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


Off-Label Worries Could Be Solved By Studies, Not Speech Reg Overhaul, FDA Suggests

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA says Par’s suit challenging its off-label promotion regulations is unfounded since the agency would not take action against speech to doctors who prescribe Megace ES for both approved and unapproved uses. FDA also lays out the rationale for its off-label promotion rules from DESI to Prempro.

You may also be interested in...

Par Pursuing Settlement Of FDA Suit And DoJ Off-Label Investigation

Parties have stayed their litigation as they continue to hammer out a potential global resolution that would also settle DoJ’s investigation of Megace sales and marketing practices.

When Is On-Label Speech Off-Label Promotion? Par Links The Two In Suit Against FDA

Par Pharmaceutical Inc.’s First Amendment suit against FDA offers a new approach to battling government allegations of off-label marketing.

FDA Off-Label Regs Face Cave-In Risk After Supreme Court Data-Mining Ruling

Lawyers have pored over the Supreme Court's decision overturning Vermont's prescriber data mining law to see how it may be applied to other forms of pharmaceutical marketing.


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