Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Off-Label Enforcement, Not Promotion, May See First Changes After Free Speech Ruling

Executive Summary

In a watershed decision, a federal appeals court declares that manufacturers cannot be prosecuted under the FD&C Act’s misbranding provisions solely for speech promoting off-label use of a drug. Industry attorneys predict the decision, if it stands, will change the government’s approach to pursuing such cases.

You may also be interested in...



False Claims Act Defenses Boosted By Amarin Decision, Attorney Says

First Amendment victory in off-label promotion case means criminal penalties and successful private qui tam actions could be less likely.

FDA May Cut Its Losses In Amarin Off-Label Promotion Case

Amarin and FDA explore settlement of Vascepa suit. The agency could allow Amarin to proceed with its statements and disclosures rather than risk a difficult appeal to the Second Circuit, the same court that handed FDA a loss in Caronia three years ago.

FDA May Cut Its Losses In Amarin Off-Label Promotion Case

Amarin and FDA explore settlement of Vascepa suit. The agency could allow Amarin to proceed with its statements and disclosures rather than risk a difficult appeal to the Second Circuit, the same court that handed FDA a loss in Caronia three years ago.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS054959

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