Recently an FDA advisory panel voted 20 to 3 to not allow Merck to sell it’s cholesterol-lowering statin, named Mevacor, as an over-the counter medication. Although most doctors agree that millions of Americans could benefit from taking statins to help control their cholesterol, the panel found that was just not enough data to prove to them that the drug would be safe to start taking with first consulting a doctor. This leaves open the possibility of Merck conducting more clinical trials and providing the panel with more safety data.

The recommendation of the advisory panel is not binding, the FDA has the right to review the data and approve or reject the application. In most cases, the FDA will accept the recommendation of the advisory panel. Many doctors joke that statins are so safe and effective that they should be distributed in the water supply. While there may be some truth to this, in today’s environment of safety questions, namely Vioxx, Celebrex, Aleve and Crestor, it is likely that the FDA is going to be taking a very conservative approach to approving any new drug or over-the-counter switch.

There are some very real issues to be concerned about if statins are switched to over-the-counter. Namely people taking them when they have medical conditions, which could cause problems, or people taking them without knowing their own cholesterol levels. People could be taking too low of a dose for the severity of their condition, and falsely believe they are handling the problem. While statins could benefit many more Americans than are currently utilizing them, the best scenario for them is to continue the status as prescription only until the public at large can fully understand the implications of taking them and actively monitor their own conditions.