WASHINGTON – Allergan Inc., maker of the anti-wrinkle drug Botox, has agreed to pay the federal government $600 million to settle civil and criminal allegations that it marketed the blockbuster treatment for unapproved uses, the Justice Department said Wednesday.

The Irvine, Calif.-based specialty pharmaceutical firm also agreed to plead guilty to a single misdemeanor count of promoting Botox for relief of headaches and other uses for which the drug, made from a form of botulism, is not approved by the Food and Drug Administration.

The agreement ends more than two years of scrutiny of Allergan’s activities spawned by whistleblowers. The company was accused of making it “a top corporate priority to maximize sales of Botox” for unapproved uses between 2000 and 2005, according to documents released by the Justice Departmen.

Allergan paid doctors to attend meetings promoting unlawful marketing and to lobby health care payers to cover off-label use of the drug, according to the documents. In addition to headaches, the drug was improperly promoted as a treatment for spasticity, pain and juvenile cerebral palsy.

“These are not victimless crimes. … It drives up the cost of health care for all of us,” said Assistant Attorney General Tony West.

 


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