• by John Gaffney , January 24, 2003

The normally staid Food And Drug Administration broke out some harsh words last week in its findings that advertisements for the drug OxyContin violated the agency’s regulations.

In a letter delivered to drug manufacturer Purdue Pharma, the agency came down hard on two ads that ran in the Journal of the American Medical Association last fall. OxyContin, a painkiller so strong it has been used for terminal cancer patients, has been widely abused by teens and young adults. Its marketing practices have come under for fire by many anti-drug and consumer groups.

“The combination in these advertisements of suggesting such a broad use of this drug to treat pain without disclosing the potential for abuse with the drug and the serious, potentially fatal risks associated with its use, is especially egregious and alarming in its potential impact on the public health,” the FDA warning stated.

Purdue does not do any direct-to-consumer advertising of OxyContin. According to a statement from the company the ads do not recommend usage of OxyContin beyond the FDA-approved label indication. “It is Purdue's opinion that the letter was the result of an honest misunderstanding, which we regret, regarding the featuring of safety information already presented in the brief summary that is a part of the two new ads for OxyContin Tablets. The boxed warning was prominently referenced in bold print on the front page of each ad and printed in its entirety on a subsequent page.”

If it was a misunderstanding the letter doesn’t hint at it. The FDA cites particular offense with “omission of material facts related to abuse liability and fatal risks. The November Ad contains a two-page spread picturing a man fishing with a boy featuring the prominent headline “There Can Be Life With Relief.” The words “Life With Relief” are the largest in the advertisement. The ad also features a graphic of two paper medication dosage cups with “8 AM” and “8 PM” next to them. The logo for OxyContin is right below, with the prominent tagline “It Works.” The October Ad includes the claim “Remember, Effective Relief Takes Just Two.”

“Neither one of your ads presents in the body of the advertisements any information from the boxed warning disclosing that the drug can be fatal if taken by certain patients or under certain conditions,” the FDA letter states. “It is particularly disturbing that your November Ad would tout “Life With Relief,” yet fail to warn that patients can die from taking OxyContin.

For its part Purdue Pharma has been working with Rudolph Giuliani Partners, LLC on various management initiatives including a program to combat prescription drug abuse. Since the commencement of this relationship four months ago, Giuliani Partners, LLC has been advising the company on a range of internal issues including solutions aimed at preventing prescription drug abuse.