Shire accused of dishonest marketing in US
pharmafile | September 25, 2014 | News story | Medical Communications, Sales and Marketing | Adderall XR, Department of Justice, DoJ, Shire, US, amphetamine, dextroamphetamine
Shire will pay a fine of $56.5 million to resolve a string of legal allegations in the US surrounding the marketing and promotion of several of its drugs between 2004 and 2010.
The Irish-based firm, which is currently in the process of being merged into AbbVie, is alleged to have promoted its ADHD drug Adderall XR (amphetamine and dextroamphetamine) with claims ‘unsupported by clinical data’.
This is according to a ruling from the US Department of Justice (DOJ) this week which has fined the company under the False Claims Act. This is a relatively small payment compared to the multi-billion dollar fines levied against firms such as GSK and J&J in recent years, but the list of wrong-doing is a long read.
The DOJ says the company also made misleading claims that Adderall XR was superior to other ADHD drugs because it could ‘normalise’ patients – making them indistinguishable from people without ADHD. Other false claims include that the drug could prevent poor academic performance, loss of employment, criminal behaviour, traffic accidents and sexually transmitted diseases.
In addition, the DOJ alleges that Shire promoted Adderall XR for the treatment of conduct disorder without FDA approval.
The company is also accused of attempting to assist doctors with the prior authorisation process for prescriptions of two other ADHD drugs, Daytrana (methylphenidate) and Vyvanse (lisdexamfetamine), and inducing the physicians to prescribe the treatments.
Shire is also alleged to have claimed that Vyvanse could prevent car accidents, divorce, arrests and unemployment, as well as being less ‘abuseable’ than competing drugs.
One Shire medical science liaison is accused of telling a state formulary board that Vyvanse ‘provides less abuse liability’ than “every other long-acting release mechanism” on the market. The company is also said to have falsely claimed that Daytrana also has less abuse liability than other medicines.
The US government contends that no trial conducted by Shire has conclusively supported these claims.
And it gets worse: Shire is also accused of promoting its ulcerative colitis treatments Lialda and Pentasa (mesalamine) for off-label uses not approved by the FDA, or covered by federal healthcare programmes. Specifically, the US government alleges that Shire promoted Lialda for the prevention of colorectal cancer.
As part of the settlement Shire will also enter into a five-year corporate integrity agreement with the Office of Inspector General for the Department of Health and Human Services to address the company’s future marketing efforts, requiring comprehensive compliance safeguards, oversight of its promotional activities, and compliance certifications from its board of directors and management.
In a statement Shire says that it has co-operated fully with the US government throughout the process but has not admitted any wrongdoing in connection with the agreement.
Flemming Ornskov, chief executive officer of Shire, says: “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.”
US attorney Zane David Memeger adds: “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.”
He adds that Shire has begun to ‘correct its marketing activities’ in advance of the settlement. Around $36 million of the $56.5 million fine will be paid to the federal government, while the rest will go to state Medicaid programmes.
George Underwood
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