Generics Bulletin 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

UsernamePublicRestriction
UsernamePublicRestriction

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

Executive Summary

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.

You may also be interested in...



REMS Abuses: Congressional Panel’s Focus Turns To Federal Trade Commission

During bipartisan, but one-sided, hearing about US FDA’s limited authority to ensure generic drug makers can access restricted distribution reference products for bioequivalence testing, one lawmaker wants to know what FTC is doing about the issue.

FDA User Fee Hearing Hijacked By US Health Care Reform Arguments

Democrats argue generic competition alone cannot fix drug pricing problem as senators attempt to pull FDA into Obamacare repeal and replace debate.

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

UsernamePublicRestriction

Register

GB002356

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

Cancel