FDA issue

[carol marcus <csmarcus@ucla.edu>]

>Date: Wed, 09 Feb 2000 16:29:30 -0800
>To: johngdSPAMNOT@bellsouth.net
>From: carol marcus <csmarcus@ucla.edu>
>Subject: FDA issue
>
>Dear John:
>
>The FDA gets paid large extra fees per year every year by a manufacturer
for each new indication listed on the package insert.  For each one, there
needs to be an FDA clinical trial.  This creates lots of work for FDA staff,
and the User Fees pay their salaries.  Physicians do not have to follow
package inserts, however, so there would be little reason for a manufacturer
of a radiopharmaceutical to go to the expense of establishing more and more
approved indications.  However, HCFA says that it will not reimburse for
procedures unless the indication is on the package insert; other indications
are "investigational".  If the doc can't get paid, he won't do the test, and
he won't buy the drug.  So, the manufacturer is pressured by the docs to get
the extra indications approved.
>
>Approvals these days are for very limited indications.  A
radiopharmaceutical that goes to cancers will be approved cancer by cancer;
a radiopharmaceutical that binds to white blood cells and lights up
infections may get approved for appendicitis, but nothing else.  It's perverse.
>
>Ciao, Carol
>

Carol S. Marcus, Ph.D., M.D.
<csmarcus@ucla.edu>

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