Decelerating the Hyperbole Over Accelerated Approval

Faegre Drinker Consulting principal Tim Franson coauthored an article with Peter Pitts, president of the Center for Medicine in the Public Interest, for BioCentury that examines the United States Food and Drug Administration’s (FDA) accelerated approval process and the prioritization of cost effectiveness over clinical benefit.

Franson and Pitts provide an overview of recent published articles that discuss why robust science should drive the conversation and how U.S. value assessment data has been overlooked. The authors outline what has been missing or inadequate in publications related to U.S. accelerated approvals and state that there should be no place for “arbitrary censuring” in this area of analysis.

The authors discuss the importance of quantitative and qualitative data in terms of unmet medical needs. In the post-pandemic “next normal,” Franson and Pitts explain that a more progressive expression of how data evolve over time is particularly relevant for innovative medicines approved via accelerated approval.