{"id":5854,"date":"2015-08-26T14:33:00","date_gmt":"2015-08-26T14:33:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/how-did-fda-capture-kim-kardashians\/"},"modified":"2019-02-21T01:15:33","modified_gmt":"2019-02-21T01:15:33","slug":"how-did-fda-capture-kim-kardashians","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/how-did-fda-capture-kim-kardashians\/","title":{"rendered":"FDA Acts on Violative Social Media Posts a Lot More Quickly Than It Does for TV and Print Ads"},"content":{"rendered":"<p>Kim Kardashian posted a violative Diclegis\u00ae ad on Instagram (read \u201c<a href=\"http:\/\/pharma-mkting.com\/blog\/2015\/08\/kim-kardashians-diclegis-instagram-post.html\">Kim Kardashian&#8217;s Diclegis Instagram Post Raises Issues of Transparency, Drug Safety, and Learning from History<\/a>\u201d). She was paid to do that by Duchesnay  &#8212; the company that makes &amp; markets Diclegis.<\/p>\n<p>But did you know that the ad also was posted to her Twitter and Facebook accounts?<\/p>\n<p>Here&#8217;s how the FDA depicted the campaign (find the original <a href=\"http:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/EnforcementActivitiesbyFDA\/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies\/UCM457965.pdf\">here<\/a>):<\/p>\n<div class=\"separator\" style=\"clear: both; text-align: center;\">\n<\/div>\n<p><\/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\/-7LP_aSnDDc4\/Vd3EZnCvC7I\/AAAAAAAAILc\/iX0by6UlWhY\/s1600\/DiclegisPromoMaterial-from-FDA.jpg\" imageanchor=\"1\" style=\"margin-left: auto; margin-right: auto;\"><img loading=\"lazy\" decoding=\"async\" border=\"0\" height=\"307\" src=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2015\/08\/DiclegisPromoMaterial-from-FDA.jpg\" width=\"400\" \/><\/a><\/td>\n<\/tr>\n<tr>\n<td class=\"tr-caption\" style=\"text-align: center;\">Click on image for an enlarged view.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>What does this show us? How did the FDA get so social media savvy? Note two things:<\/p>\n<p><a name='more'><\/a><\/p>\n<ol>\n<li>The Twitter post was only 3 hours old when it was captured in the above image.<\/li>\n<li>The Facebook post also must have been posted just before the image was captured because it is at the top of Kim&#8217;s page. It appears that the FB post was only 2 hours old when captured.<\/li>\n<\/ol>\n<p>All these posts were made on July 20, 2015 and I found out about the Instagram post the next day (see &#8220;<a href=\"http:\/\/pharma-mkting.com\/blog\/2015\/07\/omg-kim-kardashian-shills-for-pharma-no.html\">OMG. Kim Kardashian Shills for Pharma! No Worry &#8211; No Side Effects!<\/a>&#8220;). It seems, however, that someone knew about these posts hours after they were made. Was that &#8220;someone&#8221; an FDA employee, a physician, or a competitor?<\/p>\n<p>FDA says it was notified about the Instagram post through its Bad Ad program. Only physicians can submit complaints to that program (read &#8220;<a href=\"http:\/\/pharma-mkting.com\/blog\/2012\/05\/is-there-doctor-in-house-fda-bad-ad.html\">Is There a Doctor in the House? FDA Bad Ad Program is Designed for You. Not So Much for Me!<\/a>&#8220;). What physician would be so quick in noticing the post, capturing the evidence, and submitting it to the FDA? Could it be a physician working at a competing drug company?<\/p>\n<p>I know that FDA requires all drug companies to submit any promotional material to FDA\u2019s OPDP \u201cat the time of first use\u201d together with a form called Form 2253. Companies have the option to do this before the ad is run and perhaps that alerted the FDA to keep an eye out for Kim&#8217;s posts &#8212; see P.S.<\/p>\n<p>It&#8217;s interesting that FDA was able to act so quickly in the social media realm because with TV ads, it takes many months before the FDA reacts (read, for example, &#8220;<a href=\"http:\/\/pharma-mkting.com\/blog\/2008\/10\/fda-and-yaz-is-fda-helping-marketers.html\">FDA and YAZ: Is FDA Helping Marketers Work Around Regulations?<\/a>&#8220;).<\/p>\n<p><b>P.S.<\/b> John Driscoll (@OPDPresources) just pointed out to me that the image is a copy of what was submitted to OPDP by the company with form 2253. The letter states: &#8220;The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) has reviewed the Kim Kardashian Social Media Post (social media post) (2015-0069-01) 1 for DICLEGIS (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets, for oral use (DICLEGIS) submitted by Duchesnay, Inc. (Duchesnay) under cover of Form FDA 2253.&#8221; 2015-0069-01 identifies the image shown here. <\/p>\n<p>So, sorry for the misleading original title of this post. But the last point is still interesting: FDA seems to be acting much faster when it comes to social media drug promotion violations than to TV (or print) violations.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Kim Kardashian posted a violative Diclegis\u00ae ad on Instagram (read \u201cKim Kardashian&#8217;s Diclegis Instagram Post Raises Issues of Transparency, Drug Safety, and Learning from History\u201d). She was paid to do that by Duchesnay &#8212; the company that makes &amp; markets Diclegis. But did you know that the ad also was posted to her Twitter and [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":11960,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[12],"tags":[351,44,174,317,167,280],"topic":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA Acts on Violative Social Media Posts a Lot More Quickly Than It Does for TV and Print Ads - 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\/how-did-fda-capture-kim-kardashians\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Acts on Violative Social Media Posts a Lot More Quickly Than It Does for TV and Print Ads - Pharma Marketing Network\" \/>\n<meta property=\"og:description\" content=\"Kim Kardashian posted a violative Diclegis\u00ae ad on Instagram (read \u201cKim Kardashian&#8217;s Diclegis Instagram Post Raises Issues of Transparency, Drug Safety, and Learning from History\u201d). 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