FDA mulls availability of drug for cholesterol

A Food and Drug Administration advisory panel is scheduled to recommend today whether a drug aimed at treating high cholesterol should be sold from store shelves like common remedies for headaches, colds and allergies.

Merck & Co. and Johnson & Johnson, in a joint venture, have asked the FDA to let them sell a low-dose version of cholesterol-lowering Mevacor directly to consumers.

During the first day of a two-day hearing yesterday at a Bethesda, Md., hotel, FDA drug advisers questioned whether the pharmaceutical companies compiled enough evidence of Mevacor’s safety, such as for pregnant women.

“It seems to me the risk in humans has not been demonstrated,” said Alastair Wood, chairman of the advisory committee.

He noted that some of the toxicity tests were performed on rats. In human trials, there were “several cases of adverse pregnancy,” Dr. Wood said.

Potential problems include birth defects, he said.

Drug company officials said the risks were exaggerated at the 20 milligram dose that would be used for over-the-counter sales.

“We don’t believe there’s a significant risk at all,” said Edwin Hemwall, vice president for Johnson & Johnson/Merck.

Nevertheless, the companies agreed to label the drug containers with warnings against use by pregnant women, high-risk heart patients, small children and people with liver disease.

They also said they would do “post-marketing surveillance” to monitor any adverse reactions from over-the-counter sales.

Mevacor, one of a class of cholesterol-lowering drugs called “statins,” has been available by prescription since 1987. Merck lost patent protection on it in 2001, which led to generic sales of the drug.

Approval of over-the-counter sales would open the door for similar cholesterol-lowering drugs, such as Zocor and Pravachol, to be sold directly to consumers.

As a group, statins made some $14 billion in the United States alone last year.

The drug companies say selling Mevacor over the counter would provide needed treatment to about 39 million Americans at moderate risk of heart disease who are not getting the medical assistance they need. Mevacor would sell for about $1 a pill per day.

“There is an enormous and growing cardiovascular public health problem that has not been adequately addressed,” said Dr. Richard Pasternak, vice president for clinical research for Merck Research Labs.

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