Tackling drug shortages in the USA: The FDA's action plan

By Dr Nicola Davies

A drug shortage is defined by the Federal Food, Drug, and Cosmetic (FD&C) Act as a period of time when the demand or projected demand for a drug in the US exceeds its supply.1

In addition, the Food and Drug Administration (FDA) considers a drug to be in shortage when the supply of all commercially available versions of the drug cannot meet the current demand, and a registered alternative manufacturer also won’t be able to meet the current and/or projected demands.1 The main reasons for drug supply shortages are manufacturing quality issues, production delays, delays in receiving raw materials, and discontinuation of older drugs in favor of newer, more profitable ones.