Characterizing FDA’s Approach to Benefit-Risk Assessment throughout the Medical Product Life Cycle
Following the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI), the U.S. Food and Drug Administration (FDA) has committed to improving the implementation and communication of its benefit-risk assessment framework. In FY 2020, FDA plans to publish draft guidance on benefit-risk assessment of new drugs and biologics. When finalized, the guidance will provide drug sponsors and other stakeholders with a clearer understanding of how considerations on a drug’s benefits versus risks factor into FDA’s regulatory decisions throughout the drug development life-cycle, including premarket and postmarket phases.
Stakeholders’ perspectives and experiences regarding the benefit-risk framework are important to FDA’s guidance development and to FDA’s communication and implementation of the framework. Accordingly, the Duke-Margolis Center for Health Policy—under a cooperative agreement with FDA—is convening a public meeting to discuss: 1) FDA’s planned benefit-risk assessment guidance; 2) activities that occur in pre-market development that best inform FDA’s benefit-risk assessment; 3) effectively communicating benefit-risk assessment information; and 4) using benefit-risk assessment to inform FDA and sponsor decision-making in the post-marketing setting.