FDA Warns Against Sales Representative’s “False and Misleading” Oral Statements Regarding Prescription Medicine

The U.S. Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) sent an untitled letter to Eisai Inc. on October 11, 2018, based on a sales representative’s “false and misleading” oral statements during a lunch presentation about the safety of the antiepileptic medication Fycompa®, downplaying warnings, and engaging in off-label promotion of the product.

The letter, released to the public last week, explains that the representative’s statements – made during a single lunchtime presentation to health care professionals – misbranded the medicine in violation of the Federal Food, Drug and Cosmetic Act (the FD&C Act).