North, West, and the Direction of FDA Enforcement in the Social Media Age

By Christopher Robertson

Co-blogged with University of Arizona Fellow, Jonathan Loe

Breathlessly, many news outlets reported yesterday that Kim Kardashian West was in trouble with the FDA for misleading social media advertising of the drug Diclegis. For example, the reliably hyperbolic Daily Mail led with “Kim Kardashian slammed by FDA.” 

As followers of this blog may not know, Mrs. Kardashian West is pregnant with her second child.  Following on the disappointing news that the soon-to-be sibling of baby “North West” will not be named South, the celebrity-for-celebrity’s-sake shared a post on Instagram (and Facebook, and linked to from Twitter, naturally).  The post announced for the world that “OMG” her “#morningsickness” had benefited from a prescription of Diclegis—with “no increased risk to the baby.” The FDA issued a warning letter, because the social media post failed to communicate any risk information.

But is the FDA really concerned with people, however famous, commenting on their personal experiences with drugs?

The answer is…

…of course not. The FDA’s warning was directed not to Mrs. Kardashian West, but to the maker of Diclegis, Duchesnay. As it happens, the social media star is a paid spokesperson for Duchesnay.

Last year, the FDA issued draft guidance on social media marketing in particular, instructing that “regardless of character space constraints that may be present on certain Internet/social media platforms, if a firm chooses to make a product benefit claim, the firm should also incorporate risk information within the same character-space-limited communication.”  The FDA’s prescription drug rules apply to “all advertisements . . . issued or caused to be issued by the manufacturer, packer, or distributor.” 21 U.S.C. § 352. Thus, the rules apply primarily to drug companies and their agents—those who have a financial interest in the drug.  Mrs. Kardashian West’s post falls within the rules because Duchesnay paid her to issue the advertisement for Diclegis.  

If Mrs. Kardashian West had not been associated with the manufacturer of Diclegis, she would have been free to endorse it as often and on as many social media platforms as she wished.  Consumers are free to get their health information from celebrities — whatever the risk.  But paid celebrity spokespeople are not a back-door way for manufacturers to escape FDA regulation.  

This is the delicate balance the FDA has attempted to strike between free speech and the regulation of drug promotion, a balance that remains under attack from drug manufacturers.  Going forward, the FDA will likely have to continue to wrestle with advertising in the new and increasingly important medium of social media. Duchesnay must respond to the FDA’s letter and attempt to correct misconceptions generated by the original post.  Still, the company can’t be unhappy with the extra round of news mentions generated by the warning letter.

Of course, the real winner in all of this? Kim Kardashian—after all, there’s no such thing as bad publicity.   

This entry was posted in Christopher Robertson, FDA, First Amendment, Pharmaceuticals by crobertson. Bookmark the permalink.

About crobertson

Christopher Robertson is a professor at the James E. Rogers College of Law, University of Arizona, and affiliated faculty with the Petrie Flom Center for Health Care Policy, Bioethics and Biotechnology at Harvard. Robertson also leads the Regulatory Science program, a partnership with the Arizona Health Sciences Center and the Critical Path Institute. Professor Robertson's research focuses on how the law can improve decisions by individuals and institutions -- attending to informational limits, conflicting interests, and cognitive biases, especially in the domain of healthcare. Blending legal, philosophical, and empirical methods, Robertson's work has been published in the New England Journal of Medicine, New York University Law Review, Cornell Law Review, Emory Law Journal, and the Journal of Empirical Legal Studies. He has received research support from the Robert Wood Johnson Foundation, and runs the Law and Behavior Research Lab at the University of Arizona. Robertson graduated magna cum laude from Harvard Law School, where he also served as a Petrie Flom fellow and lecturer. He earned a doctorate in Philosophy at Washington University in St. Louis, where he also taught bioethics. For 2013-2014, he was a visiting professor at Harvard Law School, and will visit at NYU School of Law in 2016-2017. Robertson's legal practice has focused on complex litigation involving medical and scientific disputes.