Pharma Company Faces $35 Million Settlement Over False Claims for Cholesterol Drug

The Department of Justice (DOJ) recently announced that Aegerion Pharmaceuticals pleaded guilty to charges related to claims and actions related to lomitapide (Juxtapid).

The DOJ reports that Aegerion misrepresented the medication to patients and failed to comply with a Risk Evaluation and Mitigation Strategy (REMS), according to a press release. Under the plea, Aegerion agreed to settle allegations that the company submitted false claims to federal healthcare programs.

The company will be paying more than $35 million to resolve the allegations, according to the release.

“Today’s settlement shows that the government will continue to hold accountable drug companies that violate laws designed to protect the health and safety of patients,” said acting Assistant Attorney General Chad A. Readler of the DOJ Civil Division. “Aegerion has agreed to plead guilty to breaking the law. The Justice Department will continue to ensure that taxpayers do not foot the bill when such conduct occurs.”

Lomitapide is approved to treat homozygous familial hypercholesterolemia (HoFH) and has a black box warning advising of liver toxicity and gastrointestinal adverse events. These warnings required REMS as a part of the drug’s approval to educate prescribers on the risks and to restrict access to only patients with a laboratory diagnosis of HoFH.

In the lawsuit, the District of Massachusetts alleged that from December 2012 to December 2015, Aegerion misbranded lomitapide and violated the Federal Food, Drug, and Cosmetic Act, according to the release.

During this period, the lawsuit alleges that Aegerion did not give providers accurate data about HoFH and how to properly diagnose it, as well as submitting a misleading REMS report.

“Aegerion put profits over patient safety and enriched itself at taxpayer expense,” said acting US Attorney William D. Weinreb for the District of Massachusetts. “Our Office is committed to protecting patient safety and the integrity of federal health care programs, and we will continue to use our criminal and civil authority to ensure that drug companies play by the rules that protect the public, ensure quality of care, and preserve patient privacy.”

The lawsuit also claimed that lomitapide was distributed for the treatment of HoFH and high cholesterol, despite not receiving approval for the latter condition, according to the release.

For these violations, the DOJ reports that Aegerion will pay a $7.2 million fine.

Additionally, the company pleaded guilty to violating HIPAA by conspiring to obtain patient information without authorization for their own gain, according to the release.

Under the civil false claims settlement, Aegerion will pay $28.8 million over 3 years to resolve claims for lomitapide submitted to Medicare, Medicaid, and TRICARE.

The DOJ also alleged that the company defrayed patient co-payment obligations for the drug by funneling money through Patient Services Inc—a patient assistance organization claiming to be a non-profit—thus, violating the Anti-Kickback Statute, according to the release.

“Today’s plea and settlement with Aegerion shows how the government will hold the pharmaceutical industry accountable for violating important FDA and privacy rules that are intended to keep patients safe and ensure the confidentiality of their information,” said Special Agent in Charge Harold H. Shaw of the FBI, Boston Field Division. “The FBI will continue to investigate companies like Aegerion that profit from exploiting patients who are searching for treatments for serious medical conditions.”