Novo's Victoza REMS Settlement Opens Another Legal Door For Off-Label Promotion Cases
US government alleged sales reps gave information to physicians to create a false or misleading impression that Victoza's boxed warning and REMS messages about medullary thyroid cancer were 'erroneous, irrelevant or unimportant.' Novo's $59m settlement includes resolution of whistleblower lawsuits alleging off-label marketing.
You may also be interested in...
Drug manufacturer reimbursement support services also are garnering a growing amount of enforcement attention, and misleading promotion - whether on- or off-label - remains on the radar of government investigators.
Novo exec says CIAs can help spur culture change to improve sales rep compliance; cooperation can also help avoid corporate integrity agreements in future settlements.
Complaints should not be allowed to go forward if government knew of regulatory infraction but continued to pay for drug, Gilead argues, asking US high court to 'finish task' of its Escobar ruling.