A planned settlement between Aegerion Pharmaceuticals and federal officials will require the company to shell out $40 million and plead guilty to two misdemeanor violations of the FD&C Act, the company disclosed last week.
According to Aegerion, federal agencies were investigating the company’s sales activities for the cholesterol drug Juxtapid and its handling of a mandatory REMS for the product. The two misdemeanors are for the alleged misbranding of the drug.
Under the deal, the Justice Department and the Securities and Exchange Commission will drop the investigations into the company in exchange for the money and the pleas. Because the deal is only in principle, specific terms have not been determined.