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ed to those where the evidence indicated that there was a distinct
possibility of danger in the use of the drug or a reaction that had
serious consequences to the user.
But if there is a drug for which there was an enormous amount
of prospect of good that was being pressed upon you by three drug
companies who apparently thought the drug had enormous poten-
tial, in a case like that, I would think that you would be eager to
see if the claims that were made could be justified. You would be
looking for satisfactory proof that would square with your con-
science and your judgment that that product might give relief to a
lot of people and could be put on the market.
Now, the public-and I must say up to now I share the opinion-
has the impression that your agency, in its desire to be careful and
its desire not to let anybody be hurt, has denied perhaps a lot of
people relief in fear that if they allowed the thing to be approved
as it was presented, that they might be hurt by it; that yours is a
negative attitude, that you don't help anybody improve his applica-
tion, you don't tell them what is wrong with the application in an
informal way so they can attempt to correct it and the like; that
you are not eager to see the users of the country that might profit
from it get the advantage of it.
You say, "It is no skin off my back," as the old saying goes, "if
these folks cannot comply with the technicalities. That is the law,
it is none of our responsibility. Let them get a better lawyer or
somebody else. We are not running it. We are just sitting up here
trying to protect the public interest.
Are you sure that there is no justification for the public or even
Members of Congress having that impression of your regard of
your duties? Are you sure there is no foundation for that fear?
Dr. CROUT. I am certain that we have to cope with accusations of
the type you just mentioned. All I can tell you is we spend an
enormous amount of time internally trying not to behave in that
way.
We have meetings with industry that take up many hours. We
have special check points in the course of drug development in
which people come in and we work together on protocols. There is
no way we can write to a firm turning down a drug without
specifying the reasons for that, because the reasons can be re-
viewed in a hearing.
The CHAIRMAN. How long does it ordinarily take for the proof
that you require to be presented?
Dr. CROUT. It obviously depends upon the drug. There is an
interesting paradox. The closer the drug is to something that is
already in the marketplace, the easier it is to work up. A new
antibiotic that duplicates one already in the marketplace or a new
tranquilizer goes through more easily than a brandnew molecule
with a novel mode of action.
In the case of DMSO today there is very little that needs to be
done to finish studying some of its proposed indications. It needs
some small, carefully controlled trials-
The CHAIRMAN. How long do you think it would take to make a
proper presentation in respect to DMSO?
Dr. CROUT. For what indication?
The CHAIRMAN. To get approval.
