Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Novo's Victoza REMS Settlement Opens Another Legal Door For Off-Label Promotion Cases

Executive Summary

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...



US Enforcement 2019: Compounding, Opioids Top Priorities But Beware Of REMS Violations, Too

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.

The Benefits Of A Corporate Integrity Agreement: An Industry Perspective

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.

Gilead Asks Supreme Court To Restrict False Claims Act Cases

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.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS121482

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel