Posted by Michael Wonder on 26 Apr 2021
ICER publishes white paper evaluating policy options to strengthen FDA’s accelerated approval pathway for prescription drugs
26 April 2021 - Informed by expert input from patient groups, former regulators, payers, and life science companies, white paper analyses potential impact of a variety of reform options that address the balance between uncertainty, access, innovation, and costs.
The Institute for Clinical and Economic Review, in collaboration with researchers from the Drug Pricing Lab at Memorial Sloan Kettering Cancer Center, has published a new white paper: “Strengthening the Accelerated Approval Pathway: An Analysis of Potential Policy Reforms and Their Impact on Uncertainty, Access, Innovation, and Costs.”
This paper aims to create a clearer understanding of both the opportunities and challenges inherent in the accelerated approval pathway, and to present an analysis of the potential risks and benefits of a range of reform options that policymakers may consider in efforts to strengthen the accelerated approval pathway moving forward.
