OPDP Sends Untitled Letter to Eisai for Sales Rep’s Off-Label Comments

Regulatory NewsRegulatory News | 17 October 2018 |  By 

The US Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) on Wednesday released an untitled letter sent earlier this month to Eisai for a sales representative’s comments on off-label uses for Fycompa (perampanel).
According to a complaint made to OPDP, the Eisai sales representative “made statements that provide evidence that Fycompa is intended for new uses for which it lacks approval, and for which its labeling does not provide adequate directions for use.”
The heavily redacted untitled letter also notes that the sales representative gave a lunch presentation with comments about how to use Fycompa off-label.
“Additionally, during the presentation, the sales representative minimized serious, life-threatening, risks associated with Fycompa. Specifically, while the sales representative acknowledged the Boxed Warning risk of homicidal ideations and aggressive behavior, the representative downplayed these risks by suggesting the healthcare practitioners should not worry about it,” the untitled letter says.
As far as corrective actions, OPDP requests that Eisai immediately cease violating the Food Drug & Cosmetic Act, and submit a written response listing all promotional materials for Fycompa that contain violations such as those described in the untitled letter.
FDA’s OPDP has now issued five untitled letters and one warning letter in 2018. Last year, OPDP closed out the year with a historically low three warning letters and one untitled letter.
Untitled Letter


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