FDA Mulls Easier Access to Cholesterol Drugs

Four years ago, advisory committees of the Food and Drug Administration rejected requests by several companies to turn their prescription cholesterol drugs into over-the-counter medications. Next month, at least one of the drugs will get another chance.

Merck's(MRK Quote) Mevacor will get a hearing before a joint meeting of two FDA panels on Jan. 13 and Jan. 14. The other drug rejected as an OTC candidate four years ago is Pravachol made by Bristol-Myers Squibb(BMY Quote).

Both products, which belong to the class of drugs called statins, were rejected because advisory panel members said the companies failed to adequately demonstrate that the OTC drugs could be used safely by consumers. But in July 2004, a joint venture of Merck and Johnson & Johnson(JNJ Quote) began selling a nonprescription version of Merck's Zocor in the U.K., setting the stage for a renewed effort for OTC statins in the U.S. ...