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


The Consequences of Caronia: Impact On FDA’s Off-Label Regulation

This article was originally published in RPM Report

Executive Summary

The government has decided not to appeal the Second Circuit’s Caronia off-label promotion ruling – no doubt in part because of concerns about the broad reading of the First Amendment currently in favor at the Supreme Court. Officially, FDA has adopted a low-key response. Unofficially, agency officials – notably Bob Temple – are outraged by the ruling. What does Caronia mean for the future of FDA regulation and off-label prosecutions?

You may also be interested in...

FDA Reassessing Off-Label Policies To Address First Amendment Concerns

Guidance on scientific exchange is on the horizon; agency “carefully evaluating” existing advertising policies following recent court decisions.

Endo Lidoderm Settlements: “Golden Goose” Hatches Strong Case

Off-label promotion prosecutions are supposed to be much tougher in the post-Caronia period. However, it is not too hard for the government to make a compelling case when a marketing manager calls one off-label use the “golden goose” for a product line.

First Amendment Challenge Mulled As Amarin Seeks To Unchain ANCHOR Results

If Amarin can’t get its Vascepa expanded indication through FDA, it could try to get the courts to clarify the scope of free speech protections post-Caronia.

Related Content


Related Companies

Latest Headlines
See All



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