Two Drug Companies Forced To Pay NJ More Than $600,000

New Jersey has been paid a total of $610,381 as a result of its participation in national settlements with two major pharmaceutical manufacturers.

The manufacturers are Par Pharmaceutical Companies, Inc. and Amgen, Inc. State Attorney General Jeff Chiesa said the separate settlements resolve allegations that the two companies illegally promoted their drugs and committed other violations of state and federal law.

The California-based Amgen has paid New Jersey a total of $327,038 to resolve allegations that the company violated state and federal anti-kickback and false claims laws with respect to its nephrology drug Aranesp.

It’s been alleged that Amgen agreed to provide certain institutional pharmacies additional rebates on Aranesp in exchange for the promise that these pharmacies would promote the drug in “therapeutic interchange” programs conducted in nursing homes they served. The alleged purpose of the scheme was to induce medical professionals working at these facilities to dispense Aranesp in place of competing drugs.

In an unrelated case, New-Jersey-based Par Pharmaceutical paid the State $283,342 to resolve allegations that it marketed its drug Megace ES for uses not deemed safe and effective by the federal Food and Drug Administration, and not covered by state Medicaid programs. Par Pharmaceutical pleaded guilty in U.S. District Court in New Jersey to an information charging the company with a criminal misdemeanor for misbranding Megace ES in violation of the federal Food, Drug and Cosmetic Act, and was ordered to pay a total of $18 million dollars in fines and $4.5 million dollars in criminal forfeiture.

Megace ES is a megestrol acetate drug product approved by the FDA to treat anorexia, cachexia, or other significant weight loss suffered by patients with AIDS. Par Pharmaceutical’s civil settlement resolves allegations that the company caused false claims to be submitted to Medicaid, Medicare or other federal programs by promoting Megace ES for alternative uses  not approved by the FDA and not covered by those government health insurance programs.

It was also alleged that Par Pharmaceutical 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 Megace ES to this population. During this marketing campaign, Par Pharmaceutical allegedly was 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 patients with impaired renal function, and death.