FDA Panel Rejects OTC Cholesterol Drug
Experts Recommend That Mevacor Remain a Prescription Drug
Dec. 13, 2007 -- Expert advisors urged the FDA to reject a drug company's bid to sell a cholesterol-lowering drug without a doctor's prescription.
This was a major setback in Merck & Co's years-long effort to sell Mevacor over the counter.
The company maintains that Mevacor is safe and that the potential for consumers to take lipid-lowering medication on their own could greatly reduce rates of heart attacks and strokes.
The FDA ruled against a similar request in 2005, stating that the company had not demonstrated that average consumers can safely and effectively use the drug.
The 2005 ruling caused the company to design new product labels and conduct new studies looking at consumers' ability to fully understand those labels. But old questions returned Thursday, as experts worried that consumers may not use the drugs correctly without the advice of a doctor.
The panel voted 10-2 that Merck should not be allowed to sell Mevacor over the counter. There was one abstention.
"We're not in a position that people can make that safe, informed decision," said Mary E. Tinetti, MD, a professor of medicine at Yale University and the panel's chairwoman.
Mevacor's Track Record
Lovastatin, the active ingredient in Mevacor, has been on sale in the U.S. for 20 years. It is one of the class of prescription drugs called statins, which work by lowering both total cholesterol and low-density lipoprotein (LDL), the so-called "bad" cholesterol.
Heart disease is the No. 1 cause of death in the United States, killing more than 650,000 people per year. More than 25 million Americans have undiagnosed heart disease, according to the CDC.
Millions of patients take statins because they are proven to help lower the risk of cardiovascular events like heart attacks and strokes in patients at risk for coronary heart disease.
But Merck was hoping to use nonprescription status to reach a different group of people: those at moderate risk of heart disease because they have elevated cholesterol.
"Being over-the-counter provides overall better access and awareness," said Jerry Hansen, Merck's executive director of consumer behavior research.