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 first draft guidance on pharma use of social media is striking in its brevity, weighing in at just seven pages, and leaves a number of important topics yet to be addressed – but it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The draft guidance also draws clearer lines around what content companies “own,” in FDA’s eyes (companies are not responsible for third-party content on sites they support only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 companies should be transparent about these potential conflicts of interest.
Among the topics addressed in the agency’s hearings on pharma interactive promotion four years ago that were left unaddressed in this draft guidance: how to present fair balance info in space-constricted formats such as Twitter and paid search; and whether companies are responsible for correcting misinformation about their products online.
Bullet-pointed TLDR version:
- User-generated content on pharma properties will not be regarded as promotion, provided that the user “has no affiliation with the firm and the firm has no influence on the UGC (User-Generated Content).”
- For open-access pharma sites with real-time or interactive components (comments sections, live chat, etc.), companies may submit a monthly form and do not need to submit screenshots of every communication (for restricted sites, pharmas must submit all relevant UGC).
- Companies are responsible for promotional activity or communication on sites they control or influence. “Influence” may be limited to editorial/preview/review privilege over content or suggestions on placement of promotional messages.
- However, third-party sites that are merely supported financially by pharmas (for example, through an unrestricted educational grant) do not fall under FDA’s purview.
- Online communications by bloggers, MSLs and KOLs acting on a company’s behalf are considered promotion and must be submitted.
And here’s some smart takes from the Policy and Medicine blog, FiercePharma, MM&M, Dose of Digital and PMLive. Expect more draft guidances on these topics as a Congressionally-mandated summer deadline for FDA action approaches.
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