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


Making a Good First Impression: Launch Messages in an Era of REMS

This article was originally published in RPM Report

Executive Summary

When FDA took the unusual step of reprimanding a clinical investigator for promoting a newly approved botulinum toxin brand, the agency stressed its over-riding concern about the "first impression" of a new product in marketing messages Commercial sponsors should pay attention: just ask King.

You may also be interested in...

Why the Prasugrel Launch Was Worse Than it Looked: A Sentinel Case Study

FDA’s new Sentinel system is up and running, and the first examples of real world use of the “real world” post-marketing data network are being showcased. One example of compliance with patient selection criteria for Lilly’s Effient indicates some of the profound ways Sentinel may ultimately reshape regulation—but also suggests that the notoriously slow launch of prasugrel was even worse than it looked.

A Painful Decision for King and Acura

An FDA advisory committee rejects the idea of adding niacin to abusable drugs in order to provoke a flushing reaction and thereby discourage abuse. King and Acura respond by flushing the idea itself and focusing on physical barriers to abusability. For other sponsors, King's failed attempt to change FDA's mind looks like a study in what not to do.

FDAAA Impact (Year Two): More of Everything

The second year of the FDAAA-era is over, and FDA is using its new drug safety tools (Risk Evaluation & Mitigation Strategies and mandatory post-marketing studies) more often. Not only are more drugs requiring REMS and mandatory trials, the burden of those programs is increasing.

Related Content


Related Companies




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