Re: FDA issue

[carol marcus <csmarcus@ucla.edu>]

At 08:36 AM 2/10/00 -0600, you wrote:
>In a message dated 2/9/00 4:43:35 Pacific Standard Time, csmarcus@ucla.edu 
>writes:
>>>
> 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".  
>>>
>Carol,
>
>Soon,........... we may need no physicians, if HCFA will get more 
>comprehensive computerized testing mechanism implemented. 
>Is this the direction to which medicine is pushed by HCFA with the FDA's 
>approval? ;-)
>
>Emil.
>kerembaev@cs.com
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Dear Emil:

In my opinion, this is just one more step to socialized medicine which this
Democratic administration is sleazing out through regulation since Hilary's
terrible mess was publicly squelched.  Where it will end up depends upon how
much the public rebels.  I, obviously, am opposed to it.

In the area of radiopharmaceuticals, we are doubly cursed with a group of
medical incompetents at NRC who want very badly to further control the
physician's use of therapy radiopharmaceuticals to those on the package
insert.  This is no secret; the NRC had a rule like this that nearly killed
a few patients and was finally overturned with the "Radiopharmacy Rule".
So, the NRC staff and management are now trying to reinstitute it by forced
licensing that retracts a physician's legal and regulatory rights.  This is
evident in the draft licensing NUREG for medical licensees that was
published in August, 1998 (it needs to be retracted completely, but it
hasn't been), and in the "secret" licensing policy that came out last June
which NRC refuses to publicly release.

If Chairman Meserve is naive enough to let his staff and management hoodwink
him on this issue, he's in for a big, ugly surprise.  There are more therapy
drugs and more critically important off-label uses now than we had in 1987,
and Meserve is going to get the worst publicity he ever dreamed of.  
We are not going to attack the low level NRC employees who cooked up this
scheme.  It is Meserve and the other Commissioners who will get the full
treatment.  It may, in fact, be the most compelling reason we have ever had
to end NRC's dysfunctional "medical" program.  

Ciao, Carol

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

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