To settle a probe by the US Department of Justice, Allergan is paying $$375 million and pleading guilty to one misdemeanor count of misbranding in connection with off-label marketing of its Botox med for various unapproved uses - headache, pain, spasticity and juvenile cerebral palsy - between 2000 and 2005.

Another $225 million is being paid to in fines to cover civil claims asserted by the DOJ under the False Claims Act - there were three separate whistleblower lawsuits filed by Allergan employees that prompted the government probe (read them here, here and here). In addition, the drugmaker, which denies liability for the civil claims, is required to enter into a Corporate Integrity Agreement that will be overseen by an outside party and govern its marketing practices for several years. In a statement, Allergan issued the usual declaration that dispensing with all of the legal problems at once is in the best interest of shareholders.

“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,” says Sally Yates, US Attorney for the Northern District of Georgia, in a statement. “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.”

And here’s an interesting aspect to the deal: To resolve the criminal and civil investigation, Allergan was required to dismiss its First Amendment lawsuit (here it is) in which the drugmaker sought to win the right to distribute information about unapproved uses for Botox in the context of providing scientific and medical info to doctors. Allergan claimed an FDA ban on off-label marketing violates its First Amendment rights to free speech.

So how did Allergan promote Botox? The feds say Allergan exploited its on-label cervical dystonia (CD) indication to grow off-label pain and headache sales by developed a “CD/HA Initiative” as a “rescue strategy” in the event of negative results from its clinical trials. Allergan claimed CD was as “underdiagnosed” and doc could diagnose CD based on headache and pain symptoms, even when the doctor “doesn’t see any cervical dystonia.”

In a statement, the feds go on to say Allergan also called on docs who typically treat patients with off-label conditions. How so? In 2003, “Allergan doubled the size of its reimbursement team to assist docs in obtaining payment for off-label injections, and held workshops to teach docs and office 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, which provided a wide 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 promoting off-label uses, and created a purportedly independent online neurotoxin education organization to stimulate increased use of Botox for off-label indications,” according to the feds.

On a related note, you may recall the drugmaker recently sought to recover $460,000 in legal costs from Dee Spears, who unsuccessfully sued Allergan over the death of her 7-year-old daughter, Kristen, after she was administered a series of therapeutic Botox shots. She sued the drugmaker for $60 million, accusing it of concealing info about the dangers of the drug, which was used to relax the girl’s clenched limbs; she suffered from cerebral palsy (back story).