A panel of advisers to the Food and Drug Administration today 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 the agency has recommended against allowing the first statin drug, called Mevacor, to be sold on the shelves of drugstores. The decision, while not binding, is usually accepted by FDA regulators.
The panel experts said statins were too complicated for patients to use on their own. And panel member Sonia Caprio, a pediatrics professor at Yale University, said she feared that people who don't need a statin would be taking 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 also planned a Web site, weekly e-mails and an 800 number to get patients to learn more about the condition and stay on the drug, if warranted.
The company had planned to give exclusive U.S. marketing rights to GlaxoSmithKline, 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 over the short term where the patient can judge for themselves when it's no longer needed, he said. Statins, by contrast, require blood tests to know if you're 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 University of the Sciences in Philadelphia, said he too had misgivings about Mevacor going over-the-counter. But he proposed a middle ground: 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 expects the FDA to act on the panel's recommendation on Jan. 26.