ICER ponders options for strengthening FDA's AAP

US non-profit the Institute for Clinical and Economic Review (ICER), in collaboration with researchers from the Drug Pricing Lab at Memorial Sloan Kettering Cancer Center, has published a new white paper.

The research is entitled Strengthening the Accelerated Approval Pathway: An Analysis of Potential Policy Reforms and Their Impact on Uncertainty, Access, Innovation, and Costs.

"A good time to take stock"This paper aims to create a clearer understanding of both the opportunities and challenges inherent in the US Food and Drug Administration’s (FDA) accelerated approval pathway (AAP), 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 AAP moving forward.