Aegerion Civil Settlement Agreement

Door 9 september 2021Geen categorie

The conditions described above may change after negotiations continue and other terms of the final agreement will be subject to further negotiations. This provisional agreement is also subject to the agreement of supervisory staff, both within the DOJ and the SEC. In principle, the agreements do not cover investigations conducted by the DOJ or sec into Aegerion`s Brazilian activities. The information indicates that during the relevant period, Aegerion did not provide healthcare providers with complete and accurate information about hoFH and its correct diagnosis, and that Aegerion also submitted a misleading REMS assessment report. According to the information provided, Aegerion therefore failed to comply with the elements necessary under the REMS to ensure the safe use of juxtapide in breach of the ACF. The information also claims that Aegerion`s management and sales staff distributed juxtapid not only to treat HoFH, but also to treat high cholesterol in general, without adequate instructions for such use. As part of a pleading agreement, Aegerion agreed to plead guilty to these charges and pay a fine and forfeiture of $US 7.2 million. The deal comes in principle after the resignation of former Aegerion board chairman Marc Beer after he told CNBCs Fast Money that “patients will die from a heart event, either a stroke or a heart attack if we don`t have them in therapy.” These remarks gave life to the U.S. Food and Drug Administration (“FDA”), which claimed that these comments “misleadingly” indicated that the drug could reduce cardiovascular events and prolong life if the FDA`s approval was based on data showing that the pill lowered cholesterol levels in people with homozygous familial hypercholesterolemia. The agreement provides in principle that Aegerion will pay a fine of $40 million, payable over five years with interest arrears of 1.75% per year. The breakdown of the payment will likely be as follows: about $3 million after closing the transaction with the DOJ and SEC, about $3.7 million per year (payable quarterly) in the first three years of five-year payment, and about $13 million per year (also payable quarterly) in four and five years.

Plea Agreement. In addition to his guilty plea to the information contained in two counts, Aegerion agreed to pay a fine of $US 6.2 million and $US 1 million in reimbursement. The Plea agreement also requires Aegerion, its chairman and the board of directors of their parent company to verify and certify annually, for three years, compliance with the Plea Agreement and the approval decree. As part of the civil agreement on false claims, Aegerion will pay over a reference period of $28.8 million to clarify civil liability at the federal and regional level for the redress of false claims for juxtapid in public health programs (Medicare, Medicaid and TRICARE) resulting from the promotion of juxtapide for patients without diagnosis or in compliance with HoFH; false and misleading statements to physicians that the use of juxtapide was appropriate in patients with symptoms such as high cholesterol, whether or not these patients had a hoFH diagnosis and, despite contraindications, a hoFH diagnosis; and the modification or falsification of statements on medical necessity and prior authorizations subject to federal health programs. . . . .