Natasha Singer reports that Allergan will pay $600 million to settle federal charges that it illegally promoted and sold Botox for unapproved uses such as treating headaches and reducing pain and
severe spasms in the limbs of children with cerebral palsy through 2005.
A civil complaint alleges that Allergan had "illegally, vigorously and, without any thought to the possible
negative health effects to which it subjected patients, promoted" Botox for uses that had not been deemed safe and effective by the FDA. Prosecutors also claimed that the company taught doctors how
to get reimbursed from Medicare and Medicaid by entering codes for approved treatments while using the drug for other purposes.
"With cases like this one, we hope to put an end to
the practice in the pharmaceutical industry known as off-label marketing," Sally Quillian Yates, U.S. attorney for the Northern District of Georgia, tells Singer. A spokeswoman for Allergan says the
government's claims are unproven civil accusations.
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