Last month, celebrity-news and health-policy bloggers had a rare moment of overlap after the Food and Drug Administration issued a warning letter to the pharmaceutical company Duchesnay, which manufactures Diclegis, a prescription-only anti-nausea pill. At stake: a single selfie with pill bottle.
The image that attracted the censure of the FDA was an Instagram posted on July 20 by Kim Kardashian. The image featured her upper torso, right hand, and face, with a bottle of Diclegis prominently displayed in her grasp. “OMG,” the caption began:
Have you heard about this? As you guys know my #morningsickness has been pretty bad. I tried changing things about my lifestyle and my diet, but nothing helped, so I talked to my doctor. He prescribed my Diclegis, I felt better, and most importantly it’s been studied and there is no increased risk to the baby.
Kardashian’s post, sent to 42 million followers on Instagram and 32 million on Twitter, wrote that she was “partnering” with Duchesnay to “raise awareness about treating morning sickness”—but was less forthright about the fact that she was being paid to promote a product. By touting the benefits of Diclegis for its FDA-approved use as a paid spokesperson (which Duchesnay has confirmed), Kardashian transformed her selfie into a pharmaceutical advertisement. The FDA specifically objected to the lack of “fair balance” of risks and benefits in her Diclegis promotion, and warned that if the post was not removed or corrected to more accurately reflect the drug’s risks and limitations, Duchesnay would face further regulatory action. Kardashian deleted the offending selfie and reposted a “#CorrectiveAd” on August 30.
#CorrectiveAd I guess you saw the attention my last #morningsickness post received. The FDA has told Duchesnay, Inc., that my last post about Diclegis (doxylamine succinate and pyridoxine HCl) was incomplete because it did not include any risk information or important limitations of use for Diclegis. A link to this information accompanied the post, but this didn’t meet FDA requirements. So, I’m re-posting and sharing this important information about Diclegis. For US Residents Only. Diclegis is a prescription medicine used to treat nausea and vomiting of pregnancy in women who have not improved with change in diet or other non-medicine treatments. Limitation of Use: Diclegis has not been studied in women with hyperemesis gravidarum. Important Safety Information Do not take Diclegis if you are allergic to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any of the ingredients in Diclegis. You should also not take Diclegis in combination with medicines called monoamine oxidase inhibitors (MAOIs), as these medicines can intensify and prolong the adverse CNS effects of Diclegis. The most common side effect of Diclegis is drowsiness. Do not drive, operate heavy machinery, or other activities that need your full attention unless your healthcare provider says that you may do so. Do not drink alcohol, or take other central nervous system depressants such as cough and cold medicines, certain pain medicines, and medicines that help you sleep while you take Diclegis. Severe drowsiness can happen or become worse causing falls or accidents. Tell your healthcare provider about all of your medical conditions, including if you are breastfeeding or plan to breastfeed. Diclegis can pass into your breast milk and may harm your baby. You should not breastfeed while using Diclegis. Additional safety information can be found at www.DiclegisImportantSafetyinfo.com or www.Diclegis.com. Duchesnay USA encourages you to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
But in the meantime, Kardashian’s Instagram feed, meant to offer fans a window into her life, this time provided the public with a glimpse of something else: the enormous challenge that the FDA faces in regulating pharmaceutical marketing in an era of social media.
The rise of social media has introduced a parade of new questions for the agency: How is it supposed to monitor person-to-person pharmaceutical recommendations? Can something be considered an advertisement if it’s only 140 characters long? Who is responsible for the accuracy of tweets about a drug? But this isn’t the first time evolving technology has forced the FDA to rethink its role. Before Instagram, television advertising was once new; before television, radio. Since the agency’s founding, its ability to regulate drugs has been consistently challenged by new forms of communication.