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Shire reaches $56.5m US marketing malpractice settlement

Justice Department agreement covers activities for drugs including Adderall

Shire BasingstokeIrish biopharma company Shire has agreed to pay a multi-million dollar fine to the US Justice Department to settle allegations that it overstated the efficacy of five of its drugs.

Shire, which did not admit any wrongdoing as part of the settlement, will pay $56.5m – with the federal government receiving $35.7m and $20.8m going to state Medicaid programmes.

The company will also make an additional payment of $2.9m to the state of Louisiana.

The allegations included its attention deficit disorder (ADHD) drugs Adderall XR and Vyvanse.

The company was accused of violating the False Claims Act from 2004 to 2007 as it promoted Adderall by saying ADHD patients who took the drug would be “indistinguishable” from people who did not have the condition.

In addition to this, Shire also allegedly marketed Adderall as a treatment for conduct disorder, which it does not have the approval for, and claimed the drug would prevent poor academic performance, loss of employment, criminal behaviour, traffic accidents and sexually transmitted diseases.

The firm faced similar allegations about its ADHD drugs Vyvanse and Daytrana patch as well as Lialda, an ulcerative colitis treatment. Vyvanse sales amounted to $359.5m, 25% of the company's total revenue during the period.

The US Justice Department said claims made by Shire were not backed by results from clinical trails, though it acknowledged that the company had cooperated throughout the investigation and had “began to correct its marketing activities”.

Shire CEO Flemming Ornskov said: “We are pleased to have reached a resolution and to put this matter behind us. We remain focused on our mission of enabling people with life-altering conditions to lead better lives and we are committed to conducting our activities to meet the highest ethical standards.

“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.”

Article by
Kirstie Pickering

26th September 2014

From: Sales, Regulatory



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