FDA guidance on drug safety communication

The US Food and Drug Administration has issued final guidance, describing the agency's approach to communicating drug safety information to the public.

Steven Galston, Director of the CDER, said: "the guidance provides for timely communication of drug safety information, which has been, and continues to be, an extremely high priority for the FDA." He added: "our goal is to make emerging drug safety information available in a balanced, impartial manner so that health care professionals and patients can consider the information when making decisions about medical treatments despite uncertainties in the data."

Apart from drug product labeling, the FDA listed its methods of communicating important product safety data: Public Health Advisories, giving information and advice about an emerging drug safety issue or other important public health information to the public and health care professionals; Patient Information Sheets, plain language concise summaries of the most important drug information; Healthcare Professional Sheets, a summary of important and emerging drug safety issues, with a focus on detection of the issue and pointers for clinical decision-making; and Alerts on Patient Information and Health Professional Sheets. The latter are alerts that can be placed on each of the other communications tools, providing a summary of important issues.