Company Fined for Defrauding FDA

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

Roussel Uclaf admitted to two counts of conspiracy and introducing “adulterated” drugs in violation of the Food, Drug and Cosmetic Act, the department said.

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.

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. That company, too, has since been acquired by Aventis.

A spokeswoman for Aventis was not available for comment.

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.