Sanofi-Aventis has agreed to pay out over $190 million to the US government in order to settle allegations of drug-pricing fraud concerning Anzemet, which is used to prevent nausea and vomiting in patients undergoing intravenous chemotherapy.
The civil settlement, which is with the US Department of Justice, relates to claims that predecessor company Aventis Pharmaceuticals artificially inflated the price of Anzemet (dolasetron) which in turn increased the cost of government reimbursements for the drug. It covers the period from September 1997 to June 30, 2004, before the formation of Sanofi-Aventis, and the company said it had decided to resolve this “legacy matter” without admitting any wrongdoing.
Under the terms of the agreement, Sanofi will pay just over $182.8 million, plus interest, which includes $172.6 million to the US government to resolve all federal claims for civil damages, and a $10.2 million ‘opt-in’ fund which has been created for states looking to pursue Medicaid overpayment claims for Anzemet. Out of the pot, around $32 million will go to Ven-A-Care of the Florida Keys, a small pharmacy that used to be the leading provider of infusion drug services to homebound AIDS patients in the Key West area of the state and which now specialises in filing ‘whistleblower’ lawsuits.
Speaking about the settlement, US Attorney Alexander Acosta of the Southern District of Florida said that “again, a corporation has been caught fraudulently inflating the cost of a drug used primarily to reduce the side effects of cancer treatments without regard to the increased costs borne by government health care programmes or elderly and indigent patients”. He added that firms “cannot continue to mislead the government into paying vastly exaggerated prices by exploiting a healthcare system based on trust and fair play”.
The France-headquartered drugmaker noted that the sums involved are covered by existing reserves and its US subsidiary has entered into a five-year ‘corporate integrity’ agreement with the Department of Health and Human Services.