This has come up before, of course. In early 2005, an FDA panel voted against approving the Merck cholesterol med for OTC switch. The concerns, which will, undoubtedly, be revisited at the Dec. 13 advisory committee meeting, centered on whether consumers will be able to determine when to take a choletesterol med. You can read the Federal Register notice here.

This raises questions about whether consumers can monitor LDL and HDL levels, contraindications with other drugs, and liver enzymes. (This is a review of a patient comprehension study that was presented at the 2005 meeting).

This time, though, Merck is hoping the FDA panel will recommend Mevacor as an OTC salve for primary prevention of heart attacks. If so, it would represent a significant development for drugmakers facing patent expirations on prescription cholesterol treatments, as well as any pharma selling a med for a chronic disease.