We recently wrote about the Warning Letter MannKind Corporation received from the Office of Prescription Drug Promotion (OPDP) of the United States Food and Drug Administration (FDA), and how it was the first letter that specifically referenced the Bad Ad Program, started roughly eight years ago.
Less than one week after issuing the Warning Letter to MannKind, on October 11, 2018, OPDP issued an Untitled Letter to Eisai Inc., regarding some oral statements made by a company sales representative in his capacity as an Eisai employee. According to the Letter, a report was submitted as part of a complaint to the OPDP Bad Ad Program, alleging that statements were made to healthcare professionals regarding Fycompa® (perampanel) tablets, providing evidence that the prescription “is intended for new uses for which it lacks approval, and for which its labeling does not provide adequate directions for use.”
Unfortunately, a lot of the Untitled Letter is redacted, so we cannot be certain what exact words the sales representative used, only sure that the OPDP felt that his words minimized “the serious risks associated with Fycompa, which bears a Boxed Warning due to serious, life-threatening risks, including psychiatric and behavioral reactions, as well as numerous warnings.”
According to the letter, 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.” Further, members of the audience asked for more information about the psychiatric and behavioral reaction and the representative “further downplayed the risk of Fycompa with anecdotal claims regarding the age of pediatric patients who experienced serious psychiatric and behavioral reactions.” To even further downplay the serious risks, the sales representative “also noted that other epilepsy centers have this drug on formulary and were not concerned with the Boxed Warning.” OPDP felt that the overall presentation minimized the serious risks associated with the drug, and “misleadingly” suggested that the drug is safer than has been demonstrated.
In response to their letter, as is typical, OPDP requested that Eisai provide a written response, detailing whether the company planned to comply with the request, a list of all promotional materials for Fycompa that contain violations such as the ones described in the letter, and the company’s plan for discontinuing the use of such violative materials. Further, if Eisai does not believe the products are in violation of the Federal Food, Drug & Cosmetic Act, the company may also write that as well, including the reasoning and any supportive information or evidence.
The letter to Eisai brings the total number of Warning and Untitled Letters issued by OPDP in 2018 to six, five of them Untitled and one a Warning.