Allergan agreed on Sept. 1 to plead guilty to charges that it had illegally promoted Botox Therapeutic for uses not approved by the Food and Drug Administration.

The U.S. Department of Justice announced the plea and said that the company would pay a total of $600 million – $375 million in criminal fines and $225 million in a civil settlement with the federal government and all of the states.

The plea came as the result of three lawsuits filed by five "whistle-blowers," including Dr. Amy Lang, a pain management physician in Lawrenceville, Ga. The whistle-blowers will receive $37.8 million from the federal settlement.

In a statement, the Department of Justice said Allergan had made it a "top corporate priority" to maximize Botox off-label sales. The company was cited for promoting the therapy for headache, pain, spasticity, and juvenile cerebral palsy.

Allergan also held workshops to teach physicians and their staffs how to bill for off-label uses, wined and dined physicians in an effort to encourage off-label use, and “created a purportedly independent online neurotoxin education organization to stimulate increased use of Botox for off-label indications,” according to the statement.

Allergan "demanded tremendous growth in these off-label sales year after year, even when there was little clinical evidence that these uses were effective," said Sally Q. Yates, U.S. Attorney for the Northern District of Georgia, in a statement. The Georgia district is prosecuting the criminal case.

As a result of the investigation and settlement, Allergan has entered into a Corporate Integrity Agreement with the U.S. Department of Health and Human Services. Under the terms of the 5-year agreement, its board will be charged with reviewing the company's compliance each year.

The company will also have to post information on its Web site disclosing payments to physicians and send a letter to physicians notifying them about the settlement.

Last fall, Allergan sued the FDA, claiming that restrictions on discussions of off-label use violated the company’s first amendment right to freedom of speech, and its ability to "proactively share truthful and relevant information with the medical community," according to a company statement.

09/01/10