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Mevacor To Remain Prescription Drug

January 17, 2005

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At least for now, you will still need a prescription to purchase Mevacor, a statin cholesterol-reducing drug. A Food and Drug Administration panel has rejected a request by Merck and Johnson & Johnson to allow the drug to be sold over the counter.

Statins have become popular in recent years, with heavy advertising and marketing for drugs like Zocar and Lipitor. By making Mevacor an over-the-counter drug, available without a prescription, the drug firms argued that it might improve prevention of heart disease.

But being available without a prescription also means Mevacor would have been available without consulting a doctor, and the FDA panel concluded that would not be in the interests of promoting good health. Since there is no way to detect high cholesterol except through tests, the panel wondered how consumers would know to purchase the drug.

The panel was also put off by the results of studies simulating over-the-counter sales of Mevacor, noting that most of the people in the test who selected the drug didn't fit the label requirements. Others with a high risk of heart attack selected the over-the-counter drug but did not bother to see a doctor, who might have prescribed something stronger.

The FDA will make the final decision, but in the past has followed the recommendations of its advisory panels. In the wake of recent criticism of its approval process for other drugs, the agency is unlikely to go out on a limb for Mevacor.

Still, the drug companies say they are not going to be deterred. Bristol-Myers Squibb has announced it will petition the FDA to sell its cholesterol drug, Pravachol, over-the-counter. Merck said it planned to work with the FDA in hopes of eventually selling Mevacor over-the-counter.

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