FDA Advisers: Cholesterol Drug Shouldn’t Be Sold Over Counter

BETHESDA, Md. – Federal health advisers recommended against over- the-counter sales of a cholesterol drug Friday, saying 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 it 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.

“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.