This agreement was signed on September 2, 2015, but was not published until the end of November on the website of the Inspector General of the Bureau de la santé et des services sociaux. This CIA requires new compliance mechanisms, including the implementation of measures by Sanofi to ensure that agreements and interactions with third-party patient support programs comply with the law. In addition, the ICA requires audits by an independent audit body and compliance certifications from officers and board members. There was no admission of wrongdoing in the settlement, Reuters reports. Sanofi has entered into a company integrity agreement as part of this agreement. The agreement was signed on September 2, 2015, but was not published until late November on the website of the Inspector General of the Bureau of Health and Human Resources. This CIA is a prerequisite for other agreements between Sanofi and the United States to clarify allegations that Sanofi U.S. violated the False Claims Act between 2005 and 2009 by sending doctors to units free of Hyalgan knee injection ®, in violation of anti-bribery status that prompted doctors to purchase and prescribe the product. The regulation also resolves allegations that Sanofi US submitted false average selling price reports for Hyalgan® that did not take into account free units after the purchase of Demhyalgan®. Sanofi has also entered into a Corporate Integrity Agreement (CIA) with the Office of the Inspector General of the Ministry of Health and Human Services (HHS-OIG). The CIA requires, among other things, that Sanofi take steps to ensure that agreements and interactions with third-party patient support programs comply with the law.
In addition, the CIA requires audits by an independent audit body and compliance-related certifications from the company`s executives and board members. CAMBRIDGE, Mass., Feb. 28, 2020 /PRNewswire/ — Sanofi U.S. Announced today that it has entered into an $11.85 million settlement agreement with the federal government to resolve an investigation related to certain 2015 and 2016 financial donations to an independent patient support charity that supports patients with multiple sclerosis. “According to the allegations in today`s settlement agreement, Sanofi used an alleged charity as a conduit to funnel money to patients who were taking Sanofi`s very expensive drug, all at the expense of the Medicare program,” said U.S. Attorney Andrew E. Lelling. “This office will continue to prosecute pharmaceutical companies for violating anti-bribery laws. We commend Sanofi for promptly resolving the government`s allegations. This CIA is a condition precedent for other agreements reached by Sanofi and the United States to clarify allegations that Sanofi US violated the False Claims Act between 2005 and 2009 by giving doctors free units of its Hyalgan® knee injection in violation of the anti-bribery law to induce doctors to purchase and prescribe the product. The regulation also resolves allegations that Sanofi US provided false average selling price reports for Hyalgan® that did not take into account the free units that depended on the purchase of Hyalgan®. The government claimed that these false reports on average selling prices caused government programs to pay excessive amounts for Hyalgan® and a competing product.
On September 10, 2007, the United States The Department of Justice announced that French pharmaceutical company Sanofi-Aventis (“Aventis”), formerly Aventis Pharmaceuticals Inc., had agreed to pay $190 million to respond to allegations that the company had made false claims about Medicare and other federal health programs. The transaction agreement was the result of the alleged fraudulent pricing and marketing of ANZEMET (dolasetron mesylate), an antiemetic primarily used in oncology and radiological treatment. The government`s investigation began after Ven-A-Care of Florida Keys Inc., a merger of homes, filed a complaint with the Federal False Claims Act (“FCA”). The ACF allows individuals to take legal action on behalf of the government. As part of the settlement, Ven-A-Care whistleblowers will receive approximately $32 million. “Following the allegations in today`s transaction agreement, Sanofi used an alleged charity as a conduit to give money to patients taking Sanofi`s expensive drug, all at the expense of the Medicare program,” said Andrew E. Lelling, U.S. Attorney General. “This office will continue to prosecute pharmaceutical companies for violating anti-bribery laws. We commend Sanofi for promptly resolving the government`s allegations. A press release from Sanofi states: “All of the company`s requirements are already integrated in the U.S.
Compliance Program. Sanofi also underscored its commitment to compliance, stating that its “compliance program is regularly enhanced to ensure that its controls meet or exceed complex and evolving legal, regulatory and industry requirements, as well as patient and supplier expectations.” In addition to the $11.85 million payment agreement to resolve these claims, Sanofi has entered into a Commercial Integrity Agreement (CIA) with the Inspector General`s Office of Health and Health Services (HHS-OIG). .
