On January 13, the FDA released the inelegantly named, Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics draft guidance. In a nutshell, the intent was to provide clarity for marketers who promote regulated products using two-way digital communication channels, such as company-owned blogs or third-party platforms like Twitter.
Technically, the guidance covers what digital promotional activities require submitting a Form 2253 (human health) or Form 2301 (animal health). But inherently, the document clarifies what the FDA considers its regulatory domain and what it’s most concerned about enforcing when it comes to user-generated content (UGC).
Through the guidance, the FDA hopes to answer some of the industry’s long-pressing social media questions such as:
“Where does responsibility for content stop and start on social media sites?”
If you have control or influence over it, basically, you are responsible.
“Am I responsible for what others post about my brand on third-party sites?”
No, as long as you didn’t influence it.
“What about if I comment on it?”
Be careful that your comments stay within compliance; it’s probably safest to stay unbranded.
“Will the FDA hold companies responsible for truly independent UGC, even on a company’s own channel?”
“When it comes to constantly changing UGC, exactly what and how often must I submit to the FDA?”
Submit once upon first use or first post, and again upon any subsequent changes to static areas of the sites you own. And then once a month, marketers can submit a list of the sites—owned or third-party—that host user-generated discussions in which they are active.
“How do I report if a representative of my company posted a promotional comment on someone else’s blog? Should that trigger a 2253?”
Report the post at the time of initial display, then if you remain active in the conversation, report it in your monthly list to the FDA.
To be clear, the document is not comprehensive “social media guidance,” rather, it is another in a series of guidance documents addressing the ever-changing world of dynamic digital and social communications. So what does it mean for healthcare marketers?
Reading between the lines, the guidance provides direction and—dare we say—permission for pharma companies to engage in social media. It opens up new options. It answers questions. It makes it easier for companies to engage while staying in compliance.
What’s Still Unclear
Certainly some questions and gray areas remain. It’s not clear, for example, if elements of this draft guidance apply to paid advertising. It’s not clear if a company is liable when a paid blogger posts on a social media site but is not posting on the company’s behalf at that time. The definition of the level of influence over direct placement of content could be further clarified. And while the guidance clearly indicates that promotional content must be submitted to the FDA, the guidance lacks clarity regarding non-promotional conversations that take place on a promotional channel.
No doubt hundreds of pharma marketing professionals are eagerly reviewing and consuming what can be considered the closest thing to social media guidance that the industry has received to date—and may receive at all.
Is the draft guidance clear-cut, definitive and absolute? No.
But was it worth the wait? Absolutely.