An FDA panel will meet on Thursday to review whether consumers should be able to buy Merck’s Mevacor without a prescription. As noted previously, this marks the third time in eight years Merck will ask an FDA panel for permission to sell its cholesterol-lowering med on an OTC basis. If the panel and the FDA agree, Mevacor would become the first OTC statin, the biggest-selling class of meds.

In lengthy briefing documents posted on the FDA web site today, however, an FDA medical review expresses concerns. On one hand, the reviewer writes that a 20 mg dose, if used as directed, is “a reasonably safe and effective drug” in a “non-prescription setting.” On the other hand, a couple of studies Merck submitted - showing whether consumers correctly determine when to take and how to use an OTC Mevacor pill - “have not convinced this reviewer that there is adequate consumer comprehension of the proposed product label to ensure safe and effective use of this product.”

Later, the reviewer also wrote that “there was not a consensus on the review team as to whether treatment of high risk patients is desirable from a public health perspective, because on the one hand, those who are not under any treatment would benefit even from an OTC statin, but on the other hand, they would not be adequately treated according to the current standard of care.”

Merck argues that untold millions of Americans susceptible to heart disease and stroke who aren’t taking a statin could receive health benefits, especially since many people don’t think about their cholesterol levels if they don’t feel sick. But some docs worry an OTC cholesterol pill will be taken by people who think they are at risk and really aren’t, or by people who need treatment but take a lower dose than needed. UPDATE: Consumers Union opposes an OTC cholesterol pill and this is a letter sent to FDA commish Andy von Eschenbach.

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