Title

Pharmaceutical Regulation Failures and Changes: Lessons Learned From OxyContin Abuse and Diversion

Document Type

Article

Publication Date

4-1-2013

Department

Criminal Justice

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.

Publication Title

Journal of Drug Issues

Volume

43

Issue

2

First Page

164

Last Page

175