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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) 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).

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) 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.

A spokesman for Merck, which is collaborating with J&J to make nonprescription Mevacor, declined to comment. Earlier this year, Merck officials said the company would seek OTC status for Mevacor in 2005. A spokesman for Bristol-Myers Squibb declined to comment.

The sales pitch for OTC statins goes like this: The drugs have a long track record of safety; people with moderate risk of heart disease could use these drugs in conjunction with improved behavior such as losing weight and increasing exercise; and converting drugs to OTC status would improve patient access.

The argument against OTC statins goes like this: Even the safest statin can cause side effects such as liver damage and a rare muscle-wasting disease; doctors recommend periodic blood tests and monitoring for signals of liver problems. As for efficacy, critics say the OTC strengths of statins may be too low to be effective. As for cost, critics ask what happens to a consumer whose insurance plan covers prescription drugs but doesn't cover OTC drugs.

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