The Clouds of Social Media Guidance: Are They Parting or Is a Storm Brewing?

The Clouds of Social Media Guidance Are They Parting or Is a Storm Brewing?Pharmaguy interviews Tracy A. England, Vice President of Social Media Marketing for OpenQ. We discuss comments submitted by the Social Media Compliance Council (SMCC) to the FDA seeking clarification of when a pharmaceutical company is “responsible” for postmarketing reporting when promoting drugs on third-party sites.

Aired LIVE on: Monday, April 14, 2014

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Background

Social media risk occurs across an organization, not just within marketing. In addition, the concepts of “external” social media (e.g.; Facebook, Twitter, LinkedIn) are converging with “internal” social media (e.g.; IBM Connections®, Salesforce Chatter®, etc.). As email and websites created risk within BioPharma/Device, so does social media – with the ability to go viral.

A social media misstep can cost an organization 10% – 20% of its value (see here), can cost individuals their jobs, and create significant public embarrassment that can take months and years to recover. Social media risk exists and has held the BioPharma/Device industry hostage. Recently, the industry has begun adopting social media and the FDA developed a new guidance with plans to product three more in 2014. The clouds are starting to part, but is a storm brewing?

In 2012, the Social Media Compliance Council (SMCC) was founded to advance social media within Life Sciences and added other industries in 2013. The SMCC incorporates social media stakeholders from across BioPharma/Device companies including clinical development, regulatory, safety, commercialization, compliance, legal and others, taking a holistic, enterprise approach to social media in comparison to other organizations focused on marketing.

Focused on compliant use of social media, the SMCC develops materials, training and best practices and provides input and responses to regulatory bodies.

Questions/Topics of Discussion

• What is the SMCC, how did it get started, who are the members?
• SMCC’s response to the FDA. The main question to the agency was in regard to the scope of the guidance, is it intended to be solely focused on Postmarketing Submissions, or is “responsible” intended to be more broadly used? Based on the guidance documents on tap for the Agency’s development in 2014 (remove/correct posts, microblogs) SMCC members were under the impression the Agency was focused on the Postmarketing Submissions, however, the guidance was unclear about the term responsible.
• There is a lack of guidance for clinical development. This will continue to create risk and reduce broader adoption of social media. The SMCC is asking the Agency in their response what can be done about this. How can patients benefit from social media in clinical development? Could the industry start to overcome the challenges associated with patient recruitment?
• What are other social media risks the industry has to be concerned about, other than regulatory (costs, reputation, loss of data) and what could the potential costs of the risks entail for organizations?
• What about internal social communication platforms (IBM Connections, Salesforce.com Chatter, Microsoft Yammer, Jive)? Are they social media (yes, and based on the trouble the industry got into with email, and the “casual” nature of social tools, could these be minefields for discovery?)
• The FDA just finished an RFP for social media monitoring software. So what are they going to find and what are they going to do with it? The SMCC discussed the potential to be overwhelmed and surprised with what they find.

Guest Bio

Tracy A. England has worked in marketing and life sciences for more than 20 years in both commercialization and clinical development. As Vice President of Social Media Marketing for OpenQ, she has been involved in corporate marketing, business development and in the launch of the company’s social media risk management product.

Ms. England worked for AstraZeneca’s promotional programs team managing systems and compliance for speaker programs, for an Omnicom agency focused on Patient Reported Outcomes, and for the clinical research divisions of Express Scripts-Medco, Covance and Omnicare. She received her Master of Business Administration in Pharmaceutical Marketing from Saint Joseph’s University and a Bachelor of Arts from Indiana University of Pennsylvania. She is currently completing a post-graduate certificate program in Pharmaceutical & Medical Device Law and Compliance from Seton Hall School of Law.

Ms. England currently serves as the Executive Administrator for the Social Media Compliance Council, a cross-industry group involved in the collaborative advancement of compliant social media within regulated industries, and as the Co-Chairperson of the Drug Information Association working group on social media.