Six ethics requirements for accelerated drug approval
In a recent Bioethics article, lab members Andreoletti and Blasimme delve into the ethical dimensions of AA, proposing six crucial conditions for its justifiable use.
The U.S. FDA's controversial accelerated approval (AA) of Aducanumab, the first drug for Alzheimer's disease, ignited a fierce debate about the balance between rapid access to potentially life-changing treatments and the need for robust evidence of safety and efficacy. This decision, met with significant criticism regarding the strength of the supporting data, prompted a deeper examination of the ethical underpinnings of the AA pathway.
In a recent Bioethics article, lab members Mattia Andreoletti and Alessandro Blasimme add to the critical discussion, moving beyond the scientific arguments surrounding Aducanumab so as to explore the uncharted ethical territory of accelerated drug approval.
Of note, the authors propose a framework of six essential conditions – moral solicitude, evidence, risk mitigation, impartiality, sustainability, and transparency – that they argue must be met to ensure the ethical legitimacy of AA processes and decisions.
By outlining these conditions and suggesting practical steps for their implementation, the article aims to provide a benchmark for assessing and improving the ethical validity of fast-track drug approvals.
