LEXINGTON, Ky. (Sept. 29, 2014) Attorney General Jack Conway has announced a $56.5 million settlement with Shire Pharmaceuticals, joining with other states and the federal government to settle allegations that Shire engaged in off-label marketing campaigns that improperly promoted five of its drugs: Adderrall XR, Vyvanse, Daytrona, Lialda and Pentasa.
Shire Pharmaceuticals, a Pennsylvania based company, will pay the states and the federal government $56.5 million, of which $48.1 million will go to the Medicaid programs to resolve civil allegations that the company unlawfully marketed these drugs and thereby caused false claims to be submitted to government health care programs.
“I will not tolerate pharmaceutical companies that try to mislead Kentuckians and our doctors while attempting to cheat our state Medicaid program,” Attorney General Conway said. “They will be held accountable. My job is to protect Kentucky taxpayers and our vital state programs from this type of misconduct and deceit.”
Kentucky’s share of the settlement is $1.176 million, $828,267 of which will be returned to the federal government to repay Kentucky claims and $162,345 will be returned to the state Medicaid program.
Adderrall XR, Vyvanse and Daytrona are approved by the United States Food and Drug Administration (FDA) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Lialda and Pentasa are approved for the treatment of mildly to moderately active ulcerative colitis.
It is alleged that Shire promoted Adderall XR as clinically superior to other ADHD drugs, despite a lack of clinical data to support such claims, and marketed it for the treatment of Conduct Disorder, which treatment had not been authorized by the FDA. It’s also alleged that Shire promoted Vyvanse as preventing certain negative consequences of ADHD and more difficult to abuse than Adderrall XR or other ADHD medications, despite a lack of clinical data to support such claims.
The states also purported that Shire promoted Daytrona, a topical patch applied to the skin, as more difficult to abuse than pill-based medications, despite a lack of clinical data to support such claims. Many patients also reported difficulty with the Daytrona patch sticking to their bodies, making it therapeutically less effective.
Another allegation is that Shire promoted Lialda for the prevention of colorectal cancer, a treatment not approved by the FDA. And it marketed Lialda as having greater efficacy than other medications, despite a lack of clinical data sufficient to support such a claim. The final allegation is that Shire marketed Pentasa for the treatment of indeterminate colitis and Crohn’s Disease, treatments that had not been approved by the FDA.
As a condition for the settlement, Shire has entered into a Corporate Integrity Agreement (CIA) with the United States Department of Health and Human Services, Office of the Inspector General, which will closely monitor the company’s future marketing and sales practices.
Since Attorney General Conway took office in January 2008, his Office of Medicaid Fraud and Abuse Control has recovered or been awarded more than $260 million for the state and federal Medicaid programs. These cases range from lawsuits and settlements against pharmaceutical companies to cases against individual providers.
In 2013, General Conway’s Medicaid Fraud Unit was named one of the most aggressive in the country by the non-profit watchdog group Public Citizen.
The Attorney General’s tip line for reporting allegations of Medicaid fraud is 1-877-228-7384.