Although a Food and Drug Administration advisory panel has recommended against selling one cholesterol-lowering statin drug over-the-counter (OTC), the maker of another is moving forward with plans to seek the agency’s permission to make the switch. Bristol-Myers Squibb is seeking approval of a 20-milligram OTC version of Pravachol. “We are continuing a robust program to provide the FDA with the information it needs,” company spokesman Rob Hutchison says. “Our own studies are underway.” Hutchison declined to say when his company plans to submit an application to the FDA for OTC Pravachol, which would be marketed by Bayer. Bristol-Myers Squibb had unsuccessfully lobbied the FDA in 2000 to switch its statin. Hutchison’s comments come after an FDA advisory panel voted 20-3 Friday to recommend against allowing drugmaker Merck to sell OTC Mevacor. Panel members said Merck’s “actual use” study, which simulated pharmacies selling OTC Mevacor, failed to show that consumers could properly decide on their own whether to take the statin.
