{"id":5622,"date":"2015-02-01T00:00:00","date_gmt":"2015-02-01T00:00:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/index.php\/2015\/02\/01\/pmn1402-article01\/"},"modified":"2019-02-18T20:38:45","modified_gmt":"2019-02-18T20:38:45","slug":"pmn1402-article01","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/articles\/pmn1402-article01\/","title":{"rendered":"The Consumer Brief Summary: FDA&#8217;s New Thinking Regarding Risk Communication"},"content":{"rendered":"<p>The Consumer Brief Summary        FDA&#8217;s New Thinking Regarding Risk Communication<br \/><img loading=\"lazy\" decoding=\"async\" alt=\"Fair Balance\" src=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2019\/02\/Lyrica-Print-Ad-FB-300x412.jpg\" width=\"200\" height=\"275\" align=\"right\" hspace=\"7\" vspace=\"5\"\/>New evidence &#8212; and comments from the pharma industry &#8212; motivated the FDA to issue &#8220;revised draft guidance&#8221; on February 9, 2015, titled &#8220;Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs.&#8221;<\/p>\n<p>The new guidelines jettison the &#8220;traditional approach&#8221; to fulfilling the <a href=\"http:\/\/www.glossary.pharma-mkting.com\/briefsummary.htm\">brief summary<\/a> requirement and replaces it with what the FDA calls the &#8220;Consumer Brief Summary.&#8221;<\/p>\n<p>What no one, including the FDA, is talking about, however, is the &#8220;<a href=\"http:\/\/www.glossary.pharma-mkting.com\/fairbalance.htm\">fair balance<\/a>&#8221; section of Rx drug ads.   <\/p>\n<p> This article summarizes the new guidelines and reviews the need for additional guidelines that specifically address the fair balance section of DTC print ads.  <\/p>\n<p><b>Topics (partial list)<\/b>:<\/p>\n<ul>\n<li>Anatomy of a DTC Print Ad<\/li>\n<li>Consumer Brief Summary<\/li>\n<li>Facts Box<\/li>\n<li>What About Fair Balance?<\/li>\n<li>Consumer Attitudes Concerning Drug Ads<\/li>\n<li>Fair Balance Warning Letters<\/li>\n<li>&#8220;Reasonable Consumer&#8221; &amp; Fair Balance<\/li>\n<li>Should Digital Marketers Take Note?<\/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\/pmnews1402-article01.pdf\" linktype=\"link\">www.pharma-mkting.com\/news\/pmnews1402-article01.pdf<\/a>    <\/p>\n<p>PMN1402-01<br \/>Issue: Vol. 14, No. 2: February 2015<\/p>\n<p\/><b>Find other articles in related Topic Areas:<\/b> <\/p>\n<ul>\n<li><a href=\"http:\/\/www.news.pharma-mkting.com\/PMNRegComplianceReprints.htm\">Regulatory Compliance<\/a><\/li>\n<li><a href=\"http:\/\/www.news.pharma-mkting.com\/PMNDTCReprints.htm\">Direct-to-Consumer (DTC) Advertising &amp; Marketing<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>New FDA guidelines jettison the &#8216;traditional approach&#8217; to fulfilling the brief summary requirement and replaces it with what the FDA calls the &#8216;Consumer Brief Summary.&#8217; This article summarizes the new guidelines and reviews the need for additional guidelines that specifically address the fair balance section of DTC print ads.<\/p>\n","protected":false},"author":2,"featured_media":13101,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[64,6],"tags":[],"topic":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.0 - 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