Threat Intelligence Blog

On January 13, the Food and Drug Administration (“FDA” or “the Agency”) released draft guidance on its intended regulation of product promotion via social media, Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics (“draft Guidance”). The Guidance document is a step forward in the FDA’s regulation of prescription drug promotion on interactive media.

The Federal Food, Drug, and Cosmetic Act (“FDC Act”) and FDA regulations require that all advertisements and promotional labeling for prescription drugs be submitted to the Agency at the time of their initial publication or distribution. 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, the FDA had been silent about participation in and postmarketing submission requirements for interactive promotional media. This silence has kept pharmaceutical firms from promoting products via social media because the real-time nature of it has posed a challenge for companies wondering where to draw the line.

The draft Guidance states that it addresses the FDA’s current thinking on how “the applicant or [someone] acting on behalf of the applicant, of prescription human and animal drug and biological products (drugs) can fulfill regulatory requirements for postmarketing submissions of interactive promotional media for their FDA-approved products.” It defines “interactive promotional media” as including “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).”

The draft guidance identifies three situations in which firms are responsible for social media content:

  1. Firm Influenced Sites Pharmaceutical companies are responsible for promotional communications on sites that are owned, controlled, created, influenced or operated by the firms themselves, or on their behalf. Such promotional 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, no matter how limited in scope (e.g., content on which a firm collaborates or has editorial, preview or review privileges).
  2. Promotion on Third-Party Sites Pharmaceutical firms are responsible for promotion on third-party sites if they have any control or influence over those sites, even if that influence is limited in scope. Financial support alone does not indicate control the firm; it must have influence on the third-party site. 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. Agent-Generated Content – Pharmaceutical companies are responsible for content generated by employees or agents who are acting on behalf of the firm to promote the firm’s product. The FDA’s regulation of prescription drug promotion extends both to promotional activities that are carried out by the firm itself, and to promotion conducted on the firm’s behalf. The FDA recommends that a firm be transparent in disclosing its involvement (e.g., inclusion of the firm name or logo) as part of the communication.

The dynamic nature of interactive promotional media often results in a high volume of content and information in a short period of time, making it impractical to submit materials at the time of initial dissemination as required by the FDC Act. Appropriately, the draft Guidance does not require a firm to send the FDA copies of tweets, Facebook posts, or blog posts every time it issues one. A proactive submission of the “static product website and description of the parts that are interactive and allow for real-time communications” is sufficient. The Agency will exercise enforcement discretion for firms that submit interactive promotional media in this manner.

Pharmaceutical manufacturers and other interested entities should consider submitting comments to this draft guidance. Additional FDA guidance related to social media activities is anticipated as the July 2014 deadline set by the FDA Safety and Innovation Act approaches. Hopefully future guidance will address questions such as how to provide fair balance information within the confines of a 140-character tweet.

A copy of the draft Guidance can be found here. Comments on the draft guidance should be submitted to FDA by April 14, 2014.

As we discussed in our blog post on the new FFIEC social media guidelines for the banking industry, new guidelines like these are designed to help companies navigate the legal and compliance risks that come with using social media, but how regulatory agencies may enforce them, or the timeline between draft and final versions, remains to be seen.

Cyveillance offers a variety of ways to help pharmaceutical companies address the challenges of social media, including distribution control, cybersecurity training, anti-phishing and response services, and brand protection services, including social media compliance.

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