{"id":6311,"date":"2012-11-20T18:57:00","date_gmt":"2012-11-20T18:57:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/alcon-caught-illegally-plugging\/"},"modified":"2019-02-21T01:18:28","modified_gmt":"2019-02-21T01:18:28","slug":"alcon-caught-illegally-plugging","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/alcon-caught-illegally-plugging\/","title":{"rendered":"FDA Pulls \u201cPlug\u201d on PATANASE Detail Aid"},"content":{"rendered":"<p>Subtitled: Alcon Caught Illegally &#8220;Plugging&#8221; PATANASE Nasal Spray to Docs<\/p>\n<p>The FDA&#8217;s Office of Prescription Drug Promotion (OPDP) sent a &#8220;untitled&#8221; letter to Alcon Research regarding a PATANASE &#8220;<a href=\"http:\/\/www.glossary.pharma-mkting.com\/detailaid.htm\">detail aid<\/a>&#8220;, which the FDA claims is &#8220;misleading because it implies that Patanase has been shown to be effective in the treatment of the specific symptom of nasal congestion, when this has not been demonstrated by substantial evidence or substantial clinical experience.&#8221;<\/p>\n<p>Language in FDA&#8217;s letter regarding graphic images and the product logo appearing in the detail aid caught my attention:<\/p>\n<ul>\n<li>Graphics of a woman and child with a <b>cork in each nostril<\/b>&nbsp;[my emphasis] on the front of the sales aid and the contrasting image of the same woman and child without corks in their nostrils on the back of the sales aid.<\/li>\n<li>The tagline \u201cUnplug with\u201d in conjunction with a graphic of <b>two loose corks&nbsp;<\/b>&nbsp;[my emphasis]&nbsp;and the<br \/>\nPatanase logo<\/li>\n<\/ul>\n<p>FDA is not known for its humor, so I had to see if these images were actually in the detail aid. Fortunately, FDA linked to a pdf version of the aid <a href=\"http:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/EnforcementActivitiesbyFDA\/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies\/UCM328640.pdf\">here<\/a>. Below is the first page:<\/p>\n<div class=\"separator\" style=\"clear: both; text-align: center;\">\n<a href=\"http:\/\/4.bp.blogspot.com\/-6zcTJ9iPVsc\/UKvQwR2wabI\/AAAAAAAAE3w\/T45oiEw_Aag\/s1600\/PATANASEcorked.png\" imageanchor=\"1\" style=\"margin-left: 1em; margin-right: 1em;\"><img loading=\"lazy\" decoding=\"async\" border=\"0\" height=\"305\" src=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2012\/11\/PATANASEcorked.png\" width=\"400\" \/><\/a><\/div>\n<p>\nOf course, the &#8220;after&#8221; image shows the mom and boy without the corks up their noses and smiling:<\/p>\n<div class=\"separator\" style=\"clear: both; text-align: center;\">\n<a href=\"http:\/\/3.bp.blogspot.com\/-H18KPJ-40bA\/UKvRWM47M6I\/AAAAAAAAE34\/jK3xFaPrRWk\/s1600\/MomSonUncorked.png\" imageanchor=\"1\" style=\"margin-left: 1em; margin-right: 1em;\"><img loading=\"lazy\" decoding=\"async\" border=\"0\" height=\"216\" src=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2012\/11\/MomSonUncorked.png\" width=\"320\" \/><\/a><\/div>\n<p>\nUsually, FDA&#8217;s letters often tell pharma marketers who overstate efficacy to &#8220;put a cork in it&#8221;; i.e., stop making false claims. But, in this case, FDA would rather that Alcon just get rid of the corks altogether!<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Subtitled: Alcon Caught Illegally &#8220;Plugging&#8221; PATANASE Nasal Spray to Docs The FDA&#8217;s Office of Prescription Drug Promotion (OPDP) sent a &#8220;untitled&#8221; letter to Alcon Research regarding a PATANASE &#8220;detail aid&#8220;, which the FDA claims is &#8220;misleading because it implies that Patanase has been shown to be effective in the treatment of the specific symptom of [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":10937,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[12],"tags":[646,647,44,410],"topic":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA Pulls \u201cPlug\u201d on PATANASE Detail Aid - 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\/alcon-caught-illegally-plugging\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Pulls \u201cPlug\u201d on PATANASE Detail Aid - Pharma Marketing Network\" \/>\n<meta property=\"og:description\" content=\"Subtitled: Alcon Caught Illegally &#8220;Plugging&#8221; PATANASE Nasal Spray to Docs The FDA&#8217;s Office of Prescription Drug Promotion (OPDP) sent a &#8220;untitled&#8221; letter to Alcon Research regarding a PATANASE &#8220;detail aid&#8220;, which the FDA claims is &#8220;misleading because it implies that Patanase has been shown to be effective in the treatment of the specific symptom of [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/alcon-caught-illegally-plugging\/\" \/>\n<meta property=\"og:site_name\" content=\"Pharma Marketing Network\" \/>\n<meta property=\"article:published_time\" content=\"2012-11-20T18:57:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2019-02-21T01:18:28+00:00\" \/>\n<meta property=\"og:image\" content=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2012\/11\/MomSonUncorked.png\" \/>\n\t<meta property=\"og:image:width\" content=\"320\" \/>\n\t<meta property=\"og:image:height\" content=\"217\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\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=\"1 minute\" \/>\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\/alcon-caught-illegally-plugging\/\",\"url\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/alcon-caught-illegally-plugging\/\",\"name\":\"FDA Pulls \u201cPlug\u201d on PATANASE Detail Aid - 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