FDA Rejects Over-the-Counter Mevacor

B E T H E S D A, Md., July 13 -- Federal health officials shouldreject Merck and Co.’s bid to make its cholesterol-lowering drugMevacor available directly to consumers without a prescription,a U.S. panel advised Thursday.

A committee of experts urged the Food and DrugAdministration to keep Mevacor strictly a prescription-only drugrather than allow a low-dose version to be sold in stores overthe counter.

High cholesterol is a major risk factor for heart disease.Mevacor, known generically as lovastatin, was the pioneer in agroup of widely used drugs known as statins that can lowercholesterol. It debuted on the U.S. market in 1987.

Dubious Benefits

The drug’s maker argued that greater access to cholesterolmedicines could help fight the epidemic of heart disease, theleading killer of Americans.

But panel members voted 11-1 against the proposal, in partbecause they were not sure the drugs would produce any healthbenefit for the 15.5 million Americans with mildly elevatedcholesterol, the group Merck considers ideal candidates for anover-the-counter cholesterol drug.

Merck’s studies “did not present evidence a significantclinical benefit would be achieved,” said Dr. Eric Brass, thepanel’s chairman.

The FDA usually follows its panels’ advice. Thesame panel is set to consider today whether another statin, Pravachol, made by Bristol-Myers Squibb, should be sold over thecounter.