Allergan, Inc. just pleaded guilty in a criminal case over how it unlawfully marketed Botox, said Consumer Affairs. The drug maker was sentenced to pay $375 million for exploiting <"http://www.yourlawyer.com/topics/overview/botox">Botox for unapproved uses; a criminal fine and forfeiture were also involved.
As weâ€™ve mentioned before, the Botox probe lasted one year, with the Justice Department looking at Allerganâ€™s marketing of Botox from 2001 through 2008, said the Associated Press (AP) previously. Of note, itâ€™s illegal for drug makers to market drugs for uses not approved by the US Food and Drug Administration (FDA).
â€œThe FDA approval process is designed to help protect the public, and when a manufacturer puts potential profits and sales ahead of the approval process, they risk paying a bigger price,” United States Attorney Sally Quillian Yates said, quoted Consumer Affairs. “At the time of the offenses, Allergan knew that there was insufficient clinical evidence for the wide range of claims the company was promoting and pushing with doctors. We hope other companies are paying close attention to what can happen if they donâ€™t follow the rules and rush towards making profits,â€ Yates added.
Last April, the FDA mandated a black box label for Botox and similar products, warning of the risk of adverse events when the effects of a botulinum toxin injection spread beyond its injection site. The label revision followed an FDA safety review prompted by reports of adverse reactions that resembled botulism infections in patients receiving injections. The most serious cases involved hospitalization and death, and occurred mostly in children treated for cerebral palsy (CP)-associated limb spasticity. Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S.
â€œThe FDA had approved therapeutic uses of Botox for only four rare conditions, yet Allergan made it a top corporate priority to maximize sales of far more lucrative off-label uses that were not approved by the FDA,â€ said Yates, quoted the AP last month. â€œAllergan further demanded tremendous growth in these off-label sales year after year, even when there was little clinical evidence that these uses were effective.â€
According to Yates and court information, the drug maker â€œpleaded guilty for promoting Botox between 2000-2005 for headache, pain, spasticity, and juvenile cerebral palsy,â€ all nonapproved uses, said Consumer Affairs. Botox is only approved for crossed eyes (strabismus); blepharospasm, involuntarily eyelid muscle contraction; involuntary neck muscle contraction (cervical dystonia); and primary axillary hyperhidrosis, also known as excessive underarm sweating, explained Consumer Affairs.
In 2003, Allergan increased the size of teams to help physicians receive reimbursements for off-label reimbursements two-fold, held workshops teaching doctors offices how to bill for off-label uses, audited physician billing records to help with the reimbursement process; created a Botox Reimbursement Hotline giving doctors access to free services to better augment its massive off-label Botox program; lobbied government healthcare programs for increased off-label coverage; managed physician workshops and dinners; paid doctors for attendance at â€œAdvisory Boardsâ€; created a so-called â€œindependent neurotoxin education organization,â€ meant to increase Botox use off-label; and implemented its â€œCD/HA Initiative,â€ said Consumer Affairs.
The company signed a plea agreement, admitted guilt to a criminal misdemeanor and violating the FDCA, agreed to pay a criminal fine of $350 million, and agreed to forfeit assets of $25 million, added Consumer Affairs. Allergan also signed a civil settlement agreement and will pay another $225 million to the federal government and some states to resolve accusations that its illegal marketing caused the submission of false claims to government health care programs including Medicare, Medicaid, TRICARE, the Federal Employees Health Benefit Program, the Department of Veteransâ€™ Affairs, and the Department of Laborâ€™s Office of Workersâ€™ Compensation Programs.
Botox is approved for cosmetic use under Botox Cosmetic, which is not involved in this case.