Botox maker to pay $600m for off-label misuse

Allergan, the maker of the popular anti-wrinkle treatment Botox, said yesterday it had agreed to pay $600 million dollars to settle a US probe into illegal marketing for so-called off-label uses.

The company said in a statement it agreed to plead guilty to a single misdemeanour “misbranding” charge covering the period 2000 through 2005 and pay the government $375 million.

It will pay an additional $225 million to resolve civil claims from the Justice Department under the False Claims Act, which relates to fraud.

The misbranding case stems from the promotion of Botox for uses for which it had not been approved between 2000 and 2005, the company said.

During that time, its marketing resulted in uses for headache, pain, spasticity and juvenile cerebral palsy. Some of those uses were subsequently approved or are being considered.

The Justice Department said the settlement comes following a lengthy civil and criminal probe.

“Allergan illegally promoted Botox for uses that were not approved as safe and effective by the Food and Drug Administration, including pain, headache, spasticity, and juvenile cerebral palsy,” said Assistant Attorney General Tony West.

Mr West said the company “paid kickbacks to induce ­physicians to inject Botox for off-label uses” among other abuses.