FDA considers over the counter status for statin drugs

• Vast numbers of people would take a cholesterol drug if it were offered over the counter even though they don't meet the medical criteria, federal health advisers were told Thursday.
• Drug companies are now asking the Food and Drug Administration for permission to sell a low-dose version directly to consumers for the first time.
• The advisory committee that is meeting through Friday will make a recommendation to the FDA, which usually follows its panels' advice.
• Allowing over-the-counter sales for Mevacor would put a new sort of medication on drugstore shelves.
• Unlike treatments for coughs, colds and allergies, Mevacor is meant to prevent future heart disease, rather than treat existing symptoms.
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• The drug companies say selling Mevacor over the counter would help provide needed treatment to millions of Americans who are at moderate risk of heart disease or need to lower their cholesterol but are not taking helpful drugs.
• "There is an enormous and growing cardiovascular public health problem that has not been adequately addressed," said Dr. Richard Pasternak, vice president for clinical research for Merck Research Labs.
• To answer that, Merck and partner Johnson & Johnson conducted a pair of studies.
• One tested whether consumers would understand the label; the other simulated a real-world situation and recruited potential users into a mock pharmacy to see who would buy and use the drug.
• Another implication: If the drug is sold over the counter, health insurance will no longer pay for it, shifting the cost from insurance companies to patients.
• Mevacor was the first of the statin drugs, which lower cholesterol by limiting the buildup of artery-clogging fat deposits, reducing the risk of heart attack by about a third.