New York Times reported on September 1, 2010 the specialty pharmaceutical company Allergan has agreed to pay $600 million to settle civil and criminal accusations that it illegally marketed Botox, the drug used in antiwrinkle injections, for medical uses for which the drug had not been approved.
In the settlement with the Justice Department issued Wednesday morning, said that Allergan had made it a top corporate priority to maximize sales of Botox for off-label uses. The statement continued, ” 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 offices staff 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 physicians 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 has agreed that from 2000 to 2005 its marketing resulted in the use of Botox for unapproved uses including the treatment of headaches, pain, spasticity and juvenile cerebral palsy. The significance of the case is that Allergan promoted Botox for off-label uses, uses that were not approved by the FDA as being safe and effective.
