{"id":5916,"date":"2015-03-11T15:15:00","date_gmt":"2015-03-11T15:15:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/a-pig-cow-robot-fda-warning-letter\/"},"modified":"2019-02-21T01:15:59","modified_gmt":"2019-02-21T01:15:59","slug":"a-pig-cow-robot-fda-warning-letter","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/a-pig-cow-robot-fda-warning-letter\/","title":{"rendered":"A Pig, a Cow, a Robot, an FDA Warning Letter"},"content":{"rendered":"<p>In a March 5, 2015, Warning Letter to Discovery Laboratories, Inc. (<a href=\"http:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/EnforcementActivitiesbyFDA\/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies\/UCM437488.pdf\">here<\/a>), regarding its Surfaxin promotional website, FDA cited &#8220;evolution&#8221; as a false claim of superiority. Well, not exactly.<\/p>\n<p>FDA noted the phrase &#8220;Join the Therapeutic Evolution&#8230;&#8221;, which was used in conjunction with graphics of a pig, a cow, and a human-like robot (see screen capture below).<\/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:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2015\/03\/SURFAXIN-Screen.jpg\" imageanchor=\"1\" style=\"margin-left: auto; margin-right: auto;\"><img loading=\"lazy\" decoding=\"async\" border=\"0\" src=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2015\/03\/SURFAXIN-Screen.jpg\" height=\"162\" 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>\nHere&#8217;s what the FDA had to say about the pig, the cow, and the robot:<\/p>\n<p><a name='more'><\/a>&#8220;These claims and presentations are misleading because they imply that Surfaxin, a synthetic<br \/>\nsurfactant <i>depicted by the image of the human-like robot<\/i>, is superior because it has <b>&#8216;evolved<\/b>&#8216; from <i>more primitive<\/i>, animal-derived surfactants, such as Curosurf (poractant alfa), an extract<br \/>\nof natural porcine lung surfactant, and Survanta (beractant), an extract of natural bovine lung<br \/>\nsurfactant. We are not aware of substantial evidence that supports the implication that<br \/>\nSurfaxin is superior to Curosurf or Survanta.&#8221;<\/p>\n<p>FDA should also have pointed out that it is impossible to extract lung surfactant from robots because they don&#8217;t have lungs! Duh!<\/p>\n","protected":false},"excerpt":{"rendered":"<p>In a March 5, 2015, Warning Letter to Discovery Laboratories, Inc. (here), regarding its Surfaxin promotional website, FDA cited &#8220;evolution&#8221; as a false claim of superiority. Well, not exactly. FDA noted the phrase &#8220;Join the Therapeutic Evolution&#8230;&#8221;, which was used in conjunction with graphics of a pig, a cow, and a human-like robot (see screen [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":11816,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[12],"tags":[410],"topic":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>A Pig, a Cow, a Robot, an FDA Warning Letter - 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\/a-pig-cow-robot-fda-warning-letter\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"A Pig, a Cow, a Robot, an FDA Warning Letter - Pharma Marketing Network\" \/>\n<meta property=\"og:description\" content=\"In a March 5, 2015, Warning Letter to Discovery Laboratories, Inc. (here), regarding its Surfaxin promotional website, FDA cited &#8220;evolution&#8221; as a false claim of superiority. Well, not exactly. 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