FDA announces criminal, civil actions filed against Aegerion

Sept. 25 (UPI) -- The Food and Drug Administration has responded to charges filed against Aegerion Pharmaceuticals, Inc., of violating the Federal Food, Drug and Cosmetic Act.

Aegerion Pharmaceuticals agreed Friday to plead guilty in U.S. District Court to two misdemeanor counts of violating the FD&C Act for the introduction of a misbranded drug into interstate commerce.

Juxtapid, or lomitapide, was approved by the FDA in December 2012 as a therapy for the treatment of homozygous familial hypercholesterolemia, or HoFH, a rare disorder causing high cholesterol levels and early cardiovascular disease.

The FDA's Office of Criminal Investigation was involved in the case charging Aegerion with failing to comply with the requirements of the Juxtapid Risk Evaluation and Mitigation Strategy, or REMS, based on the absence of sufficient directions for all of Juxtapid's intended uses on the drug's label.

Aegerion pleaded guilty to failing to follow the REMS requirement to distribute the drug only for the narrow indication the FDA approved. The company sought to give the diagnosis of HoFH as vague and indefinite in order to expand the product use to additional patient populations beyond its approval.

Aegerion was also charged with not providing healthcare providers complete and accurate information about HoFH and how to diagnose it.

"We sometimes require companies to put in place certain measures to more closely manage a drug's risks when we don't believe a medicine's benefits would outweigh its side effects without these risk mitigation strategies. This might include requiring prescribers to undergo certain training on a drug's risks, or having providers take steps to more closely monitor patients," FDA Commissioner Dr. Scott Gottlieb, said in a press release.

"By failing to follow the safety requirements that Aegerion had agreed to, the company put patients' lives at risk and didn't honor the safety commitments they made as a condition of gaining approval for their drug. This is unacceptable."