DIA 2025 Global Annual Meeting

Component Type: Session
Level: Intermediate

The FDA Accelerated Approval Program has been criticized for employing lower regulatory standards than traditional approval, undue delays in withdrawing therapies approved under Accelerated Approval for which studies have not confirmed clinical benefit, and confirmatory trials not being pursued with due diligence . Of specific focus for critics has been withdrawn treatments, which are being used as examples of the program’s ineffectiveness and basis for proposed changes. However, the purpose of the program is to allow acceptable risk in order to address patients with a large unmet need. The small percentage of drugs whose clinical benefit is ultimately not confirmed should not be viewed as a failure of the accelerated approval program. Rather, they represent an expected trade-off in expediting drug development that benefits patients with serious or life-threatening diseases. Withdrawals make up a small percentage of the total number of therapies approved under Accelerated Approval and do not reflect overall management of the program over its 30-year history, particularly improvements seen in the last decade in the time from accelerated approval to conversion. In addition, the reasons for the withdrawals are complex and need to be understood within the context of the overall impact on patient outcomes due to early access enabled by the program.

Learning Objectives

Examine the reasons for product withdrawals after Accelerated Approval and identify the different situations where a withdrawal may occur; Recognize clinical impact including life years gained and uptake after Accelerated Approval of oncology products that were later withdrawn; Describe the benefits and challenges encountered by regulators, industry, and patient organizations when it comes to the use of AAP and withdrawals.

Chair

Bridget Doherty, MPH, MS

Speaker

Industry Perspective
Kevin Bugin, PhD, MS, RAC

Non-Profit Perspective
Jeff Allen, PhD