Allergan, the maker of Botox, has agreed to pay a $600 million fine to resolve criminal and civil complaints of illegal off-label marketing of Botox.
According to the New York Times, Allergan denies most of the complaints in lawsuits by whistle-blowers and federal prosecutors; documents released by the Justice Department related to the settlement outlined claims that Allergan had systematically built Botox sales by promoting it for unapproved treatments to relieve conditions such as muscle spasticity and cerebral palsy in children.
Doctors are allowed to prescribe drugs for unapproved, i.e., off-label, uses that they deem medically appropriate, but it is illegal for a drug maker to promote off-label uses.
While Botox is most famous as a wrinkle treatment, it can also used to treat a range of muscle and gland disorders. The FDA has approved Botox for a number of conditions, including uncontrolled blinking, certain neck muscle spasms, and excessive underarm sweating. Currently, the FDA is considering whether to approve Botox as a treatement for migraines.
Despite the fine, Caroline Van Hove, an Allergan spokeswoman, said that Allergan has denied the criminal and civil accusations, except for the one misbranding charge.
“I want to be clear that Allergan is not charged with misleading doctors or causing any patient harm,” Ms. Van Hove wrote in an e-mail to a reporter, “and we adamantly deny any implication that this occurred.”
Allergan, she added, has spent hundreds of millions of dollars in medical research and development of new uses for Botox. The drug is approved in 81 countries to treat 21 different conditions, she said.
Allergan is also studying Botox as a possible treatment for overactive bladders, and it owns patents on dozens of other potential treatments.