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Prescription for Better AccessAuthor: Mark Hansan and Dr. Scott Howell
With pharmaceutical and biotech manufacturers launching more high-cost specialty drugs and the insurance industry increasing the use of more restrictive barriers to access, those who need these medicinesthe patients themselvesare caught in the middle, not only shouldering the cost of higher copays and deductibles, but for many, rationing or even abandoning treatment altogether. While manufacturers invest in programs to help navigate the challenges impeding access and affordability, the entire healthcare industry can agree -- the status quo is unsustainable. There has to be a better way. And two industry veterans have joined forces to co-host a new interview-focused podcast to help shape the future of patient access and affordability. Language: en-us Genres: Health & Fitness, Life Sciences, Medicine, Science Contact email: Get it Feed URL: Get it iTunes ID: Get it |
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Understanding the Impact of the Accelerated Approvals Program
Tuesday, 25 November, 2025
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 Questions or comments? Email us at comments@prescriptionforbetteraccess.com. Find us on social media: X, LinkedIn, YouTube, and Threads.
