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Allergan To Pay $600 Million for Botox Off-Label Promotion

Pharmaceutical company Allergan  agreed to pay $600 million to settle allegations of off-label promotion of its best-selling Botox.   The company will plead guilty to one misdemeanor charge of misbranding for promoting Botox as a treatment for a number of unapproved uses, including cerebral palsy in children, and headaches.   Under the agreement that the company has now reached with the Department Of Justice, Allergan will pay $375 million in settlement of criminal fines and $225 million in settlement of civil claims.

The Department Of Justice had also charged that Allergan indulged in unethical practices, including teaching doctors how to miscode Botox claims.  This resulted in millions of dollars of false claims being filed.

It isn’t the first time that Allergan has faced allegations that it promoted Botox for unapproved uses.  In fact, the company has faced several lawsuits over the years related to this off-label use of Botox.  Just this year, a Texas woman took Allergan to court alleging that the company’s promotion of Botox injections for off label use was responsible for her daughter’s death.  The child who suffered from cerebral palsy was six years old when she began receiving Botox injections to treat muscle spasms.  The woman’s lawsuit alleged that Allergan promoted untested and unapproved uses of the drug.

Botox has been used not just to treat muscular spasms from cerebral palsy, but also to treat a variety of other conditions, including pain.  Pain specialists have used Botox to provide pain relief for a longer period of time.  While traditional painkilling injections provide just three days of maximum pain relief, Botox can relieve pain for as long as three months.  However, the Food and Drug Administration has not approved Botox as a painkilling drug.

Off label marketing involves pharmaceutical companies promoting their drugs and medical devices for purposes and uses that are not approved by the Food and Drug Administration.  Some medications may work on more than one kind of illness, and the Food and Drug Administration may not have approved the use of the drug to treat all these conditions.  However, that doesn’t stop many pharmaceutical companies from promoting use of the drug for unapproved uses.  Sales representatives promote the drugs at doctors’ offices, and even offer doctors kickbacks and gifts in the form of vacations, fancy dinners and spa trips.

Off label promotion is a serious problem in the pharmaceutical industry.  California product liability lawyers believe that this will continue to be a serious problem until the Food and Drug Administration can act more effectively to stop such unethical practices.  The $600 million that Allergan will now pay out in settlement of civil and criminal cases, is peanuts for a company that has made hundreds of billions of dollars selling Botox.  These low fines do nothing at all to warn pharmaceutical companies, and until the FDA takes a stronger stand and begins imposing tough penalties, we will continue to see Americans being placed at risk from using unapproved drugs.

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