FDA admonishes medical device maker for promoting unapproved use
The U.S. Food and Drug Administration (FDA) recently sent medical device manufacturer St. Jude Medical, Inc. a letter warning the company to stop promoting its Epicor surgical ablation devices to treat a heart rhythm disorder. The FDA says that several marketing statements made by the company violate the Federal Food, Drug and Cosmetic Act.
Ablation devices like Epicor are approved by the FDA to use for cauterizing tissue during surgery. However, St. Judge has also promoted the device as a means to surgically treat atrial fibrillation, a heart-rhythm disorder. St. Jude and other manufacturers of similar devices do not have FDA approval to market them for use as a treatment for atrial fibrillation. Marketing drugs or medical devices for unapproved uses is against the law because the benefits and risks of using the drug for that purpose have not been evaluated.
In addition to the warning letter by the FDA, the Justice Department is currently investigating the marketing practices of St. Jude and two other manufacturers of surgical ablation devices, Medtronic Inc. and Boston Scientific Group. Two other makers of ablation devices, AtriCure Inc. and Estech, have agreed to pay fines based on civil allegations of illegal marketing practices.
For the full story, go to the Wall Street Journal.