A Framework for Evaluating the Impact of Prescription Drug Postmarketing Safety Labeling Changes

Changes by the Food and Drug Administration (FDA) to drug safety labeling are an important way to provide patients and providers with the most up-to-date information about a product’s risk. However, too little is known about the impact of these changes on health systems behavior and patient outcomes.

The Duke-Margolis Center for Health Policy examined this issue, developed recommendations, and a research agenda intended to help FDA better understand the impact of its labeling changes and its communications about drug risks. Duke-Margolis undertook this work as part of a cooperative agreement with FDA and in collaboration with nationally renowned experts on this topic, including Becky Briesacher, Northeastern University; Stacie Dusetzina, Vanderbilt University School of Medicine; Chester “Bernie” Good, University of Pittsburgh; Kenneth Hornbuckle, Eli Lilly and Company; and Joseph Ross, Yale University.

The Duke-Margolis white paper outlines an effective research approach to better determine both the impact and unintended consequences of changes made to a drug’s labeling once it is in the marketplace. Duke-Margolis also made several recommendations for the FDA’s consideration, including:

• improving its Safety Labeling Changes website to ensure it provides robust and accessible information;
• announcing priority topics for study, which Duke-Margolis identified, to the research, funding,  and pharma communities;
• publishing FDA’s intended goals for labeling changes to allow for better evaluation of those changes; and
• establishing an expert consortium to systematically evaluate the impact of labeling changes, using real-time data on key health and behavioral outcomes, leveraging existing partnerships, including those maintained through the Agency’s Sentinel initiative and other sources.