Shire will pay $56.5 million to settle accusations of making false claims in the marketing of its attention deficit disorder drug Adderall XR and other medicines, according to the New York Times (Sept 24, 2014). The drug company was accused of promoting Adderall with claims that it was superior over competitive medications without clinical data to back up such claims. Shire was further accused of promoting Adderall off-label (i.e., for uses not approved by the FDA) and other claims not supported by scientific evidence. For instance, Adderall XR was marketed to “prevent poor academic performance, loss of employment, criminal behavior, traffic accidents and sexually transmitted disease,” according to the Times. The allegations cover activities by the company between January 2004 and September 2010.
Specifically, Shire was accused of promoting Adderall XR as clinically superior to other ADHD drugs despite a lack of clinical data to support such claims and for the treatment of Conduct Disorder, an indication not approved by the FDA.
“Marketing efforts that influence a doctor’s independent judgment can undermine the doctor-patient relationship and short-change the patient,” said U.S. Attorney Zane David Memeger and announced by the US Department of Justice. “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.”
Also on its website, Acting Assistant Attorney General for the Justice Department’s Civil Division, Joyce R. Branda, said that “Patients and health care providers must receive accurate information about available prescription drugs so that they can make safe and informed treatment decisions…The Department of Justice will be vigilant to hold accountable pharmaceutical companies that provide misleading information regarding a drug’s safety or efficacy.”
Other state settlements
Shire also settled with the state of Louisiana for $2.9 million to resolve a separate civil complaint for violations of state law. And The Montana Attorney General added to the fray, announcing that Montana has joined 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: Adderall XR, Vyvanse, Daytrona, Lialda and Pentasa
“While Montana’s share of this settlement is fairly small, the big news here is that we’ll continue to hold pharmaceutical companies responsible when they deceive our providers and patients in the way they promote their products,” Attorney General Tim Fox told the Targeted News Services. Montana will receive almost $30,000 that will go toward restitution and other recoveries for the Medicaid program.
The settlement came about from two qui tam lawsuits filed by whistleblowers in the United States District Courts for the Eastern District of Pennsylvania and the Northern District of Illinois under the federal False Claims Act and various state false claims statutes.
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If you are a medical doctor or pharmaceutical company insider and have documented proof of a drug company selling its product under false pretenses, or the drug is being sold off-label, The Corporate Whistleblower Center urges you to call them at 866-714-6466. Given the reward paid to Dr. Torres, it’s something to consider.
As a condition for the settlement, Shire is entering a Corporate Integrity Agreement (CIA) with the US Department of Health and Human Services, Office of the Inspector General, which will closely monitor the company’s future marketing and sales practices. Shire has not admitted any wrongdoing in connection with the settlement.