FDA panel: No can do on Mevacor OTC

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

ALSO: Merck's CEO defines the perfect biotech buyout. Report