(CN) – Allergan will pay $600 million for pushing Botox for unapproved uses and plead guilty to misdemeanor misbranding of the drug. Allergan pushed its paralyzing drug for headaches, pain, spasticity and juvenile cerebral palsy, though the Food and Drug Administration never approved it for any of that.
The payment includes $375 in criminal fines and forfeiture, $210 million in civil fines to the federal government and $15 million to states, Allergan said in announcing the settlement. The drug giant admitted it misbranded the drug from 2000 through 2005.
Doctors are allowed to prescribe drugs for off-label uses, but drug companies cannot push the drugs for that.
Federal prosecutors filed a criminal information against Allergan last week, claiming that Allergan made it a top corporate priority to increase sales of Botox for off-label uses.
In 2003, Allergan doubled the size of its reimbursement team to help doctors get paid for off-label Botox injections, prosecutors said. The company held workshops to teach doctors and their 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 a Botox Reimbursement Hotline to provided an 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” to promote off-label uses, and created a “independent” online neurotoxin education organization to increase off-label use.
“The 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 FDA,” said Sally Yates, U.S. Attorney in Atlanta.
“Allergan further demanded tremendous growth in these off-label sales year after year, even when there was little clinical evidence that these uses were effective.”
The civil settlement also resolves three federal lawsuits in Atlanta. The whistleblower plaintiffs – Dr. Amy Lang, Charles Rushin, Cher Beilfuss, Kathleen O’Conner-Masse, and Edward Hallivis – will receive $37.8 million from the federal share of the settlement.