{"id":3151,"date":"2016-09-01T00:00:00","date_gmt":"2016-09-01T00:00:00","guid":{"rendered":"http:\/\/www.pharma-mkting.comindex.php\/2016\/09\/01\/pmnissuev1504sep2016archive\/"},"modified":"2019-02-06T02:36:09","modified_gmt":"2019-02-06T02:36:09","slug":"pmnissuev1504sep2016archive","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmnissuev1504sep2016archive\/","title":{"rendered":"Pharma Marketing News Vol. 15, Issue No. 4: September 2016"},"content":{"rendered":"<p><b>Vol. 15, Issue No. 4: September 2016 &#8211; EXECUTIVE SUMMARY<\/b><\/p>\n<p>Off-Label DTC Advertising        Will FDA Be Forced to Allow It?<br \/><img loading=\"lazy\" decoding=\"async\" src=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2016\/09\/GandpaSimpson-v-TV-Off-Label-DTC.jpg\" width=\"300\" height=\"225\" align=\"right\" hspace=\"7\" vspace=\"5\"\/>In what has been described as a &#8220;surprise move&#8221; the FDA recently published a Federal Register notice announcing that it will hold a 2-day public hearing November 9-10, 2016, to obtain input on issues related to off-label communications by manufacturers regarding FDA-regulated drugs and medical devices. FDA says it is &#8220;engaged in a comprehensive review of its regulations and policies governing firms&#8217; communications about unapproved uses of approved\/ cleared medical products, and the input from this meeting will inform FDA&#8217;s policy development in this area.&#8221;<\/p>\n<p> What&#8217;s even more surprising is that FDA is asking questions about off-label direct-to-consumer (DTC) and direct-to-patient communications in addition to the typical questions about such promotions directed at physicians. <\/p>\n<p>This article summarizes the First Amendment assault on FDA&#8217;s ability to regulate off-label communications.<\/p>\n<p><b>Topics (partial list)<\/b>:<\/p>\n<ul>\n<li>A Brief History of Off-Label Promotion<\/li>\n<li>Chart: 25 Years of Pharma Criminal and Civil Penalties<\/li>\n<li>First Amendment Challenges<\/li>\n<li>Is the Battle Lost?<\/li>\n<li>A Slippery Slope<\/li>\n<li>Cancer Off-Label DTC May Be First Case?<\/li>\n<li>Has It Already Happened?<\/li>\n<li>Duke Chimes in on Off-Label Drug Promotion<\/li>\n<\/ul>\n<p>Download the full article (PDF file) here:<br \/><a style=\"color: #993300;\" track=\"on\" shape=\"rect\" href=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/news\/pmnews1504-article01.pdf\" linktype=\"link\">www.pharma-mkting.com\/news\/pmnews1504-article01.pdf<\/a>    <\/p>\n<p><a name=\"pmn1504-02\"\/><\/p>\n<p>Breakthrough Cancer Therapy DTC        Boldly Emphasizing the Positive<br \/><img loading=\"lazy\" decoding=\"async\" src=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2016\/09\/OpdivoChance.jpg\" width=\"300\" height=\"277\" align=\"right\" hspace=\"7\" vspace=\"5\"\/>As of July 18, 2016, the FDA has approved 46 breakthrough therapy designated products. According to the Friends of Cancer Research, nearly 75% (34) of these are for the treatment of cancer. One of these drugs &#8212; Bristol-Myers Squibb&#8217;s PD-1 inhibitor Opdivo &#8212; has been extensively covered in the media. <\/p>\n<p>A recent <i>NYT<\/i> OpEd piece, for example, called the TV ads for Opdivo &#8220;utterly misleading and exploitive&#8221; and said that if BMS really wishes to thank patients who participated in the Opdivo drug trials, it should pull the ads because the drug &#8220;doesn&#8217;t work&#8221;. <\/p>\n<p>This article explores the trend in direct-to-consumer (DTC) ads for &#8220;breakthrough&#8221; cancer therapies.