Pravachol OTC Marketing Retailer Involvement Anticipated By BMS
This article was originally published in The Tan Sheet
A Pravachol OTC marketing program designed to emphasize the "importance of keeping the doctor in the loop" would include point-of-purchase messages encouraging physician consultation, Bristol-Myers Squibb Rx-to-OTC Marketing Senior Director Patricia Kriger told FDA advisory committees July 14.
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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.
Bristol-Myers Squibb may need to better demonstrate consumers' ability to make self-selection choices based on appropriate cholesterol levels in order to convince FDA that an OTC version of Pravachol is approvable.
Merck would support an OTC version of its statin drug Mevacor with an ambitious customer education program that would ensure proper usage of the cholesterol-lowering medication, the firm stated July 13 at a joint meeting of FDA's Nonprescription and Endocrinologic & Metabolic Drugs Advisory Committees.