The U.S. Department of Health and Human Services, Food and Drug Administration (FDA) recently issued draft guidance entitled “Guidance for Industry-Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media For Prescription Human and Animal Drugs and Biologics.”
The draft guidance is intended to describe the FDA’s current thinking about how manufacturers, packers, and distributors (firms) can fulfill regulatory requirements for post marketing submissions of interactive promotional media (e.g. blogs, microblogs such as Twitter, social networking sites like Facebook, online communities, and online podcasts) for FDA-approved products.
Under FDA regulations, if a firm has any control of, or influence on a site, it must submit promotional material about its product(s) to the FDA under the FDA’s postmarketing submission requirements.
Recognizing the challenges of submitting promotional materials that display real-time information, the FDA provided recommendations for submitting interactive promotional media. In its examples, the FDA explained:
- At the time of initial display, a firm should submit in its entirety all sites for which the firm is responsible, including submission in a way that allows the FDA to view and interact with the submission in the same way as the end user;
- For third-party sites on which the firm’s participation is limited to interactive or real-time communications, a firm should submit the third-party site’s home page, along with the interactive page within the third-party site and the firm’s first communication;
- Once a 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;
- If a site has restricted access, a firm should submit all content related to the discussion to adequately provide context to facilitate the review; and
- A submitting firm should take formatting factors into consideration to enable the FDA to view the communications as a whole.
When finalized, the guidance will not create or confer any rights, and will not operate to bind the FDA or the public. Rather, the guidance should be viewed as recommendations, unless specific regulatory or statutory requirements are cited.
Specific industry guidance concerning social media is not a novel idea. In fact, the financial industry issued its own guidance late last year. When examining your businesses social media participation, it is imperative you familiarize yourself with any applicable industry specific guidance.