AZ pays $355m after US Zoladex investigation

AstraZeneca will pay out $355m (€307m) as settlement of a multi-year investigation into US sales and marketing practices for Zoladex (goserelin acetate implant), a treatment for prostate cancer.

Under the terms of the settlement, AstraZeneca Pharmaceuticals LP will admit to having violated the Prescription Drug Marketing Act by providing free samples of Zoladex to physicians during the period 1993 through 1996, with the understanding that these physicians would bill Medicare for reimbursement. AstraZeneca will also settle, without admitting liability, civil claims involving allegations that the company provided inducements to physicians to purchase Zoladex and for improperly setting and reporting its price.

The settlement also provides for a five-year Corporate Integrity Agreement with the Office of Inspector General (OIG) for the Department of Health and Human Services under which AZ is required, among other obligations, to keep in place its current Compliance Program and provide periodic reports to the OIG on the status of compliance activities.

The total payment amount includes funds set aside to cover individual settlement agreements with the states involving related claims.

The FDAdministration called it a 'large-scale healthcare crime' and said the firm's fraudulent activities resulted in multi-million dollar losses to both insurance organisations and patients. Charges have also been levied against three doctors involved in the scam, two of which have pleaded guilty.