ICER Proposes Accelerated Approval Reforms Ahead Of FDA Meeting

The Institute for Clinical and Economic Review on Monday (April 26) released a slate of 10 policy reforms FDA and payers could undertake to strengthen FDA’s accelerated approval pathway. Some of the policy suggestions, ICER says, constitute minor adjustments to the current accelerated approval path, while others “will be considered radical reconstruction of the entire process” that require congressional intervention, including the potential to create an annual renewal or “sunset” timeline for accelerated approvals that lack postmarket confirmatory evidence and...