AG Sam Olens: Announces Settlement with Shire Pharmaceuticals Over False Marketing Allegations

8
Oct

AG Sam Olens: Announces Settlement with Shire Pharmaceuticals Over False Marketing Allegations

Your Georgia Desk

From Attorney General Sam Olens

Sam Olens

Attorney General Olens Announces Settlement with Shire Pharmaceuticals Over False Marketing Allegations

Attorney General Sam Olens has announced that Georgia has joined with other states and the federal government to settle allegations that Shire Pharmaceuticals, LLC engaged in off-label marketing campaigns that improperly promoted five of its drugs: Adderall 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 the government health care programs. Georgia Medicaid’s share of the settlement is over $1.78 million.

“Misleading health care information is a danger to the public and will not be tolerated in Georgia,” said Olens. “My office continues to hold pharmaceutical companies responsible for how they market their products.”

Adderall XR, Vyvanse and Daytrona are approved by the U.S. Food and Drug Administration (FDA) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Lialda and Pentasa are approved for the treatment of mildly to moderately active ulcerative colitis. Specifically, 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 for the treatment of Conduct Disorder, an indication not approved by the FDA;

-promoted Vyvanse as preventing certain negative consequences of ADHD and as less abuseble than Adderall XR or other ADHD medications despite a lack of clinical data to support such claims;

-promoted Daytrona as less abuseable than pill-based medications despite a lack of clinical data to support such claims; and that Daytrona, a patch applied product, demonstrated difficulty in sticking to the patient’s body, making it therapeutically less effective;

-promoted Lialda for the prevention of colorectal cancer, an indication not approved by the FDA and marketed Lialda as having greater efficacy than other medications, despite a lack of clinical data sufficient to support such a claim; and

-promoted Pentasa for the treatment of indeterminate colitis and Crohn’s Disease, indications for which it had not been approved by the FDA.

As a condition for the settlement, Shire has entered into a Corporate Integrity Agreement with the U.S. Department of Health and Human Services, Office of the Inspector General, which will closely monitor the company’s future marketing and sales practices.

The settlement resulted from two qui tam lawsuits originally 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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