>

Sanofi Genzyme Corporate Integrity Agreement

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.” 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”). The Cia d`Aventis contains requirements: In addition to approving the $11.85 million payment to settle these claims, Sanofi has entered into a Business Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General (HHS-OIG). This CIA requires new compliance mechanisms, including Sanofi`s implementation of measures to ensure that agreements and interactions with third-party patient assistance programs comply with the law. In addition, the CIA requires audits through an independent audit organization and compliance certification of business leaders and board members. 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. The agreement was signed on 2 September 2015, but was not published on the website of the Inspector General of the Office of Health and Human Resources until the end of November.

This CIA is a precondition for other agreements reached by Sanofi and the United States to resolve accusations that Sanofi U.S. violated the False Claims Act between 2005 and 2009 by sending doctors to units free of its Hyalgan knee injection ® in violation of the anti-kickback status that led doctors to purchase and prescribe the product. The comparison also resolves accusations that Sanofi US filed false average selling price reports for Hyalgan® that did not take into account free units after Demhyalgan® purchase. The government claimed that these false average sales price reports led government programs to pay excessive amounts for Hyalgan® and a competing product. “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 U.S. Attorney General Andrew E.

Comments are closed.