FDA Policy/General

Eisai Sales Rep Made False, Misleading Statements: OPDP

A CDER Office of Prescription Drug Promotion (OPDP) Bad Ad Program complaint says that an Eisai sales representative made false and misleading statements to healthcare professionals about the company’s Fycompa (perampanel) tablets and oral suspension. A 10/11 untitled letter says the sales representative made statements providing 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 drug labeling says that Fycompa is indicated for treating partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy age 12 and older, and as adjunctive therapy for treating primary generalized tonic-clonic seizures in patients with epilepsy age 12 and older. There is a Boxed Warning for serious psychiatric and behavioral reactions, along with various Warnings and Precautions.

The letter redacts the unapproved indication that the sales representative referenced. It says the representative also “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. Although the members of the audience asked for more information about the serious psychiatric and behavioral reactions, especially the homicidal ideations, the representative further downplayed the risks of Fycompa with anecdotal claims regarding the age of pediatric patients who experienced serious psychiatric and behavioral reactions. To further downplay this risk, the sales representative also noted that other epilepsy centers have this drug on formulary and were not concerned about the Boxed Warning. The presentation minimizes the serious risks associated with Fycompa and misleadingly suggests the drug is safer than has been demonstrated.”

Eisai was told to stop violating the Federal Food, Drug, and Cosmetic Act as described in the letter and to submit a plan for discontinuing any such violative promotions.

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