FDA Targets Misleading Online Promotions of Medical Devices
The FDA is appropriating "more resources" to track and fight "misinformation" about health care products on the Internet, targeting the "pervasive problem" of false online advertising, the Los Angeles Times reports. While FDA officials declined to comment on the number of complaints they have received about promotions and advertisements from medical device makers, the agency has issued 15 reprimands and "dozens of informal warnings" this year, compared to just four reprimands two years ago. The Times describes the case of Z'Strong International, which received an FDA warning letter for promoting a battery-operated device called the Bioelectrical Discharger to "regulate and stabilize hypertension," though the FDA had only approved it for sale as a muscle relaxer. Threatened with an injunction, fine or seizure, Z'Strong removed the promotions from its Web site. FDA officials say they are finding a "growing number" of "questionable practices," such as "inappropriate testimonials" from customers or hyperlinks that direct users to "affiliated businesses" that promote or support unapproved uses. The FDA said it handles violations on a "case-by-case basis," and the agency posts the warning letters it issues on its Web site. These letters are among the "more serious" actions available to the agency, according to FDA officials. Bryon Tart of the FDA's center for devices and radiological health, oversees ad and promotion investigations and said the agency takes "all violations seriously." He added, "If consumers, competitors or government officials find something objectionable or untrue, they can call our agency. We'll follow up" (Ballon, Los Angeles Times, 12/13).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.