By Colin Stewart/The Orange County Register

The blockbuster drug Botox has just one FDA-approved cosmetic use – wrinkles between the eyebrows. But its manufacturer, Irvine, Calif-based Allergan, rakes in an estimated $650 million a year from the sale of Botox for treatments unapproved by the FDA.

The popularity of these off-label uses has brought Allergan into conflict with the federal government, which is probing whether the company illegally advertised or promoted unapproved treatments.

Off-label uses have also landed the company in court. Nine lawsuits blaming Botox for illnesses and deaths include one this spring in which the company was ordered to pay $15 million to an Oklahoma woman who said a series of on- and off-label cosmetic Botox shots left her in pain and partially paralyzed. Allergan is appealing that verdict.

Allergan, meanwhile, has sued the FDA for the right to tell doctors more about off-label uses of Botox. The company already helps spread the word by donating hundreds of thousands of dollars each year to independent medical institutes that train doctors on how to inject Botox as a treatment for ailments not authorized by the FDA.

Allergan’s lawsuit questions the FDA’s control over how drug companies communicate with doctors and patients. Also at stake is the future of Botox sales, currently totaling $1.3 billion a year. Most importantly, patients’ health is at stake.

The dispute over off-label therapies highlights a gap between the American system of regulating drugs and the way the medical community prescribes them. As long as a drug is approved by the FDA for one use, doctors have the right to prescribe it for any use that they believe to be medically appropriate.


[Source: The Orange County Register]