OMG: Drug Maker Hits Publicity Grand Slam with Misleading Kim Kardashian Post

A pharmaceutical company reprimanded by the FDA for misleading social media marketing ironically gained enormous additional publicity about its drug to treat morning sickness.  

The FDA ordered Duchesnay Inc. to take down its Kim Kardashian promotion on Instagram, calling the social media post false and misleading.

In a letter to the company, the FDA said the post on the prescription morning sickness pill Diclegis “fails to communicate any risk information associated with its use and it omits material facts.”

In the post, Kardashian said, “OMG. Have you heard about this? As you guys know my #morningsickness has been pretty bad.” She then related to her 42.4 million followers how she feels much better after taking Diclegis, calls the drug safe, and urges women with morning sickness to ask their doctors about it. To get the point across, the post features a photo of the very pregnant Kardashian holding a bottle of the pills.

She concludes by saying women can visit the company website and diclegisimportantsafetyinfo.com for more information.

A Lack of Information

“The social media post, however, entirely omits all risk information,” the FDA states, emphasizing the word “all.” It does not mention limitations on its use, possible side effects or say it has not been studied in women with hyperemesis gravidarum, a pregnancy complication characterized by constant vomiting. Adding the informational website at the end of the post is not sufficient.

The FDA called the misleading promotion “particularly troubling” since it had previously warned the company about similar marketing practices. In 2013, the FDA warned Duchesnay about its announcement of regulatory approval of Diclegis, saying it omitted risk information and use limitations.

Because of the violations were serious and repeated, the FDA requested the pharma company to provide a plan for distributing accurate information and to disseminate corrective messages through the same media.

The company, according to The New York Times, issued a statement saying: “Duchesnay USA takes its regulatory responsibilities very seriously, and acknowledges that its communications, including in social media as in this particular instance, need to be in accordance with applicable rules and regulations.”

The Intersection of PR, Marketing and Social Media

Duchesnay’s Kardashian promotion combines the benefits of PR and social media marketing. The FDA rules are very clear about acknowledging paid celebrity endorsements, even by bloggers. All pharma companies know the rules about promotion of prescription drugs. They must include information about side effects. By knowingly dangling one leg over the edge, Duchesnay risked getting its wrist slapped (maybe just tapped) but got millions of dollars of promotional value in the news coverage of the FDA reaction.

The promotion certainly demonstrated the enormous power of publicity. News stories on the drug maker’s misstep repeated the Kardashian promotion. For instance, The New York Times article on the incident includes a photo of Kardashian holding a bottle of the pills. Most every pregnant woman with morning sickness has now undoubtedly heard of Diclegis as a result of the print, broadcast and online news coverage. Prescriptions of drugs to control morning sickness are largely driven by patients demanding a solution from their physicians.

Breaking the rules and getting reprimanded got Diclegis more exposure than Duchesny could otherwise afford. The company was certainly aware of the regulations about including side effects in any promotion. It’s highly unlikely that the company’s product managers were unaware that the regulations applied to the Kardashian promotion. Most likely, they simply ignored the regulation. They were willing to take the risk of minor regulatory penalties in order to gain significant competitive advantage of reaching Kardashian’s 42 million social media followers. The publicity from the FDA reprimand was a magnificent bonus.

FDA penalties will not retract the gains the promotion achieved. The FDA has a history of imposing penalties that reflect the gains that the promotion achieved. The agency mandates corrective information that includes the required balance about risks. Those “balanced promotions” can be costly – but they still call attention to the product and most companies are able to turn the “correction” into a “promotion.” The corrections will probably never overcome the gains in product awareness and increases in sales the original promotion achieved.

As of now, the marketers at Duchesnay hit a grand slam for Diclegis. If the marketers receive year-end bonuses based on sales, they’re going to be very happy in December. But such conduct should be punished, not rewarded. As with executives who can be banned from the financial industry for egregiously breaching government regulations, the FDA should have the authority to forbid executives who flagrantly flout government regulations from working in the pharmaceutical industry.

Better Media Monitoring Needed

The FDA learned about the Instagram post from a whistle-blower through its Bad Ad Program. The huge volume of social media posts and other types of online content challenge the FDA’s ability to oversee pharma companies and enforce its regulatory powers. The agency needs more proactive media monitoring to scrutinize drug advertising and promotion on social media.

“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,” said Thomas Abrams, director of the FDA’s Office of Prescription Drug Promotion, in an earlier consumer update.

Interestingly, also this week, a federal court has challenged the authority of the FDA to regulate truthful promotion of prescription drugs. Without any government regulation of advertising and promotion of drugs, consumers and their physicians will be left to sort out the truth in drug advertising. In the absence of government oversight, drug advertising and promotion is likely to become less truthful, transparent and balanced. That can be a recipe for a medical disaster.

Bottom Line: The admonishment by the FDA of Duchesnay for the pharma company’s misleading social media marketing illustrates how testing regulatory limits can be used to gain competitive advantage. It also illustrates the power of publicity, the unintended consequences of a issuing an FDA reprimand, and the absence of any real risk for executives who ignore the regulations.

How do you feel about marketers and product managers who disregard government regulations in order to gain competitive advantage? We welcome your comments below.