{"id":6962,"date":"2009-11-05T13:39:00","date_gmt":"2009-11-05T13:39:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/my-fda-social-media-hearing\/"},"modified":"2019-02-21T01:22:24","modified_gmt":"2019-02-21T01:22:24","slug":"my-fda-social-media-hearing","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/my-fda-social-media-hearing\/","title":{"rendered":"My FDA Social Media Hearing Presentations"},"content":{"rendered":"<p>As you no doubt know, FDA is hosting a public hearing on pharma&#8217;s use of social media for Rx drug (and device) promotion next week (<a href=\"http:\/\/www.forums.pharma-mkting.com\/showthread.php?t=21169\">see here<\/a>). I will be making two presentations at that meeting (<a href=\"http:\/\/www.forums.pharma-mkting.com\/showthread.php?p=23616#post23616\">see speaker schedule here<\/a>):<\/p>\n<ul>\n<li>9:30-9:45 AM on Thursday, Nov 12 (following PhRMA)<\/li>\n<li>10:20-10:30 AM on Friday, Nov 13<\/li>\n<\/ul>\n<p>You can find my presentations here (warning: BIG pdf files):<\/p>\n<ul>\n<li><a href=\"http:\/\/www.virsci.com\/JMack-FDASM-Slides_Part1.pdf\">Part 1<\/a>, covering FDA issues 1 (Accountability) &amp; 2 (Fulfilling Regulatory Requirements)<\/li>\n<li><a href=\"http:\/\/www.virsci.com\/JMack-FDASM-Slides_Part2.pdf\">Part 2<\/a>, covering FDA issues 3 (Posting Corrective Information) &amp; 5 (Adverse Event Reporting)<\/li>\n<\/ul>\n<p>These presentations summarize most of the results to date of the ongoing survey I have been running since 20 September 2009 (<a href=\"http:\/\/bit.ly\/GgW14\">find the survey here<\/a>). The survey includes all 19 questions for which FDA seeks answers. There were 354 respondents as of 1 November 2009.<\/p>\n<p>Some key points I will make include:<\/p>\n<ul>\n<li>Media agnostic regulations are not popular among industry experts.<\/li>\n<li>The \u201cOne-Click Rule\u201d is desired by the industry. However, most often it takes two clicks to reach the approved labeling (PI). Since the PI is virtually unreadable, there needs to be a better way to provide the fair balance regardless of the number of clicks! <\/li>\n<li>There are some ideas for dealing with space limitations imposed by certain social media apps.<\/li>\n<li>DISCLOSURE of involvement with or influence over 3rd-party social media content should be prominently displayed alongside relevant content when possible. <\/li>\n<li>Each company should have a Public Social Media Policy (SMP) that includes a notice of its transparency\/disclosure and other policies relating to social media. [Just like every pharma company has a public privacy policy that applies to all its product Web sites, each pharma company should have a public SMP that applies to all its social media activities, whether owned or sponsored by the company.]<\/li>\n<li>Companies should monitor social media sites for unauthorized use or modification of its approved content and make a best effort to remove or correct the content. But they should be REQUIRED to do so only for sites owned or directly sponsored by them.<\/li>\n<li>Vast majority of \u201cAdverse Experiences\u201d reported on social media sites do NOT meet the requirements for AE reporting.<\/li>\n<li>Although there are monitoring tools available, the resources required to monitor all social media sites for adverse events are not justifiable.<\/li>\n<li>Consequently, few companies have standard operating procedures for processing adverse event information from social media sites.<\/li>\n<li>However, pharma companies can help consumers report adverse events directly to the FDA using social media tools such as widgets placed on drug.com Web sites.<\/li>\n<li>Some innovative ideas for fulfilling regulatory requirements to submit social media promotional materials to FDA were suggested, including:<\/li>\n<p><UL><\/p>\n<li>Register sites with FDA for agency to monitor<\/li>\n<li>Submit \u201ctemplate\u201d (design and\/or sample content) of social media site to FDA for pre-approval\/approval<\/li>\n<p><\/UL><\/p>\n<li>But there was no consensus opinion about satisfying regulations regarding submission of social media promotional materials.<\/li>\n<li>Too stringent regulations will prevent companies from carrying on two-way social media conversations with consumers and HCPs. Such conversations can have a beneficial impact on public health, especially when clarifying or correcting misinformation.<\/li>\n<\/ul>\n<p>While I am in favor of some new and relaxed FDA regulations\/guidelines regarding pharma&#8217;s use of social media, I am also in favor of HIGHER standards, the development of which should be a collaborative effort among all stakeholders. That is, FDA regulations merely define the BASEMENT level best practices that pharma needs to adopt for effective use of social media. I believe there is a need to look beyond the FDA and start building the FIRST &amp; UPPER FLOOR level best practices. More about that in later posts.<\/p>\n<p>Right now, all eyes are focused on the FDA. No matter what guidelines the FDA comes up with, I will continue to &#8220;out&#8221; pharmaceutical marketing worst practices on this blog.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>As you no doubt know, FDA is hosting a public hearing on pharma&#8217;s use of social media for Rx drug (and device) promotion next week (see here). I will be making two presentations at that meeting (see speaker schedule here): 9:30-9:45 AM on Thursday, Nov 12 (following PhRMA) 10:20-10:30 AM on Friday, Nov 13 You [&hellip;]<\/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":[12],"tags":[44,182,167],"topic":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>My FDA Social Media Hearing Presentations - 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\/my-fda-social-media-hearing\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"My FDA Social Media Hearing Presentations - Pharma Marketing Network\" \/>\n<meta property=\"og:description\" content=\"As you no doubt know, FDA is hosting a public hearing on pharma&#8217;s use of social media for Rx drug (and device) promotion next week (see here). I will be making two presentations at that meeting (see speaker schedule here): 9:30-9:45 AM on Thursday, Nov 12 (following PhRMA) 10:20-10:30 AM on Friday, Nov 13 You [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/my-fda-social-media-hearing\/\" \/>\n<meta property=\"og:site_name\" content=\"Pharma Marketing Network\" \/>\n<meta property=\"article:published_time\" content=\"2009-11-05T13:39:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2019-02-21T01:22:24+00:00\" \/>\n<meta property=\"og:image\" content=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2019\/03\/pmn-logo-intro-post-1.