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Sanofi Corporate Integrity Agreement 2020

“According to the allegations made in today`s transaction agreement, Sanofi used an alleged charity as a channel to give money to patients taking Sanofi`s expensive drug, all at the expense of the Medicare program,” said Andrew E. Lelling, the U.S. Attorney General. “This office will continue to sue drug companies for violations of anti-kickback laws. We commend Sanofi for quickly resolving the government`s accusations. February 28, 2020 The U.S. Department of Justice (DOJ) announced that Sanofi-Aventis U.S., LLC (Sanofi) has agreed to pay $11.85 million to refute allegations that it violated the False Claims Act (FCA) by paying bribes to Medicare patients through a non-profit foundation, the Assistance Fund (TAF). On September 10, 2007, the U.S. Department of Justice announced that French pharmaceutical company Sanofi-Aventis (“Aventis”), formerly Aventis Pharmaceuticals Inc., had agreed to pay $190 million to respond to accusations that the company had caused false allegations about Medicare and other federal health programs. The transaction agreement was the result of the alleged fraudulent pricing and marketing of ANZEMET (Dolasetron-Mesylat), an antiemetic drug used primarily in relation to oncology and radiological treatment. The government investigation began after Ven-A-Care of Florida Keys Inc., a home merger, filed a complaint with the Federal False Claims Act (“FCA”). The ACF allows individuals to file legal action on behalf of the government.

As part of the comparison, Ven-A-Care whistleblowers receive approximately $32 million. According to a Sanofi press release, “all requirements are already integrated into the company`s U.S. compliance program.” Sanofi also emphasized its commitment to compliance and stated that its “compliance program is regularly improved to ensure that its controls meet or exceed complex and evolving legal, regulatory and sector requirements, as well as patient and supplier expectations.” CAMBRIDGE, Mass., February 28, 2020 /PRNewswire/ — Sanofi U.S. today announced that it has reached a $11.85 million settlement agreement with the federal government to clarify an investigation into certain financial donations made in 2015 and 2016 to an independent charitable association support foundation that supports patients with multiple sclerosis. In exchange for the Department of Health and Human Services Office of Inspector General `OIG` agreement not to exclude Aventis from federal health programs, Aventis agreed to enter into a five-year enterprise integrity agreement (“CIA”).