SHOULD ANTIBODIES BE REGULATED BY THE FDA ?

Jose Perdomo biotech at slip.net
Sat Apr 8 03:18:59 EST 1995


belglobul at aol.com (Belglobul) wrote:
>
> Hi,
> I did not know that and it is far to please me. The trend of the American
> society to create rules and laws for evrything has reached a new altitude.
> I guess that the FDA try to regulate the use of antibody in human therapy.
> If your are right, the majority of the most efficient antibody that have
> been developed against human antigen may be soon "protected" by the FDA.
> One could imagine a loophole to this. A lot of drugs regulated by the FDA
> are sold in laboratory with the restricition: "for research use only" .
> This trick could be used by laboratory to escape the restriction imposed
> by the FDA.
> 
> Best regards
>        Thierry Sornasse
>        Elm: Belglobul at aol.com      or   Sornasse at dnax.org





Dear Thierry:



I think I did send you a message yesterday thanking you for 
responding to my posting. Just in case I did not, I am doing it again.

You are right, we must find pleasure in complicating life. If we do not
watch out soon distilled water will be a Medical Device.

The problem is that they appear to expand they criteria of the
Medical Devices to an extreme that will surely result in serious 
damage to the scientific community in US.

To regulate as Medical Device a kit design for detecting PSA in 
blood is a reasonable regulatory activity of the FDA, however, 
to classify as Medical Devices all antibodies to PSA is unnecessary
and only reflects gross overregulation. There are thousands of
researchers using antibodies to PSA in many different ways. Why
should they be restricted of the use of these tools just because the
antibody has a clinical significance?

Because a heart pump implant is made of polycarbonate that should not
convert polycarbonate to be a Medical Device. The extreme of this 
regulation is such that a biotin-labelled goat anti mouse IgG and 
peroxidase labeled avidin are all considered Medical Devices. 
I honestly believe that if we continue on this course, distilled 
water will soon also be considered to be a Medical Device.

How ridiculous and silly are we going to allow this to get?

Someone told me the other day that the "tongue depressor" is 
a Medical Device. That explains the amount of money they charge 
in hospital bills for such a simple piece.You can be sure that 
the companies that make this prefer that the little stick be a 
Medical Device so that they can charge accordinly.

There is a posting on this newsgroup as well as in sci.bio posted
by Biodesign which includes a lot of info on this antibody regulatory
issue. 

I strongly recommend you to read their posting and learn what 
is cooking in the pot of FDA right next to your backyard.

Thank you again for your time and interest.

Best regards,


Jose Perdomo

biotech at slip.net
:-) 

>        




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