Aegerion Pharmaceuticals Reaches Settlement Agreements in Principle with the Department of Justice

Aegerion Pharmaceuticals has reached agreements in principle with the Department of Justice ("DOJ") and the Securities and Exchange Commission ("SEC"), relating to the ongoing investigations by both agencies into the Company's sales activities and disclosures related to JUXTAPID® capsules. The inquiries into the company started last year, following an investigation done by Brazilian authorities to determine whether or not Aegerion's commercial activities violated local anti-corruption laws. The agreement in principal comes after former Aegerion Chief Executive Marc Beer resigned after saying on CNBC's Fast Money that "patients are going to die of a cardiac event, either a stroke or a heart attack, if we don't have them on therapy." Those remarks set off the U.S. Food and Drug Administration ("FDA"), who claimed that those comments "misleadingly" suggested that the drug could reduce cardiovascular events and prolong life, when the FDA approval was based on data that showed that the pill lowered cholesterol in people with homozygous familial hypercholesterolemia. The agreement in principle has Aegerion paying a fine of $40 million, payable over five years with outstanding amounts accruing interest at 1.75% per annum. The breakdown of payment will likely proceed as follows: approximately $3 million upon the finalization of the settlement with the DOJ and the SEC, approximately $3.7 million per year (payable quarterly) during the first three years of the five-year payout, ...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs