FDA gives the green light to UGC

Today's blog post comes from Matthew Arnold, Principal Analyst of Manhattan Research.The FDA’s long-awaited (four years-plus in the making?) first draft guidance on pharma use of social media is striking in its brevity, weighing in at just seven pages, and leaves a number of important topics yet to be addressed – but it answers the most important question for the industry in the social space.It says: Okay, we recognize the impossibility of submitting promotional materials with real-time components “at the time of initial dissemination,” per the requirements of the 75-year-old FD&C Act. Yes, you can engage consumers interactively through social media. You can turn comments on. The agency won’t regard user-generated content on your site to be promotion (provided that they’re not company-sponsored sock puppets, of course), and you don’t have to submit a Form 2253 or 2301 to OPDP every time you respond to a commenter (rather, monthly submissions will do).The draft guidance also draws clearer lines around what content companies “own,” in FDA’s eyes (companies are not responsible for third-party content on sites they support only financially, but if they have any influence on that content – editorial review privileges, for example – it’s regarded as promotion). But it says content created by “third parties acting on behalf of the firm,” including not just agency execs but bloggers and physician speakers paid by pharmas, must be submitted, and that...
Source: ePharma Summit - Category: Medical Marketing and PR Tags: Digital Pharma Rules Draft FDA Guidance ePharma ePharma Summit Social Media Guidance Source Type: blogs