Understanding the Impact of the Accelerated Approvals Program

The FDA’s Accelerated Approval Program (AAP) aims to bring promising, potentially life-saving medicines to patients sooner by allowing approvals based on surrogate endpoints while requiring timely confirmatory evidence. In this episode, we speak with Bridget Doherty, MPH, MS (Johnson & Johnson Innovative Medicine), and Jeff Allen, PhD (Friends of Cancer Research). Bridget discusses her team’s review of the AAP’s real-world impact, showing that hundreds of thousands of meaningful life-years have been gained for patients. Jeff shares findings from work strengthening biomarkers as reliable surrogate endpoints—helping define when increased speed can still preserve scientific rigor. We also explore the core access challenge: how payer coverage and utilization management help or hinder patients the AAP is designed to serve. We close with practical policy steps to ensure that earlier regulatory access truly leads to better outcomes for people who need treatments most.

• Bridget Doherty, MPH, MS, Johnson & Johnson

• Jeff Allen, Friends of Cancer Research

• J&J Center for U.S. Healthcare Policy Research

• Friends of Cancer Research

• Accelerated Approvals in Oncology Tracker

• Drug Development Dashboards

• 30 Years of Accelerated Approval: Data-Driven Insights

• Analysis of FDA Biomarker Qualification Program

• Original JNCCN Study

• How Gleevec Transformed Leukemia Treatment

• Immunotherapy

• Surrogate Endpoints

• Confirmatory Trials

• Years Gained from the FDA Accelerated Approval Program (2024)

• Circulating Tumor DNA (ctDNA)

• ctMoniTR Project

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