And so Merck's third time isn't a charm. The drugmaker lost another bid to sell an over-the-counter version of its Mevacor cholesterol pill this afternoon, when an FDA advisory committee voted against the idea.
And the voting wasn't close, either. The panel voted 10-2, with one abstention, against Merck's plan for a low-dose version, and expressed concerns about that a study failed to show that consumers could make appropriate decisions about taking an OTC cholesterol pill. The panel also voted 11-2 that a Merck study failed to show that consumers could make appropriate decisions about whether to take an OTC version of Mevacor.
The Merck proprosal drew a great deal of opposition from such groups as the American Medical Association and Public Citizen, which argued an OTC cholesterol pill would generate inappropriate use. For instance, an FDA review found that people who shouldn’t take Mevacor - such as women of childbearing age, some people who had heart attacks and those whose heart risk is too low to need such a med - would buy an OTC pill if available.