Anti wrinkle products have a huge market and great acceptability among consumers as no one wants a wrinkled skin. Be careful when you buy an anti-wrinkle cream, lotions or get a treatment done in spa for your wrinkles. Allergen, a maker of the popular wrinkle smoother Botox, agreed to pay $600 million and plead guilty of illegal marketing of Botox between 2000 and 2005 for uses for which it had not been approved by Food and Drug Administration.
The company will pay 375 million dollars to the federal government and an additional 225 million dollars to resolve civil claims from the Justice Department under the False Claims Act, which relates to fraud.
The company allegedly promotes Botox to doctors to give Botox shots for treatment of headaches, chronic migraine, pain, spasticity and juvenile cerebral palsy. These uses were not approved as safe and effective by the FDA.
Allergan taught doctors how to bill for off-label uses including coaching doctors on how to miscode Botox claims. This offensive practice led to millions of dollars of false claims being submitted to federal and state government programs like Medicare and Medicaid.
The company did not admit fraud but agreed...
to the settlement.
Botox contains botulinum toxin which works by blocking nerves that control muscles. The blocked nerves cause muscles to relax and that, in turn, helps reduce wrinkles for a few months. With the same mechanism Botox can prevent muscles from going into spasms, becoming stiff or causing pain.
Since 1989, The FDA has approved Botox for the treatment of eyelid spasms, certain neck muscle problems, excessive underarm sweating, as well as a cosmetic treatment to smooth furrows between the eyebrows. Earlier this year the drug got an approval as a treatment for increased muscle stiffness in the elbow, wrist and fingers. However, the application for Botox treatments for chronic migraines is still under review.