David S. Egilman, MD, MPH, Department of Community Health, Brown University, 8 North Main St., Attleboro, RI 02703, 508-226-5091, degilman@egilman.com and Julie Falender, BA, Never Again Consulting, 8 North Main Street, Suite 404, Attleboro, MA 02703.

Pharmaceutical Companies have found ways to manipulate the regulatory process to allow drugs to be marketed for inappropriate uses. Purdue Pharma has aggressively marketed OxyContin through an advertising campaign that misled health providers and the public about the dangers of OxyContin. In many ways, Purdue’s formulated a marketing strategy to ease the concerns of patients and physicians regarding the risks of abuse, diversion, addiction and death by overdose with OxyContin.

In July of 2001, the FDA recognized shortfalls in the OxyContin label after numerous reports of abuse and drug-related deaths. After the FDA cited Purdue for understating the dangers of OxyContin, Purdue revised its OxyContin label to include a “black box warning” regarding abuse risks, and added a new section on “Misuse, Abuse, And Diversion of Opioids.” Much of the information in the new “Black Box Warning” --the strongest warning found on prescription drugs-- included additional information related to addiction. Ironically, Purdue recognized that they could transform the FDA’s reprimand into a marketing advantage with “enormous opportunities.”

We will review the steps taken by Purdue and other pharmaceutical companies to use marketing to mislead the public and health care providers and we will suggest how the drug regulatory process can be changed to better protect public health.

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