OPDP Issues First Letter for Facebook Page Activity

March 12, 2014 Analyst: Dale Cooke

Regulatory Alert

EXECUTIVE SUMMARY
On February 24, 2014, the Food and Drug Administration (FDA) issued an untitled letter to Institut Biochimique SA (IBSA) for a branded Facebook page for Tirosint (levothyroxine sodium) capsules for oral use.1 This action is notable because it is the first enforcement action taken by the FDA for any social media activity since FDA issued its first social media guidance on January 13, 2014.2 This also is the first time FDAs Office of Prescription Drug Promotion (OPDP) has issued an enforcement action for promotional activities occurring on Facebook.com, though OPDP has previously taken action for Facebook sharing activities implemented on product sites.3 The enforcement action was taken because the branded Tirosint Facebook page (see image 1) included the product name and an abbreviated statement of the product indication, but did not include any risk information. In light of this action, Digitas Health recommends companies take the following actions: 1. Review existing social media policies to ensure they appropriately specify who may create product promotions using social media and how to properly use channels 2. Review procedures for the review and approval of promotional material to ensure all material is vetted through a companys promotional review processes, with a particular emphasis on how digital tactics are reviewed4 3. When creating a branded social media account, begin with complete, compliant brand information.

BACKGROUND
The specific activity that resulted in OPDP issuing this letter is at one and the same time remarkably straight forward and inexplicable. The Facebook page for Tirosint (see image 1) included the product name and an abbreviated statement of the product indication, but did not include any risk information.This is a clear violation of the requirement of 21 CFR 202.1(e)(5) to reveal facts that are material in light of the representations or with respect to consequences (risks) that may result from the use of the drug as recommended or suggested by the materials.5

Image 1: Taken from the materials posted by OPDP on their website

In fact, it is precisely the clear cut nature of the violation that makes this violation somewhat inexplicable. It seems highly improbable that anyone familiar with FDA regulations could have considered this piece compliant. Moreover, the image posted by the FDA includes timeline information dating back to 2010 (see Image 2). Facebook pages generally include timeline dates going back only to the original date a page joined Facebook, unless a user intentionally posts material with a date prior to the launch of the Facebook page.6

Image 2: With highlighting of timeline in red box added

Typically, the FDA indicates in its enforcement actions whether the violative material being cited was submitted under cover of Form 22537 or that the information was not submitted under cover of Form 2253, in which case failure to submit is an additional violation.8 The letter to IBSA does neither. Given the paucity of information on the Facebook page (there were zero posts to the timeline that were still active when the FDA took the screenshot of the page), the presence of the timeline years dating back to

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2010, and the lack of any mention of a filing with the FDA, it seems plausible that this Facebook page was initially created in 2010. Perhaps this was done accidentally by a page administrator who wanted to reserve the page URL for future marketing purposes.

IMPLICATIONS
This enforcement action from the FDA does not itself provide additional insight into OPDPs view of how to appropriately use social media because the violations cited were so straightforward. It does, however, highlight the need for companies who are engaging in social media to ensure that the appropriate safe guards are in place to do so appropriately. It is not known whether this page was launched intentionally by a wellmeaning employee who merely wanted to hold the URL while determining a future use or whether this page was published accidentally by someone who did not realize that the page itself was live and accessible to the nearly 500 people who liked the page. Regardless of those circumstances, this action emphasizes that FDA is monitoring social media activity, and companies that wish to use these emerging channels need to put into place the appropriate processes and policies to do so safely. In light of this action, Digitas Health recommends companies take the following actions: 1. Review existing social media policies to ensure they appropriately specify who may create product promotions using social media and how to properly use channels 2. Review procedures for the review and approval of promotional material to ensure all material is vetted through a companys promotional review processes, with a particular emphasis on how digital tactics are reviewed 3. When creating a branded social media account, begin with complete, compliant brand information.

ENDNOTES
1

4 5 6

Last accessed on March 12, 2014, from http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLetters andNoticeofViolationLetterstoPharmaceuticalCompanies/ucm380323.htm Herein after Tirosint, MA#42. For more on the FDAs first social media guidance, see Digitas Health Regulatory Alert: 2253 Filing Requirements for Social Media, published January 13, 2014. Last accessed March 12, 2014, from http://www.scribd.com/doc/199434412/DH-Regulatory-Alert-2253-Filing-Requirements-for-Social-Media For more on the FDA first action targeting Facebook sharing, see Digitas Health Regulatory Alert: FDAs First Facebook Enforcement Action, published August 4, 2010. Last accessed March 12, 2014 from http://www.scribd.com/doc/35466006/Digitas-Health-Facebook-Regulatory-Alert-20100805 For more on FDA enforcement action targeting Facebook issued by offices other than OPDP, see Digitas Health Regulatory Alert: Facebook Commenting Enforcement Action, published February 28, 2013. Last accessed March 12, 2014 from http://www.scribd.com/doc/157009316/DH-Regulatory-Alert-Facebook-Commenting For more on appropriate processes for reviewing digital promotional tactics, see Cooke, Dale, Effective Review and Approval of Digital Promotional Tactics, Food and Drug Law Institute, 2013, page 11ff. Tirosint, MA#42, page 2. For example, many companies post information about their history, including major milestones from their launch through the present. If the company does so, then its timeline will stretch back to include those dates, even if they precede the Facebook pages launch by decades or centuries. For example, see the January 2014 letter sent to Mission Pharmacal, MA#45, last accessed March 12, 2014, from http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/War ningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM383197.pdf For example, see the December 2013 letter sent to Pernix Therapeutics, MA#241, #211, last accessed March 12, 2014 from http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/War ningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM379858.pdf

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