Dec 19 French drugmaker Sanofi has
agreed to pay $109 million to settle charges that it violated
the False Claims Act by providing free drugs as a form of
kickbacks to physicians, the U.S. Justice Department announced
The settlement resolves allegations that Sanofi submitted
false average sales price reports for the drug Hyalgan, a knee
injection to treat arthritis, that did not account for free
units distributed contingent on future purchases.
Average sales prices are used to determine reimbursement
rates by government health programs, such as Medicare. The
Justice Dept said the practice caused government programs to pay
inflated amounts for Hyalgan and a competing product.
Sanofi sales representatives were given thousands of free
"sample" Hyalgan syringes and used the free drug as kickbacks
with a promise to provide negotiated numbers of the syringes in
order to lower Hyalgan's effective price, the government
The drugmaker said it had taken "strong, proactive and
effective steps" to address the issue and voluntarily halted the
Hyalgan sampling program in 2009.
The settlement with the U.S. Attorney's Office, District of
Massachusetts, the U.S. Department of Justice and several states
resolves all claims arising out of the investigation into
sampling of Hyalgan, Sanofi said.
In addition to the $109 million payment, Sanofi said it
expects to enter into a Corporate Integrity Agreement with the
Office of the Inspector General of the United States Department
of Health and Human Services that will place its operations
under enhanced scrutiny.
There are no criminal charges against the company related to
the Hyalgan allegations.