On December 13, 2007, a Food and Drug Administration (FDA) panel rejected Merck?s third request to sell its cholesterol drug, Mevacor, without a prescription. The panel said it was concerned patients would not be taking the medication correctly, or that patients who don?t need to take it will use it. The panel voted 10-2 against permitting over the counter (OTC) Mevacor sales.

Approved as a prescription medication in 1987, cholesterol drug Mevacor was the first in a class of drugs known as statins. The drug works by reducing production of specific fatty substances in the body, including cholesterol. Merck?s target market for the OTC version of Mevacor is millions of Americans at moderate heart risk who are not being treated. Members of the FDA panel said they were not persuaded the right patients would take the drug without a doctor?s guidance, however, echoing one of the reasons the agency rejected the drug?s OTC approval in 2000 and 2005.

In addition, the FDA is investigating a connection between statins and an increase in the risk of developing Lou Gehrig?s disease, a neurological condition. A reviewer for the FDA, Eric Colman, said the potential for an elevated risk of the disease appeared during a complex analysis, but said more research is needed.

In its efforts to gain approval, Merck funded a study during which patients came to a ?fake? pharmacy believing a new cholesterol drug was available. These ?customers? then made their decisions whether or not to purchase Mevacor based on the label alone.

The FDA panel was concerned about the results of this study because several patients who did not fit the criteria for taking the drug believed they should buy Mevacor. There were also some consumers already on potent prescription statins who incorrectly thought they could simultaneously take Mevacor, or wanted to switch out their existing prescription drugs for Mevacor.

In response to decisions like this one, the FDA has considered creating a ?behind the counter? regulatory category, in which drugs would be allowed to be purchased without a prescription but would have to be dispensed by pharmacists.

Sources: Anna Wilde Mathews, ?FDA setback for Merck drug,? Wall Street Journal, December 14, 2007; Jacob Goldstein, ?Will third time be the charm for over-the-counter statin??, Wall Street Journal, December 11, 2007; Anna Wilde Mathews, ?FDA calls for research on Lou Gehrig?s-Statin Link,? Wall Street Journal, December 13, 2007.