FDA Advisers Reject Over-the-Counter Statin

They cite concerns that consumers wouldn't use the cholesterol-lowering drug Mevacor safely

By Steven Reinberg
HealthDay Reporter

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THURSDAY, Dec. 13 (HealthDay News) -- For the third time in seven years, U.S. Food and Drug Administration advisers have voted to deny Merck & Co.'s request to make the cholesterol-lowering drug Mevacor available over the counter.

In a 10 to 2 vote with one abstention, the FDA advisers said Thursday that it would be too complicated for consumers to determine on their own if they were a good candidate for the drug, part of a class of medications called statins.

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"The general consensus is that these are safe medications, but the concerns were whether consumers could make an informed decision," said Dr. Mary Tinetti, chairwoman of the FDA's Nonprescription Drugs Advisory Committee. "We need to see more real world experience with consumer decision-making," Tinetti said.

The proposal was rejected during a joint meeting of the FDA's Nonprescription Drugs Advisory Committee and its Endocrinology and Metabolic Drugs Advisory Committee. While the FDA doesn't have to follow the advice of its advisory panels, it typically does so.

In 2000 and in 2005, the FDA rejected similar proposals from Merck because of concerns about how the drug would be used by consumers, potential side effects, and the need to monitor people taking statins.

Groups such as the American Medical Association and Public Citizen had lined up against Merck's latest request.

"The third time is not the charm," Dr. Steven E. Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic, said before the vote. "It's time to move on."

In its proposal, the Whitehouse Station, N.J.-based pharmaceutical giant noted that many people with high cholesterol go untreated, increasing the risk for heart attack and other heart problems.

"The availability of a statin without a prescription is anticipated to help narrow the cholesterol treatment gap," Merck said in a prepared statement. "Consumers already attempt to manage their cholesterol by purchasing unproven food and dietary remedies, and the availability of an OTC statin would give them the option of purchasing an effective pharmacologic therapy. Mevacor Daily [lovastatin 20 mg] is an appropriate choice for an OTC statin. The efficacy and safety of lovastatin has been well-established through the 20 years of marketed use of the product as well as by the post-approval megatrials."

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