Draft guidance from the U.S. Food and Drug Administration (FDA) titled, “Draft Guidance for Industry on Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics; Availability” was published today in the Federal Register.  The FDA defines “interactive promotional media” in the draft guidance as “tools and technologies that often allow for real-time communications and interactions (e.g., blogs, microblogs, social networking sites, online communities, live podcasts, etc.), which [manufacturers, packers, and distributors] use to promote their drugs.”  According to the FDA, “this draft guidance responds to stakeholder requests for specific guidance on FDA’s current views on how manufacturers, packers, and distributors (firms), that may either be the applicant or 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.”  Comments to the draft guidance must be submitted to the FDA by April 14, 2014. 

Specifically, the FDA stated that its regulatory authority extends to promotional activities that are carried out by a firm itself and to promotion conducted on the firm’s behalf. This includes activities where the firm, or anyone acting on the firm’s behalf, influences or controls the promotional activity or communication, in whole or part, either on a firm-sponsored or third-party site.  In determining whether the firm has influence or control that would trigger postmarketing submission requirements for the interactive promotional media, the FDA considers the following:

  1. 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.
  2. Under certain circumstances, a firm is responsible for promotion on third-party sites if the firm has any control or influence on the third-party site, even if that influence is limited in scope.  This includes, by way of example, collaboration or editorial, preview, or review privileges.  It does not include websites where the firm provides financial support only with no additional control or influence over the promotional site. 
  3. 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.  This includes, by way of example, activities by medical science liaisons and paid health care professional speakers. 

With regard to the process for submitting interactive promotional media to the FDA, the FDA provided the following guidance: (i) at the time of initial display, a firm should submit in its entirety all sites for which it is responsible on Form FDA 2253 or Form FDA 2301; (ii) for third-party sites on which a firm’s participation is limited to interactive or real-time communications, a firm should submit the home page of the third-party site, along with the interactive page within the third-party site and the firm’s first communication on Form FDA 2253 or Form FDA 2301 at the time of initial display; (iii) once every month, a firm should submit an updated listing of all non-restricted sites for which it is responsible or in which it remains an active participant and that include interactive or real-time communications; (iv) if a site has restricted access and, as such, FDA may not have access to the site, a firm should submit monthly all content, including screenshots or other visual representations, related to the discussion to adequately provide context to facilitate the FDA’s review on Form FDA 2253 or Form FDA 2301; and (v) when submitting the site, FDA recommends that a firm take formatting factors (e.g., appearance, layout, visual impression) into consideration to enable the FDA to view the communications as a whole. 

The FDA intends to exercise enforcement discretion regarding the regulatory requirements for postmarketing submissions for promotional labeling and advertising for firms that submit interactive promotional media in accordance with the draft guidance.  However, the FDA’s expectations are unchanged regarding the submission of static promotional materials that are substantially similar to traditional promotional materials, such as websites that do not allow real-time communications.

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.

Posted by Cooley

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