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PP09-62: Otsuka’s Journey Leveraging the Power of Digital/Social Media Platforms to Compliantly Meet Innovative Business Objectives

Poster Presenter

      Stephanie H. Jameison

      • Senior Director, Promotion Compliance
      • Otsuka Pharmaceutical Development & Commercialization, Inc.
        United States


Demonstrate how Otsuka defied limitations through vigorous research, implementation, and e-submissions of social media materials with and without user generated content (UGC) to the FDA in order to effectively and compliantly communicate important information to patients and HCPs


After an FDA Public Hearing in 2009, Otsuka began to put policies and procedures in place for compliant use of social media while awaiting formal FDA guidance. A cross-functional committee was established to review proposals, and a stepwise approach put in place to implement social media projects


After establishing policies and a formalized Digital/Social Media Committee (DSMC), Otsuka began evaluating proposals leveraging an experimental approach. The cross-functional DSMC reviewed proposals to address various considerations and challenges including, regulations, privacy, information security, liability, safety reporting, return on investment, risk/benefit, competitive intelligence, and corporate image. In addition, the DSMC, which is focused on platform considerations, is a separate and distinct workstream from the content review team (e.g. Promotional Review Committee (PRC)/ Medical, Legal, and Regulatory (MLR) Review Committee). Initial proposals either had no UGC, were unbranded or presented on a closed network. This allowed for careful monitoring and learning. In parallel, the company was formulating monitoring methodologies such that we could capture safety reporting requirements and other comments of interest in preparation for engagement on open forums with 2-way interactions. The learnings from these initial experimental proposals provided confidence that Otsuka could successfully defy limitations and consider the use of digital/social media platforms for branded promotion. The DSMC, in collaboration with the PRC, implemented processes for handling UGC, including misinformation, on digital/social media platforms used for branded promotion. The PRC took a methodical approach to content development and OPDP submission for branded promotion on digital and social media platforms with a focus on compliance with regulations, FDA Guidance and company policies and procedures. First, PRC carefully vetted social media platform capabilities (layout, share features, 2-way interactions) to ensure compliant presentation of information relative to Otsuka products across all platform mediums. Additionally, the Otsuka Regulatory team ensured submission of materials to FDA.


Companies in virtually every industry have embraced digital/social media to engage with their customers, and healthcare is no exception. HCPs and patients alike have adopted social media as a way of consuming and sharing information. Given the sensitive nature of the highly regulated pharmaceutical industry, implementation at Otsuka had to be well thought out in order to ensure compliance. Formal processes for use of these platforms and forming a DSMC were necessary prior to developing a digital/social media presence. The Otsuka Regulatory team ensured submission of materials for branded promotion on digital/social media platforms to OPDP on FDA Form 2253 via the electronic gateway in compliance with FDA regulations and guidance. This included the additional content and frequency requirements applicable to digital/social media platforms permitting UGC. Otsuka worked closely with the FDA eSubmission team to resolve issues to ensure successful submissions. Since implementing policies and procedures, the DSMC has approved proposals in the areas of Corporate Communications, Clinical Management, Human Resources, Medical Affairs, and ultimately to provide product information developed by the Commercial/Marketing teams. Overall, the patient was at the center of the decision-making process which helped inform decisions on the types of platforms to be used for engagement, and the relative risk benefit of disseminating such communications. Currently, Otsuka fully engages on a variety of digital/social media platforms where patients and HCPs interact in two-way communications in public forums regarding their conditions and potential treatment options including Twitter, Facebook, Instagram, and LinkedIn. In summary, Otsuka has laid the foundation for full engagement in branded promotion leveraging social media communications and continues to defy limitations to effectively and compliantly provide important information about Otsuka products to patients and HCPs.