OPDP to Study Targeted Mechanism of Action in Ads

FDA says the CDER Office of Prescription Drug Promotion is proposing to investigate the influence of targeted mechanism of action claims, graphics, and disclosures that provide context about a drug’s targeted mechanism of action in both consumer and healthcare professional promotions. A Federal Register notice says the research will explore how varied targeted mechanism of action presentations affect consumer and healthcare professional understanding of a drug’s mechanism of action, perception of drug benefits and risks, attention to risk information, and interest in the drug.

The notice says the investigation will build on earlier research that appeared to show a tendency to the impression that products with promotional materials using the term targeted mechanism of action would be safer and more effective than other similar treatments.