Press Release: A Path For FDA, Consumers Toward More Effective Drug Safety Labeling

July 23, 2019

WASHINGTON, D.C. -- 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 and whether they dissuade patients from taking a medication from which they might benefit or result in prescribing practices that do not comply with the labeling change.

The Duke-Margolis Center for Health Policy examined this issue and 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 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, and leveraging existing partnerships, including those maintained through the Agency’s Sentinel initiative and other sources.

“Communicating the most up-to-date information on a product’s safety to patients and providers is one of FDA’s most important functions,” said Mark McClellan, MD, PhD, director of Duke-Margolis. “This work reflects the collaborative contributions of experts to help FDA advance its understanding of the impact of post-marketing safety efforts.”