Botox Marketing Settlement Approved: $600 Million For Misleading Branding

ATLANTA — A federal investigation into Allergan Inc.'s misleading marketing of its wrinkle-smoothing Botox medication is over after a judge in Georgia on Tuesday approved the pharmaceutical firm's decision to pay $600 million and plead guilty to misbranding the product.

U.S. District Court Judge Orinda D. Evans sentenced the Irvine, Calif.-based company to pay $375 million in connection with the plea. The company also said it would pay $225 million in civil fines.

The sentencing came a month after the company said in a statement that it would admit to a charge that the company's marketing tactics led physicians to use Botox for unapproved uses such as headaches, pain and cerebral palsy in children between 2000 to 2005.

Botox, which was introduced in 1989, is one of Allergan's top drugs, accounting or more than $1.3 billion of the company's $4.4 billion sales in 2009. The drug is most famous for its ability to smooth frown lines on aging foreheads, but it's also approved to treat neck spasms, eye muscle disorders and excessive underarm sweating.

The drug last year won approval to treat spasms in the elbows, wrists and fingers. But it's also widely used off-label to treat conditions such as cerebral palsy, and Allergan says it is working with U.S. health officials to approve the use of Botox for children with the neuromuscular disorder.

Federal prosecutors launched the investigation into Allergan when two whistle blowers – a physician and a Botox sales representative – filed a complaint in Atlanta, said U.S. Attorney Sally Quillian Yates. She said Allergan put potential profits ahead of the federal approval process, risking public safety.

"We hope other companies are paying close attention to what can happen if they don't follow the rules and rush towards making profits," she said.

Comments

[hellboundtrain]

08:08 PM on 10/06/2010

Will it make her face smooth like a plastic mannequin? Oh, boy.

[DUSAA-1775]

09:59 AM on 10/06/2010

how much money will Pelosi get?

[stape45]

08:02 AM on 10/06/2010

The usual mantra (That's socialism!) doesn't apply here so, here goes: THAT'S CAPITALISM!

[ya right]

07:48 AM on 10/06/2010

Just look at the faces of some Hollywood actresses and you know Botox Is BS.

[VOTER]

08:03 AM on 10/06/2010

Did you read the article?
Botox used to ease or eliminate wrinkles is fine.
The Company is charged with promoting its product for other conditions.

[RodneyMesriani]

03:24 AM on 10/06/2010

While there are actually no adverse (or at least reportedly adverse) effects of Allergan's misleading branding which lead to unapproved uses for headaches, pain and cerebral palsy in children, allowing companies to just get away with such practices all in the name of profit could only lead to more consumer fraud. There may not have been any ill effects but it doesn't mean that millions of consumers from 2000-2005 should be misled further.

http://www.mesrianilaw.com/Products-Liability-Claim.html

[Debbie338]

09:42 PM on 10/05/2010

I started using Botox years ago for intractable tension headaches. It works. There was never a drug or "relaxation technique" that worked. Just because it isn't approved for that doesn't mean it doesn't work.

[MaryanneNJ]

11:58 PM on 10/05/2010

That is true...and a doctor is not regulated by the FDA so can administer a drug off-label for uses that are not yet approved by the agency. However a drug company is regulated by the FDA and cannot market or promote claims to either a doctor or a consumer for uses not stated in the drug FDA labeling for approved use. That is where the problem was likely the conversations between the reps and doctors.

[J Accuse]

08:44 PM on 10/05/2010

So by lying about their product and inventing off-label uses, they sold billions in additional product but are only fined for roughly less than half that. Way to send a message, guys.