Social Media Guidelines and Safeguards        for the Pharmaceutical Industry:    What You Need to Know (For Now)         ...
Social Media Guidelines and Safeguards for thePharmaceutical Industry: What You Need to Know (For Now)         Various bus...
In addition, company representatives (or representatives of company subsidiaries andaffiliates) should always identify the...
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Social Media Guidelines and Safeguards for the Phamaceutical Industry: What You Need to Know (For Now)

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This is a POV I wrote in June 2010 advising pharmaceutical companies on what they should do in the social media space until the FDA issues its official guidelines. It will soon be updated.

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Social Media Guidelines and Safeguards for the Phamaceutical Industry: What You Need to Know (For Now)

  1. 1. Social Media Guidelines and Safeguards for the Pharmaceutical Industry: What You Need to Know (For Now) Author: Stacy Lukasavitz Social Media Strategist June, 2010
  2. 2. Social Media Guidelines and Safeguards for thePharmaceutical Industry: What You Need to Know (For Now) Various business sectors have embraced the new communication channels of social media as a valuable means for marketing and disseminating information. The FDA-regulated pharmaceutical industry has been slow to adapt to these ever-changing technologies and has yet to fully embrace and adopt official policies or guidelines. Since 1996, the FDA has expressed interest in developing an official position on internet marketing and promotion but has continued to delay the process. In November 2009, the FDA held a public hearing and solicited written comments through a public docket that was open from September 2009 to February 2010 with the intention of issuing a guidance document in 2010 on social media and the promotion of prescription products. Trends in internet usage suggest this issue cannot be ignored in the meantime. It is reported that in 2008, more than 60 million consumers used social media to communicate and research health and medical information1. There is a lot of information and misinformation about pharmaceutical products online, and the industry has more questions than answers right now on how to address issues concerning them. This paper serves to address some of these concerns and advise on appropriate actions to take online until the FDA issues its official position and guidelines. Accountability Marketers are responsible for any communications they create, collaborate on, or cause to be created. This includes online communications paid for by, or performed on behalf of, the manufacturer. For example, a video on YouTube created by a media agency for Drug X should be treated as directly attributable to the manufacturer, despite involvement of the media company. Facebook Privacy: Marketers should not be responsible for content online that is not under their control or Implications for Marketers influence, such as discussions on third-party, unrelated forums. However, if a manufacturer owns a social media site, such as a discussion forum for diabetics that is owned by a manufacturer of diabetes management supplies, it is their responsibility to monitor and correct misinformation and adverse effects on their domain. Transparency and Regulatory Requirements June, 2010 In addition to all sites hosted or financially affiliated with the manufacturer, there should be a statement of sponsorship and/or disclosure on all social media properties associated with the manufacturer. It should be the company’s responsibility to ensure that such disclosures are in place and accurate, and if a social media site’s content is commonly viewed through other applications or platforms, such as TweetDeck, Tweetie, or Hootsuite, the disclosure must also be visible on those platforms. To include fair balance, Important Safety Information should be included alongside any branded message. However, in the instance of space-constrained social tools, the “one-click” rule should be put into place – ensuring that Important Safety Information should be AT MOST one click away from any branded message. It should be noted that although the industry had developed the “one-click” rule as a way to PREPARED BY comply with the FDA’s requirement to provide comprehensive product information (including safety information) in promotional material, and it was accepted by the FDA as satisfactory, Stacy Lukasavitz the rule was suddenly placed into question when the FDA issued enforcement letters to 14 companies in 2009 for their failure to include risk information in Google banner advertisements2. The FDA has subsequently stated that it “never Social Mediaare referring had what some Strategist to as a ‘one-click’ rule.”3 stacy.lukasavit@mslworldwide.com Because of the FDA’s sudden switch on position in this matter, having “one-click” links to important product and safety information should be approached with caution. However, it is expected that the FDA will go back to accepting this as satisfactory when it issues its official guidelines later this year.
  3. 3. In addition, company representatives (or representatives of company subsidiaries andaffiliates) should always identify their relationship to the company whenever participating in anonline forum accessible to the public. This includes forums such as message boards,chat rooms, blog and news comments, etc. In the case of a threaded discussion or otherinstances where the entirety of a discussion is not visible on a single page, such identificationshould be in each instance they sign or make a claim.Corrective InformationCompanies are not responsible for information created by third parties and available ongenuinely independent third-party sites (that is, sites that the manufacturer has not created,cannot control, and does not fund).Wikipedia provides the clearest illustration. For many pharmaceutical products, the Wikipediaentry is likely to be among the sources of information most accessed by consumers. Mostcontent on Wikipedia can be changed at any time, by anyone. A company may reasonablychoose to monitor relevant Wikipedia entries, but cannot be fairly held accountable for thecontent. However, if content is inaccurate, a manufacturer may post corrective information onthe third-party site, but in doing so must be transparent, non-misleading, and compliant withexisting requirements (such as for risk communications).Adverse Event ReportingPrior FDA guidance on adverse event reporting states that manufacturers should review anyinternet sites they sponsor for adverse experience information, and they are responsible forreviewing third-party sites only when they become aware of a potentially reportable issue onthe site4. But until FDA takes a position on adverse events reported through social media, thisguidance does not necessarily apply to social media.That said, the FDA might require manufacturers to actively monitor all social media sites foradverse events. However, due to the breadth and growth of the internet, it is simply notpossible to do so. It will more likely require companies to actively monitor only websites theycontrol or influence. Facebook Privacy:It is still unresolved as to whether incomplete adverse event reports (e.g. anonymous postings) Implications for Marketersshould be pursued, and whether certain social media is even appropriate context for theindustry to investigate potential adverse events.Until the FDA has issued its decision on what, where, when, or how to investigate and reportadverse event reports, nothing is mandatory. But monitoring of company-controlled orinfluenced sites early is highly encouraged. June, 20101. Manhattan Research, Cybercitizen Health v8.0, The State of eHealth: Trends of Today’s eHealth Consumer, at 203 (2008), available at http://www.ahdionline.org/ca/ahdi-wa/news/articles/The_State_of_eHealth.pdf.2. See http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Enforce mentActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompani es/UCM143487.pdf. PREPARED BY3. FDA Response to Ignite Health FDA Social Media, Questions for the FDA Regarding ‘Next Steps’ for Guidance Related to the Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools, Dec. 11, 2009, Stacy Lukasavitz http://www.fdasm.com/docs/FINAL%20DDMAC%20Responses%20to%20FDASM_Questions.pdf Social Media Strategist4. FDA, Post-Approval Safety Data Management:stacy.lukasavit@mslworldwide.com Definitions and Standards for Expediting Reporting, ICH Harmonized Tripartite Guideline Draft (July 18, 2003), available at http://www.fda.gov/RegulatoryInformation/Guidances/ucm129457.htm

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