US says Aventis unit fined $33 mln for fraud 

WASHINGTON (Reuters) - A French company that is now part of pharmaceutical giant Aventis SA was fined $33 million Friday after pleading guilty to defrauding the U.S. Food and Drug Administration, the Justice Department said.

Roussel Uclaf SA admitted to two counts of conspiracy and introducing "adulterated" drugs in violation of the U.S. Food, Drug and Cosmetic Act, the department said.

The case centers on an antibiotic, manufactured by Roussel Uclaf, called Cefaclor. The government said that in 1995 and 1996 the company "willfully sought to mislead the Food and Drug Administration about where and how Cefaclor was being manufactured."

Cefaclor is manufactured by Roussel through an Italian subsidiary called Biochimica S.p.A. That company, too, has since been acquired by Aventis.

The fine was among the largest ever imposed in a criminal pharmaceutical prosecution, according to the department and Thomas DiBaggio, U.S. Attorney for the District of Maryland, who co-prosecuted the case.

Aventis spokeswoman Lori Kraut said the plea marks "the closing of a very old chapter" for the company. "We are happy to have this behind us," she said.

Roussel became part of the company in 1999 when its parent company, Hoechst Marion Roussel, merged with French pharmacuetical company Rhone-Poulenc in 1999 to form Aventis.

FDA regulators who approve drugs sold in the United States need to know where they are manufactured so they can monitor and inspect facilities and production methods.

According to the department, "members of the conspiracy" at the company gave the FDA records on the production of Cefaclor that "falsely misrepresented the production method for Cefaclor and falsely showed the manufacturing facilities involved in the production of the drug," the department said.

In addition, they kept a false set of records about the manufacturing process and gave false records to FDA inspectors, the department said.