Has FDA Lost Its Grip? The Amarin Deal
This article was originally published in Scrip
Executive Summary
While the FDA was insistent its settlement with Amarin Corp. plc, which a federal district judge has signed off on, only applies to that company, in which the agency has agreed to not stand in the way of the firm sharing "truthful and non-misleading" information about certain unapproved uses of its fish-oil pill Vascepa (icosapent ethyl), the deal, nonetheless, shows US regulators can be flexible, or at least, when they're backed into a corner.
You may also be interested in...
'That's Huge, Folks': Amarin's Vascepa Cuts CV Risk By 25% On Top Of Statins
Cardiovascular outcomes data exceeded expectations for the fish oil pill, vindicating Amarin, which has fought long and hard for Vascepa's place in the CV disease prevention market. A filing based on REDUCE-IT is expected in early 2019.
Drug Promotion: FDA Loosens Reins But Industry Wants More Room To Run
Agency proposes a safe harbor for certain communications with payers about approved uses and investigational drugs, but drug manufacturers ask the US agency to expressly protect from enforcement manufacturer communications about off-label uses.
Moderna's Valera Takes mRNA Approach To Combat Zika
With new funding in hand, Moderna and its infectious disease venture Valera are going full-speed ahead with a Zika vaccine, taking an mRNA approach, which they said could be a more rapid strategy to try to stop the disease.