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On 23 Sep 2005 21:39:47 -0700, "Sbharris[atsign]ix.netcom.com" wrote:
>It was the dumbest of times. The FDA's OTC regulatory and application
>policies resulted in a situation where, for nearly two decades, the
>only safe non-drowsiness producing antihistamine was only by
>prescription, not OTC. While meanwhile we struggled along with OTC
>antihistamines that put people to sleep at the wheel, and other
>prescription antihistamines that were still sedating or (even worse)
>lethal causes of heart arrhythymias. This situation was so bad it
>finally got to the point that one HMO company (Wellpoint) actually
>petitioned the FDA to make ANOTHER company's drug available OTC.
Wellpoint is not a drug manufacturer. Wellpoint is not an "applicant"
in the FDA regulatory sense of holding an approved New Drug
Application (NDA), and therefore responsibility for complying with
FDA regs (Title 21, U.S. Code of Federal Regulations) in the way
a pharmaceutical product's manufacturer (either innovator or generic)
must. Wellpoint is just another Mangled Care [or is that "Managed
Money"?] Organization (MCO).
Wellpoint's effort was entirely self-serving. If I remember aright,
Wellpoint's petition covered all of the "second-generation" prescrip-
tion antihistamines (including desloratadine) but not in order to
improve OTC access to less sedating medications. They wanted
to be able to stop paying for drugs like Zyrtec, Allergan, and
Clarinex under the prescription benefits plans for which Wellpoint
was receiving hefty payments from Wellpoint's clients. Third-party
"health insurance" payers almost never have any obligation whatsoever
to cover the costs of any *non*-prescription medications (even, for
example, aspirin taken under the explicit direction of a physician)
and *that* was Wellpoint's true motivation.
The fact that you and I might agree with the contention that
drugs like cetirizine and fexofenadine are even more appropriate
candidates for OTC sales than are "first-generation" antihistamines
like diphenhydramine (Benadryl) and chlorpheniramine maleate
(Chlor-Trimeton) has nothing to do with what those penny-
pinching bastards at Wellpoint were trying to diddle their clients
out of.
------------------
Mr. Azae: You don't care whether you impress people or not, do you?
Richard Sumner: You wait until you get my bill. You'll be impressed.
-- *Desk Set* (William Marchant, 1957)
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