A federal court in New Jersey has imposed an $18-million criminal penalty on Par Pharmaceutical Cos., which entered a guilty plea to one charge of introducing a misbranded drug into interstate commerce. United States v. Par Pharm. Cos., No. n/a (U.S. Dist. Ct., D.N.J., sentencing March 5, 2013). The court also ordered the company to forfeit $4.5 million, the value of the misbranded appetite-stimulating drug Megace® ES sold since 2005. The company will also reportedly pay $20.5 million to the United States and $2.1 million to certain other states to settle three qui-tam actions filed under the False Claims Act. The company faces further separate settlements under Medicaid.
The drug was apparently approved by the U.S. Food and Drug Administration (FDA) to treat anorexia, cachexia or other significant weight loss experienced by AIDS patients. The company allegedly promoted the drug for the treatment of non-AIDSrelated geriatric wasting, an unapproved use and for which the drug’s approved labeling lacked adequate directions. According to the government, the company launched a long-term-care sales force to market the drug to this demographic and allegedly encouraged providers to switch medications for elderly patients, claiming that its drug—known in this population to increase the risk of deep vein thrombosis, cause toxic reactions in those with impaired renal function, and mortality—was more effective.
As part of its plea, the company also entered a corporate integrity agreement that will require it to change is business practices, including a prohibition on linking sales representatives’ compensation to the volume of the drug’s sales. The company has also agreed to dismiss with prejudice litigation that it filed in 2011 challenging FDA regulations on off-label promotions as a violation of its First Amendment rights.