Sanofi fines for fraud, kickbacks, etc

April 3, 2017. Sanofi agreed to pay $19.9 million to resolve allegations under the False Claims Act that the company overcharged the U.S. Department of Veterans Affairs (VA) for drugs under two contracts between 2002 and 2011. According to the DOJ press release:

Sanofi Pasteur disclosed to the VA that it had incorrectly calculated the FCP for certain drugs from 2007 to 2011 and overcharged the VA. The Office of Inspector General for the VA investigated the matter, and it determined that the error resulted in overcharges going back to 2002. “Overcharging VA depletes funds that are available to care for our veterans,” said Director of the Healthcare Resources Division Mark Myers of Veterans Affairs, Office of Inspector General. “We will continue to hold companies accountable for errors in drug pricing.”

2015. Genzyme — a Sanofi subsidiary — paid $32.5 million in fines and entered into a consent agreement to resolve allegations under the False Claims Act over deliberately marketing an adulterated surgical device meant for use in abdominal or pelvic laparatomy, Serafilm, for an unapproved use. According to the press release:

During the course of the government’s investigation regarding Seprafilm slurry, Genzyme voluntarily disclosed to the government that it had distributed promotional material for Seprafilm that implied that Seprafilm had been proven safe and effective for use in gynecologic cancer surgeries, even though Seprafilm’s FDA-approved label cautioned that the device had not been clinically evaluated in the presence of malignancies. Genzyme based its claim on a study that involved only fourteen patients, which was far too few to support such an assertion. A separate count in the government’s information charges that Genzyme’s use of this misleading promotional material caused Seprafilm to become misbranded while held for sale.

“Patients rely heavily on the integrity and efficacy of claims made by manufacturers of medical products,” said U.S. Attorney A. Lee Bentley III of the Middle District of Florida. “When manufacturers make misleading statements about using their products in ways that have not been approved by the FDA, patient care, confidence, and safety are put at risk.”

2014. Sanofi paid almost $40 million in fines in 2014, following criminal convictions in Germany over bribes paid by former employees to consultants for one of Sanofi’s clients between 2007 and 2010. According to Fierce Pharma:

That timeline puts the convictions just before Chinese bribery allegations erupted in the pharma world last summer. After authorities in China targeted GlaxoSmithKline ($GSK) for funneling $490 million to Chinese doctors through travel agencies, whistleblower accusations radiated outward to ensnare several multinational drugmakers–including Sanofi. The company allegedly paid ¥1.7 million ($277,000) in bribes to 503 doctors around the country, forking over ¥80 to doctors each time a patient bought its products.

2013. Following an investigation, the French Competition Authority fined Sanofi $52.8 million for discouraging the use of generic competition to its blood thinner Plavix by telling doctors that other generic versions would harm their patients. According to the Competition Authority, Sanofi “created a doubt over the quality and the safety of generics, without any proven basis, as nothing could demonstrate that Plavix generics were less safe than (the original drug).” Sanofi appealed, but the Paris Court of Appeals upheld the fine in 2014.

2012. A whistleblower lawsuit over kickbacks paid to doctors and an attempt to defraud the government through false price reports resulted in Sanofi paying a $109 million settlement to resolve allegations of violations of the False Claims Act in 2012. The United States had alleged that Sanofi “violated the False Claims Act by giving physicians free units of Hyalgan, a knee injection, in violation of the Anti-Kickback Statute, to induce them to purchase and prescribe the product. The settlement also resolves allegations that Sanofi US submitted false average sales price (ASP) reports for Hyalgan that failed to account for free units distributed contingent on Hyalgan purchases. The government alleges that the false ASP reports, which were used to set reimbursement rates, caused government programs to pay inflated amounts for Hyalgan and a competing product.” The press release highlighted several examples of some of Sanofi’s arrangements:

  1. A Southern California-based Sanofi US sales representative who allegedly provided 25 Hyalgan samples to a physician practice for every 100 Hyalgan units purchased, and who supplemented these kickbacks by regularly treating the entire practice to lavish dinners at Sanofi US’s expense and with Sanofi US’s approval.
  2. A New York-based Sanofi US sales representative who allegedly provided 12 Hyalgan samples to a physician practice for every 50 Hyalgan units purchased, and whose manager supplemented these kickbacks by treating the practice, along with friends and family members, to a lavish dinner in Manhattan at Sanofi US’s expense and with Sanofi US’s approval.
  3. A Central Texas-based Sanofi US sales representative who allegedly promised a physician practice 125 free Hyalgan syringes in exchange for a purchase of 500 Hyalgan units and was lauded by Sanofi US’s Texas sales team for “[u]tiliz[ing] samples to provide value for the office.”

2009. Aventis, another Sanofi Subsidiary, paid $95.5 million over allegations that it lied to Medicaid about the “best price” charged to commercial consumers for steroid-based anti-inflammatory nasal sprays Azmacort, Nasacort and Nasacort AQ in order to reduce the company’s Medicaid Drug Rebate obligations.