{"id":5805,"date":"2016-01-28T15:36:00","date_gmt":"2016-01-28T15:36:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/fdas-2016-guidance-agenda-just-like\/"},"modified":"2019-02-21T01:15:16","modified_gmt":"2019-02-21T01:15:16","slug":"fdas-2016-guidance-agenda-just-like","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/fdas-2016-guidance-agenda-just-like\/","title":{"rendered":"FDA&#8217;s 2016 Guidance Agenda &#8211; Just Like the 2014 &#038; 2015 Agendas &#8211; Promises Publication of Guidance Regarding Use of Links to 3rd-Party Internet Sites"},"content":{"rendered":"<p>FDA\/CDER has published its 2016 Guidance Agenda (<a href=\"http:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM417290.pdf\">here<\/a>). Here&#8217;s what&#8217;s under the Advertising Category:<\/p>\n<ul>\n<li>Health Care Economic Information in Promotional Labeling and Advertising for Prescription Drugs Under Section 114 of the Food and Drug Administration Modernization Act<\/li>\n<li><b>Internet\/Social Media Advertising and Promotional Labeling of Prescription Drugs and Medical Devices \u2013 Use of Links to Third-Party Sites<\/b><\/li>\n<li>Manufacturer Communications Regarding Unapproved, Unlicensed, or Uncleared Uses of Approved, Licensed, or Cleared Human Drugs, Biologics, Animal Drugs and Medical Devices<\/li>\n<li>Presenting Risk Information in Prescription Drugs and Medical Devices Promotion; Revised Draft<\/li>\n<\/ul>\n<p>I highlighted one item on the list having to do with &#8220;Internet\/Social Media Advertising&#8221; &#8212; Use of Links to Third-Party Sites. This was also on FDA&#8217;s 2014 AND 2015 Guidance Calendars, but as we know no web link guidance was issued in 2014 OR 2015.<\/p>\n<p>[Note: The 2016 Calendar was updated on August 8, 2916 (see <a href=\"http:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM417290.pdf\">here<\/a>). &#8220;Use of Links to Third-Party Sites&#8221; is still there.]<\/p>\n<p>Perhaps none will be issued in 2016 either. Why not?<\/p>\n<p><a name='more'><\/a>Links were discussed by several presenters at the November 2009 public hearing. I also surveyed <i>Pharma Marketing News\/Blog<\/i> readers to get their opinions. The survey was closed on February 26, 2010 after collecting responses from 274 people. A summary of the results &#8212; including 731 comments &#8212; was submitted to the FDA. You can download the results <a href=\"http:\/\/www.news.pharma-mkting.com\/fdaSM_SurveyResults.pdf\">here<\/a> (pdf).<\/p>\n<p>When asked &#8220;When is the use of links appropriate? Should parameters be established for links to and from Web sites?,&#8221; 55% of 181 survey respondents said &#8220;Yes&#8221; whereas only 24% said &#8220;No&#8221; (see chart):<\/p>\n<table align=\"center\" cellpadding=\"0\" cellspacing=\"0\" class=\"tr-caption-container\" style=\"margin-left: auto; margin-right: auto; text-align: center;\">\n<tbody>\n<tr>\n<td style=\"text-align: center;\"><a href=\"http:\/\/2.bp.blogspot.com\/-RFb9tKP_7Tg\/U6LQiGVXUsI\/AAAAAAAAG5Y\/k9bzeD6cITw\/s1600\/LinksChart-fdaSMSurvey.jpg\" imageanchor=\"1\" style=\"margin-left: auto; margin-right: auto;\"><img loading=\"lazy\" decoding=\"async\" border=\"0\" height=\"261\" src=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2016\/01\/LinksChart-fdaSMSurvey.jpg\" width=\"400\" \/><\/a><\/td>\n<\/tr>\n<tr>\n<td class=\"tr-caption\" style=\"text-align: center;\">PHARMA=pharma industry respondents, AGENT=pharma ad\/marketing agency respondents<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>The comments were more interesting:<\/p>\n<p>\nProbably, but good luck drafting them.<\/p>\n<p>Not practical to police this. it is a hyperlinked world.<\/p>\n<p>If a sponsor is going to itself enable or allow a link to another site where information<br \/>\nabout that sponsors product is known to be posted and or discussed then the sponsor is<br \/>\nresponsible for monitoring the information from an accuracy, appriateness (sic) and legal<br \/>\npoint of view using best &#8220;commercially reasonable&#8221; efforts. If information is posted that<br \/>\nis incorrect, inapropriate or illegal then it is the sponsors responsibility to take all<br \/>\nnecessary steps to correct, change, eliminate or comment about the offending<br \/>\ninformation to the site owners where the information is posted.