AstraZeneca has confirmed that it will pay $520 million to the US government to settle alleged claims about improper marketing of its blockbuster schizophrenia drug Seroquel.
The final agreement has been reached with the likes of the US Department of Justice, various other federal agencies and the National Association of Medicaid Fraud Control Units. Of the $520 million, for which AstraZeneca had already made provision last year, $301.9 million will be paid to the federal government and the rest will be shared by the states. The whistleblower who reported the alleged fraud, James Wetta, will pocket more than $45 million.
The US government had alleged that AstraZeneca illegally marketed Seroquel (quetiapine) from January 2001 to December 2006 for certain uses that were not approved by the US Food and Drug Administration. These included aggression, Alzheimer’s disease, anger management, anxiety, attention deficit hyperactivity disorder, bipolar maintenance, dementia, depression, mood disorder, post-traumatic stress disorder, and sleeplessness.
It is also claimed that the Anglo-Swedish drugmaker promoted the unapproved uses “by improperly and unduly influencing the content of, and speakers, in company-sponsored continuing medical education programmes”. In addition, the DoJ claims AstraZeneca recruited doctors to serve as authors of articles that were ghostwritten by medical literature companies and about studies the doctors in question did not conduct. Those studies and articles were then used as the basis for promotion about unapproved uses of the antipsychotic, it is alleged.
In March 2006, AstraZeneca brought “certain conduct” to the attention of the government and then cooperated in the investigation of the allegations which have now been settled. The response from across the pond has been caustic and Attorney General Eric Holder said that “illegal acts by pharmaceutical companies and false claims against Medicare and Medicaid can put the public health at risk, corrupt medical decisions by healthcare providers, and take billions of dollars directly out of taxpayers’ pockets”.
He added that the government “is committed to recovering taxpayer money lost to health care fraud, whether it’s by bringing cases against common criminals operating out of vacant storefronts or executives at some of the nation’s biggest companies”.
The company denies the allegations but its US general counsel Glenn Engelmann said “it is in the best interest of AstraZeneca to resolve these matters and to move forward with our business of discovering and developing important, life-changing medicines while avoiding the delay, uncertainty, and expense of protracted litigation”. In addition to the payment, AstraZeneca has also agreed to a five-year “corporate integrity agreement” to ensure compliance with US laws.
