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.