On January 13, 2014, the Food and Drug Administration (“FDA” or “the Agency”) announced the availability of a much-anticipated draft guidance on its intended regulation of product promotion conducted via social media, titled Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.The draft guidance explains when a prescription drug manufacturer, packer or distributor (“firm”) is responsible for submitting interactive promotional media, and provides recommendations for how to satisfy postmarketing submission requirements for real-time information appearing in such media. The most significant aspect of the draft guidance is FDA’s new position that it does not intend to regulate as promotional content any independent user-generated content (“UGC”) on social media sites owned or controlled by firms.

Background

The Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations require that all advertisements and promotional labeling for a prescription drug product be submitted to the Agency at the time of their initial publication or dissemination. This postmarketing submission requirement has been well understood to apply to traditional promotional materials, such as sales aids, print advertisements and even product websites; however, submission “at the time of initial dissemination” for interactive promotional media — which includes technologies such as blogs, microblogs, social networking sites, online communities and live podcasts — poses a unique challenge, particularly when communications and information are displayed in real time. Until the release of this draft guidance, FDA had been silent about participation in and postmarketing submission requirements for interactive promotional media, leaving many pharmaceutical companies wondering where to draw the line.

Guidance Overview

Social Media Communications and Content

The draft guidance identifies three situations in which firms are responsible for social media content:

  1. Firm-Operated Sites: A firm is responsible for promotional communications on sites that are owned, controlled, created, influenced or operated by, or on behalf of, that firm. Such communications may include firm-sponsored microblogs (e.g., Twitter), social networking sites (e.g., Facebook), blogs and other sites that are under the control or influence of the firm, including any communications for which a firm’s influence may be limited in scope (e.g., content on which a firm collaborates or has editorial, preview or review privileges).
  2. Third-Party Sites: A firm is responsible for promotion on a third-party site if the firm has any control or influence over that site, even if that influence is limited in scope. If a firm merely provides promotional material to a third-party site but does not direct the placement of the material within the site and has no other control or influence on that site, the firm will be responsible only for the limited content it places there, and not for the site in its entirety.
  3. Representative-Generated Content: A firm is responsible for content generated by an employee or agent who is acting on behalf of the firm to promote the firm’s product. For example, communications on third-party sites by a sales representative, medial science liaison or promotional speaker acting on the firm’s behalf about the firm’s product would trigger postmarketing submission requirements. In such cases, FDA recommends that the firm’s involvement be disclosed (e.g., inclusion of the firm name or logo) as part of the communication.

While the above criteria may prove useful in determining a firm’s responsibility for communications and content on social media sites, the true significance of the draft guidance is the announcement of FDA’s new position that it “will not ordinarily view UGC on firm-owned or firm-controlled venues … 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 is an unexpected new direction in FDA’s regulation of prescription drug promotion and advertising, and opens the door for firms to actively participate in interactive social media that allow consumers to engage in public discussions about their products — even on firm- sponsored, product-specific sites — without limitations as to the content or scope of the information.

Postmarketing Submissions

Under the draft guidance, if a firm is responsible for social media content, a postmarketing report must be submitted to the Agency (e.g., Form FDA-2253 submission). Interactive promotional media often result in a high volume of content and information in a short period of time, making it impractical, if not impossible, to submit materials at the time of initial dissemination. Accordingly, the draft guidance sets forth the process by which FDA expects firms to prepare and update these submissions. The Agency intends to exercise enforcement discretion for firms that submit interactive promotional media in the manner described in the draft guidance.

Unanswered Questions

The draft guidance is a meaningful step forward in FDA’s regulation of prescription product promotion on interactive social media, but it does not resolve all issues. Significantly, FDA has yet to address how firms should meet fair balance requirements in the context of social media sites that restrict space or impose character limits (e.g., Twitter or paid search advertisements). This omission from the draft guidance is particularly surprising given that the disclosure of risks associated with product use is a fundamental principle of compliant product promotion.

Comments on the draft guidance should be submitted to FDA by April 14, 2014.