FDA Rejects Over-the-Counter Mevacor

B E T H E S D A, Md., July 13, 2000 -- Federal health officials should reject Merck and Co.’s bid to make its cholesterol-lowering drug Mevacor available directly to consumers without a prescription, a U.S. panel advised Thursday.

A committee of experts urged the Food and Drug Administration to keep Mevacor strictly a prescription-only drug rather than allow a low-dose version to be sold in stores over the counter.

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

Dubious Benefits

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

But panel members voted 11-1 against the proposal, in part because they were not sure the drugs would produce any health benefit for the 15.5 million Americans with mildly elevated cholesterol, the group Merck considers ideal candidates for an over-the-counter cholesterol drug.

Merck’s studies “did not present evidence a significant clinical benefit would be achieved,” said Dr. Eric Brass, the panel’s chairman.

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