Digital Pharma Conf. Thurs. Morning 8

Live blogging the eXL Digital Pharma conference, from Princeton, NJ. This second day will focus on the Regulatory environment.

Craig Audet, VP, US Regulatory Affairs Marketed Products, Sanofi-Aventis: Laying the Groundwork for Engagement in Social Media

– Pharma needs to engage – more. 87% of people using Wikipedia to search for health info think it is reliable. Media professionals are looking for story leads.

– Those who have dared – some of the unbranded excursions into Social Media. J&J. Pfizer. Filtered/vetted  comments.

– We’ve been here before – early DTC. 14 years from first broadcast to formal DTC guidance.

– Adverse event and Off-label discussions on websites are 2 key problem areas. Details about what that means: 4 specific criteria for adverse events – Identifiable patient [what is the due diligence between identified, and identifiable?]; etc.

– Questions company must ask selves: Whether corporate culture is social-media friendly; how company interprets FDA regs; tolerance for uncertainty.

– How will you handle negative commentary?

– Ready to be the market leader?

– How will you resource (note: lots of ongoing monitoring work – can’t just launch-and-leave -SW)

– Maybe start with advertising on soc med websites as a toe in the water.

:: You WILL engage in social media at some point. Wade in and test the waters to start.