Legal news for marketing attorneys. AstraZeneca reaches $520 million settlement for off-label drug promotion.
The FDA reaches a settlement with AstraZeneca for off-label pharmaceutical marketing of Seroquel, an antipsychotic drug.
Washington, D.C.—Pharmaceutical manufacturer AstraZeneca, has reached a multi-million dollar settlement with the federal government to resolve allegations that the drug maker promoted an antipsychotic drug for off-label purposes. AstraZeneca was accused of promoting Seroquel for purposes like insomnia and other psychiatric issues other than schizophrenia and bipolar disorder, which it is intended for, as reported by MSNBC.
AstraZeneca and the federal government reached a $520 million settlement for the off-label promotion. Philadelphia U.S. Attorney Michael Levy stated the company had “turned patients into guinea pigs in an unsupervised drug test.” The federal government went after AstraZeneca after they discovered that Seroquel was being promoted for uses that are not approved by the U.S. Food and Drug Administration (FDA) http://www.fda.gov.
The FDA approves drugs for specific purposes and uses, but doctors are reportedly allowed to prescribe medication to what they deem to be appropriate. In drug regulation, such off-label use of medications is a gray area that has been involved in an ongoing controversy. Drug manufacturers are only supposed to promote and market drugs for FDA approved uses, but drug sales people get around the rule by telling doctors that research showed promise for other purposes.
It is not known if anyone was injured as a result of using the drug for unapproved purposes.
The off-label use of Seroquel made the drug manufacturer $4.9 billion in 2009.
Legal News Reporter: Nicole Howley-Legal news for marketing lawyers.