Draft FDA Guidance on Real-Time Promotional Statements Made Via Social Media

In January 2014, the US Food and Drug Administration (FDA) gave the pharmaceutical industry another glimpse of its thinking on social media marketing. The agency’s draft guidance, titled “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics,” sheds some light on circumstances where a manufacturer of a prescription drug or biologic should submit to the FDA content generated through “interactive promotional media.” Despite this small peek behind the curtain, numerous questions and issues remain unaddressed for companies regulated by the FDA. This advisory provides a brief overview of the current landscape.

What the FDA Considers to Be “Interactive Promotional Media”

In what is likely an effort to stay relevant in the exceptionally dynamic field of social media, the FDA does not employ the term “social media,” but instead describes tools such as Twitter and Facebook as “interactive promotional media.” The draft guidance states broadly that this term encompasses “modern tools and technologies that often allow for real-time communications and interactions (e.g., blogs, microblogs, social networking sites, online communities and live podcasts) that firms use to promote their drugs.” While Facebook, Instagram, Twitter and Wikipedia certainly fall within this definition, the definition is broad enough to provide room for future innovation in online marketing platforms.

Please see full advisory below for more information.

LOADING PDF: If there are any problems, click here to download the file.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Katten Muchin Rosenman LLP | Attorney Advertising

Written by:


Katten Muchin Rosenman LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.