FDA Enforcement Against Pharmaceutical Companies in the Product Promotion Arena: What the Medical Device Industry Can Learn

Alan G. Minsk, Partner and Chair of the Food and Drug Practice Team, authored an article published in the March 2011 issue of the Law Journal Newsletter’s Product Liability Law & Strategy. Titled “FDA Enforcement Against Pharmaceutical Companies in the Product Promotion Arena: What the Medical Device Industry Can Learn” (subscription may be required to view full article) the article reviews several enforcement and warning letters within the pharmaceutical promotion area that were issued by the Food and Drug Administration’s Division of Drug Marketing, Advertising, and Communications (DDMAC) and Center for Devices and Radiological Health (CDRH). When examining the letters, one can see that off-label use is a recurring theme and, more specifically, the DDMAC and CDRH target off-label-use promotion that may raise public health concern due to inadequate directions and warnings. Mr. Minsk advises that the medical device industry should closely examine these enforcement and warning letters to understand the promotional rules and governmental concerns so that they do not make the same mistakes as those made by drug companies. He writes, “By remembering the past and not repeating others’ mistakes, firms can try to avoid government condemnation.”