Indeed the social media age has brought a new wrinkle in the FDA’s regulatory agenda. Social media marketing schemes are often designed to appear casual and conversational, as if friends are discussing an issue over coffee. While certainly not illegal and for the most part, and a useful form of advertisement, FDA risk statements rarely fit within 144 character-limit social-media parameters.
The Queen of Self (and the selfie) Kim Kardashian may have stumbled upon a major problem for the Food and Drug Administration (FDA). The agency sent a warning letter dated August 7th to Pennsylvania-based drugmaker Duchesnay, after Kardashian posted her endorsement of the morning sickness drug Diclegis, for which she is a paid spokesperson, on the social media site Instagram last month. In the post, Kardashian is holding a bottle of Diclegis, writing “OMG. Have you heard about this? As you guys know my #morningsickness has been pretty bad. I tried changing things about my lifestyle, like my diet, but nothing helped, so I talked to my doctor. He prescribed me #Diclegis, and I felt a lot better and most importantly, it’s been studied and there was no increased risk to the baby.” The post also contains a small link highlighting the safety warnings at www.DiclegisImportantSafetyInfo.com.
In the warning letter, the FDA determined that simply posting a link providing the risks and safety data was not sufficient communication of these risks. The letter states that “the social media post misbrands DICLEGIS within the meaning of the Federal Food, Drug, and Cosmetic Act.” As a paid spokesperson, the law has specific requirements for the publication of risk and safety information on any drug advertisement, hence the long stream-of-consciousness side-effects disclaimer at the end of most drug television ads that often make the viewer forget what the drug was supposed to cure or treat. The FDA wrote that the link to the risk information did not meet the legal requirements for risk disclosure. The FDA’s lengthy list of risks for Diclegis includes, “Fatalities have been reported from doxylamine overdose in children. Children appear to be at a high risk for cardiorespiratory arrest.” The FDA wrote, “Leaving out these details can mislead people.”
Indeed the social media age has brought a new wrinkle in the FDA’s regulatory agenda. Social media marketing schemes are often designed to appear casual and conversational, as if friends are discussing an issue over coffee. While certainly not illegal and for the most part, and a useful form of advertisement, FDA risk statements rarely fit within 144 character-limit social-media parameters. According to Thomas Abrams, who directs the FDA’s drug promotion office, has said that the speed and the ever-changing nature of social media advertising make enforcement often difficult. Abrams said in a 2013 interview, “It is important to know that although we closely monitor what companies say, we generally do not have authority over statements made by independent organizations or persons, what we call third parties, unless they are acting on behalf of a company.” Although sifting through countless social media posts for violations may be laborious, it is mathematically impossible for any human on Earth to avoid seeing Kim Kardashian. The difference this time, according to former FDA commissioner Dr. David Kessler, is “Once you are paid, you are under FDA rules.”
NBC News – Maggie Fox
New York Times –Christine Hauser