Although an FDA advisory panel voted 20-3 Friday to recommend against allowing Merck to sell over-the-counter (OTC) Mevacor, a cholesterol-lowering statin drug, 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." 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.
Nearly six out of 10 study participants who used OTC Mevacor still ended up consulting a doctor. And even so, nine out of 10 failed to meet at least one of the criteria set forth on the drug’s label.
By switching a drug to OTC status, manufacturers hope to boost sagging sales resulting from generic competition. When a drug is switched, its manufacturer gets exclusive rights to sell it OTC for three years. Prescription Mevacor already is off patent, so it faces competition from generic lovastatin. Pravachol’s patent expires in April 2006. OTC Mevacor would have been the first non-prescription drug to treat a symptomless chronic condition. The FDA has until Feb. 24 to reach a decision about OTC Mevacor.
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