Bryan Cohen Mar. 7, 2013, 6:47pm

WASHINGTON, DC (Legal Newsline) - Multiple states and the federal government reached a $22.5 million civil and criminal settlement Wednesday with Par Pharmaceutical Companies Inc.

Par Pharmaceuticals, based in Woodcliff Lakes, N.J., allegedly promoted sales of the drug Megace ES, also known as megestrol acetate, for uses not approved as safe and effective by the U.S. Food and Drug Administration and not covered by state Medicaid programs. Megace was approved by the FDA as an appetite stimulant to prevent severe weight loss and malnutrition in advanced cancer and AIDS patients.

Par was allegedly aware of severe adverse side effects associated with the use of Megace in elderly patients, but the company launched a long-term marketing campaign to improperly and deliberately target elderly patients with weight loss problems. The patients did not suffer from AIDS, cancer or any other medically accepted conditions to warrant use of Megace. Adverse side effects included blood clots, toxic reactions, death and cachexia, the loss of body mass that cannot be nutritionally reversed.

Par also allegedly tried to convince doctors to switch from the cheaper generic form of Megace by making false and misleading statements that Megace ES was more effective without any well-controlled studies to back up the claim.

"This is another example of a drug company that has put profits ahead of patient care," Kentucky Attorney General Jack Conway said. "I am pleased that we were able to work with our state and federal partners to recover money for the Medicaid program and for Kentucky taxpayers. This settlement will also ensure that Par does not engage in these illegal marketing activities in the future."

In addition to paying $22.5 million, Par will plead guilty to the criminal charge of improperly introducing a misbranded drug into interstate commerce. Additionally, Par will be required to enter into a Corporate Integrity Agreement with the U.S. Department of Health and Human Services' Office of the Inspector General to stop illegal marketing activities from happening in the future.

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