By Jennifer Corbett Dooren
WASHINGTON--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.
Write to Jennifer Corbett Dooren at jennifer.corbett@dowjones.com
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