Allergan, the maker of Botox®, is being forced to pay over $600 million following a civil settlement and charges that marketed the popular drug for off-label purposes. According to the New York Times, Allergan was marketing Botox®—which is currently used to treat wrinkles and hyperhidrosis—for the off-label treatment of migraines.
Botox® is currently not approved by the Food and Drug Administration for the treatment of migraines. The issue was not that Botox® was being used to treat migraines; it was that doctors were receiving incentives from Allergan if they actively promoted the headache treatment to their patients. The Justice Department issued this statement:
“In 2003, Allergan doubled the size of its reimbursement team to assist doctors in obtaining payment for off-label Botox® injections. Allergan held workshops to teach doctors and their office staffs how to bill for off-label uses, conducted detailed audits of doctors’ billing records to demonstrate how they could make money by injecting Botox®, and operated the Botox® Reimbursement Hotline, which provided a wide array of free on-demand services to doctors for off-label uses. Allergan also lobbied government health care programs to expand coverage for off-label uses, directed physician workshops and dinners focused on off-label uses, paid doctors to attend “advisory boards” promoting off-label uses, and created a purportedly independent online neurotoxin education organization to stimulate increased use of Botox® for off-label indications.”
Allergan, based in Irvine, CA, admitted to marketing unapproved uses of Botox®—including treatment of headaches and blepharospasm—between 2000 and 2005. The company agreed to pay $225 million to resolve civil charges that it endorsed falls Medicare and Medicaid claims, however, they denied liability. The company is schedule to pay between $610-$615 million in the third quarter of 2010, nearly half of Botox®’s $1.3 billion from last year.
Botox® was originally approved by the FDA in 1989 for the treatment in hyperhidrosis and then again in 2002 for wrinkle reduction. There is still concern as to whether or not the settlement will have an effect on the FDA’s decision on whether or not to approve Botox® for migraine treatment. The FDA’s decision is due to be announced at the end of October.