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: