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Pharmaceutical Giant AstraZeneca to Pay $520 Million for Off-Label Drug Marketing
Date:4/27/2010

o know that pharmaceutical companies are marketing their drugs only for uses approved by the FDA and that their doctors' judgment has not been affected by misinformation from a pharmaceutical company trying to boost revenues."

In addition to the civil settlement agreement, resolution of the matter includes a  Corporate Integrity Agreement (CIA) between AstraZeneca and the Office of Inspector General of the Department of Health and Human Services. The five-year CIA requires, among other things, that a board of directors committee annually review the company's compliance program and certify its effectiveness; that certain managers annually certify that their departments or functional areas are compliant; that AstraZeneca send doctors a letter notifying them about the settlement; and that the company post on its website information about payments to doctors, such as honoraria, travel or lodging.  AstraZeneca is subject to exclusion from Federal health care programs, including Medicare and Medicaid, for a material breach of the CIA and subject to monetary penalties for less significant breaches.

"As a result of this Corporate Integrity Agreement, the actions of AstraZeneca will be more transparent, its Board of Directors held more accountable, and the names of physicians receiving payments will be disclosed -- all leading to better protection for patients," said Department of Health and Human Services Inspector General Daniel R. Levinson.

The government's investigation was triggered by a whistleblower lawsuit filed under the FCA's qui tam provisions in the Eastern District of Pennsylvania.  As part of today's resolution, James Wetta, the whistleblower in that action, will receive more than $45 million from the federal share of the
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SOURCE U.S. Department of Justice
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