Shelley Jazowski

Jul 10, 2023 | jamanetwork.com | Shelley Jazowski |Avi U. Vaidya |Julie M. Donohue |Stacie B. Dusetzina

Commercial Health Plan and Enrollee Out-of-Pocket Spending on Accelerated Approval Products in 2019 Under the accelerated approval program, the US Food and Drug Administration (FDA) may approve a drug based on surrogate end points and requires manufacturers to complete postmarketing studies to confirm a drug’s clinical benefit.1,2 Accelerated approval products, including those of low3 or uncertain therapeutic value, have cost Medicare and Medicaid billions of dollars annually.1,2 Given the...

May 22, 2023 | jamanetwork.com | Shelley Jazowski |Julie M. Donohue |Stacie B. Dusetzina |Avi U. Vaidya

Time to Confirmatory Study Initiation After Accelerated Approval of Cancer and Noncancer Drugs in the US Under the accelerated approval pathway, the US Food and Drug Administration (FDA) may approve a drug based on surrogate end points that are reasonably likely to predict clinical benefit.1 Although FDA-required studies must be conducted to confirm a drug’s clinical benefit, the accelerated approval pathway has received growing criticism due to manufacturers’ delays in completing these...