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do. I am wondering whether anybody or yourself at the FDA thinks
it would be useful to clarify the statutory standards.
As I have heard the evidence this morning and this afternoon,
the FDA is in fact living up to the statutory standards, indicating
this drug will not be approved because there is no substantial
evidence of effectiveness.
You say that quite categorically, and you have the National
Academy of Sciences behind you, and you have the Arthritis Foun-
dation, a representative who will testify.
Do you people feel, in view of the controversy over this, that the
Congress should think of clarifying or refining or even altering the
statutory standard?
Dr. CROUT. I appreciate your comments. Let me say that I cannot
speak for the administration on a legislative issue. But my suspi-
cion is we should not.
I think it is really quite a profound thing for the Congress to
begin to tinker with a standard like that, which we use every day
for many, many new drugs coming by, simply because there is a
controversy over one particular drug.
I think I would urge that we use some of the measures that the
chairman suggested, of mutual cooperation, that we let Research
Industries reappraise perhaps whether they want to take up some
controlled trials for DMSO in soft tissue injury, and let the usual
processes run.
My suspicion is that this is one of those items that properly
doesn't deserve congressional attention, that is legislative atten-
tion.
Mr. DRINAN. I thank you, Doctor. That is my intuition, too. I am
impressed, to repeat, by the Academy of Sciences and by the evi-
dence and by the carefulness of your testing. You say quite categor-
ically-and I really didn't hear this refuted-you say on page 8:
"There is no evidence that DMSO alters the course of any disease.'
So I just commend you.
Dr. JACOB. That is not true.
Mr. DRINAN. And I say that clarification for the Congress of
what we talked about, of that statute, would be important to me.
One last question. On page 3 you speak of a final form on this
proposal now being prepared for publication. Would you tell me
when that comes out and what that will finalize?
Dr. CROUT. I don't know when that will come out. That is a
matter of cleaning up some paperwork on an old regulation that is
now obsolete.
Mr. DRINAN. But that is not in the main run of what we are
discussing here today.
Dr. CROUT. No, not really an important item at all relative to
this hearing.
Mr. DRINAN. Maybe I should ask this of the next witness: Is the
Arthritis Foundation bothered, I supposed, or importuned by
people who want them to give some encouragement to this drug?
Dr. CROUT. They will have to comment on that themselves.
Mr. DRINAN. Thank you very much.
The CHAIRMAN. Thank you, Father.
Doctor, I just want to ask you one other thing.
