Pharmaceutical Regulation Failures and Changes

Abstract

OxyContin, a controlled-release opioid developed and produced by Purdue Pharma, was given Food and Drug Administration (FDA) approval in December 1995. By 1999, to the apparent surprise of Purdue Pharma, the Drug Enforcement Administration (DEA), and the FDA, extensive reports of OxyContin abuse and diversion began to circulate. The drug abuse assessment liability system in the United States has often been criticized and the experience with OxyContin did nothing but buttress those criticisms. However, as seven investigational hearings conducted by the U.S. Congress would expose, several changes were made to the abuse liability assessment to correct deficiencies in the system which had aggravated OxyContin abuse and diversion—a welcome sign from what many have considered an American tragedy.