<\/p>\n<p>A simple notice that the user is being redirected to a new site should suffice. Most<br \/>\naudiences are sophisticated these days to know how these campaigns work and if they<br \/>\ndon&#8217;t want to continue on to read about a treatment they don&#8217;t have to.<\/p>\n<p>blogs are often used to draw traffic to a website to restrict this handcuffs companies and<br \/>\nalso robs the public from accessing the support documents for the view they are<br \/>\nreading. Even FDA has links.<\/p>\n<p>Linking of off-label information from an unbranded site is clearly a no-no. I am<br \/>\nsurprised companies would even try that trick.<\/p>\n<p>As I did in 2015, I anxiously await FDA&#8217;s 3rd and final Internet\/SM guidance document it originally promised for 2014 and hope it addresses the above comments.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>FDA\/CDER has published its 2016 Guidance Agenda (here). Here&#8217;s what&#8217;s under the Advertising Category: Health Care Economic Information in Promotional Labeling and Advertising for Prescription Drugs Under Section 114 of the Food and Drug Administration Modernization Act Internet\/Social Media Advertising and Promotional Labeling of Prescription Drugs and Medical Devices \u2013 Use of Links to Third-Party [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":12095,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[12],"tags":[304,44,145,305,167],"topic":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA&#039;s 2016 Guidance Agenda - Just Like the 2014 &amp; 2015 Agendas - Promises Publication of Guidance Regarding Use of Links to 3rd-Party Internet Sites - Pharma Marketing Network<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/fdas-2016-guidance-agenda-just-like\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA&#039;s 2016 Guidance Agenda - Just Like the 2014 &amp; 2015 Agendas - Promises Publication of Guidance Regarding Use of Links to 3rd-Party Internet Sites - Pharma Marketing Network\" \/>\n<meta property=\"og:description\" content=\"FDA\/CDER has published its 2016 Guidance Agenda (here). Here&#8217;s what&#8217;s under the Advertising Category: Health Care Economic Information in Promotional Labeling and Advertising for Prescription Drugs Under Section 114 of the Food and Drug Administration Modernization Act Internet\/Social Media Advertising and Promotional Labeling of Prescription Drugs and Medical Devices \u2013 Use of Links to Third-Party [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/fdas-2016-guidance-agenda-just-like\/\" \/>\n<meta property=\"og:site_name\" content=\"Pharma Marketing Network\" \/>\n<meta property=\"article:published_time\" content=\"2016-01-28T15:36:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2019-02-21T01:15:16+00:00\" \/>\n<meta property=\"og:image\" content=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2016\/01\/LinksChart-fdaSMSurvey.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"787\" \/>\n\t<meta property=\"og:image:height\" content=\"516\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Pharma Guy\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Pharma Guy\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/fdas-2016-guidance-agenda-just-like\/\",\"url\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/fdas-2016-guidance-agenda-just-like\/\",\"name\":\"FDA's 2016 Guidance Agenda - Just Like the 2014 & 2015 Agendas - Promises Publication of Guidance Regarding Use of Links to 3rd-Party Internet Sites - Pharma Marketing Network\",\"isPartOf\":{\"@id\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#website\"},\"datePublished\":\"2016-01-28T15:36:00+00:00\",\"dateModified\":\"2019-02-21T01:15:16+00:00\",\"author\":{\"@id\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#\/schema\/person\/763fc249c59c91ce203db612d81a75a1\"},\"breadcrumb\":{\"@id\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/fdas-2016-guidance-agenda-just-like\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/fdas-2016-guidance-agenda-just-like\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/fdas-2016-guidance-agenda-just-like\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"FDA&#8217;s 2016 Guidance Agenda &#8211; 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