<\/p>\n<p><b>Topics (partial list)<\/b>:<\/p>\n<ul>\n<li>What FDA Means by &#8220;Breakthrough Therapy&#8221;<\/li>\n<li>Chart: Strong Opdivo Sales, For Now<\/li>\n<li>Big, Bold DTC Ad<\/li>\n<li>BMS&#8217; View<\/li>\n<li>Majority of Physicians Do Not Understand What Level of Evidence Supports FDA&#8217;s &#8220;Breakthrough&#8221; Therapy Designation<\/li>\n<li>Oncologists Say Cancer Drug Advertising Fosters Misinterpretation of Efficacy by Patients <\/li>\n<li>Impact on Sales<\/li>\n<li>The Media&#8217;s Role<\/li>\n<\/ul>\n<p>Download the full article (PDF file) here:<br \/><a style=\"color: #993300;\" track=\"on\" shape=\"rect\" href=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/news\/pmnews1504-article02.pdf\" linktype=\"link\">www.pharma-mkting.com\/news\/pmnews1504-article02.pdf<\/a>    <\/p>\n<p><a name=\"pmn1504-03\"\/><\/p>\n<p>The Dark World of Disease Awareness Ads        Pharma Marketers Use Scary Ads to Motivate Consumers<br \/><img loading=\"lazy\" decoding=\"async\" src=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2016\/09\/ScaryDTC-Ads-sm.jpg\" width=\"250\" height=\"285\" align=\"right\" hspace=\"7\" vspace=\"5\"\/>Pharmaguy was quoted in a recent <i>Ad Age<\/i> story (see <a href=\"http:\/\/sco.lt\/8kIIhF\">here<\/a>) about the recent spate of scary drug ads seen on TV and in print. <\/p>\n<p>&#8220;A trend with companies, especially ones with injectable drugs and vaccines, which also have big price increases, is to scare people into buying their product or getting their vaccine,&#8221; said Pharmaguy. <\/p>\n<p>Lately many disease awareness ads have taken a distinctly dark approach and, in some cases, placed blame on parents and grandparents.<\/p>\n<p>This article describes recent dark and ominous &#8220;disease awareness&#8221; ads, the goal of which is to instill fear in the viewing public and motivate them to see the doctor.<\/p>\n<p><b>Topics (partial list)<\/b>:<\/p>\n<ul>\n<li>Traditional Disease Awareness Marketing<\/li>\n<li>No Risk, No Foul?<\/li>\n<li>Stealthy Product Promotions<\/li>\n<li>Going Dark &amp; Scary<\/li>\n<li>Gambling in the Social Media Age<\/li>\n<li>Take a Lesson from Mylan<\/li>\n<li>Is It Motivational?<\/li>\n<li>Fear Sells More Than Logic<\/li>\n<li>Slideshare Presentation<\/li>\n<\/ul>\n<p>Download the full article (PDF file) here:<br \/><a style=\"color: #993300;\" track=\"on\" shape=\"rect\" href=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/news\/pmnews1504-article03.pdf\" linktype=\"link\">www.pharma-mkting.com\/news\/pmnews1504-article03.pdf<\/a>    <\/p>\n","protected":false},"excerpt":{"rendered":"<p>Welcome to Vol. 15, Issue No. 4 (September 2016) of Pharma Marketing News. This issue focuses on off-label promotions directed to consumers, dark and scary disease awareness advertising, and breakthrough cancer therapy DTC.<\/p>\n","protected":false},"author":2,"featured_media":3184,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[65,6,15],"tags":[],"topic":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Pharma Marketing News Vol. 15, Issue No. 4: September 2016 - 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\/articles\/pmnissuev1504sep2016archive\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharma Marketing News Vol. 15, Issue No. 4: September 2016 - Pharma Marketing Network\" \/>\n<meta property=\"og:description\" content=\"Welcome to Vol. 15, Issue No. 4 (September 2016) of Pharma Marketing News. 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