Untested Drugs to Treat Ebola: A Case of Uncompassionate Compassionate Use?

Abstract

This Article examines the FDA’s Expanded Access or, as they are commonly referred to, “compassionate use” regulations. The purpose of these regulations is to provide access to promising unapproved drugs without exposing patients to unnecessary risk, jeopardizing on-going clinical trials, or delaying the development of new medication for marketing approval. However, since their enactment over thirty years ago, Expanded Access regulations have been a continual source of criticism from patients, pharmaceutical manufacturers, and physicians alike. In response, the FDA has repeatedly tried to find the appropriate balance between authorizing access to experimental treatments and ensuring the integrity of the drug approval process. Beginning with the recent Ebola outbreak and then continuing the discussion to include other practical and legal issues central to Expanded Access debate, this Article posits that, in large part, the FDA’s balancing efforts have failed. Next, this Article sets forth an Expanded Access regulatory framework that reconciles a patient’s desire to access experimental therapies and society’s interest in the efficient development of new drugs to treat life-threatening conditions while protecting vulnerable patients from unnecessary risks. In doing so, this Article concludes by striking that elusive balance.