Aventis Agrees to $33M in Fines for Defrauding FDA
Drug maker Aventis SA on Friday pleaded guilty to charges that a French subsidiary misled the FDA about the production of its antibiotic cefaclor in order to receive the agency's approval, the Washington Post reports. The company admitted in U.S. District Court to one count of conspiracy and one count of "introducing adulterated drugs in interstate commerce with the intent to defraud," and agreed to pay a criminal fine of $23.2 million and a civil fine of $10 million. No consumers were harmed by the antibiotics, and no evidence was produced indicating that any harmful substances existed in the drug. The agreement marks the first time a foreign corporation has been found guilty of a crime and punished for defrauding the FDA regarding a medication made outside the United States but marketed to U.S. consumers. The fines are the fourth-largest ever involving the manufacture of drugs (Castaneda, Washington Post, 10/20). Between April 1995 and Sept 1996, Roussel Uclaf SA, which later became part of Aventis, manufactured Cefaclor in labs in Italy, France and Romania that had not been listed on the company's FDA application. The company also provided "false records" -- including raw data books, software and work orders -- to the FDA. According to the plea agreement, the "purpose of the deception" was to make more Cefaclor available in the United States (McQuillen, Bloomberg News/Bergen Record, 10/20). Roussel Uclaf has since been sold by Aventis, and none of its employees still work for Aventis. Aventis also settled a civil lawsuit brought by competitor Eli Lilly and Co. for $110 million and agreed to pay $55 million in restitution to companies that purchased Cefaclor. "Today's massive criminal penalty sends an unmistakable message to all pharmaceutical companies worldwide. 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," Thomas DiBiagio, Maryland U.S. Attorney-designate, said (Washington Post, 10/20).