Allergan, the Orange County-based maker of Botox, has settled a case with the federal government for over $600 million. The L.A. Times reported that the settlement came about after the Justice Department pursued criminal charges against Allergan for marketing Botox for off-label use.
Allergan reportedly marketed Botox, the popular anti-wrinkle injectable, for the off-label purpose of migraine relief. While pharmaceutical firms are allowed to use their products for unapproved purposes, FDA approval is necessary in order to market the product to doctors and consumers.
It is estimated by the Justice Department that the settlement was one of the top ten largest healthcare settlements by the department.
The case came about more than two years ago following scrutiny by whistle-blower groups. Allergan promoted the popular injectable by lobbing health insurance companies to cover the off-label uses and by offering incentives to physicians who actively treated migraine patients with the drug. According to the Justice Department, Allergan spent $8 million alone on an online neurotoxin education organization to “stimulate increased use of Botox.”
Botox was also promoted to treat a plethora of medical conditions—including blepharospasm, pain and cerebral palsy—that it was not FDA approved for. While cosmetic doses, which are relatively small, carry minimal side effect, therapeutic doses can be more dangerous. Botox and competing products carry “black box” warnings that the toxin can spread from the injection site and cause life-threatening symptoms, such as trouble swallowing or breathing.
Allergan is currently awaiting FDA approval for the use of Botox on migraine sufferers. With the decision expected at the end of October, the timing of this settlement may affect the FDA’s final verdict on Botox.
To Your Health & Beauty,