Allergan, the makers of BOTOX, agreed to pay a penalty of $600 million in September 2010 to settle charges that the pharmaceutical company engaged in illegally promoting the drug for off-label promotion. Simply put, an ???off-label??? use is when a pharmaceutical agent is being used in a way not approved by the U.S. Food and Drug Administration (FDA). These off-label violations usually fall into one of three categories:
- The drug is used for a different medical condition or disease.
- The drug is administered using a different method of administration (ie topical vs. oral).
- Or the drug is administered at a different dose than that provided on the approved label.
The FDA reviews the data from the clinical trials and, assuming the data indicate that the drug works the way it should and is ???safe??? in this capacity, can approve a drug. As of September 2010, BOTOX is approved for use in about 75 countries.
In the United States, BOTOX is approved by the FDA to treat the following conditions: blepharospasm, cervical dystonia, severe primary axillary hyperhidrosis that is not appropriately managed through the use of topical agents, and strabismus. According to the information provided in the U.S. government???s civil complaint, Allergan had developed and implemented a wide-ranging marketing program that included paying physicians to prescribe BOTOX for conditions such as pain or severe spasms in children afflicted with cerebral palsy. Furthermore, the federal prosecutors accused Allergan of providing instruction to physicians as to how they could get reimbursed through Medicaid and Medicare for off-label use of BOTOX.
Allergan denied these charges, but did agree to plead guilty to a charge of misbranding BOTOX by promoting BOTOX for unapproved uses (this amounted to $375 million). In addition, Allergan agreed to pay $225 million to settle a claim that it resulted in false claims being filled to Medicare and Medicaid, as well as other health programs sponsored by the U.S. government.
