Megace: Potential Liability and Regulatory Impact
Megace: Potential Liability and Regulatory Impact
Par Pharmaceutical Co., has agreed to pay $45 million to settle allegations it improperly labeled and marketed its prescription drug Megace ES to elderly patients, the U.S. Department of Justice said.
Among other things, the company was accused of criminally misbranding Megace, which was approved by the FDA to treat weight loss tied to AIDS, as a treatment for non-AIDS-related geriatric wasting.
Despite being aware of harmful side effects, Par also targeted sales to nursing home residents with weight loss, and launched a sales force specifically for this market, according to the Justice Department.
A representative from the company didn't immediately respond to a request for comment. On behalf of Par, Chief Executive Paul V. Campanelli pleaded guilty to criminal misdemeanor charges in a New Jersey federal court on Tuesday, the Justice Department said. The company was fined $18 million and ordered to pay $4.5 million in criminal forfeiture, and agreed to pay $22.5 million to resolve its civil liability. "Today's resolution emphasizes the importance of the U.S. government's coordinated efforts to combat health care fraud," said Stuart F. Delery, of the Justice Department's civil division. "We expect companies to make honest, lawful claims about the drugs they sell."
Megace, a megestrol acetate drug, lacked adequate directions for use in the treatment of geriatric wasting unrelated to AIDS, a use that wasn't approved by the FDA, the Justice Department said. The civil allegations against the company were related to claims submitted to federal health-care programs for uses that weren't approved by the FDA. U.S. officials alleged that Par was aware that megestrol acetate carried potentially fatal risks for elderly patients, including a heightened potential for deep vein thrombosis and toxic reactions in patients with impaired kidney function.
Please see the attached release from the U. S. Department of Justice for additional details.
We wanted you to be aware of the above information as you continue to review all medications in conjunction with your Pharmacist and physician and work with your physician on providing documentation in the event medications are used for off-labeled use.
US Department of Justice - Misbranding of Megace 