Botox manufacturer Allergan has agreed to plead guilty and pay $600 million to settle federal criminal and civil charges for illegally marketing Botox for uses not approved by the FDA, such as pain and headache.
"Fraudulent marketing of drugs through off-label promotion or kickbacks to prescribers undermines the protections afforded by the drug approval process and medical decision-making," says Daniel Levinson, Inspector General of the U.S. Department of HHS.
As part of the case, Justice officials Wednesday filed "criminal information" against Allergan "for promoting Botox for headache, pain, spasticity and juvenile cerebral palsy—none of which were approved by the FDA. According to the criminal information, Allergan made it a top corporate priority to maximize sales of Botox for such off-label uses."
"As a result of this settlement, OIG (Office of Inspector General) will oversee a Corporate Integrity Agreement with Allergan that increases the transparency of Allergan's interactions with physicians and helps to ensure the company's future compliance and accountability," the Department of Justice said Wednesday in a statement.
"The criminal information alleges that Allergan exploited its on-label cervical dystonia (CD) indication to grow off-label pain and headache (HA) sales," according to the Justice Department statement. "In 2003, Allergan developed the 'CD/HA Initiative' as a 'rescue strategy' in the event of negative results from its clinical trials to ensure continued expansion into the pain and headache markets.
"As part of this initative, Allergan claimed that cervical dystonia was 'underdiagnosed' and that doctors could diagnose cervical dystonia based on headache and pain symptoms, even when the doctor 'doesn't see any cervical dystonia,' " the Department of Justice statement said.
The resolution includes a criminal fine totaling $375 million and a civil settlement with the federal government andstates of $225 million.