66
like to see how long before you come to a full decision on this
particular application.
Do you reckon you couldn't make it any shorter than a year, if
the other applicants did a good job?
Dr. CROUT. Let me say that all of us in the Food and Drug
Administration, like every other institution in this world, are
people. We have to cope with disease in our own families. I think
we are quite sensitive to some of the health issues you have men-
tioned.
The core of our staff are all physicians, so that they have at one
time or another in their lives practiced medicine, though they are
not practicing at the Food and Drug Administration. So, I think
the human sensitivity you are asking for is there.
We would be delighted obviously to cooperate with the firm in
advising on DMSO. I promise you that.
The CHAIRMAN. Well, we are going to advise these gentlemen
here who are interested in the presentation of this application to
prepare it with all deliberate speed, and to get the best person
qualified to present it. We want them to make as good a showing
before you as they can. We ask you to try to cut as much legal red-
tape as you can, and give us as speedy a decision as you think is
right in this matter.
Dr. CROUT. Fine.
The CHAIRMAN. Now, just one other question.
To what extent does the Food and Drug Administration and the
National Institutes of Health cooperate or consult?
Dr. CROUT. I think fairly extensively. We are both in the Depart-
ment of HEW. We both report to the Secretary. So that we have
common bureaucratic bonds.
We also have a lot of informal interchange; that is, members of
the NIH staff may be on our advisory committees. We may in turn
consult with them.
In my testimony, when I mentioned my talking to them about
the group that has promised to do a trial on scleroderma, that is an
example of the informal contact that goes on back and forth.
The CHAIRMAN. Do you have an administrative setup and re-
quired personnel so that there is no undue delay in the Food and
Drug Administration when proper data are presented in the deci-
sion of the case?
Dr. CROUT. Well, I think every institution probably thinks it
could use more people, but I would not argue that case, today,
given the overall state of the economy and general constraints on
Federal spending.
We are in pretty good shape staffwise. Certainly for DMSO no
staff limitations to handling an application.
The CHAIRMAN. Thank you.
I am advised by the staff that Research Industries has a DMSO
application pending. It has been pending since 1978, I believe you
said. What is holding up the decision of the Food and Drug Admin-
istration on that?
Dr. CROUT. That was in my testimony. Their 1978 application
was on two indications—one was interstitial cystitis which we ap-
proved. The other was on scleroderma, which we turned down.
There is no active application pending now, to my knowledge.
