Aegerion Pharmaceuticals agreed to plead guilty in the United States District Court for the District of Massachusetts to two misdemeanor counts of violating the Federal Food, Drug, and Cosmetic Act (FD&C Act) involving the introduction of misbranded Juxtapid (lomitapide) into interstate commerce.
In connection with this agreement, the criminal information filed charged that Juxtapid was misbranded because Aegerion failed to comply with the requirements of the Juxtapid Risk Evaluation and Mitigation Strategy (REMS) program and because the drug's labeling lacked adequate directions for all of Juxtapid's intended uses. This agreement resolves a criminal investigation in which the FDA's Office of Criminal Investigations played an important role.
Aegerion and one of its senior vice presidents, Charles M. Gerrits, PharmD, Ph.D, also agreed to enter into a consent decree of permanent injunction with the United States. The consent decree includes a comprehensive compliance program and legal tools for the FDA to ensure that the defendants comply with the law, subject to judicial oversight. The FDA's Center for Drug Evaluation and Research was instrumental in crafting the compliance obligations agreed to in the consent decree.
"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," said FDA Commissioner Scott Gottlieb, M.D. "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. We will continue to pursue those who skirt the law, and flout patient safety and other post-market commitments, using all of the enforcement tools available to us. Post-market safety requirements are a key element of the FDA's public health protections and we will ensure that they are fulfilled."
As alleged in court documents filed by the U.S. Department of Justice, 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. As part of the required REMS, Aegerion failed to give health care providers complete and accurate information about HoFH and how to properly diagnose it. Aegerion also 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. As such, Aegerion failed to comply with the required elements under the REMS to assure safe use of Juxtapid, in violation of the FD&C Act. In addition, Aegerion management and sales personnel also distributed Juxtapid not only for the treatment of HoFH, but also as a treatment for high cholesterol generally, without adequate directions for such use.
Once entered by the court, the plea and consent decree will be part of a global resolution of multiple government investigations into Aegerion's conduct with respect to the marketing and distribution of Juxtapid. This resolution was the result of a coordinated effort by the U.S. Department of Justice and several government agencies, including the FDA.
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 Juxtapid REMS requires Aegerion to, among other things, (1) 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 (2) ensure that Juxtapid is prescribed and dispensed only to those patients with a clinical or laboratory diagnosis consistent with HoFH.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.