220;Solicited Request&#8221;<\/li>\n<li>Proving Solicitation is Difficult<\/li>\n<li>Twitter Example of &#8220;Solicited Request&#8221;<\/li>\n<li>Private Responses and Serving the Public Interest<\/li>\n<li>Sales and Marketing May be Seen, but Should NOT Be Heard From!<\/li>\n<li>The Burden of Responding<\/li>\n<li>Docket Open for Comments<\/li>\n<li>Legal Challenges<\/li>\n<li>Chart: FDA Guidance Translator<\/li>\n<\/ul>\n<p><b><a href=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/news\/pmn111-article02.pdf\">Download full article<\/a><\/b> (PDF)    <\/p>\n<p>PMN111-02<br \/> Issue: Vol. 11, No. 1<br \/>Publication date: 26 January 2012<br \/>Word Count: 3,784<\/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\/PMNeMktingReprints.htm\">eMarketing &amp; ePromotion<\/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>Two days after Christmas, on December 27, 2011, while most of us were still on vacation, the FDA quietly issued <\/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":[61,6],"tags":[],"topic":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.0 - 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