Processing Your Payment

Please do not leave this page until complete. This can take a few moments.

March 11, 2021

FDA reprimands Biohaven over Kardashian migraine drug ad

PHOTO | Contributed Khloé Kardashian
By Natalie Missakian

Biohaven Pharmaceuticals’ hiring of a reality TV star to pitch its new migraine pill is stirring up some drama for the New Haven drug maker – in the form of a rebuke from the Food and Drug Administration.

The regulatory agency is taking issue with a Biohaven-sponsored interview in which celebrity spokeswoman Khloe Kardashian heaps praise on the company’s Nurtec ODT for changing her life as a longtime migraine sufferer.

During the paid spot, which originally aired last July on the ABC talk show “The View,” Kardashian hails the drug as a “game changer” that works better than other treatments she has tried and says it stops her headaches in as little as 15 minutes.

The problem? None of those claims are supported by clinical trial data the FDA used to approve the drug, the agency’s Office of Prescription Drug Promotion (OPDP) told Biohaven this week.

The reprimand came Monday in the form of an “untitled letter” –  an FDA communication that stops short of a warning but alerts a company to a violation that needs to be corrected. 

The FDA said the promotional interview, which is still accessible on The View’s YouTube page, “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 FDA specifically took issue with Kardashian’s use of the phrase “game changer” and her assertion that Nurtec ODT worked better than the “handfuls of different prescription and over-the-counter medications” she has tried. 

“While these claims may be an accurate reflection of the spokesperson’s own experience with Nurtec ODT, their personal experience does not support the suggestion that Nurtec ODT is more advanced than or superior to other migraine drug products on the market,” the agency said. 

Kardashian told "The View" hosts that the drug “literally works within, for me, 15 minutes,” but the FDA said clinical trial data only measured the drug’s effectiveness in relieving pain two hours after taking it. 

The FDA also raised concerns that information about potential risks appears only briefly during the last four seconds of the video, in small-font text “where it is unlikely to draw the viewer’s attention.”  

The agency said it received a complaint about the video through its “Bad Ad Program.”

Biohaven said Wednesday that it is “working closely with the FDA to evaluate their comments and respond,” which it must do within 15 working days.

Khloe is not the first Kardashian in trouble with the FDA. In 2015, drug maker Duchesnay received an FDA warning after her sister, Kim Kardashian, promoted a morning sickness drug on her Instagram account without labeling it as an advertisement.

Biohaven has also recruited former Beverly Hills 9021 star Tori Spelling and Nascar driver Cody Ware, both migraine sufferers, as celebrity spokespeople for the drug. 

Contact Natalie Missakian at news@newhavenbiz.com

Sign up for Enews

Most Recent

Most Recent

0 Comments

Order a PDF