FDA Enforcement Update From CDRH, CDER, and CBER: Advertising and Promotion

Keeping track of the Food and Drug Administration’s enforcement of advertising and promotion of drugs, devices, and biologics is a challenging task that requires constant monitoring. At this year’s 2015 DIA Annual Meeting in Washington, DC, FDA representatives from the Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research (CDER), and the Center for Biologics Evaluation and Research (CBER) provided a good summary of enforcement activity and priority areas that manufacturers should take note of.   CDRH Update: Promotion and Advertising of Devices Deboarah Wolf spoke from her perspective as Regulatory Counsel within the Division of Premarketing and Labeling Compliance (DPLC) of CDRH’s Office of Compliance. The DPLC enforces premarket clearance and approval requirements, as well as labeling and promotion and advertising requirements for medical devices. Wolf focused on a number of particular products and promotional activities that have drawn DPLC’s ire. Devices promoted without approval or without a prescription Decorative Contact Lenses, which Wolf noted are Class II or Class III prescription medical devices, have been sold at dollar stores or street kiosks either without a prescription or that are unapproved. There was also an increase in websites offering these decorative lenses for sale without a prescription—including lenses offered on Ebay and Amazon. Wolf noted that FDA, along with the FTC, sent a warnin...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs