Digital Insights: FDA Social Media Guidance… FDA? AstraZeneca? Bueller? Anyone?

FDA, where is the guidance? If you don’t issue some, Big Pharma will.

By Michele Vaccarello Wagner, Senior Digital Editor

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It’s been 16 months since FDA held hearings with industry and other interested parties on the topic of social media. (See “Social Media Marketing Goes to Washington,” Nov/Dec 2009.) With still no official guidance issued, it doesn’t seem that FDA is in much of a hurry. Where’s the urgency, Agency?

With more than x number of companies on Twitter, x number of Facebook brand pages and more and more companies developing brand channels on YouTube, it seems a perfect storm for compliance disaster. The industry needs guidance now more than ever.

Several Big Pharma companies such as Roche and AstraZenenca have taken matters into their own hands. In September of last year, Roche instituted company guidelines not only for professionals performing work under Roche brands but also for employees’ personal and professional social media pages.

Other companies such as AstraZeneca are following suit. After seeking advice and feedback from industry bloggers and pharma digital media leaders, AZ recently published a white paper report, “Social Media in the Pharmaceutical Industry,” that discusses the guiding principles of their activities in social media.

AstraZeneca claims that the document is not a “traditional white paper” but rather a report of feedback and insights on “how pharmaceutical manufacturers have engaged in social media and how they should engage, while also suggesting approaches for FDA regulation.”

Last year, AZ developed five principles for the industry’s engagement in social media and the report maintains that these principles must be the “floor” for ongoing discussion with FDA, not the “ceiling”.

Those five Principles of Pharmaceutical Industry Engagement in Social Media:

  1. Truth and Accuracy: Content must be created, developed, or made available that is truthful, balanced, accurate, and not misleading.
  2. Be Respectful:  Encourage product sponsor participation that respects the interests of patients, caregivers, and health care providers, particularly related to matters of privacy and the primacy of the patient/physician relationship.
  3. Protect and Advance Patient Health: Facilitate patient access to quality information for use with their physician to improve their health and protect patients through encouraging accurate and timely reporting on medicine safety.
  4. Transparency: Any product sponsor participation should be accomplished in a manner that, at all times, is entirely transparent to other participants as to the role of product sponsors as participants in online discussion.
  5. Respect the Views of Others: Acknowledge that patients, caregivers, clinicians and others who participate in social media have their own opinions and that, when they differ from those of the product sponsor, it is not the role of a product sponsor to censor or limit these views but to add the product sponsor’s own views to the discussion.

These are great starting points, and they allude to a key ingredient for Big Pharma’s social media engagement: outreach and communication. Companies, bloggers and digital media specialists in the drug industry should be learning from one another, and not competing, in the social media arena. Especially without clear-cut FDA guidance, it just makes sense to share the digital wealth.

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