Botox maker pays top dollar to resolve investigation

Allergan Inc., maker of the world famous wrinkle smoother Botox, will pay $375 million after pleading guilty to a misdemeanour misbranding charge related to off-label use of the cosmetic drug, a statement on the company’s website said.

In Allergan’s multi-year investigation plea deal, the company admitted that between 2000 through 2005, its marketing of Botox resulted in off-label uses for the treatment of headache, pain, spasticity and juvenile cerebral palsy.

To settle the investigation, Allergan was asked to terminate it’s First Amendment lawsuit pending in Washington D.C., in which it attempted a ruling to proactively share truthful scientific and medical information with the medical community in evaluating the risks and benefits of Botox off-label to treat certain forms of spasticity.

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

Global sales of Botox were $691 million for the first half of 2010 for both therapeutic and cosmetic uses. Botox is well known as a cosmetic treatment, but slightly more than half of the injectable neurotoxin’s $1.31 billion in sales last year involved therapeutic uses such as treating severe underarm sweating and muscle spasms in the neck.