{"id":13274,"date":"2011-06-09T00:00:00","date_gmt":"2011-06-09T00:00:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/uncategorized\/off-label-dtc-survey\/"},"modified":"2019-03-01T12:12:19","modified_gmt":"2019-03-01T12:12:19","slug":"off-label-dtc-survey","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/surveys\/off-label-dtc-survey\/","title":{"rendered":"Direct-to-Consumer Off-Label Drug Promotion Survey"},"content":{"rendered":"<p> Direct-to-Consumer Off-Label Drug Promotion Survey              <\/p>\n<p> Survey began 4 September 2016<br \/>           Survey will end 7 November 2016<\/p>\n<p>             <br clear=\"all\"\/> <b>Background<\/b><\/p>\n<p>           Under pressure from the drug industry and &#8220;First Amendment&#8221; legal issues, the FDA has hinted in a recent public hearing notice that it may allow pharmaceutical and Medical device companies to engage in off-label communications directly to &#8220;patients and consumer audiences&#8221; and not just to physicians.           <\/p>\n<p> In the <a href=\"https:\/\/www.federalregister.gov\/articles\/2016\/09\/01\/2016-21062\/manufacturer-communications-regarding-unapproved-uses-of-approved-or-cleared-medical-products-public\">Federal Register Notice [Docket-FDA-2016-N-1149]<\/a> announcing the public hearing (&#8220;Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products&#8221;), FDA asked these questions related to the off-label promotion of drugs and medical devices to consumers:           <\/p>\n<p> &#8220;To what extent is it appropriate for firms to communicate information about unapproved uses of their approved\/cleared medical products to patient and consumer audiences? What disclosures and additional information would be needed to help ensure that a communication to lay audiences is truthful and non-misleading, given consumers&#8217; lack of medical training and expertise in critically evaluating this type of information?&#8221;           <\/p>\n<p> For more background, read &#8220;<a href=\"http:\/\/pharmamkting.blogspot.com\/2016\/09\/fda-readies-itself-for-direct-to.html\" target=\"_BLANK\">FDA May Have No Choice But to Allow Direct-to-Consumer Off-Label Drug Promotion<\/a>&#8221;            <\/p>\n<p> <b>Preliminary Results<\/b><\/p>\n<p>             The following preliminary results from the survey were submitted as comments to Docket-FDA-2016-N-1149 on 14-Oct-2016 (Comment Tracking Number: 1k0-8sge-hi48; <a href=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/surveys\/PMNews-Comment-Docket-FDA-2016-N-1149.pdf\">download PDF<\/a>). A more complete summary will be presented at the Public Hearing on November 7, 2016. Your de-identified responses and comments will be included. <\/p>\n<p><b>Q1:<\/b> Indicate your level of agreement\/ disagreement with the following statements. Note: FDA regulations are legally-binding federal laws, whereas guidelines have no legal standing. &#8220;Promotions&#8221; include print and TV advertising as well as drug.com websites and other forms of digital advertising. <\/p>\n<ul>\n<li>FDA should create non-legally binding GUIDELINES for off-label direct-to-consumer promotions by pharma companies.<\/li>\n<li>FDA should create legally binding REGULATIONS for off-label direct-to-consumer promotions by pharma companies.<\/li>\n<li>Under NO circumstances should FDA allow off-label drug promotion to patients or consumers.<\/li>\n<\/ul>\n<p>             <img decoding=\"async\" src=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2019\/02\/Off-Label-Q1-Chart.jpg\" width=\"500\" alt=\"Direct-to-Consumer Off-Label Drug Promotion Survey Q1 Chart\" border=\"0\"\/>           <br \/><b>Q2:<\/b> A Duke University think tank suggested that a new independent entity be created to review claims and recommend exactly what off-label information drug and device makers should be allowed to share with doctors. Should such an independent entity do the same with regard to off-label information shared with consumers?<\/p>\n<p>             <img decoding=\"async\" src=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2019\/02\/Off-Label-Q2-Chart.jpg\" width=\"500\" alt=\"Direct-to-Consumer Off-Label Drug Promotion Survey Q2 Chart\" border=\"0\"\/>           <\/p>\n<p>Please Take the Survey                                                                      <a href=\"https:\/\/www.surveymonkey.com\/r\/8ZV5ZXQ\"><img loading=\"lazy\" decoding=\"async\" src=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/banners\/Off-Label-DTC-Survey-Banner-528x91.jpg\" width=\"528\" height=\"91\" alt=\"Direct-to-Consumer Off-Label Drug Promotion Survey\" border=\"0\"\/><\/a><br \/><b><a href=\"https:\/\/www.surveymonkey.com\/r\/8ZV5ZXQ\">Direct-to-Consumer Off-Label Drug Promotion Survey<\/a><\/b>                                                                                                   This survey solicits your opinion possible FDA future decisions regarding off-label drug promotion to patient and consumer audiences. For more background information, read &#8220;<a href=\"http:\/\/pharmamkting.blogspot.com\/2016\/09\/fda-readies-itself-for-direct-to.html\">FDA May Have No Choice But to Allow Direct-to-Consumer Off-Label Drug Promotion.<\/a>&#8220;<\/p>\n<p><strong><a style=\"color: blue; text-decoration: underline;\" track=\"on\" shape=\"rect\" href=\"https:\/\/www.surveymonkey.com\/r\/8ZV5ZXQ\" linktype=\"1\">CLICK HERE<\/a> to take the survey<\/strong>.                                                       <br \/>           Your comments are confidential (anonymous) unless you specifically provide your contact information at the end of the survey and allow us to attribute comments to you personally.           <\/p>\n<p> <i><a href=\"http:\/\/www.surveys.pharma-mkting.com\/surveys-hp.htm\">Return to list of surveys&#8230;<\/a><\/i>         <\/p>\n<p\/>\n","protected":false},"excerpt":{"rendered":"<p>This survey solicits your opinion possible FDA future decisions regarding off-label drug promotion to patient and consumer audiences.<\/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":[1204],"tags":[],"topic":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.0 - 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