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AstraZeneca Fined $520 Million

  • April 30, 2010
  • RPh on the Go

Drug maker AstraZeneca is facing a $520 million fine for off-label promotion of its drug Seroquel. Seroquel is an antipsychotic that is the second highest seller for the drug maker and brought in $4.9 billion in sales in 2009.
The federal government is collecting the fine to settle accusations that AstraZeneca promoted Seroquel for additional conditions including insomnia and psychiatric conditions that the FDA has not approved to be treated by the drug. Although Seroquel has FDA approval for use as an anti-psychotic, it is considered unlawful for drug companies to market products for conditions that the FDA has not specifically reviewed for treatment by that medication.
Although the off-label marketing is not legal, doctors are free to prescribe medication for conditions as they see fit. The conflict creates a grey area that can be exploited by drug sellers who sometimes provide physicians with study findings that encourage off-label prescribing.

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