FDA to Research Provider Boxed Warning Perceptions

The CDER Office of Prescription Drug Promotion is proposing research to determine healthcare providers’ awareness, perceptions, and beliefs about the benefits and risks of an FDA-approved product that carries a Boxed Warning. A Federal Register notice says Boxed Warning information may be included as part of prescribing information at the time of FDA approval. It also may be added to or modified in the prescribing information of drugs already on the market on the basis of new safety information.

“Boxed Warnings are an important and frequently used communication tool,” the notice says. To address gaps in the research on Boxed Warning perceptions, FDA plans to conduct a Web-based survey of healthcare providers. The proposed collection of information is expected to strengthen the agency’s understanding of how healthcare providers may receive, process, and used Boxed Warning and other safety labeling information.