FDA Draft Guidelines for Pharmaceutical Social Media

Samantha Reba

Junior Writer

Last week, the US Food and Drug Administration (FDA) released draft guidelines addressing responsibilities of pharmaceutical manufacturers and distributors related to real-time online communications and interactions. The proposal outlines various levels of responsibility related to content posted by or about a company. The guidelines cover but are not limited to corporate blogs, microblogs, online communities, podcasts, Facebook, and Twitter.

The guidelines limit pharmaceutical companies’ responsibility for content posted via social media where they have no control over or ownership of the platform or content. Firms would be held increasingly responsible in situations where they have powers of editorial review or otherwise influence posted content. The FDA draft calls for companies to send monthly reports of all covered online activity to the agency. If companies have any input into posted material, it would need to be reported to the FDA. 

The pharmaceutical industry has until April to submit comments and suggestions to the FDA concerning the guidelines. Until then, firms are being asked to file monthly reports while the debate over user-generated content continues. The new rules should allow more flexibility regarding interactions with patients via social media channels without requiring an audit of every comment submitted. Many questions remain to be answered but for now the discussion appears to be moving in the right direction.