Astrazeneca Corporate Integrity Agreement

“AstraZeneca makes no concessions or admissions of error in the transaction agreements,” the company said in a statement. AstraZeneca denies the charges, but it is in the company`s interest to resolve these issues and move forward. As part of the CIA, AstraZeneca must also develop a non-promotional follow-up program for monitoring medical fellowships. The agreement states that the company has already set up a Medical Education Grants Office (MEGO) within its Medical Affairs Department as an exclusive mechanism by which applicants can apply for or receive scholarships for independent medical education activities. There will also be a subsidy monitoring program, launched by the CIA, which will be used by the company: yet, Zayas can rest to know that AstraZeneca will pay at least $110 million in this latest comparison. Under the agreement, $31.4 million will be distributed among whistleblowers; US$45.8 million will be paid to Texas to cover state taxpayers` money that was stolen from the Medicaid system; $32.8 million goes to the federal government to cover the loss to federal taxpayers. The agreement prohibits the company from promoting its antipsychotic drugs Seroquel (queiapin fumarate) and its cholesterol drug Crestor (Rosuvastatin Calcium) for unauthorized FDA applications, but the state has claimed that the company engaged in off-label marketing anyway. In 2010, the U.S. Department of Justice announced that AstraZeneca would pay $520 million to clarify allegations that it illegally marketed its antipsychotic drug Seroquel for applications that are not licensed as safe and effective by the FDA. According to the terms of the comparison, $302 million was allocated to the federal government and $218 million to government Medicaid programs. In particular, the company has been accused of paying doctors to give speeches and publish articles (written by the company) promoting these unauthorized uses.

AstraZeneca has agreed to sign an agreement on the integrity of the company regarding its future conduct. In 2011, AstraZeneca resolved a related case of Seroquel, which was brought by federal state governments by agreeing to pay an additional $69 million. The agreement would make a formal agreement in principle that the company reached last October with the U.S. attorney in Philadelphia. At the time, AstraZeneca said in a notification to the Securities and Exchange Commission that it had set aside $520 million for the investigation.