{"id":6053,"date":"2014-04-01T10:22:00","date_gmt":"2014-04-01T10:22:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/fda-launches-social-media-educationa\/"},"modified":"2019-02-21T01:16:46","modified_gmt":"2019-02-21T01:16:46","slug":"fda-launches-social-media-educationa","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/fda-launches-social-media-educationa\/","title":{"rendered":"FDA Launches Social Media Educational Initiative for Pharma"},"content":{"rendered":"

FDA NEWS RELEASE<\/b><\/p>\n

For Immediate Release<\/b>: Apr. 1, 2014
\nMedia Inquiries<\/b>: Iadora Newcomer, 301-796-1234, iadora.newcomer@fda.hhs.gov
\nMedia Inquiries<\/b>: 888-INFO-FDA<\/p>\n

\n<\/a><\/div>\n

The U.S. Food and Drug Administration today announced the launch of an educational initiative to assist the U.S. pharmaceutical industry to correctly interpret and implement recent social media and document submission guidances published by the Center for Drug Evaluation and Research.<\/p>\n

The \u201cC\u2019mon! It\u2019s Simple!\u201d campaign is the FDA\u2019s first of several planned social media education campaigns using the new authority granted under the For Gosh Sakes, It\u2019s Not Rocket Science Act, signed into law by President Obama in 2013.<\/p>\n

\u201cPharmaceutical use of social media is minimal,\u201d noted Thomas Abrams, Director of the Office of Prescription Drug Promotion (OPDP). \u201cWhile the industry often blames lack of guidance from the FDA as a major cause of this situation, we feel that the industry simply does not get it. They just don\u2019t understand what\u2019s in the guidance we\u2019ve already published. What\u2019s the sense of publishing guidelines if they are not correctly interpreted by the industry? I tell you,\u201d bemoaned Abrams, \u201cwe\u2019re thinking of not publishing any further guidance until the industry at least posts some comments and questions to the current docket so that we can respond and educate them.\u201d<\/p>\n

While the drug industry typically submits comments and questions at EXACTLY one minute before midnight of the deadline, the FDA has decided to be pro-active and develop a series of Q&A\u2019s that anticipate what the industry should be asking about recent guidance.<\/p>\n

The \u201cC\u2019mon! It\u2019s Simple!\u201d campaign uses a comprehensive multimedia approach, compelling facts and vivid imagery designed to educate over time using real-life scenarios \u2013 or what could be real-life scenarios if the drug industry had a better understanding of the guidelines. <\/p>\n

In one scenario, \u201cJoe Johnson,\u201d a fictitious paid spokesperson of Pfastraglax, a fictitious pharmaceutical company, posts a Pfastraglax product message on his personal Facebook page. Is this reportable according to “Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Dog Drugs” that was published by FDA in January, 2014?<\/p>\n

<\/a>\u201cIt has come to our attention,\u201d said Abrams, \u201cthat this same scenario recently was published in Pharma Marketing News<\/i>, a leading online industry publication (see \u201cQuestions Raised by FDA Guidelines with Answers, Sort Of<\/a>\u201d). Unfortunately, the lawyer presenting the scenario in this article vacillated between \u2018probably reportable\u2019 and it \u2018may not be reportable.\u2019 Lawyers! Pharma can\u2019t live with them and Pharma can\u2019t live without them! Am I right?\u201d<\/p>\n

\u201cC\u2019mon! It\u2019s Simple!\u201d will provide definitive, actionable answers to such questions using several social media platforms to create space where industry regulatory professionals can engage in peer-to-peer conversations about the issue in ways that are authentic to who they are.<\/p>\n

Supported by the best available non-legally binding opinions from OPDP, the \u201cC\u2019mon! It\u2019s Simple!\u201d campaign will be evaluated to measure its effectiveness over time. It is the first of several campaigns that the FDA will launch over the next few months as new social media guidances are published. Subsequent campaigns will target additional discrete audiences, including so-called agency experts, pundits who endlessly blog about these issues, and lesbian, gay, bisexual, and transgender (LGBT) pharma product managers.<\/p>\n

\u201cThe FDA has collaborated with some of the brightest and most creative minds to develop a multimedia initiative designed to make the target audience acutely aware of the guidelines by highlighting consequences that our pharma clients are really concerned about,\u201d said Abrams.<\/p>\n

The \u201cC\u2019mon! It\u2019s Simple!\u201d campaign, created with award-winning global marketing communication agency DumbDraftfcb, uses a comprehensive multimedia approach including television, radio, print, online and native advertising. The $135 million campaign is funded by industry user fees and launches nationwide on April 1, 2014.<\/p>\n","protected":false},"excerpt":{"rendered":"

FDA NEWS RELEASE For Immediate Release: Apr. 1, 2014 Media Inquiries: Iadora Newcomer, 301-796-1234, iadora.newcomer@fda.hhs.gov Media Inquiries: 888-INFO-FDA The U.S. Food and Drug Administration today announced the launch of an educational initiative to assist the U.S. pharmaceutical industry to correctly interpret and implement recent social media and document submission guidances published by the Center for […]<\/p>\n","protected":false},"author":2,"featured_media":11506,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[12],"tags":[304,354,44,167],"topic":[],"acf":[],"yoast_head":"\nFDA Launches Social Media Educational Initiative for Pharma - 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\/fda-launches-social-media-educationa\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Launches Social Media Educational Initiative for Pharma - 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