Over-the-Counter Sales of Statins and Other Drugs for Asymptomatic Conditions

Abstract

Merck recently submitted its third application to the Food and Drug Administration (FDA) to allow it to sell its cholesterol-lowering drug lovastatin in 20-mg tablets over the counter.^1,2 Targeted consumers are men over the age of 45 years and women over the age of 55 years who have levels of low-density lipoprotein (LDL) cholesterol of 130 to 170 mg per deciliter and an intermediate 10-year risk of a cardiovascular event (5 to 20%) but no previous event.¹ Merck's arguments for the switch from prescription-only to over-the-counter sales focused on the “treatment gap” — at-risk persons who are not receiving therapy — and on the desire of consumers for more control over their health care decisions.¹