FDA Advisors Say Greater Insight Needed On Self-Selection Of OTC Statins
This article was originally published in The Tan Sheet
More information from "real world" experiences on how consumers make OTC selections may be needed to pull off a successful Rx-to-OTC switch of a statin
You may also be interested in...
Using web app for self-selection was successful with more than 95% concordance for the primary endpoint comparing results obtained by participants and independent clinical assessments, say researchers led by cardiologist and consumer health innovation advocate Steven Nissen.
OTC switches are more challenging for sponsors as concerns over label communication, drug interactions and consumers understanding increase, says FDA official Francis Becker. Rx label precautions and warnings must go on OTC labels, too.
Harbor-UCLA Center for Clinical Pharmacology director Eric Brass says FDA should change DFL requirements, considering container labels as part of OTC labeling and reconsidering what information should be included on labels and threshold for consumer comprehension of labels.