Pharmaceutical company Warner Chilcott was sentenced Friday in U.S. District Court in Boston to pay $125 million to resolve criminal and civil liability stemming from the illegal promotion of various drugs including Actonel, Asacol, Atelvia, Doryx, Enablex, Estrace Loestrin and various formulations of these drugs, the U.S. Attorney's Office announced Friday.
Authorities say Warner Chilcott, which has since merged with Activis, made payments to physicians so that they would prescribe their drugs. Warner Chilcott also provided meals and other incentives linked to so-called "Medical Education Events". The events were often held at lavish restaurants, often contained little or no actual educational content, and were in fact used to "pay prescribing physicians in an attempt to gain a competitive advantage over other pharmaceutical companies". Finally, the company paid a number of physicians to serve as "speakers" for the company for the purpose of ascertaining prescriptions, the U.S. Attorney's Office said.
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At the same time, Warner Chilcott submitted "false, inaccurate, or misleading" prior authorization requests to federal healthcare programs for the osteoporosis medications Atelvia and Actonel. These requests contain protected health information including biographical and medical condition information. Warner Chilcott falsified and manipulated prior authorizations by providing false medical justifications for the prescriptions, often filling out the authorizations themselves, authorities said.
The fraudulent requests were given to particular insurance companies in order to get around restrictions that favored less expensive osteoporosis drugs, occasionally submitting the prior authorizations directly to insurance companies and falsely representing themselves as physicians, according to the U.S. Attorney's Office.
Their plea agreement stipulates that Warner Chilcott be fined $22.7 million, forfeit $2 million due to its illegal promotion, and will pay $191,467 in restitution to Humana and $6,479 to Blue Cross Blue Shield of Massachusetts in connection with Actonel and Atelvia claims that were paid based on fraudulent prior authorizations.
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Under their civil settlement, which is a separate matter, Warner Chilcott will pay $102 million to the federal government and the states to resolve false claims it submitted to government healthcare programs, thus resolving illegal payments made to prescribing physicians for the "Medical Education Events" and submission of false prior authorization requests for Atelvia and Actonel. Some of the settlement will go to the federal government, and the state Medicaid share of the civil settlement totals roughly $10.6 million.
"VA spends billions of dollars on medical care, so pursuing health care fraud investigations with our Federal law enforcement partners is a priority for VA OIG," said Jeffrey G. Hughes, special agent in charge, Department of Veterans Affairs, Office of Inspector General. "The importance of pharmaceutical cases such as this one is magnified because VA civil damages are returned to the VA's Pharmaceutical Supply Fund for the direct benefit of our Nation's veterans."
The civil and criminal cases were investigated by various agencies, including FDA's Office of Chief Counsel and Office of Criminal Investigations, the National Association of Medicaid Fraud Control Units, FBI, HHS-OIG, the Department of Defense's Defense Criminal Investigative Service, the Department of Veterans Affairs and the Office of Personnel Management's Office of Inspector General.
Twitter: @BethJSanborn