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The encyclopedia · Advertising & PR · Marketing decision · 2015

Kim Kardashian's Diclegis Instagram post drew the drug's first FDA warning

Aug 2015: the FDA warned Duchesnay — Kim Kardashian's paid Instagram post for the morning-sickness drug Diclegis omitted all risk information.

Duchesnay USA · 2015-08

What happened

In July 2015 Kim Kardashian, then pregnant, posted on Instagram that Diclegis had relieved her morning sickness. The post was a paid endorsement for Duchesnay USA, the Rosemont, PA maker of Diclegis — a delayed-release doxylamine succinate and pyridoxine HCl drug approved in 2013 for nausea and vomiting of pregnancy. It drew roughly 464,000 likes before being taken down.

In an August 7, 2015 warning letter, the FDA's Office of Prescription Drug Promotion told Duchesnay the post was 'false or misleading' because it presented efficacy claims while 'fails to communicate any risk information associated with its use and it omits material facts'. The agency noted the post's links to the drug's website and safety information did not mitigate the omission, and that the post failed to state the drug is not approved for hyperemesis gravidarum.

The letter asked Duchesnay to correct the record in the same media, with similar reach and duration. Duchesnay said it took its regulatory responsibilities seriously and would respond quickly. The warning is remembered as the first FDA letter to contain the acronym 'OMG' — a small detail that made regulation of paid social-media endorsements visible to the general public.

Why it happened

  • A paid celebrity post made efficacy claims with no mention of any risk information.
  • The endorsement read as if the drug were safer than it has been shown to be.
  • Links to safety pages did not count as communicating the required risk information.
What it costFDA warning letter; corrected in the same mediacostly

The lesson

A paid endorsement is promotional material: omit a drug's risk information for a clean post and the FDA calls it misbranding. Linking to safety pages does not count as disclosing it.

Aftermath

Duchesnay withdrew the post and said it would work with the FDA on corrective messaging. The letter became a reference point for how the FDA polices celebrity social-media endorsements of prescription drugs.

Sources

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