WASHINGTON — Government advisers on Thursday rejected Merck & Co.’s bid for over-the-counter sales of Mevacor, the granddaddy of 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 would persuade millions of people with moderately high cholesterol to take the pills.
FDA advisers, however, were struck by how many people, in a study of almost 1,500, wanted to buy the drug even though they were bad candidates.
