FDA Social Media Guidance Removes Some Barriers

This week, the FDA issued draft social media guidance specifically focused on requirements, responsibility and process for postmarketing submission for approved drugs and biologics. While the long official title is “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics” the document covers two primary areas:

  • Considerations to determine when interactive media (Facebook, Twitter, blogs, forums, etc.) are subject to the FDA’s postmarketing submission requirements
  • How firms can maintain regulatory compliance given the unique features of real-time communications platforms and user generated content (UGC)

Many in the healthcare communications industry have been eagerly awaiting feedback on these exact topics from the FDA. Healthcare and pharmaceutical companies that manage real-time communications channels, like Twitter and Facebook, have spent years balancing the channel value, audience needs and unclear regulatory risk with their legal teams. The previous lack of clarity over submission requirements and responsibility for UGC have been significant obstacles for many healthcare and pharmaceutical companies trying to effectively use social media.

Although many other regulatory questions remain unanswered and we don’t expect a flood of pharmaceutical companies to now join social media, we do anticipate that this draft guidance will have a more significant impact than the FDA’s previous social media guidance that focused on responding to unsolicited requests for off-label information.

What It Means:

This guidance, while nonbinding, provides some much-needed answers to healthcare and pharmaceutical companies looking to leverage social media while maintaining regulatory compliance. A lack of clarity over responsibility and submission requirements for both UGC and brand-owned content within social media has been one of many barriers to many healthcare and pharmaceutical companies wanting to fully engage their audiences via social media programs.

Not surprisingly, the FDA recommends that all promotional communication through interactive media be submitted for FDA review, whether it is on an owned website or third-party account. For content on third-party sites, no matter how small of an influence the company had in its development, review or placement, it should be submitted for FDA review. This same submission responsibility extends to posts from employees, sales reps or other agents acting on the company’s behalf. The FDA notes the importance of transparency in these cases, clearly disclosing the poster’s relationship with the company.

Most interestingly, the guidance addresses that the FDA will not consider companies responsible for UGC that is not in any way influenced by the company. This reduces concerns over areas of potential risk, including patient posts on company Facebook pages, blogs or forums and any FDA submission requirements.

The FDA also concedes that submitting promotional content “at the time of initial dissemination” is not realistic for modern interactive media and will exercise its “enforcement discretion” when reviewing. In the example of a company engaging in real-time Twitter postings, the FDA recommends monthly submissions with links to all of the company’s social media channels, but does not require screenshots of every post if the account is public and unrestricted. This significantly reduces the regulatory burden for many public and real-time communications channels, like Twitter.

Considerations for Healthcare Marketers:

  • Assess the current landscape and determine whether healthcare and pharmaceutical companies have influence over any digital content hosted on third-party channels and further understand any additional implications of this guidance and ensure continued compliance.
  • Review employee or contractor social media guidelines to ensure that all appropriate company representatives not only understand the need for transparency of their relationship to the company, but also understand any potential FDA submission process implications when posting promotional information online.
  • Reevaluate any digital strategies or submission processes that could be optimized given the potential reduced regulatory burden that UGC poses.

Read what others are saying about this draft guidance: