Par Pharmaceutical has joined the off-label rogue's gallery. The drugmaker agreed to pay $45 million to wrap up charges that it promoted Megace ES, a treatment for appetite loss in AIDS patients, for a variety of unapproved uses. Par also pleaded guilty to a misdemeanor violation of the Food, Drug and Cosmetic Act.
According to prosecutors, Par not only pushed Megace ES for nursing home and hospice residents, but continued to market it off-label after FDA warned it not to--twice. Prosecutors say Par spent more time promoting Megace for unapproved uses than it did for its approved indications. It allegedly set up a sales force dedicated to promoting Megace at long-term care facilities.
In fact, the government says in court documents, Par's reps and management "knew that they called on very few, if any, facilities with AIDS patients and very few practitioners that treated AIDS patients."
"The conduct of this company was in some real measure flagrant," U.S. Attorney Paul Fishman told Reuters. "The company was told on at least two occasions in 2005 that it did not have permission from the FDA to market this drug as appropriate for senior citizens, and it chose to ignore that. And it made the wrong choice."
A New Jersey judge fined Par $18 million and ordered $4.5 million in criminal forfeiture, and the company agreed to pay $22.5 million in civil penalties to the federal government and several states. The civil settlement covers three whistleblower lawsuits.
The company also signed an unusual corporate integrity agreement. Par's board and executives could forfeit annual bonuses if they violate it--and even if their subordinates do. And sales reps will be punished, too. Under the deal, reps can no longer receive incentive pay for marketing Megace, or for promoting "successor branded versions," the Justice Department said in a statement.
- see the DOJ release
- get more from Reuters
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