Merck Mines Mevacor Switch Data To Press FDA On Self-Selection Stance
This article was originally published in The Tan Sheet
Executive Summary
Purchase decisions in OTC switch self-selection studies offer insight into subjects’ thinking “and how they might act in a real-world pharmacy setting,” Merck tells FDA in response to a draft guidance that says such decisions are driven by cost and are “an unreliable surrogate” for self-selection.