NEWARK (CN) - Par Pharmaceuticals pleaded guilty and will pay $45 million in criminal and civil fines for promoting its anorexia drug Megace ES for off-label uses, federal prosecutors said.
Doctors are allowed to prescribe drugs for off-label uses, but drug companies cannot push drugs that way.
The FDA approved Megace to treat anorexia for AIDS patients.
Par promoted it for other uses.
The New Jersey-based company on Tuesday was criminally fined $18 million, ordered to forfeit another $4.5 million in criminal gains, and agreed to pay $22.5 million in civil penalties.
"The civil settlement resolves allegations that Par, by promoting the sale and use of Megace ES for uses that were not FDA-approved and not covered by Federal health care programs, caused false claims to be submitted to these programs," the U.S. Attorney's Office said in a statement announcing the settlement. "The United States further alleged that Par deliberately and improperly targeted sales to elderly nursing home residents with weight loss, whether or not such patients suffered from AIDS, and launched a long-term care sales force to market to this population. During this marketing campaign, Par was allegedly aware of adverse side effects associated with the use of megestrol acetate in elderly patients, including an increased risk of deep vein thrombosis, toxic reactions in elderly patients with impaired renal function, and mortality. The United States alleged that Par made unsubstantiated and misleading representations about the superiority of Megace ES over generic megestrol acetate for elderly patients to encourage providers to switch patients from generic megestrol acetate to Megace ES, despite having conducted no well-controlled studies to support a claim of greater efficacy for Megace ES."
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