October 25, 2018

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

Faegre Drinker on Products Blog

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).

Full Article

Services and Industries

The Faegre Drinker Biddle & Reath LLP website uses cookies to make your browsing experience as useful as possible. In order to have the full site experience, keep cookies enabled on your web browser. By browsing our site with cookies enabled, you are agreeing to their use. Review Faegre Drinker Biddle & Reath LLP's cookies information for more details.