We have recently run across a couple of clinical trial agreements with
the following clause:
 In one agreement it is worded as follows:

 "By executing this clinical trial agreement contractee represents,
covenants, warrants and agrees that neither the investigator nor any employee
of the research facility selected to perform the study pursuant to this
agreement, is under investigation by the FDA for debarment action or is
presently debarred pursuant to the Generic Drug Enforcement Act of 1992
(21 U.S.C. 301 et. seq.) (the "Act").  Further, Contractee agrees that it
shall not use in any capacity the services of any person debarred or under
investigation under the provisions of the Act."

 In another agreement it is worded as follows:

 "...contractee will not use...any person that has been debarred under
Section 306(a) or Secton 306(b) of the Federal Food, Drug and Cosmetic Act or
that has a conviction that could lead to debarment under Sections 306(a) or
306(b).  Furthermore, contractee will notify the Sponsor immediately of any
action toward conviction or debarment under the above sections of any person
working on the study"

 Has anyone else run across this clause?  Does the FDA publish a list
of physicians that it has debarred, if so where?  To whom does the FDA report
debarment actions - individuals, hospitals, universities?  Since these
investigations are presumably confidential, do they even publish the names of
persons under investigation?  If reported to your institution, to which office
is it reported?

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