- The Washington Times - Saturday, October 20, 2001

A French drug manufacturer pleaded guilty yesterday to felony charges of conspiracy and defrauding the Food and Drug Administration.

Roussel Uclaf SA was ordered to pay criminal and civil penalties of more than $33 million in the felony case, the Justice Department said one of the largest penalties ever imposed in a criminal pharmaceutical prosecution.

It is the first time a foreign company has been criminally punished for defrauding the FDA about a drug it manufactured entirely outside the United States but marketed to the American public.

U.S. Attorney Thomas M. DiBaggio in Maryland said the fine was included in a plea agreement among his office, Aventis, Pharma AG the successor to Roussel Uclaf and the Justice Department.

"Today's massive criminal penalty sends an unmistakable message to all pharmaceutical companies worldwide," Mr. DiBaggio said. "If you plan on selling drugs to the American public, you must play by our rules, whether your company is located inside or outside the United States. This kind of fraud will cost you dearly."

The company pleaded guilty under a two-count indictment charging it with conspiracy and the introduction of adulterated drugs in interstate commerce with the intent to defraud or mislead, in violation of the Federal Food, Drug and Cosmetic Act.

According to the statement of facts to which a Roussel Uclaf representative admitted, the case involved Roussel Uclaf's manufacture of the drug cefaclor in 1995 and 1996 through an Italian company, Biochimica Opos SpA, a wholly owned subsidiary of Roussel Uclaf.

Cefaclor is an antibiotic used to treat various infections, including respiratory infections, tonsillitis, and urinary tract infections. Although manufactured outside the United States, Roussel Corp., another wholly owned subsidiary of Roussel Uclaf, distributed cefaclor and other drugs manufactured by Roussel Uclaf and Biochimica Opos in the United States.

Since then, Roussel Uclaf has become part of Aventis.

According to the plea agreement, between April 1995 and September 1996, various individuals, including authorized agents of Roussel Uclaf, sought to mislead the FDA about where and how cefaclor was being manufactured. The purpose was to increase the amount of the drug available for sale by Roussel Corp. in the United States.

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