Help with FDLI Presentation

[Richard Schifreen]

I have been asked to join a panel discussion at this year's Biologics 
Update sponsored by the Food and Drug Legal Institute and the American 
Bar Association.  The topic I've been asked to cover is "ancillary 
reagents" which CBER defines as being used in the manufacture or 
preparation of the biologic, but not a component of the biologic.  This 
might include cell culture media used to expand cells for ex vivo therapy 
or recombinant cytokines used in ex vivo therapy to modify cellular 
growth characteristics.  In general, CBER appears to be taking a 
reasonable approach to trying to make these reagents available for 
clinical research.

These "ancillary reagents" may also be viewed as devices and fall under 
the strict regulation of CDRH.  It is illegal to promote the use of a 
"device" for an application which is not included in its approved 
labelling.  The FDA typically requires manufacturers to perform due 
diligence that devices are not being promoted "off label."  This was the 
basis for taking the Centocor 19.9 test off the market and the recent 
changes in the labelling and approval of monoclonal antibodies used in 
immunopathology.  This is all despite the right of physicians to pretty 
much do as they please with respect to their own practice or hospital.

Can anyone help me with specifics.  I know there was a post here about a 
month ago on monoclonal antibodies which I didn't save - does anyone have 
a copy?  Does anyone have any specific examples which I could use in my 
presentation?

Best regards,
Rich Schifreen          phone: 301-840-4163
Life Technologies       fax:   301-670-1493
   E-Mail: rschifre at access.digex.net