Medtech Insight 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


Device Firms Should Not Ignore Pharma Off-Label Suits, Experts Say

This article was originally published in The Gray Sheet

Executive Summary

While recent case law that appears to give industry more leverage in off-label communications involves drugs, the precedent should apply equally to devices, attorneys say. Nonetheless, companies should be cautious about moving full-steam ahead with off-label promotions

You may also be interested in...

BIO Lays Ethical Foundation For Change In Off-Label Communications

The industry group's future advocacy around legal and regulatory reforms affecting product sponsor communications with payers and health-care providers will align with four bioethical considerations.

Experts Debate Prospects Of Third-Party Agency To Oversee Off-Label Communications

The Duke-Margolis Center has released a list of policy changes that experts argue could improve how off-label communication is disseminated. Among the proposals is a third-party organization to vet off-label communication and a tiered labeling system.

FDA Seeks To Resolve First Amendment Suit By Pacira

Judge extends date for agency response to firm's complaint as parties continue settlement talks; case reveals two chinks in FDA’s off-label regulatory regime armor, former FDA advisor says.

Related Content


Related Companies




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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