Addressing Looming Prescription Drug Shortages Through Legislative and Regulatory Approaches

Abstract

An alarming increase in drug shortages in recent years presents a crisis affecting medical facilities across the nation, compromising patient care in a wide variety of serious illnesses. Many of the medications affected by these shortages are critical products, including oncology drugs, anesthetics, and antimicrobials. The frequency of drug shortages has steadily increased since 2005, nearly tripling over the span of five years. This Note proceeds in two parts. Part I provides back-ground on the recent drug shortage problems afflicting patients and medical facilities throughout the country and the current and proposed regimes available to address these problems. Part I.A provides background on the numerous underlying causes of drugs shortages, including the role of raw material supplies and manufacturing capabilities, and Part I.B examines the subsequent impact of shortages on patient care and the resources of medical facilities. Part I.C, Part I.D, and Part I.E explain the FDA’s existing drug shortage program, provide background on both the pending legislation in Congress meant to address current and future shortages, and the recent executive order issued in response to the shortage problem, respectively. Part II of this Note provides analysis of the proposed legislation for addressing the drug shortage problem and provides additional, alternative approaches for mitigating the occurrence and severity of shortages. This Note concludes that existing legislation makes important steps in assisting the FDA to adequately manage these shortages, but ultimately falls short of providing the multifaceted approach necessary to address the many underlying problems influencing these shortages.