Pink Sheet 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

Playing It Too Safe?: FTC Investigating Use Of REMS To Block Generics

Executive Summary

The Federal Trade Commission is looking into whether companies are using their Risk Evaluation and Mitigation Strategies to thwart generic competition.

You may also be interested in...



FTC Backs Mylan’s REMS Antitrust Lawsuit Against Celgene

FTC files second amicus brief saying use of risk management programs to impede generic competition could violate antitrust laws; commission launched an investigation of Celgene four years ago.

REMS Modification Guidance Coming As FDA Rejects Petition For Shared REMS Rules

Agency will wait until it has more experience with shared REMS before deciding whether to issue regulations or guidance on their implementation, but for now it hopes sponsors can work out problems on their own.

Brand, Generic Disputes Over Access Move Beyond REMS Restrictions

Generic companies say innovators are using voluntary restricted distribution programs to prevent them from obtaining reference drugs for bioequivalence testing; a July hearing is set in a dispute involving Actelion’s Gaucher disease drug Zavesca, which is not subject to a Risk Evaluation and Mitigation Strategy.

Related Content

Topics

UsernamePublicRestriction

Register

PS052734

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