CHICAGO – Allergan Inc has agreed to pay $600 million to settle a federal investigation of its marketing practices for the injectable wrinkle smoother Botox.
Allergan will record non-recurring pre-tax charges of $610 million to $615 million in its third fiscal quarter related to the settlement with the US department of justice. The settlement was announced by the company on Wednesday. The justice department declined immediate comment.
The investigation centred on the company’s marketing of Botox for certain therapeutic treatments, such as pain, that had not been approved by US health authorities.
Allergan agreed to plead guilty to a misdemeanour “misbranding” charge covering 2000 until 2005, and pay $375 million.
The company also agreed to pay $225 million to resolve civil claims asserted by the department under the civil False Claims Act.
As part of its plea, Allergan agreed that between 2000 and 2005, its marketing of Botox resulted in uses for the therapeutic treatment of headache, pain, spasticity and juvenile cerebral palsy.
These were considered “off-label” uses because Botox had not been approved for those uses during that time period and the labelling for Botox did not contain directions for those uses.
In March 2010, the US Food and Drug Administration approved Botox for the treatment of increased muscle stiffness in the elbow, wrist and fingers in adults with upper-limb spasticity. The label now included directions for that use, the company said.
Based on positive phase III trials announced in September 2008, Allergan has filed for FDA approval of Botox for the treatment of chronic migraine and expects a ruling before the end of 2010.
While Botox is approved in 70 countries, including the UK and Canada, to treat symptoms associated with juvenile cerebral palsy, it does not have that approval in the United States, where it is currently used off-label.
Allergan said it was in discussions with the FDA regarding additional clinical development for juvenile cerebral palsy in the United States.
Under US law, once a drug has been approved for a particular use, doctors can prescribe it for other purposes. However, pharmaceutical companies are not permitted to promote the drug for those uses.
Allergan, which has a manufacturing facility in Westport, Co Mayo, was accused of making it a priority to maximise sales of Botox for unapproved uses.
In a statement, the Irish Medicines Board has said that in Ireland, “Botox is a prescription-only medicinal product”, adding that the advertising of prescription-only medicinal products to the public is prohibited.
It has said that Irish doctors may prescribe a product for a patient under his or her care for use other than those included in the product’s summary of characteristics. – (Reuters)