Corporate Integrity Agreement Sanofi

Sep 16, 2021 |

This agreement was signed on September 2, 2015 but was not published on the website of the Inspector General of the Office de la santé et des services sociaux until the end of November. “According to the allegations in today`s settlement agreement, Sanofi used an alleged charity as a channel to transfer money to patients who were taking a very expensive drug from Sanofis, 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-kickback laws. We commend Sanofi for the swift resolution of the government`s accusations. View Original Content: www.prnewswire.com/news-releases/sanofi-us-reaches-settlement-agreement-to-resolve-allegations-related-to-patient-assistance-301013619.html In exchange for the agreement of the Department of Health and Human Services Office of Inspector General (“OIG”), Aventis has agreed to enter into a company agreement (“CIA”) for five years. The Aventis CIA contains requirements regarding: according to a press release from Sanofi, “all requirements are already integrated into the company`s existing U.S. compliance program.” Sanofi also underscored its commitment to compliance and said its “compliance program will be steadily enhanced to ensure that its controls meet or exceed complex and developing legal, regulatory and industry requirements, as well as patient and supplier expectations.” CAMBRIDGE, Mass., Feb. 28, 2020 /PRNewswire/ — Sanofi U.S.

announced today that it has entered into an $11.85 million agreement with the federal government to resolve an investigation into certain financial donations in 2015 and 2016 to an independent charitable patient aid foundation that helped patients with multiple sclerosis. On September 10, 27, 2007, the U.S. Department of Justice announced that the French pharmaceutical company Sanofi-Aventis (“Aventis”), formerly Aventis Pharmaceuticals Inc., had agreed to pay $190 million to respond to allegations that the company had filed false claims with Medicare and other federal health programs. The transaction agreement was the result of the alleged fraudulent pricing and commercialization of ANZEMET (Dolasetronmesylat), an antiemetic primarily used in connection with oncology and radiation treatment. The government`s investigation began after Ven-A-Care of Florida Keys Inc., a home-based merger company, filed a complaint against the Federal False Claims Act (“FCA”). The ACF allows individuals to file, on behalf of the government, a lawsuit that Tam or denunciation. As part of the transaction, Ven A-Care whistleblowers receive approximately $32 million. 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 providing doctors with free units of its knee injection hyalgan® in violation of anti-kickback status, in order to induce doctors to purchase and prescribe the product. The comparison also makes allegations that Sanofi US submitted erroneous average selling price reports for Hyalgan® which did not take into account free units dependent on Hyalgan® purchase.

The government claimed that these false average selling price ratios led government programs to pay excessive amounts for Hyalgan® and a competing product. In addition to agreeing to pay $11.85 million to resolve these allegations, Sanofi has entered into a corporate agreement with the Department of Health and Human Services Office of Inspector General (HHS-OIG). That the CIA needs new compliance mechanisms, including the implementation of measures to ensure that agreements and interactions with third-party patient support programs are in compliance with the law. In addition, the CIA requires audits by an independent verification organization and compliance-related certifications from the company`s officers and board members….

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