The U.S. Food and Drug Administration (“FDA”) regulates the use of social media to disseminate information about prescription drugs and medical devices. Our blog previously covered the social media guidance released by the FDA in 2014, and a sampling of Warning and Untitled Letters that the FDA has issued to drug manufacturers advertising on Twitter, Facebook, and Tumblr.
Our firm sister blog, Health Law Pulse, covered last year’s controversy surrounding Kim Kardashian’s Instagram post that endorsed the morning sickness drug Diclegis® without including relevant risk information in the text of her post. After the manufacturer of Diclegis® received an FDA Warning Letter, Kim posted a corrective ad stating the risk information associated with that drug.
FDA Requests Public Comment on New Studies
On November 7, 2016, the FDA announced an opportunity for public comment on a collection of proposed studies entitled “Character-Space-Limited Online Prescription Drug Communications.” The stated objective of the FDA’s proposed research is to test whether a link to prescription drug risk information on an external site can effectively convey the risks associated with a drug when benefit claims about that drug are made within the text of a character-space-limited post.
Certain social media platforms place a limit on the character space permitted in a single post, forcing users to be concise and find creative ways to communicate within the constraints of the platform. For example, Twitter imposes a 140-character limit on each Tweet.
A character-space-limited communication, such as a Tweet, poses unique challenges for drug manufacturers who wish to promote their products on social media. Complete risk information may be several pages long, yet the FDA guidance currently requires risk information to be visible in the main text of a post that touts the benefits of a drug. As a practical matter, at the present time, prescription drugs with lengthy risk information cannot effectively be advertised on social media without running afoul of the FDA guidance.
The “One-Click Rule”
Many drug manufacturers advocate for a “one-click rule,” which would allow risk information to be excluded from the main text of a post, as long as the information was only one click away. For example, Kim Kardashian’s first endorsement of Diclegis® on Instagram instructed readers to “find out more” by clicking a link to the full safety information on the manufacturer’s website. The FDA Warning Letter noted that the inclusion of a link “does not mitigate the misleading omission of risk information.”
Under a one-click rule, Kim Kardashian’s post might have been permissible because it included a direct link to safety information. The research proposed by the FDA will focus on the likelihood that users will actually click a link to risk information. The studies also aim to compare how well consumers will retain knowledge of risk information when it is presented in the text of a post versus when it is accessed via link.
The ultimate goal of FDA regulations for social media is to protect consumers by ensuring that they receive complete information to weigh the risks and benefits of prescription drugs. If the proposed research finds that social media users are adequately informed by receiving a link to medical risk information, then the “one-click rule” may gain some traction in future FDA rulemaking.
Does your company use social media to advertise prescription drugs or medical devices? Do you utilize social media “influencers” to recommend or endorse your products? Stay tuned to our blog for more updates on these issues.