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

Gottlieb: Branded Industry 'Gaming' Tactics Have Shifted From Regulatory To Commercial Space

Executive Summary

US FDA's focus on areas such as REMS abuse may have prompted certain brand sponsors to shift their focus to the commercial space to keep generic competition off the market, former commissioner Scott Gottlieb tells the Association for Accessible Medicines.

You may also be interested in...



REMS Abuse Website: Has It Changed The Behavior Of Innovators?

Updated numbers from the US FDA's REMS abuse website show that Celgene has received two additional safety determination letters, raising question's about whether the public list has changed the practices of brand companies hindering generic company access to samples.

REMS Abuse Website: All Sizzle, No Steak?

AAM President Davis contends he hasn't seen any evidence showing that reference listed drug access inquiries webpage has changed innovator behavior.

REMS Abuse Website: Celgene, Actelion Top List Of Suspected 'Gamers'

Other sponsors could be using tactics other than REMS abuse to game the system, US FDA Commissioner Scott Gottlieb says.

Topics

Related Companies

UsernamePublicRestriction

Register

PS141143

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