Originally published January 27 2005
Drugmaker seeks over-the-counter status for cholesterol drug
by Mike Adams, the Health Ranger, NaturalNews Editor
Bristol-Myers Squibb is trying to win approval of a 20-milligram over-the-counter 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." The campaign is occurring despite an FDA advisory panel’s decision to recommend against Merck selling another cholesterol drug over-the-counter.
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.
Hutchison declined to say when his company plans to submit an application to the FDA for OTC Pravachol, which would be marketed by Bayer.
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.
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, such as an LDL cholesterol level of 130 to 170 or under age 55 for women.
Use by premenopausal women raised committee members' concerns about the possible harm of statin use early in pregnancy.
By switching a drug to OTC status, manufacturers hope to boost sagging sales resulting from generic competition.
Prescription Mevacor already is off patent, so it faces competition from generic lovastatin.
OTC Mevacor would have been the first non-prescription drug to treat a symptomless chronic condition.
Many committee members say they wished that in the USA, non-prescription Mevacor could be sold the same way that non-prescription Zocor, another Merck statin, is sold in the U.K. Before a prescription drug goes over-the-counter in the U.K., it spends several years "behind the counter."
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