Astrazeneca Corporate Integrity Agreement

What makes these accusations even more shocking is that AstraZeneca had already entered into a “corporate integrity agreement” with the federal government in 2010 that prohibited the company from promoting off-label applications for any of the drugs. This agreement was reached following another complaint about similar allegations. The 2013 complaint alleges that AstraZeneca essentially ignored the integrity agreement and continued to promote other uses for Crestor and Seroquel. The deal prevented the company from promoting its antipsychotic Seroquel (quetiapine fumarate) and cholesterol drug Crestor (Rosuvastatin Calcium) for unauthorized FDA applications, but the state said the company still exploited off-label marketing. Still, Zayas can rest assured, knowing that AstraZeneca will pay at least US$110 million in this latest comparison. Under the agreement, $31.4 million will be distributed among whistleblowers; $45.8 million will go to Texas to cover taxpayers` money that has been stolen from the Medicaid system. $32.8 million goes to the federal government to cover the loss for federal taxpayers. As part of the CIA, AstraZeneca must also establish a non-promotional surveillance program for tracking medical training grants. The agreement establishes that the company has already established a Medical Education Grants Office (MEGO) within its Medical Affairs Department as an exclusive mechanism for applicants to apply for or obtain grants for independent medical training activities.

There will also be a Grants Monitoring Program, created by the CIA, that will use the company: in 2010, the U.S. Department of Justice announced that AstraZeneca would pay US$520 million to clarify allegations that it illegally marketed its antipsychotic Seroquel for unsafe and effective applications authorized by the FDA. Under the terms of the transaction, $302 million of the total amount is expected to go to the federal government and $218 million to the state`s Medicaid programs. Among other things, the company has been accused of paying doctors to make speeches and publish articles (the company`s ghostwritten) that encourage these unauthorized uses. AstraZeneca has agreed to sign a corporate integrity agreement on its future behavior. In 2011, AstraZeneca resolved a related seroquel case filed by state governments by agreeing to pay an additional $69 million. “Texas is the leader in the country in protecting its Medicaid system from pharmaceutical fraud,” said Texas Attorney General Ken Paxton. “The charges that led to this agreement are particularly worrying, as the well-being of the children and the integrity of the public hospital system were threatened. The cooperation and support of the Texas Health and Human Services Commission played a crucial role in this exceptional outcome for Texans. With respect to clinical trials, the CIA requires researchers to enter into written agreements with AstraZeneca: according to the settlement agreement, AstraZeneca directed its illegal marketing of the antipsychotic seroquel to physicians who do not normally treat schizophrenia or bipolar disorder, such as physicians treating the elderly, family physicians, paediatricians and young doctors, as well as in long-term care centres and prisons. Reports have shown that the drugs have caused rapid weight gain in children and side effects, including deaths. In 2001, a coalition of 17 consumer groups filed complaints against AstraZeneca and Barr Laboratories accusing them of illegally taking off the market a generic version of the cancer drug Tamoxifen.

The two companies reached an agreement under which AstraZeneca Barr paid $US 21 million to sell its drug rather than manufacture a low-cost generic drug. The proceedings were subsequently dismissed. The deal would reach a formal tentative agreement the company reached with the U.S. attorney in Philadelphia last October. At the time, AstraZeneca said in a filing with the Securities and Exchange Commission that it had set aside $520 million for the investigation. . . .