Social media guidance coming soon

Eye on FDA reports that the Food and Drug Administration will issue its draft guidance on Internet and social media promotion of agency-regulated medical products sometime during the first three months of next year.

Laptop AstraZeneca looks forward to the FDA bringing greater clarity on the industry's participation in online channels to provide accurate and regulated information about our medicines in conversations with patients, caregivers, and health care providers.

Earlier this year, we announced the five principles that should be at the core of any company 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.

On top of these principles, AstraZeneca proposed a regulatory framework that defines, distinguishes, and distinctly regulates three types of communications on the Internet and in social media: Company-controlled, hosted online communications; company-controlled communications; and real-time, social media participation communications.

Click here to view AstraZeneca's full submission to the FDA.

– By Tony Jewell