{"id":6039,"date":"2014-04-17T18:33:00","date_gmt":"2014-04-17T18:33:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/digital-health-coalition-urges-fda-to\/"},"modified":"2019-02-21T01:16:42","modified_gmt":"2019-02-21T01:16:42","slug":"digital-health-coalition-urges-fda-to","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/digital-health-coalition-urges-fda-to\/","title":{"rendered":"Digital Health Coalition Urges FDA to Launch a Social Media &#8220;Laboratory&#8221; to Ensure Adequate Guidance Progress"},"content":{"rendered":"<p>In comments submitted to the FDA regarding recent social media guidance (read &#8220;<a href=\"http:\/\/www.news.pharma-mkting.com\/pmn1301-article04.htm\">FDA Publishes First Piece of Long-Awaited Social Media Guidance<\/a>&#8221; for background), the Digital Health Coalition (DHC) &#8212; comprised mostly of pharma companies and digital agencies &#8212; suggested that the FDA establish a \u201clab\u201d to &#8220;help ensure the guidance progresses in a manner and at a rate to be informative and protective for all parties involved.&#8221;<\/p>\n<p>&#8220;One critical point of any guidance is applicability in the real world,&#8221; said DHC. &#8220;It will be helpful for the DHC and its members, for the FDA to take as many practical and real examples of current social media tools and environments and <i>run simulations on what this guidance could mean in each case<\/i> [my emphasis].&#8221;<\/p>\n<p>&#8220;To complicate things, there are innovations and new platforms coming out all the time and one could never be exhaustive about it without being dated months later, but such a detailed and joint exercise with industry and agency experts would be highly informative and would reveal the practical realities of this evolving guidance.&#8221;<\/p>\n<p>&#8220;Realizing we do not live in a world of black and white,&#8221; noted DHC, &#8220;we do need additional and more concrete real-\u00adworld examples of what &#8216;limited scope&#8217; with regard to &#8216;influence&#8217; means in practical terms to further foster innovation of interactive patient communication.&#8221;<\/p>\n<p>The DHC said it is willing to &#8220;partner with the FDA to identify such concrete examples and perhaps create mock-\u00adups in a laboratory environment for further analysis and discussion.&#8221; I guess this is a pitch for an RFP from DHC.<\/p>\n<p>What would such a &#8220;laboratory&#8221; look like?<\/p>\n<p><a name='more'><\/a>It might look like this:<\/p>\n<div class=\"separator\" style=\"clear: both; text-align: center;\">\n<\/div>\n<div class=\"separator\" style=\"clear: both; text-align: center;\">\n<a href=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2014\/04\/DHC-SocialMediaLab.jpg\" imageanchor=\"1\" style=\"margin-left: 1em; margin-right: 1em;\"><img loading=\"lazy\" decoding=\"async\" border=\"0\" src=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2014\/04\/DHC-SocialMediaLab.jpg\" height=\"292\" width=\"400\" \/><\/a><\/div>\n<p>\nAll seriousness aside, DHC has taken up an idea I hinted at a long time ago.<\/p>\n<p>Back in 2011, when many pundits first sensed the FDA was dragging its feet developing the promised social media guidance, I suggested that FDA was financially strapped and understaffed and clearly needed help. I asked &#8220;To get this help, does the FDA plan to pull in any outside consultants, hire additional experts internally, or approach the drug industry itself to help craft the guidelines?&#8221; (see &#8220;<a href=\"http:\/\/pharma-mkting.com\/blog\/2011\/08\/fda-intern-quest-for-social-media.html\">FDA Intern &amp; the Quest for Social Media Guidelines<\/a>&#8220;).<\/p>\n<p>While DHC thinks FDA needs help, FDA may feel pharma needs some schooling itself. See &#8220;<a href=\"http:\/\/pharma-mkting.com\/blog\/2014\/04\/fda-launches-social-media-educational.html\">FDA Launches Social Media Educational Initiative for Pharma<\/a>&#8220;.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>In comments submitted to the FDA regarding recent social media guidance (read &#8220;FDA Publishes First Piece of Long-Awaited Social Media Guidance&#8221; for background), the Digital Health Coalition (DHC) &#8212; comprised mostly of pharma companies and digital agencies &#8212; suggested that the FDA establish a \u201clab\u201d to &#8220;help ensure the guidance progresses in a manner and [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":11542,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[12],"tags":[304,479,44,145,167],"topic":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Digital Health Coalition Urges FDA to Launch a Social Media &quot;Laboratory&quot; 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