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Published on 17 December 2007

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FDA panel rejects Mevacor request

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Government advisers to the US Food and Drug Administration in the US have rejected a request for a cholesterol-lowering drug to made available over the counter.

Merck asked for the panel to approve sales of Mevacor (lovastatin) without a prescription, but the move was defeated 10-2 in a vote.

The pharmaceutical firm argued that offering a low dose pill on store shelves could persuade millions of people with moderately high cholesterol to take the medication, and potentially prevent heart attacks.

But the FDA’s advisers found many people wanted to buy the drug, even though they were bad candidates.

Research found around 25% of people who wanted the pill did not have a high enough risk of heart disease to qualify, meaning they would face unnecessary side-effects.

Dr William Shrank, of Harvard Medical School, who sat on the panel, said: “The patients couldn’t figure out whether the drug was for them.”

But Edwin Hemwall, executive director of Merck’s worldwide OTC regulatory and scientific affairs, said: “We are disappointed. We felt we presented a compelling case.”

The FDA is not bound by the advisers’ recommendations, but usually follows them. The regulator has twice turned down a request for Mevacor to be made available over the counter.

Copyright © PA Business 2007

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