Pharma maker pleads guilty that one of its major drugs was misbranded in a federal court case brought by FDA and the US Department of Justice.
Aegerion Pharmaceuticals Inc. plead guilty that one of its major drugs was misbranded in a federal court case brought by FDA and the US Department of Justice.
Last week, the pharmaceutical manufacturer plead guilty in federal court to misbranding lomitapide (Jaxtapid) to treat familial hypercholesterolemia.
Rather than following the REMS requirement to distribute Juxtapid only for the narrow indication for which it was approved, “Aegerion instead sought to render 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,” FDA said in a statement.
The company also distributed Juxtapid as a treatment for high cholesterol generally, without adequate directions for such use, according to FDA.
Aegerion failed to give healthcare providers complete and accurate information about HoFH and how to properly diagnose it, FDA said. In addition, the manufacturer 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, FDA said.
“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,” said FDA Commissioner Scott Gottlieb, MD, in the FDA statement. “This is unacceptable…Post-market safety requirements are a key element of the FDA’s public health protections and we will ensure that they are fulfilled.”
Juxtapid, approved in December, 2012, as an adjunct therapy to treat HoFH, is subject to a REMS to ensure that its benefits outweigh its risks. The REMS requires Aegerion to, among other things, educate prescribers about the risks of hepatotoxicity (liver toxicity) associated with the use of Juxtapid and the need to monitor patients who are treated with Juxtapid and ensure that Juxtapid is prescribed and dispensed only to those patients with a clinical or laboratory diagnosis consistent with HoFH.