FDA's Authority in Drug Approval and Withdrawal

The chapter explores the FDA's power to revoke drug approvals based on new data and the statutory standard, focusing on safety concerns rather than lack of efficacy. It delves into case studies of drug approvals like Reliberto and AMLEX, examining the decision-making process, international influences, drug pricing, and societal implications. The conversation also addresses the aftermath of ineffective drug trials, highlighting the challenges faced by patients with ALS and the importance of regulatory decisions for the ALS community.