OTC Statin Physician Follow-Up Label Comprehension Not Shown - FDA

Merck and Bristol Myers-Squibb should design label comprehension studies that do not assume consumers would understand how to use Mevacor and Pravachol in an OTC setting, FDA's Karen Lechter, PhD, advised during joint meetings of the Nonprescription and Endocrinologic & Metabolic Drugs Advisory Committees July 13-14.