FDA Debarment Tony Silbert, x2685 11 Jan 1995 17:59 EST

About 4 or 5 months ago those debarment clauses started showing up in every
clinical study agreement.  Apparently, the result of FDA requirements.

I understand, although I have not seen it, that the FDA does have a list
of debarred parties.  However, we have requested that the words "to the best
of our knowledge" qualify our assertion that we do not deal with debarred
parties.  So far, everyone has agreed to this and, given the size of our
organization and the fact that purchasing, public relations, accounts payable,
and all other departments act somewhat independently, it is really the best
we can do.  This solution mollified all parties-- including our lawyers.

Tony Silbert
Grant & Contract Officer
Cedars-Sinai Medical Center
Los Angeles, CA