10 ways to reform the FDA's accelerated approval pathway: ICER and MSKCC offer options
The FDA’s top cancer doctor Rick Pazdur recently called the FDA’s accelerated approval pathway “under attack,” and three top drug pricing experts from Memorial Sloan Kettering Cancer Center and ICER are now calling the pathway “in flux, and many would say, in crisis.”
As the alarm bells sound, Pazdur’s Oncology Center for Excellence initiated a review of the accelerated approval pathway about a year ago, while more recently, HHS’ Inspector General said it also will review the pathway, following a quick accelerated OK for Biogen Alzheimer’s drug Aduhelm. The latter review came in the face of conflicting data over whether the drug could actually slow patients’ mental decline.
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