Regulatory And Legislative Responses To Drug Shortages

Over the past year, the problem of drug shortages has received markedly increased attention from the federal government. This July, Congress passed new legislation addressing shortages (Title X of the Food and Drug Administration Safety and Innovation Act, which is better known as the User Fee Bill). President Obama issued an Executive Order last October. The Food and Drug Administration ("FDA") has promulgated new regulations and a new guidance, and it has devoted increasing resources to addressing shortages.

This increased focus followed in the wake of the much-quoted statistic that the number of shortages tracked by the FDA almost tripled between 2005 and 2010, from 61 to 178. The number rose again in 2011, to 251, amid increasing attention from health-care providers and the mainstream media.¹