Today, Aegerion Pharmaceuticals Inc., a subsidiary of Novelion Therapeutics, has agreed to plead guilty on 2 counts of violating the Federal Food, Drug, and Cosmetic Act (FD&C Act) involving the introduction of misbranded Juxtapid (lomitapide) into interstate commerce. The guilty pleas come with a fine of $40.1 million to be paid to the Justice Deparment and the Security Exchange Commission (SEC).
Juxtapid was approved by the FDA in December 2012 for the treatment of homozygous familial hypercholesterolemia (HoFH), a very rare genetic condition in which patients are unable to lower their cholesterol using conventional treatments.
According to a statement from the U.S. Food and Drug Administration (FDA), Aegerion failed to comply with the requirements of the Juxtapid Risk Evaluation and Mitigation Strategy (REMS) program.
Court documents indicate the company attempted to market the drug indirectly to non-HoFH patients. The FDA noted that the drug’s approval came with a REMS program that required the company to educate doctors about the risks associated with Juxtapid and that it is only to be used for patients with a clinical or laboratory diagnosis of HoFH. Court documents showed that the company was using a definition of HoFH that was inconsistent with Aegerion’s pre-approval filings with the FDA and did not correspond to any peer-reviewed clinical standard for diagnosing HoFH.
In other words, Aegerion’s sales force were a bit too aggressive.
In a news release
, FDA Commissioner Scott Gottlieb, M.D. stated, “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.”
Dr Gottlieb added, “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.”
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