FDA Advertising and Promotion Enforcement Activities: Update

FDA Advertising and Promotion Enforcement Activities: Update

April 15, 2021, Covington Alert

This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.

In March, the Office of Prescription Drug Promotion (OPDP) posted the following untitled letter on FDA’s website:

• Untitled letter to Biohaven Pharmaceuticals re: NDA 212728 NURTEC® ODT (rimegepant) orally disintegrating tablets, for sublingual or oral use MA 71 (Mar. 8, 2021) (Nurtec ODT Untitled Letter)

The Nurtec ODT Untitled Letter is the third enforcement letter OPDP has issued this year. The Office of Product Evaluation and Quality (OPEQ) at the Center for Devices and Radiological Health (CDRH) and the Office of Medical Device and Radiological Health Operations (OMDRHO) in the Office of Regulatory Affairs (ORA) have not yet posted any enforcement letters related to advertising and promotion in 2021. FDA’s Advertising and Promotional Labeling Branch (APLB) in the Office of Compliance and Biologics Quality (OCBQ) has not posted any enforcement letters since 2018.

This alert merely summarizes the allegations contained in FDA’s letters. It does not contain any analyses, opinions, characterizations, or conclusions by or of Covington & Burling LLP.  As a result, the information presented herein does not necessarily reflect the views of Covington & Burling LLP or any of its clients.

Nurtec ODT Untitled Letter

OPDP’s untitled letter to Biohaven Pharmaceuticals (“Biohaven”) states that a direct-to-consumer video featuring an interview with Khloé Kardashian misbrands Nurtec ODT, a drug indicated for the acute treatment of migraine with or without aura in adults. In the video, which originally aired on ABC’s The View, Kardashian is identified as a paid Biohaven spokesperson.[1] FDA received a complaint about the video through the Bad Ad Program.

OPDP alleges that the video “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.” OPDP also states that Biohaven did not submit the material to FDA at the time of initial dissemination or publication. 

False or Misleading Claims about Efficacy

OPDP alleges that the video is misleading with respect to efficacy because it makes claims unsupported by clinical evidence and fails to adequately communicate the drug’s full FDA-approved indication and limitations of use. OPDP begins by stating that the video misleadingly suggests that patients will experience “relief” within 15 to 30 minutes of taking Nurtec ODT. In the video, Kardashian makes claims such as:

• “. . . something that works in about 15-30 minutes . . .”
• “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.”

OPDP states that “[w]hile these claims may be an accurate reflection of [Kardashian’s] own experience with Nurtec ODT,” there were no pre-specified endpoints that evaluated the efficacy of the drug at 15 to 30 minutes after dosing. OPDP acknowledges that the video includes superimposed text providing that treatment results may vary, but it adds that “this does not mitigate the misleading impression.”

OPDP also alleges that Kardashian’s description of Nurtec ODT as a “gamechanger” and her statement that the drug does not give her rebound headaches like “other medications” suggest that the drug is clinically superior to or more effective than other prescription and over-the-counter migraine treatments. Furthermore, OPDP states that the term “gamechanger” “misleadingly suggests that Nurtec ODT represents a significant advance over other currently available products.” OPDP adds that it “is not aware of evidence to support these claims.”

Finally, OPDP states that the interview fails to convey that Nurtec ODT is approved for the acute treatment of migraine and not for preventative treatment. OPDP notes that presenting the full indication briefly in script/text format on the screen at the end of the video, following the interview, is insufficient..

False or Misleading Risk Presentation

OPDP further alleges that the video is misleading because it fails to provide risk information “with a prominence and readability reasonably comparable with the presentation of information relating to the benefits of Nurtec ODT.” OPDP states that risk information is presented in text-only format and in small font (whereas benefit information is provided in the audio portion of the video) and appears only briefly for four seconds after the interview has concluded. Additionally, OPDP notes that the video does not alert the viewer that important risk information follows the interview, particularly given that the host ends the discussion with, “[W]e’ll be right back,” which typically signals the close of a presentation. 

Failure to Submit Under Form FDA-2253

OPDP also alleges that Biohaven did not submit the video to OPDP as required under federal regulations. 21 C.F.R. § 314.81(b)(3)(i) requires the submission of “labeling or advertising devised for promotion of the drug product at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement.” Each submission must be accompanied by a completed transmittal Form FDA-2253 (Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use) and a copy of the product’s current professional labeling.

If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Drugs, and Devices practice.