Re: Previous query about FDA Debarment Brock 13 Jan 1995 16:08 EST

I don't remember who asked the orginal question about the debarrment
provision that is appearing in clinical trial agreements with increasing
frequency.  We are seeing this provision frequently enough that we prepared a
brief explanation of the requirements (which do indeed appear in the Generic
Drug Enforment Act of 1992 rather than in the standard ferderal debarrment
provisions for recipients of federal funds) and a certification form that we
place in our files to show that we asked the right questions.  I would be
happy to share these by Fax if you make a request directly to me and include
your Fax number.

Elaine L. Brock
Senior Project Representative
The University of Michigan
Phone (313) 764-7250
FAX (313) 763-4053

From: Research Administration Discussion Group on Fri, Jan 13, 1995 9:11 AM
Subject: Previous query about FDA Debarment
To: Multiple recipients of list RESADM-L

 Thanks to everyone who responded to my previous question concerning
FDA debarment.  Most of the responses equated FDA debarment with the typical
debarment from federal acquisition programs, but I am not sure that it IS the
same.  The FDA does not fund pharmaceutical company sponsored clinical
but it does have to pass final judgement on the data obtained in the clinical
trials.  I rather suspect (without the burden of information to argue either
way) that being debarred by the FDA simply means that they will not accept
data generated by the debarred clinician in support of a company application
for FDA approval of a drug.  Anyone know whether my conjecture is correct or

Doug Wilkerson, Ph.D.           VOICE:  (419) 381-4252
Assoc. V.P. for Research        FAX:    (419) 381-4262
Professor of Pharmacology       e-mail: xxxxxx@GEMINI.MCO.EDU
Medical College of Ohio
3000 Arlington Ave.
Toledo, OH 43614