Warning and untitled letters issued to manufacturers of medical products offer unique insight into FDA’s enforcement practices. To help identify themes and trends in the agency’s recent enforcement activity, Covington & Burling has reviewed all warning and untitled letters related to advertising and promotional materials issued in 2016 and tabulated the most frequently cited allegations. The full 2016 End-of-Year Summary of FDA Advertising and Promotion Enforcement Activity can be found here.
In 2016, the Office of Prescription Drug Promotion (OPDP) issued 11 letters related to advertising and promotion. The Office of Compliance of the Center for Devices and Radiological Health (CDRH) did not issue any warning or untitled letters related to promotion this year, nor did the Office of Compliance and Biologics Quality (OCBQ) of the Center for Biologics Evaluation and Research (CBER).
In keeping with past practice, OPDP issued more untitled letters than warning letters. Of the 11 letters OPDP issued in 2016, eight were untitled letters. This difference reflects the agency’s general approach to untitled and warning letters; the latter reflect more serious agency concerns and are therefore less common.
OPDP issued letters addressing a wide range of promotional materials, including print materials (e.g., patient vouchers and display panels), Internet-based materials (e.g., websites), and video materials (e.g., patient vouchers and display panels). Videos were the most frequently cited medium, accounting for more than 50% of OPDP’s letters. This may suggest that FDA is giving increased attention to promotional materials in video format.
With respect to specific allegations in the letters, OPDP most frequently found fault with the presentation of risk information (in particular that the risks were omitted altogether or that the presentation was false and misleading). Four letters cited companies for allegedly promoting an investigational drug.