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Panel: Keep Mevacor off shelves

Merck wants its statin to be over-the-counter. FDA advisers said no.

Merck is seeking FDA approval to sell Mevacor over-the-counter. Meanwhile, the firm settled for $20 million a case involving a chemical spill 18 months ago. Story, A1.
Merck is seeking FDA approval to sell Mevacor over-the-counter. Meanwhile, the firm settled for $20 million a case involving a chemical spill 18 months ago. Story, A1.Read moreJB REED / Bloomberg News

A panel of advisers to the Food and Drug Administration yesterday rejected a request by Merck & Co. Inc. to sell its cholesterol-lowering statin drug without a prescription.

The 10-2 vote marked the third time since 2000 that an agency panel has recommended against allowing the first statin drug, called Mevacor, to be sold on drugstore shelves. The decision, while not binding, is usually accepted by FDA regulators.

The expert panel said statins were too complicated for patients to use on their own. Panel member Sonia Caprio, a pediatrics professor at Yale University, said she feared that people who did not need a statin would take it.

"There is going to be abuse," she said.

Merck's experts had argued that high cholesterol, which leads to heart disease, is vastly undertreated. Fewer than one-third of the 20 million Americans with moderately high cholesterol are getting treated, said Edwin Hemwall, who heads Merck's regulatory affairs for over-the-counter drugs.

"We are disappointed in today's outcome," Hemwall said in a statement. "We felt we presented a compelling case."

Merck had hoped to sell a 20-milligram dose under the name Mevacor Daily. It had planned a Web site, weekly e-mails, and an 800 number to get patients to learn more about their condition and stay on the drug if warranted.

The company had planned to give exclusive U.S. marketing rights to GlaxoSmithKline P.L.C., which hoped the drug would further expand its consumer-drug division.

Brian L. Strom, an expert on drug safety and a medical professor at the University of Pennsylvania, said: "I think [the recommendation] makes enormous sense." He added: "I would have been surprised if they had voted for it."

An over-the-counter drug is usually taken for a short time, and when patients can judge for themselves if it is no longer needed, he said. Statins, by contrast, require blood tests to know if you are taking the right amount and whether the dosage needs to be cut or increased. They also need to be taken long term to get beneficial effects, Strom said.

Daniel A. Hussar, a pharmacy professor at the University of the Sciences in Philadelphia, said he, too, had misgivings about Mevacor going over-the-counter. But he proposed an alternative: making the drug available after a consultation with the pharmacist.

The idea has been tried in England, where pharmacists have been entrusted with overseeing the dispensing of a 10-milligram dose of another Merck statin, Zocor, since 2004.

Many people are already treating themselves, Hussar said, with herbal supplements, which are not regulated for purity or effectiveness the way prescription drugs are.

The vote by the FDA panel, which met in Silver Spring, Md., came after the U.S. stock market had closed. Shares of Merck closed up 7 cents at $59.79. Merck said it expected the FDA to act on the panel's recommendation Jan. 26.