Connecticut’s Medicaid program received $388,145 this month as part of a broader $56.5 million settlement that states and the federal government reached with Shire Pharmaceuticals.
The settlement resolves allegations that Philadelphia-based Shire “inappropriately” marketed several drugs for uses that have not been approved by the U.S. Food and Drug Administration. Terms of the agreement recently were announced by state Attorney General George Jepsen, Chief State’s Attorney Kevin Kane and state Department of Social Services Commissioner Roderick Bremby.
Connecticut and other states allege that Shire made claims about the drugs without sufficient clinical data to support them and without the backing of the FDA, according to state officials. The drugs involved are Adderall XR, Vyvanse, Daytrona, Lialda and Pentasa, and the misleading marketing took place between February 2007 and September 2010.
According to allegations brought forth by the states, Shire advertised Adderall XR as being better than other drugs at treating attention deficit hyperactivity disorder (ADHD) and also marketed it as a treatment for conduct disorder, which is a behavioral and emotional disorder most common in children and teenagers.
The company also claimed Vyvanse prevents certain negative consequences of ADHD and that it, along with Daytrona, is more difficult to abuse than Adderall XR or other ADHD medications, according to the states.
Shire also allegedly marketed Lialda to prevent colorectal cancer and Pentasa to treat indeterminate colitis and Crohn’s Disease, according to the states, when those indications were not supported by the FDA.
Adderall XR, Vyvanse and Daytrona are approved by the FDA to treat ADHD; Lialda and Pentasa are approved to treat mild to moderate ulcerative colitis, according to Jepsen.
The states claimed that Shire’s actions led to fraudulent claims filed with their Medicaid systems.
Under the terms of the settlement, Shire agreed to pay states and the federal government a total of $56.5 million. The bulk of that, $48.1 million, will go to Medicaid programs to resolve allegations that false claims were submitted to government health care programs as a result of Shire’s actions.
“Improper marketing of drugs leads to false and fraudulent claims against our Medicaid program,” Jepsen said in a statement. “We take all allegations of fraud and abuse very seriously and we will continue to work to hold accountable those who seek to defraud our taxpayers.”
In addition to the $388,145 for Connecticut’s Medicaid program, the state also got another $15,152 for certain drug programs administered by the state Department of Social Services.
The state has already received the money from the settlement, according to Jepsen’s office.
Shire officials said in a statement that the company cooperated with the government throughout the settlement process.
“We are pleased to have reached a resolution and to put this matter behind us,” Flemming Ornskov, the company’s chief executive officer, said in the statement. “The company has had, and will continue to have, a comprehensive compliance program and internal controls to ensure we comply with applicable laws and regulations.”
Under the settlement, Shire also entered into a Corporate Integrity Agreement with the U.S. Department of Health and Human Services. The department will monitor the company’s marketing and sales practices going forward.
In Connecticut, the Medical Fraud Control Unit of the Office of the Chief State’s Attorney, the Attorney General and DSS continually work to recover public resources and “protect the integrity of the Medicaid program,” Kane said.
