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FDA expert committees reject over-the-counter sale of drug



Published: Sat, January 15, 2005 @ 12:00 a.m.



Merck officials said they still haven't abandoned the idea.

WASHINGTON POST

WASHINGTON -- Federal advisers rejected a proposal Friday to allow the sale of a powerful cholesterol-lowering pill without a prescription, saying the risk of side effects outweighed the possible benefits of preventing more heart attacks and strokes.

At the conclusion of an unusual joint meeting of two Food and Drug Administration expert committees, the experts voted 20 to 3 that the agency should deny a request from Merck & amp; Co. and Johnson & amp; Johnson to market a low-dose version of Merck's drug Mevacor to consumers without a doctor's order.

While many panel members said they endorsed the general idea of increasing the use of cholesterol drugs called statins by making them more easily available, they said the proposal failed to do enough to ensure that only the right patients take the drug and are then closely monitored. Specifically, the advisers were concerned pregnant women might take the drug, resulting in birth defects, and that patients might suffer rare but potentially life-threatening liver and muscle complications.

"I think that it is the right thing to do, but I don't think we're there yet," said panel member Frank Davidoff, editor emeritus of the Annals of Internal Medicine, a medical journal. "I think you could argue that going [over-the-counter with] statins would in effect be a massive uncontrolled experiment."

Several panel members said they would have preferred a plan that allowed the drug to be sold without a prescription, but only after consulting a pharmacist. A similar scheme was recently approved in Britain for a cholesterol drug.

The final decision

The FDA will make the final decision on the Mevacor proposal, but the agency usually follows the advice of its advisers. The FDA rejected a similar request from Merck four years ago.

Merck officials, who had argued the move would prevent thousands of heart attacks each year, said they were disappointed by the decision but had not abandoned the idea.

"We continue to believe in the benefits of Mevacor ... as an over-the-counter medication to help lower cholesterol and contribute to improved overall health," said Merck spokesman Tony Plohoros. "We will continue to work with the FDA toward that end."

The move would have marked a major shift in how the nation combats heart disease, the leading cause of death in the United States, by allowing millions of Americans much easier access to a drug that sharply reduces one of the leading risks. Had the proposal won approval, other companies were expected to follow, including Bristol-Myers Squibb Co., which has said it wants to sell an over-the-counter form of its statin, Pravachol.

The proposal came at a time when the FDA has come under intense criticism for being too lax about safeguarding the public from drug risks. Merck recently took its blockbuster painkiller Vioxx off the market after discovering it increased the risk of heart attacks, and similar concerns have arisen over other drugs in the same class. Safety questions have also been raised about other statins, including Baycol, which was taken off the market, and Crestor.

While the FDA has allowed drugs to switch from prescription to over-the-counter status in the past, it has always been for acute illnesses.

such as colds, aches and pains and heartburn. The Mevacor change would have marked the first time approval had been granted for nonprescription sale of a medication that would be taken for years to prevent a disease.

Research has clearly established that statins can sharply reduce the risk of heart attacks and strokes, primarily by lowering levels of so-called "bad," or LDL, cholesterol. While the




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