Botox maker to pay $600m in settlement

Allergan said it will pay $375 million in connection with the plea, which includes the forfeiture of $25 million in assets.

Additionally, it will pay $225 million in civil fines — $210 million to the federal government and the rest to several states — related to the investigation, although the company denies liability for the civil claims.

Allergan, based in Irvine, Calif., also agreed with the Department of Health and Human Services’ Office of the Inspector General to submit compliance reports and to post on its website any payments to doctors, such as honoraria or travel or lodging expenses.

Allergan “paid kickbacks to induce physicians to inject Botox for off-label uses and Allergan also taught doctors how to bill for off-label uses, including coaching doctors how to miscode Botox claims, leading to millions of dollars of false claims being to submitted to federal and state programs,’’ Assistant Attorney General Tony West said.

Allergan officers are to make their first appearance in federal court today. The settlement is not official until approved by a federal judge.

“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 the FDA,’’ said Sally Yates, US attorney for the Northern District of Georgia. “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 investigation was sparked by a whistle-blower complaint, officials said, and five whistle-blowers will split $37.8 million of the government’s share of the settlement.

Allergan’s product sales topped $4.4 billion in 2009, with Botox accounting for more than $1.3 billion of that total.

The Justice Department’s investigation covered Allergan’s marketing of Botox from 2001 through at least 2008.

A Wells Fargo analyst, Larry Biegelsen, said the settlement is a positive thing for the company’s stock because it removes uncertainty.