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Mevacor Over-the-Counter Status to Be Considered by FDA Advisory Panel

Dec 11, 2007 | Parker Waichman LLP

Mevacor, a statin medication that treats high cholesterol, could soon be sold as an over-the-counter drug if Merck & Co. has its way.  The Food & Drug Administration (FDA) is considering the pharmaceutical company’s application to sell a low dose version of Mevacor without a prescription.  Merck is claiming that doing so would help thousands of people with moderately high cholesterol.  But critics say that selling Mevacor over-the-counter would put many patients at risk of side effects and serious injuries.

Mevacor, which was approved by the FDA in the 1980s, was the first cholesterol-lowering statin on the market.  Merck says that the over-the-counter version would benefit many people who are at moderate risk of heart disease.  But others contend that by requesting permission to sell Mevacor without a prescription, Merck is really more concerned with its bottom line.   While it was once a blockbuster for Merck, sales of Mevacor have dropped significantly since Merck’s patent ran out in 2001.  When that happened, generic drug makers began putting cheaper versions on the market.  Merck has stated that an over-the-counter version of Mevacor could reach 14 million more people.

This is the third time that Merck has sought the FDA’s permission to market an over-the-counter Mevacor.  The drug maker first went before an advisory panel in 2000 with a proposed 10-mg dose, but was told to come back with a larger 20-mg dose. At the next meeting, in 2005, the panel voted that Mevacor was safe and effective, but the advisors wanted more data showing that patients could properly "self-select" the drug without a prescription.

Last Tuesday, the FDA said that its preliminary review of Merck’s application indicated that nonprescription Mevacor would be "a reasonably safe and effective" option — if consumers used it as directed.  But that’s the big problem – there is really no way to guarantee that this would happen.  When Merck tested if consumers could judge who was a proper Mevacor candidate, only 20 percent answered all the questions completely correctly — 50 percent if researchers counted people who said they'd check some things with their doctor before purchasing, concluded the FDA's lead medical reviewer. Even more disturbing, 30 percent of people who already were diagnosed with heart disease, diabetes or had had a stroke wanted to purchase over-the-counter Mevacor.  Those are the people most in need of a doctor’s supervision when using a statin.

Those studies left the FDA with doubts, as the agency reviewer wrote that the findings "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.”

For its part, Merck argues that most people made the right decision on whether they should buy over-the-counter Mevacor even if they missed some answers.  Merck will have a chance to make its case for a non-prescription version of the statin this Thursday, when the FDA convenes an advisory panel to again consider over-the-counter Mevacor

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