Aegerion recently finalized a $40.1 million settlement that resolves civil and criminal charges over its marketing of JUXTAPID®. We previously published an article outlining agreements in principle with the Department of Justice (DOJ) and Securities and Exchange Commission (SEC), following inquiries into the company to determine whether the company’s commercial activities violated laws and regulations.
The $40.1 million settlement is split between cases brought by the DOJ and the SEC – with $36 million resolving cases by the DOJ and $4.1 million resolving an SEC lawsuit. Sales representatives were trained to tell doctors and patients that JUXTAPID® would “take patients out of harm’s way” and prevent “impending” heart attacks and strokes, despite the lack of data supporting those claims, prosecutors alleged.
On September 22, 2017, Aegerion agreed to plead guilty to two misdemeanor counts of violating the Federal Food, Drug, and Cosmetic Act (FD&C Act) regarding the introduction of misbranded JUXTAPID® into interstate commerce. The criminal information alleged that JUXTAPID® was misbranded because Aegerion failed to comply with the requirements of the JUXTAPID® Risk Evaluation and Mitigation Strategy (REMS) program and because the labeling lacked adequate directions for all of the prescription’s intended uses.
The FDA approved JUXTAPID® in 2012 to treat high cholesterol in patients with a rare genetic disease called homozygous familial hypercholesterolemia. Prosecutors have said that Aegerion managers and sales staff touted JUXTAPID® as a treatment for high cholesterol generally, and failed to give healthcare providers sufficient information to safely prescribe the drug.
Aegerion and one of its senior vice presidents, Charles M. Gerrits, agreed to enter into a consent decree of permanent injunction with the United States. The consent decree includes a comprehensive compliance program and legal tools for the FDA to ensure that the defendants comply with the law, subject to judicial oversight.
As alleged in court documents filed by the DOJ, instead of following the REMS requirement to distribute JUXTAPID® for the narrow indication for which it was approved, Aegerion sought to include the diagnosis of homozygous familial hypercholesterolemia (HoFH), a rare disorder that that causes high cholesterol levels and early cardiovascular disease, as vague and indefinite as possible in order to extend the product use to additional patient populations.
As part of the required REMS, Aegerion failed to give health care providers complete and accurate information about HoFH and how to properly diagnose it. Aegerion also filed a misleading REMS assessment report to the FDA in which the company failed to disclose that it was distributing JUXTAPID® using a definition of HoFH that was inconsistent with Aegerion’s pre-approval filings with the FDA and that did not correspond to any peer-reviewed clinical standard for diagnosing HoFH. With these actions, Aegerion failed to comply with the required elements under the REMS to assure safe use of JUXTAPID®, in violation of the FD&C Act. In addition, Aegerion management and sales personnel also distributed JUXTAPID® not only for the treatment of HoFH, but also as a treatment for high cholesterol generally, without adequate directions for such use.
The SEC’s complaint alleges that Aegerion told investors that the number of unfilled prescriptions for JUXTAPID® was not material and the “vast majority” of patients receiving prescriptions ultimately purchased the drug. The SEC alleges that Aegerion’s records reflect that it was actually around 50 percent of prescriptions that resulted in actual drug purchases.
Once entered by the court, the plea and consent decree will be part of a global resolution of multiple government investigations into Aegerion’s conduct with respect to the marketing and distribution of JUXTAPID®. This resolution was the result of a coordinated effort by the DOJ and other government agencies.