High-Risk Pharma Marketing Violations Draw Scrutiny
Much has been made of the decline in FDA warning and “untitled” letters citing pharma companies for violating marketing and communications requirements and policies.
It may be that marketers are being more careful to avoid serious violations, observe some experts. But the change may be due more to the agency’s shift in enforcement focus to actions that raise serious safety issues, as opposed to overstepping disclosure rules.
In recent comments, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), noted that FDA’s Office of Prescription Drug Promotion (OPDP) is being very careful to issue enforcement letters that challenge actions that could lead to patient harm, as opposed to practices involving unlabeled uses.
This approach was emphasized by FDA regulators and legal experts at the Advertising and Promotion Conference sponsored by the Food and Drug Law Institute (FDLI) in October in Washington, D.C.