Matthew Katz writes:

>I just recently received a drug study agreement for a study involving the use o
f
>a FDA approved drug.  The agreement is in very basic language but does not
>include an indemnification agreement.  The drug is not being studied for new
>usage but will be used as it was federally approved.  I have put in a call to t
h
>e
>company to see if they will supply us with an indemnification agreement.  And I
>have asked our legal department to review.  Unfortunately, our attorney's turn
>around time is any where from 2 weeks to infinitum.  I don't want to hold this
u
>p
>anymore then I have too, considering the rest of the agreement is very simple.
>what is the general consensus regarding indemnifications for FDA approved
>drugs.

Don't know why, but I get the impression from your comments that this is from
a generic manufacturer trying to get approval to sell their product.  So I
might be way off, but the fundamental principle that an institution should be
protected from something they cannot control applies regardless.

If it is a new manufacturer of an approved drug, then their manufacturing
processes can introduce variables which you need to protect against.

If it is from the original company which developed the drug, then why are they
seeking FDA approval again?  A question which immediately makes me want to
worry about indemnification.

IMHO, anytime an institution receives a drug for evaluation, it should be
indemnified against any possible adverse effects of the product.  What if
the company mislabelled the product and sent you something which was not
intended for evaluation?

Get indemnification!  If the company cannot, or will not, provide it, then
there is something wrong.

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