Allergan, the maker of Botox, has
agreed to pay $ 600 million to settle charges of illegally promoted and sold
the drug until 2005 for unauthorized uses, such as treatment of headache. This
regulation, the latest in a Justice Department crackdown continues in the
promotion of drugs by pharmaceutical companies offlabel comes with an unusual
postscript. In recent months, the Food and Drug Administration has seriously
considered the approval of Botox for the treatment of chronic headaches, a move
that was cited as beneficial in other studies and confirmed last month in the UK. The costs of illegal marketing covers the first half of
this decade, before the FDA review. Government civil claim Allergan said it had
"illegally, forcefully and without thinking about the possible negative
effects on the health of patients under that promoted" Botox for purposes
that had not been considered safe and effective FDA.
The company has developed and
implemented a comprehensive marketing program, according to the complaint,
which paid rebates to doctors to induce them to prescribe Botox to the
conditions - such as pain and cramping in the legs of children with paralysis
brain - not included in the product label. In a statement, Allergan said it
agreed that the marketing of 2000-2005 had resulted in the use of Botox for
unapproved uses, including treatment of headaches, pain, spasticity and youth
with cerebral palsy.
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