FDA, Social Media, and Creeping (but positive) Incrementalism

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  • 01/13/2014

In case you missed it – here's the FDA's latest addition to the social media draft guidance compendium. Nothing earth shattering, but more guidance is better than less.

Some useful tidbits …

* A firm is responsible for product promotional communications on sites that are owned, controlled, created, influenced, or operated by, or on behalf of, the firm.

* A firm is responsible for promotion on a third-party site if the firm has any control or influence on the third-party site, even if that influence is limited in scope. For example, if a firm collaborates, or has editorial, preview, or review privilege, then it is responsible for its promotion on the site and, as such, that site is subject to submission to FDA to meet postmarketing submission requirements. However, if a firm provides only financial support (e.g., through an unrestricted educational grant) and has no other control or influence on that site, then the firm is not responsible for information on a third-party site, and has no obligation to submit the content to FDA. Furthermore, if a firm is merely providing promotional materials to a third-party site but does not direct the placement of the promotion within the site and has no other control or influence on that site, the firm is responsible only for the content it places there and, thus, is responsible only for submitting to FDA promotional content that was disseminated on that site.

* FDA recommends that a firm be transparent in disclosing its involvement on a site by clearly identifying the UGC (User-Generated Content) and communications of its employees or third parties acting on behalf of the firm.

* ... a firm generally is not responsible for UGC that is truly independent of the firm (i.e., is not produced by, or on behalf of, or prompted by the firm in any particular). FDA will not ordinarily view UGC on firm-owned or firm-controlled venues such as blogs, messgae boards, and chat rooms as promotional content on behalf of the firm as long as the user has no affiliation with the firm and the firm had no influence on the UGC.

This last item is both new and clear in it's meaning. And it's important as social media is and should be driven by independent UGC.

Will any of this “free” Pharma to pursue more aggressive social media strategies. Probably not. And that’s too bad.

Compliant social media is in the eyes of the engager -- and it's about the content not the platform.



Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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