by Ben Vernia | September 1st, 2010
In a settlement announced on September 1, the Department of Justice and Allergan, Inc., have reached an agreement to settle allegations that the company marketed its blockbuster drug Botox for off-label uses. The company will plead guilty a criminal information alleging a single misdemeanor allegations of misbranding under the Food, Drug & Cosmetic Act, pay $375 million in criminal fines, and another $225 million in a civil settlement. According to DOJ’s press release:
Tony West, Assistant Attorney General for the Civil Division of the Department of Justice, and Sally Quillian Yates, U.S. Attorney for the Northern District of Georgia, today announced the filing of a criminal information against Allergan for promoting Botox® for headache, pain, spasticity and juvenile cerebral palsy – none of which were approved by the FDA. According to the criminal information, Allergan made it a top corporate priority to maximize sales of Botox® for such off-label uses.
In 1989, the FDA approved Botox®, a prescription biological product containing botulinum toxin type A, a purified neurotoxin, to treat strabismus (crossed eyes) and blepharospasm (involuntary eyelid muscle contraction). In 2000 and 2004, approval was given to treat cervical dystonia (involuntary neck muscle contraction) and primary axillary hyperhidrosis (excessive underarm sweating), respectively. In 2010, approval was given to treat adult upper-limb spasticity.
The criminal information alleges that Allergan exploited its on-label cervical dystonia (CD) indication to grow off-label pain and headache (HA) sales. In 2003, Allergan developed the “CD/HA Initiative” as a “rescue strategy” in the event of negative results from its clinical trials to ensure continued expansion into the pain and headache markets. As part of this initiative, Allergan claimed that cervical dystonia was “underdiagnosed” and that doctors could diagnose cervical dystonia based on headache and pain symptoms, even when the doctor “doesn‟t see any cervical dystonia.”
Allergan‟s off-label marketing tactics also included calling on doctors who typically treat patients with off-label conditions. 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.
The Department announced that the case arose from three separate whistleblower suits. The relators will split $37.8 million of the civil settlement (a 16.7% relators’ share).
The company announced in a press release that as part of the settlement, it was required to dismiss its pending suit seeking to enjoin the FDA’s off-label enforcement. Allergan also agreed to enter a Corporate Integrity Agreement with HHS.
