$600 million fine for ‘mislabelling’ Botox
A US company has settled claims of marketing products for non-approved use, acknowledging that it misleadingly marketed Botox.
Allergan’s marketing campaign promoted Botox for treating migraines – but the US watchdog – the Food and Drug Administration (FDA) – had never approved it for this use.
Allergan says it has reached a resolution with the US Department of Justice regarding a government investigation into sales and marketing practices relating to therapeutic uses of Botox (onabotulinumtoxin A).
It agreed to plead guilty to a single misdemeanour ‘misbranding’ charge, covering 2000-2005 and will pay the government the settlement.
The payout is reported to have been $600 million.
The FDA had not approved Botox for such uses, although Allergan jumped the gun – the FDA has since considered giving the green light to some of the claims made and Botox is awaiting FDA approval for migraine use.
As part of the deal, Allergan has agreed to drop its own lawsuit against the FDA challenging the agency’s authority to restrict off-label uses.