Accelerated Approvals Could Have Expiration Dates, Annual Reviews To Promote Confirmatory Trials, ICER Suggests

29 Apr 2021

Institute for Clinical and Economic Review tackles reform of US FDA’s accelerated approval program in white paper responding to payer concerns about managing high-cost drugs supported by limited efficacy data and patient frustrations over possible access restrictions.

FDA stamp — Cumulative Annual Net Cost For Many Accelerated Approvals Could Exceed $150,000

Sponsors of drugs approved through the US Food and Drug Administration’s accelerated pathway could be encouraged to produce high quality confirmatory evidence in a more timely way if the approvals are subject to expiration when the evidence is not presented by a specified deadline, the Institute of Clinical and Economic Review suggests in a new white paper.

One way to “fortify requirements for confirmatory evidence is to avoid putting the FDA in the position of having to...