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"744\" \/>\n\t<meta property=\"og:image:height\" content=\"419\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\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=\"3 minutes\" \/>\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\/my-fda-social-media-hearing\/\",\"url\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/my-fda-social-media-hearing\/\",\"name\":\"My FDA Social Media Hearing Presentations - Pharma Marketing Network\",\"isPartOf\":{\"@id\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#website\"},\"datePublished\":\"2009-11-05T13:39:00+00:00\",\"dateModified\":\"2019-02-21T01:22:24+00:00\",\"author\":{\"@id\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#\/schema\/person\/763fc249c59c91ce203db612d81a75a1\"},\"breadcrumb\":{\"@id\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/my-fda-social-media-hearing\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/my-fda-social-media-hearing\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/my-fda-social-media-hearing\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"My FDA Social Media Hearing Presentations\"}]},{\"@type\":\"WebSite\",\"@id\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#website\",\"url\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/\",\"name\":\"Pharma Marketing Network\",\"description\":\"Pharma Marketing Network\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/?s={search_term_string}\"},\"query-input\":\"required name=search_term_string\"}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#\/schema\/person\/763fc249c59c91ce203db612d81a75a1\",\"name\":\"Pharma Guy\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#\/schema\/person\/image\/\",\"url\":\"http:\/\/2.gravatar.com\/avatar\/87853617a5e31233716811d09cdefdf7?s=96&d=identicon&r=g\",\"contentUrl\":\"http:\/\/2.gravatar.com\/avatar\/87853617a5e31233716811d09cdefdf7?s=96&d=identicon&r=g\",\"caption\":\"Pharma Guy\"},\"description\":\"Pharmaguy\u2122 is a \u201cconstructive critic\u201d of pharma marketing and publishes commentary on the Pharma Marketing Blog and on Scoop.it.\",\"url\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/author\/ehs-pharmaguy\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"My FDA Social Media Hearing Presentations - Pharma Marketing Network","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/my-fda-social-media-hearing\/","og_locale":"en_US","og_type":"article","og_title":"My FDA Social Media Hearing Presentations - Pharma Marketing Network","og_description":"As you no doubt know, FDA is hosting a public hearing on pharma&#8217;s use of social media for Rx drug (and device) promotion next week (see here). I will be making two presentations at that meeting (see speaker schedule here): 9:30-9:45 AM on Thursday, Nov 12 (following PhRMA) 10:20-10:30 AM on Friday, Nov 13 You [&hellip;]","og_url":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/my-fda-social-media-hearing\/","og_site_name":"Pharma Marketing Network","article_published_time":"2009-11-05T13:39:00+00:00","article_modified_time":"2019-02-21T01:22:24+00:00","og_image":[{"width":744,"height":419,"url":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2019\/03\/pmn-logo-intro-post-1.jpg","type":"image\/jpeg"}],"author":"Pharma Guy","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Pharma Guy","Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/my-fda-social-media-hearing\/","url":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/my-fda-social-media-hearing\/","name":"My FDA Social Media Hearing Presentations - Pharma Marketing Network","isPartOf":{"@id":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#website"},"datePublished":"2009-11-05T13:39:00+00:00","dateModified":"2019-02-21T01:22:24+00:00","author":{"@id":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#\/schema\/person\/763fc249c59c91ce203db612d81a75a1"},"breadcrumb":{"@id":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/my-fda-social-media-hearing\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/my-fda-social-media-hearing\/"]}]},{"@type":"BreadcrumbList","@id":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/my-fda-social-media-hearing\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/"},{"@type":"ListItem","position":2,"name":"My FDA Social Media Hearing Presentations"}]},{"@type":"WebSite","@id":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#website","url":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/","name":"Pharma Marketing Network","description":"Pharma Marketing Network","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/?s={search_term_string}"},"query-input":"required name=search_term_string"}],"inLanguage":"en-US"},{"@type":"Person","@id":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#\/schema\/person\/763fc249c59c91ce203db612d81a75a1","name":"Pharma Guy","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/#\/schema\/person\/image\/","url":"http:\/\/2.gravatar.com\/avatar\/87853617a5e31233716811d09cdefdf7?s=96&d=identicon&r=g","contentUrl":"http:\/\/2.gravatar.com\/avatar\/87853617a5e31233716811d09cdefdf7?s=96&d=identicon&r=g","caption":"Pharma Guy"},"description":"Pharmaguy\u2122 is a \u201cconstructive critic\u201d of pharma marketing and publishes commentary on the Pharma Marketing Blog and on Scoop.it.","url":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/author\/ehs-pharmaguy\/"}]}},"_links":{"self":[{"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/posts\/6962"}],"collection":[{"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/comments?post=6962"}],"version-history":[{"count":1,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/posts\/6962\/revisions"}],"predecessor-version":[{"id":9648,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/posts\/6962\/revisions\/9648"}],"wp:featuredmedia":[{"embeddable":true,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/media\/13101"}],"wp:attachment":[{"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/media?parent=6962"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/categories?post=6962"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/tags?post=6962"},{"taxonomy":"topic","embeddable":true,"href":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-json\/wp\/v2\/topic?post=6962"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}