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Dr. CROUT. We take steps to accelerate the handling of applica-
tions that come to us. We have a priority system for handling
drugs of medical importance on a faster track than we do drugs
that simply duplicate products already in the marketplace. The
basic advocacy for the drug comes from the outside party, however.
however.
The CHAIRMAN. This drug has been on the track for 15 years.
Has it been on the slow or the fast track?
Dr. CROUT. No; the applications for DMSO have been handled in
a timely way. That is not the issue. We have not had pending
applications in front of us for 15 years.
The CHAIRMAN. Have you denied all that have been presented?
Dr. CROUT. No; we approved the one in 1978 for interstitial
cystitis.
The CHAIRMAN. And you have not had any application for the
approval of this drug since 1978?
Dr. CROUT. The scleroderma application was presented by Re-
search Industries, also in 1978. That we turned down in 1979.
The CHAIRMAN. I believe the evidence indicates that three drug
houses of national repute applied for approval to market this drug
in the country, and you turned down all three of those applica-
tions. You mean those drug houses did not know how to present an
application to Food and Drug to show proper evidence of value in
the use of it?
Dr. CROUT. Yes, sir, that is right.
The CHAIRMAN. Had they ever had any drugs approved before?
Dr. CROUT. Oh, yes.
The CHAIRMAN. Well, they had had experience, then, in the
presentation of drugs for your approval.
Dr. CROUT. Yes; but they have also had some turned down.
The CHAIRMAN. And they did not complain about your finding
that they had not made any satisfactory showing of the efficacy of
that drug?
Dr. CROUT. No; they did not pursue that. This occurred before I
was at the Food and Drug Administration. So I cannot speak with
personal knowledge of exactly what happened. No, they did not
pursue those applications further.
The CHAIRMAN. Well, now, you have heard here this morn-
ing-
Dr. CROUT. Nor did they pursue their legal right to a hearing
which every drug firm has.
The CHAIRMAN. You heard the testimony here of several wit-
nesses this morning. You would not regard any of that testimony
as testimony as to the efficacy of that drug in the treatment of
pain and sores and sprains and that sort of thing?
Dr. CROUT. It has to be, as I point out, assembled into a scientifi-
cally designed study. There is no reason to think that the testimo-
nies are necessarily wrong. I don't want to imply that. But there is
a certain discipline that research has to go through, that every
drug goes through before it gets approved, in which the studies are
designed and patients are very carefully selected for the study.
Right from the start one must know what is going to be measured
in those patients and those measurements must be made objectively.
And to the extent it is possible, the study should be blinded.
