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Black Box Warning

Senior Director of Strategic Alliances
LexisNexis Risk Solutions - Government

A “Black Box” warning is the U.S. Food and Drug Administration’s (FDA) strictest warning for drugs and medical devices on the market. They alert the public and healthcare providers to serious side effects such as injury or death. (Examples include warnings about smoking on the side of cigarette packages or warnings on wine bottles cautioning women to avoid drinking alcohol while pregnant.)

As a former pharmaceutical sales representative, Mark Moffett, 49, of Springfield, Ill., ignored the “Black Box” warning on a drug he sold, all so he could make a cool $11,000 kickback per prescription. He exploited his relationships with medical staff, stole doctors’ identities, falsified medical documents, and deceived insurance companies to carry out his fraudulent scheme.

Moffet was paid bonuses by Aegerion, the pharmaceutical company that produced Juxtapid. This specialized drug was only approved by the FDA to treat high cholesterol in patients with a rare genetic disease called homozygous familial hypercholesterolemia (HoFH). The Black Box warning on Juxtapid was due to the serious risk of side effects, including liver damage. (But that didn’t stop Moffet from convincing doctors to prescribe this drug to anyone and everyone.)

According to the Centers for Disease Control and Prevention (CDC), nearly 94 million U.S. adults aged 20 or older suffer from High Cholesterol. (Moffett saw lots of dollar signs. He didn’t care if anyone was harmed, he just wanted to collect his take on the prescription, which cost more than $300,000 per year for patients without HoFH.)

This crook convinced Medicare and private sector employee health plans to pay for Juxtapid by using fake prescriptions, falsified documents including statements of medical necessity, bogus patient test results, false clinical histories and incorrect diagnoses.

Further research shows that Aegerion pleaded guilty to misbranding Juxtapid and agreed to pay $40.1 million to resolve U.S. criminal and civil problems. Despite the FDA approving the drug for very limited and strict usage, Aegerion promoted the drug for off-label purposes. Knowing that, Moffett convinced doctors to prescribe Juxtapid to patients with high cholesterol, but not HoFH.

Moffett was convicted by a federal jury on nine counts of wire fraud and six counts of aggravated identity theft. He was sentenced to 54 months in prison and three years of supervised release. In 2018, Aegerion was formerly a unit of Novelion Therapeutics. Now the pharmaceutical company is part of Amryt Pharma after filing for bankruptcy in 2019.

Today’s Fraud of the Day comes from a Department of Justice press release, “Former Pharmaceutical Sales Representative Sentenced to More Than Four Years in Prison for Insurance Fraud and Aggravated Identity Theft,” dated October 29, 2021.

BOSTON – An Illinois man was sentenced yesterday for defrauding insurance companies in relation to a high-priced drug made by Cambridge-based pharmaceutical company Aegerion Pharmaceuticals Inc., and for using the identities of physicians to carry out the fraud.

Mark Moffett, 49, of Springfield, Ill., was sentenced by U.S. Senior District Court Judge William G. Young to 54 months in prison and three years of supervised release. In December 2019, Moffett was convicted by a federal jury of nine counts of wire fraud and six counts of aggravated identity theft.

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