WASHINGTON, DC USA (News Release) - November 9, 2012 - A federal advisory panel Friday raised concerns about Merck & Co.'s (MRK) effort to sell an overactive- bladder product without a prescription.
Merck has asked the FDA to allow it to switch the status of prescription patch Oxytrol, currently sold by Watson Pharmaceuticals Inc. (WPI), to an over-the-counter item for women.
The proposal was discussed Friday by the FDA's nonprescription drugs advisory panel, which is made up of non-FDA medical experts. The panel was not asked to directly vote on whether a switch from prescription to over-the-counter status should be allowed. The panel instead was asked to vote on whether consumers could "appropriately self-select" to use the product in an over-the-counter setting. The panel voted 5-to-6, or against the question. However, the FDA considers close votes a split vote.
While many panel members said they were concerned about selling a bladder treatment without a prescription, they also said it could be done with stronger warnings suggesting women first see a doctor. The FDA isn't required to follow the advice of its advisory panels but usually does.
Overactive bladder results from an involuntary contraction of the bladder that causes a frequent or sudden and unstoppable need to urinate. The condition is estimated to affect 20 million women, according to Merck.
The FDA is expected to make a decision on whether to allow Oxytrol to be sold to women without a prescription by the end of January.
Copyright (c) 2012 Dow Jones & Company, Inc.
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