Merck & Co.'s Mevacor cholesterol drug should require a doctor's prescription to ensure an effective dose and prevent kidney damage, physicians said before a government meeting today on the company's request to sell the medication over the counter.
Merck and marketing partner Johnson & Johnson are expected to tell a Food and Drug Administration advisory committee in Bethesda, Maryland, the drug can be sold without a prescription because the risk of kidney and muscle damage has been shown to be low.
Merck's withdrawal of the Vioxx painkiller Sept. 30 over safety concerns has made the agency wary, doctors said.
``The FDA needs to be more careful at this time, especially about post-marketing surveillance of drugs,'' said Robert Phillips, chairman of the department of medicine at New York's Lenox Hill Hospital, who is a critic of the Merck plan.
U.S. House and Senate committees are conducting separate inquiries into whether the FDA failed to protect the public from the elevated risk of heart attacks and strokes that prompted the Vioxx withdrawal.
Merck has conducted research, including a 26-week study known as Custom, which shows Mevacor can be taken safely without a prescription, said Hemwall said in a Jan. 11 interview.
Over-the-counter Mevacor would help for people who might be reluctant to take a prescription drug, said Jerry Hansen, vice president of marketing for the Johnson & Johnson and Merck joint venture.
The FDA asked its panel of leading doctors and scientists this week to evaluate whether Merck has shown that a 20-milligram over-the-counter Mevacor pill can safely help patients lower their cholesterol.
An over-the-counter drug might take some sales away from prescription cholesterol medicines, including Merck's biggest product, the Zocor cholesterol drug, he said.