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 The agency’s draft guidance, titled “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and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 The draft guidance states broadly that this term encompasses “modern tools and technologies that often allow for real-time communications and interactions (e.g., blogs,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.

Written by:

Published In:

FDA

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

Don't miss a thing! Build a custom news brief:

Read fresh new writing on compliance, cybersecurity, Dodd-Frank, whistleblowers, social media, hiring & firing, patent reform, the NLRB, Obamacare, the SEC…

…or whatever matters the most to you. Follow authors, firms, and topics on JD Supra.

Create your news brief now - it's free and easy »

All the intelligence you need, in one easy email:

Great! Your first step to building an email digest of JD Supra authors and topics. Log in with LinkedIn so we can start sending your digest...

Sign up for your custom alerts now, using LinkedIn ›

* 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.
×
Loading...
×