FDA advisers urges not selling cholesterol drug over the counter

BETHESDA, Md. -- Federal health advisers recommended against over-the-counter sales of a cholesterol drug Friday, saying that patients need medical guidance for treatment of a chronic condition that has no symptoms and could require drugs for life.

The safety of Mevacor is well-established, but advisers worried that the wrong people might take it if sat on open drugstore shelves, particularly after a probable aggressive advertising campaign to sell it.

The vote on the advisory committee was 20-3.

Advisers expressed misgivings because studies that simulated over-the-counter sales indicated that 90 percent of people who took Mevacor didn't meet the requirements of the label. Some people were too young or not sick enough to need it. In other cases, the risk of heart disease was so high that the patients should have seen a doctor and received a stronger drug.

The panel advising the Food and Drug Administration also voiced concern that women who were pregnant and did not know it would take Mevacor and possibly damage the developing fetus.

Supporters argued that making Mevacor more easily available would help get needed treatment to millions of Americans at moderate risk of heart disease who needed to lower cholesterol levels but were not taking helpful drugs.

And several advisers said they liked the idea of wider availability of statins like Mevacor, which lower cholesterol by limiting the buildup of artery-clogging fat deposits and reduce risk of heart attack by about a third.

'Uncontrolled experiment'

"There have been times in my career when I thought the statins ought to be in the drinking water," said Dr. Frank F. Davidoff, editor emeritus of Annals of Internal Medicine. But at this point, making them available over the counter "would be a massive, uncontrolled experiment."

The application was filed by Johnson & Johnson-Merck Consumer Pharmaceuticals Co., a joint venture set up to market over-the-counter versions of drugs with expiring patents.

The companies said in a statement Friday they were disappointed by the decision but encouraged by the discussion and would work with the FDA toward getting the drug sold without prescription. "We continue to believe in the benefits of Mevacor ... as an over-the-counter medication to help lower cholesterol and contribute to improved overall public health," said spokesman Tony Plohoros.

The FDA, which rejected a similar application in 2000, isn't bound by its advisers' recommendations but usually follows them. The agency has been under intense scrutiny lately by critics who question whether it is vigilant enough in policing the safety of drugs already on the market. That criticism could weigh on the government as it makes a final decision.

The agency has until Feb. 24 to decide whether to continue the drug's prescription-only status.

As is, allowing over-the-counter sales for Mevacor would mark an unprecedented step. Unlike treatments for coughs, colds and allergies, Mevacor is meant to prevent future heart disease, rather than treat existing spymptoms. And while a cough or cold is apparent, the only way to know one's cholesterol level is to be tested.

Several members of the panel said they would like to see an in-between option, where patients can buy the drug without a prescription but only after speaking with a pharmacist. This option is available in Britain, which last year began selling a similar drug, Zocor, under these rules. U.S. states sometimes order the drugs only be sold be from "behind-the-counter."

FDA officials said they believe it would take a change in federal law to make that option available nationally under FDA rules, though they were consulting their attorneys to be certain. In any case, the pending application asks for freely available, over-the-counter sales, so that's what will be considered, said Dr. Charles Ganley, director of the FDA's over-the-counter drug products division.

He had no comment on what the FDA would do with the application but suggested nonprescription sales may be coming eventually.

The committee, he said, offered "a lot of various, very positive statements, even though the vote may seem lopsided."

"Personally, I think it's an option we ought to look at, particularly when you're trying to control health care costs and provide therapies to people without health insurance," he said.

Over-the-counter drugs are typically less expensive than prescription medication, making them more affordable for those without insurance. It can raise the price for those who have insurance, however, because insurance companies pay nothing toward over-the-counter drugs.

Company officials have said they would charge about $1 for each daily 20-milligram pill if over-the-counter sales were approved.

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On the Net:

FDA Advisory Committee: http://www.fdaadvisorycommittee.com/