The manufacturer of Botox has agreed to pay $600 million to settle an ongoing federal investigation of its marketing, which included promoting the wrinkle smoother to treat children with cerebral palsy.
Allergan, which makes Botox, put out a press release Wednesday about the resolution of the five-year-old investigation by the U.S. Department of Justice.
http://agn.client.shareholder.com/releasedetail.cfm?ReleaseID=503974
The drug maker will plead guilty to one misdemeanor of “misbranding” from 2000 to 2005 and pay the government $375 million for that count. Allergan will also ante up $225 million in civil fines stemming from the probe, even though the drug maker denies any liability in the civil allegations.
“This settlement is in the best interest of our stockholders as it resolves all matters at issue in the investigation, avoids substantial costs of litigation, as well as the substantial risks to Allergan associated with Government enforcement action in these matters, and permits us to focus our time and resources on productively developing new treatments for patients and the medical community,” Douglas Ingram, Allergan’s executive vice president, said in a prepared statement.
The Justice Department was investigating Irvine, Calif.-based Allergan’s marketing of Botox, a wrinkle smoother, from 2000 to 2005. The marketing push prompted doctors to use Botox for unapproved treatments, including cerebral palsy in children, headaches, spasticity and pain, according to the Associated Press.
http://www.google.com/hostednews/ap/article/ALeqM5gCEyQ9eA4fFGeudlfvUBZt2qjWiAD9HV7NBG0
Drug makers are barred from marketing drugs for so-called “off-label,” or non-approved, uses.
Botox became a household name because of its success temporarily erasing facial wrinkles, but it also has approval for use for eye muscle problems, underarm sweating and spasms of the neck, elbows, wrists and fingers.
It’s also been used off-label to treat cerebral palsy in children and adults, and Allergan is talking to the federal regulators about getting formal approval for Botox to be used for children, according to AP.
The wire service also reported that this year the American Academy of Neurology gave Botox its imprimatur as an “effective and generally safe treatment” for children with cerebral palsy.
Under the settlement, Allergan will drop a lawsuit it has pending against the Food and Drug Administration. In the suit, the company argued that it had a First Amendment right to talk to doctors about safe uses for Botox, even off-label uses it doesn’t have approval for.
The criminal resolution is subject to approval by the federal court in Northern District of Georgia, and the civil settlement is contingent upon such approval.
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