Friday, December 14, 2007
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Gwinnett Daily Post
WASHINGTON - Government advisers on Thursday rejected Merck & Co.'s bid for over-the-counter sales of Mevacor, the granddaddy of the famed cholesterol-lowering drugs.
Too many of the wrong people would use the drug if it no longer required a prescription, advisers to the Food and Drug Administration concluded in a 10-2 vote against nonprescription sales of the medication.
'The patients couldn't figure out whether the drug was for them,' said one FDA adviser, Dr. William Shrank of Harvard Medical School.
Merck argued that offering a low dose of Mevacor on open drugstore shelves, next to the aspirin, would persuade millions of people with moderately high cholesterol levels to take a pill that might prevent a first heart attack.
'This is a real opportunity,' said Edwin Hemwall, executive director of Merck's worldwide OTC regulatory and scientific affairs. After the meeting, Hemwall said, 'We are disappointed. We felt we presented a compelling case.'