Sanofi recently signed their latest Corporate Integrity Agreement (CIA) to settle the latest round of charges of violating the Anti-kickback statute. This is a far-reaching settlement involving Sanofi US Services Inc. and Sanofi-Aventis U.S., LLC (Sanofi US); Aventis, Inc.; and Genzyme Corporation (Genzyme) and will impact Sanofi until September 2, 2020.
This CIA is a condition precedent for other agreements set by Sanofi and the United States to resolve allegations that between 2005 and 2009, Sanofi US violated the False Claims Act by giving physicians free units of its knee-injection Hyalgan® in violation of the Anti-Kickback Statute, to induce the physicians to purchase and prescribe the product. The settlement also resolves allegations that Sanofi US submitted false average sales price reports for Hyalgan® that failed to account for free units contingent on Hyalgan® purchase. The government alleged that those false average sales price reports caused government programs to pay inflated amounts for Hyalgan® and a competing product.
This agreement was signed on September 2, 2015, but was not made public on the Health and Human Services Office Inspector General’s website until late November.
At first glance, this Sanofi CIA might look similar to the GlaxoSmithKline and Johnson & Johnson CIA’s. However, as we have seen many times from the OIG, there are several subtle, but important, differences.
The differences and nuances cover a wide range of topics, from the scope and breadth of this CIA, to a puzzling departure relating to certifications, to differences in training requirements. For a more in-depth review of the recent Sanofi CIA, see the December issue of Life Science Compliance Update (subscription required).