Shire Pharmaceuticals to Pay $56 Million to Settle False Claims Act Allegations

According to a recent announcement by the Department of Justice, Shire Pharmaceuticals has agreed to pay $56 million to settle claims it fraudulently marketed the popular attention-deficit drug Adderall and thereafter submitted claims to U.S. government healthcare programs for reimbursement. The allegations differ from the oft-cited problem of “off-label marketing,” which occurs when a company markets a drug to treat conditions not previously tested by the FDA. In this case, Shire was marketing to an approved class of patients (those suffering from attention-deficient hyperactivity disorder) but is alleged to have made inaccurate statements about the effectiveness and safety of the drug.

Details of allegations against Shire

Shire Pharmaceuticals, located in Pennsylvania, is a subsidiary of the Dublin-based company known as Shire PLLC. The specific drugs at issue in the case, aside from Adderall, include the ADHD drugs Vyvanse and Daytrana, and two other drugs used to treat the intestinal condition ulcerative colitis, Pentasa and Lialda. The settlement between the U.S. government and Shire settles a wide array of marketing allegations surrounding drugs, some of which occurred for several years.

The first allegation pertains to alleged misconduct occurring between January 2004 and December 2007 with regard to the drug Adderall XR. According to the DOJ, Shire made several unsupported claims that Adderall XR was “clinically superior” to all other ADHD drugs, primarily due to its ability to “normalize” patients and make them indistinguishable from peers who did not suffer from the effects of ADHD.

Shire made promises that competitors could not achieve comparable results and that Adderall XR would correct such personal problems as “poor academic performance, loss of employment, criminal behavior, traffic accidents and sexually transmitted disease.” Of course, these statements were not studied or supported by clinical data.

Second, Shire settled claims that from February 2007 through September 2010 it instructed sales representatives to make “false and misleading statements” about the efficacy of Vyvanse to Medicaid regulators and physicians. More specifically, a “Shire medical science liaison” is alleged to have told a state Medicaid regulator that Vyvanse “provides less abuse liability” than similar drugs on the market. However, there have been no studies conducted regarding this statement, and Vyvanse is an amphetamine carrying a mandatory Black Box warning label (the highest required by the FDA). Shire is also alleged to have made promises that Vyvanse could prevent “car accidents, divorce, arrests, and unemployment.”

Third, the settlement with Shire resolves allegations that from April 2006 through September 2010, Shire employees were instructed to market Daytrana as less likely to be abused than its counterparts, touting its unique transmission method through a transdermal patch. These assertions were also made to state Medicaid regulators.

Last, the settlement with Shire resolves allegations that it marketed Lialda and Pentasa for off-label use not approved by the FDA – primarily, for the prevention of colon cancer.

The U.S. Attorney for the Eastern District of Pennsylvania said in a comment:

“Marketing efforts that influence a doctor’s independent judgment can undermine the doctor-patient relationship and short-change the patient…. Where children’s medication is concerned, it can interfere with a parent’s right to clear information regarding the risks to the safety and health of their child.  Shire cooperated throughout this investigation and, in advance of this settlement, began to correct its marketing activities.”

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