FDA considers over-the-counter sales for cholesterol drug

BETHESDA, Md. — 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.

The cholesterol drug Mevacor has long been available by prescription. 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 today 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. And while a cough or cold is apparent, the only way to know one’s cholesterol level is to be tested.

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.

But opponents worry that patients will skip necessary doctor visits, where they might get important advice about changing diet and exercise.

And there are questions about whether consumers will accurately determine whether the drug is right for them.

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.