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
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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.
Merck & Co.'s three lovastatin switch attempts showed "it would be essentially impossible to present what they needed just within the confines of those simple boxes,” says Pegasus Research CEO Clark Richardson. Two decades after DFL launched, FDA, labeling experts and other industry stakeholders recognize its limits and have more consumer comprehension study data to guide decisions on what to include as well how to format an OTC label.