By Ann Neuer 

 

January 31,2014 | The long awaited draft guidance on social media, released by the Food and Drug Administration (FDA) on January 13, 2014, is a much needed tool for companies looking to properly submit interactive promotional materials to the agency. Entitled Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics, the draft guidance spells out for the first time the agency’s thinking on when companies should make these submissions to FDA in this era of Facebook, Twitter, YouTube, and media blogs.

 

Specifically, the draft guidance notes that while some interactive media are substantially similar in content to traditional advertising approaches for marketed products, such as television and print, FDA acknowledges that today’s web-based promotions are essentially different as they allow consumers to interact in real time.  The key sticking points for companies are—do all consumer comments need to be submitted routinely, and what if promotional content appears on a website over which the company has little or no control?  These are pivotal questions as advertising and promotional materials are tightly regulated by FDA, must contain specific fact-based elements, and must be reported either on Form 2253 for human drugs or on Form 2301 for animal drugs.  

 

Glenn Byrd, Senior Director of Promotional Regulatory Affairs for MedImmune/AstraZeneca and former Chief for the Advertising and Promotional Labeling Branch in the Center for Biologics Evaluation and Research, explains, “This draft guidance is a positive first step as it provides clarity to our industry, and recognizes that interactive media is different than static media.  Importantly, it gives us some ways of working that are very progressive, particularly as it relates to industry communications on unrestricted sites.”

 

Byrd is referring to the fact that for the purposes of post-marketing reporting, the draft guidance distinguishes between websites that are publicly accessible versus those requiring credentials, such as an ID, password, or subscription.  The draft guidance explains that when information is first posted online by a sponsor, that company is to submit in its entirety all sites for which it is responsible on Form FDA 2253 or Form FDA 2301. This information should include descriptions of the parts of the websites that are interactive and allow for real-time communications.  After the initial submission or resubmission, however, if the site is publically accessible and remains unchanged other than real-time information, additional screenshots of the interactive or real-time communication are not required except for monthly updates.  

 

According to Byrd, “The information in the draft guidance, starting on line 239, frees us to only submit information monthly for unrestricted sites.  And for those unrestricted sites, such as Facebook, where the public can post comments every day, we only have to send information the first time we start activity, and then monthly, as long as the site is active.  We no longer have to rely on the past practice of submitting content to FDA at the time of dissemination.  This new recommendation is much less burdensome.” 

 

To provide additional insight into the agency’s thinking, the draft guidance offers five scenarios describing whether companies must submit certain types of content to fulfill post-marketing submission requirements.  In these scenarios, the draft guidance differentiates among websites that are operated by the company; not operated by the company, but the company has some degree of control or influence over that website; or the company has no control over a third party website.  For example, if a company provides an online forum on its own product website for users to post comments about the product, the company is responsible for submitting that website to FDA.  Similarly, if a company makes suggestions on the placement of its promotional messages on an independent third-party site, the company is to submit that information to FDA, along with the surrounding pages, to provide context and facilitate review of the third-party site.

 

Currently, this draft guidance is in a 90 day comments period, after which the agency will review the received comments.  It is unknown if or when the draft guidance will become a final guidance.  As Byrd explains, “Although this is a draft guidance, it is in effect, and going forward, we are looking to FDA to provide additional guidance on advertising and promotion in areas like interactive media.  With this first guidance, FDA did a really good job of providing clarity where there wasn’t clarity before.”