Adverse event reports from toll-free numbers considered "spontaneous" in PhRMA proposal.
This article was originally published in The Tan Sheet
Executive Summary
OTC SWITCH ADVERSE EVENT REPORTS FROM TOLL-FREE NUMBERS would be processed as spontaneous or unsolicited reports under a Pharmaceutical Research & Manufacturers of America proposed approach to adverse event reports from consumers that are medically unconfirmed. "Adverse experience reports that come to the attention of the marketing authorization holder through toll-free number(s) which appear as part of the approved labeling for an NDA prescription-to-OTC switch product should be handled as a spontaneous (unsolicited) report," PhRMA suggested.