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The CHAIRMAN. Mr. Bonker.
Mr. BONKER. Thank you, Mr. Chairman.
Dr. Crout, I have not joined the chorus of criticism of FDA
policies and have always resisted the temptation to co-sponsor leg-
islation that is challenging basic decisions that you have made
precisely because you are a specialized agency, and I have no
means of making judgments that could contest your conclusions.
But as a legislator, I have listened to the testimony today, I have
followed Dr. Jacob's career for the last 15 or 16 years, and we have
not heard from unreliable witnesses today-very credible, highly
regarded, professionally grounded witnesses on this particular
subject.
The testimony seems compelling. If you cannot find within your
statutory authority a basis of making a more positive decision, then
perhaps something is wrong with the statute. Either that or the
testimony that we have received today is flawed in some way.
I have looked at a copy of the Federal Food, Drug and Cosmetic
Act as amended, section 505, and it seems to me that it is con-
cerned primarily with safety and efficacy.
In section 505(e), since we seem to be talking about substantial
evidence as a means of decisionmaking for your agency, it says
here:
The term "substantial evidence" means evidence consisting of adequate and well-
controlled investigations including clinical investigations by experts qualified by
scientific training and experience to evaluate the effectiveness of the drug involved.
You have covered that--
on the basis of which it could fairly and responsibly be concluded by such
experts that the drug will have the effect it purports or is represented to have
under the conditions of use prescribed, recommended or suggested in the labeling,
proposed labeling thereof.
It appears to me that your agency has considerable discretion in
making these decisions, and you can make a case either way,
depending on what you perceive to be the right decision.
Now, when I go to the drug store and I look for medication, my
wife may have an ailment of sorts, I know that most of the drugs
that are over-the-counter are fairly marginal in their effectiveness.
If we get cough syrup or aspirin or some of the more complicated
prescriptions, that maybe it will work, maybe it won't work. But
obviously at some point your agency must have made a determina-
tion that there was substantial evidence in favor of that drug.
It seems to me that the testimony presented today after 15 or 16
years of notable success attested to by Dr. Jacob, and last night on
"60 Minutes," and others who have appeared before this panel,
that this drug must be at least comparable in its effectiveness to
other drugs that are on that shelf.
Can you join me in that conclusion?
Dr. CROUT. For over-the-counter drugs, it is not always clear.
That is true for some of them and not for others. We have a major
review going on of all over-the-counter drugs to evaluate their
safety and effectiveness.
You raise the issue of aspirin, for example. The evidence behind
DMSO as an effective remedy is not nearly as great as the scientif-
ic evidence behind aspirin, that it is an effective drug. The trials
are not nearly of the same quality.
