Kardashian's Nurtec claims garner OPDP untitled letter
A celebrity interview has overstepped the bounds of permissible direct-to-consumer advertising of a prescription drug, garnering an untitled letter from the US Food and Drug Administration (FDA).The agency’s Office of Prescription Drug Promotion (OPDP) issued the letter on Monday to Biohaven Pharmaceuticals, which markets Nurtec (rimegepant) orally disintegrating tablets (ODTs) to treat migraine with or without aura.
OPDP found fault with an interview given by Khloé Kardashian, who was paid by Biohaven as a spokesperson; the videotaped interview aired on 15 July 2020 on the ABC TV show The View and was later posted to the show’s YouTube page, according to the letter.
The Kardashian segment, said FDA, is concerning ”because the promotional communication creates a misleading impression regarding the overall benefit a patient may expect as a result of Nurtec ODT treatment and minimizes the risks associated with taking the drug.” The agency added that the segment had also been the subject of a Bad Ad complaint.
Among the claims Kardashian made in the interview regarding Nurtec is the assertion that “It literally works within, for me, 15 minutes. And anyone with a migraine, for 15 minutes, of pure agony, they’re like knives in my head. So to have this relief, and to not be in a fog afterwards... I’m able to just go with the rest of my day.”
Though OPDP does not dispute that this may be Kardashian’s own experience, the assertion is at odds with clinical trial data, which looked at freedom from pain and from the most bothersome migraine symptom at the 2-hour mark after using Nurtec ODT. “Claims that Nurtec ODT provides relief in 15-30 minutes are not supported by the clinical trial data,” wrote ODT in the letter. “If you have data to support these claims, please submit to FDA for review.”
A superimposed banner with text reading “As everyone experiences migraine differently. Treatment results may vary” is not sufficient to mitigate the misleading impression given by Kardashian’s statement, said ODT.
Kardashian also called Nurtec a “gamechanger,” adding that the medication, unlike others she had tried, did not leave her with rebound headaches. These statements give the impression of clinical superiority over other migraine therapies, asserted OPDP. Here again, FDA made clear that personal experience does not supplant accurate portrayal of clinical trial findings.
The video interview also came up short because the full FDA-approved indication and limitations of use for Nurtec were not conveyed, in OPDP’s view. Risk information is not mentioned by Kardashian, but rather is presented in small-font text for a scant 4 seconds at the end of the video, after the host signed off.
The video falls under FDA’s requirements to submit promotional material along with FDA’s form 2253, according to OPDP, but the agency noted that the video was not submitted to FDA when it was initially disseminated.
Nurtec, a calcitonin gene-related peptide receptor antagonist, may be taken sublingually or used on the tongue. It was approved by FDA in March of 2020.
The letter is evidence of OPDP’s ongoing willingness to examine advertising and promotional material disseminated through a variety of conventional and modern outlets, ranging from radio ads to email campaigns to Facebook posts. (RELATED: FDA’s OPDP Warns MannKind for Facebook Post, Regulatory Focus 16 October 2020; FDA warns Sprout for misleading Addyi come-on, Regulatory Focus 15 September 2020; Azurity garners OPDP untitled letter for problematic emails, Regulatory Focus 03 December 2020)
And this is not the first time a Kardashian's drug promotional activity has landed a firm in hot water with FDA. In 2015, sister Kim Kardashian's promotional Instagram posts for morning sickness treatment Diclegis prompted OPDP to send a letter to Duchesnay. Kim Kardashian's post, which began, "OMG. Have you heard about this?" led FDA to address the fact that the post failed to communicate any risk information about Diclegis. (RELATED: Kim Kardashian selfie prompts FDA warning letter, Regulatory Focus 14 August 2015)
OPDP is requesting a response from Biohaven within 15 days of the firm’s receipt of the untitled letter.
OPDP warning letter