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May 11, 2007

Pharmaceuticals

Purdue Pleads Guilty In OxyContin Case

Drugmaker to pay $600 million for misleading promotion of narcotic painkiller

Rick Mullin

Purdue Pharma has pleaded guilty in a federal court in Abingdon, Va., to charges by the federal government that the company made misleading statements to doctors and patients about its painkiller OxyContin. Purdue agreed to pay a fine of $600 million.

Michael Friedman, the president of Purdue Pharma; Howard R. Udell, a lawyer for the firm; and Paul D. Goldenheim, its former medical director, also pleaded guilty in the settlement, agreeing to pay $34.5 million in fines.           

The U.S. attorney for the Western District of Virginia charged that the company falsely claimed to physicians that the drug's slow-release delivery mechanism made it less susceptible to abuse than other painkillers on the market. The drug’s sales hit the blockbuster mark of more than $1 billion a year.

Abuse of OxyContin, however, became a serious problem, largely in rural areas, where the drug, a concentrated version of the narcotic oxycodone, was chewed, snorted, or injected to produce what users described as a heroin-like high.

The company issued a statement acknowledging that employees were responsible for making claims inconsistent with the FDA-approved prescribing information for the drug more than six years ago.

Purdue's plea settlement comes amid heightened pressure from federal regulators on drug companies regarding misbranding—the issuing of misleading statements in labeling, advertising, or promotion to physicians.

Bristol-Myers Squibb yesterday said it would plead guilty to two counts of making false statements in a federal antitrust investigation regarding the patent on its anticlotting drug Plavix. The charges carry a maximum fine of $1 million.

Chemical & Engineering News
ISSN 0009-2347
Copyright © 2008 American Chemical Society

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