Top Viewed Bioethics Article

We would like to highlight the success of our lab member's article, "external page Accelerated Drug Approval: Meeting the Ethical Yardstick," recently awarded as a top-viewed publication in Bioethics.

This work critically examines the ethical dimensions of expedited regulatory pathways for pharmaceuticals addressing unmet medical needs. While accelerated approval (AA) mechanisms intend to expedite access to potentially life-altering treatments, recent controversies, notably surrounding the authorization of Aducanumab for Alzheimer's disease, have amplified concerns regarding the inherent trade-offs between rapid access and the rigor of safety and efficacy data.

Addressing a gap in existing scholarship, the article posits a structured ethical framework comprising six core conditions for the justifiable application of AA as shown in the table below. The authors argue that these interconnected principles provide essential benchmarks for evaluating the ethical legitimacy of both AA frameworks and specific approval decisions. Furthermore, the paper offers pragmatic considerations for the integration of these ethical imperatives within regulatory science and oversight practices.