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

Shkreli Fallout Continues: PhRMA Seems To Soften Stance On REMS Legislation

This article was originally published in The Pink Sheet Daily

Executive Summary

Brand drug representative tells Senate subcommittee there are problems with bill that would make it easier for generics to obtain samples, but did not appear interested in scrapping it.

You may also be interested in...



REMS Could Block ANDAs With 'Legitimate Business Justification' In Senate Bill

Sen. Leahy's reintroduced CREATES Act allows generic sponsors to sue innovators who fail to provide sufficient quantities of REMS covered products, but seems to give wide latitude to courts; bill reflects Congress' broader focus on generic drugs to address drug pricing issue.

REMS Could Block ANDAs With 'Legitimate Business Justification' In Senate Bill

Sen. Leahy's reintroduced CREATES Act allows generic sponsors to sue innovators who fail to provide sufficient quantities of REMS covered products, but seems to give wide latitude to courts; bill reflects Congress' broader focus on generic drugs to address drug pricing issue.

REMS Reform Seems Distant Goal For Generics After Limited Support At US House Hearing

Although panelists expressed concerns about REMS misuse as barrier to competition, Republicans did not appear interested in the topic.

Related Content

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

PS079541

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