Questran "actual use" studies needed to prove consumer compliance, FDA panel says.
This article was originally published in The Tan Sheet
Executive Summary
BRISTOL-MYERS SQUIBB QUESTRAN "ACTUAL USE" STUDIES NEEDED to bolster the company's data supporting an Rx-to-OTC switch of the cholesterol-lowering drug, members of FDA's Nonprescription Drugs and Endocrinologic & Metabolic Drugs Advisory Committees suggested during the Sept. 27 review of the switch. The committee members questioned whether the company's available data address concerns about long-term patient compliance if the drug were to be made available as an OTC.