Chalk up a third strike against over-the-counter statins. Yesterday, an FDA advisory panel voted overwhelmingly against allowing Merck to sell Mevacor without a prescription.
Drug makers--including Merck--have been trying for seven years to convert statins to over-the-counter status. The FDA rejected Merck's bid for OTC Mevacor in 1999 and again in 2005; officials declined to say whether they plan to try a fourth time.
At issue was whether the average Joe or Jane can safely self-medicate with a statin. Yesterday, Merck presented a study showing that almost three-fourths of consumers could. But the one-fourth remaining included patients at risk of serious side effects. Of course the fat lady--er, the FDA itself--hasn't sung yet. But the agency usually does take its panelists' advice. A decision is expected in late January.
- see the statement from Merck
- read the report from the Chicago Tribune
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