Mr. HARROP. I will withdraw my statement that he has nothing to worry about. That is too broad a statement, anyway.

Mr. WOLVERTON. That is all.

Mr. BEAMER. I have just one question, if I may, Mr. Chairman. Did I understand that in your page 2, you made a suggestion for a substitute and later on I think you stated, too, that probably the part that disturbed most of the folks was the efficacy provision?

Mr. HARROP. Yes, sir.

Mr. BEAMER. Suppose there be some substitute language that might clarify that, or would you recommend a listing, and if so would you like to suggest for the consideration of the committee some wording that might assist them in that direction?

Mr. HARROP. I can't fairly recommend a listing because we are opposed to it. We don't think it is a proper approach and our experience is not too good with administrative hearings. We think a standard like this is a fair way of approaching it. You can amend that by striking out "and efficacious."

Mr. BEAMER. Just striking it out, that would be your answer?

Mr. HARROP. And say "as safe for use." You have left "toxic potential for harmful effect." That is a pretty good standard. Probably it is the only needful standard.

Mr. BEAMER. I think that answers my question.
The CHAIRMAN. Thank you, Mr. Harrop.
(Telegram of Parke, Davis & Co. follows:)

ELTON J. LAYTON,

DETROIT, MICH., May 2, 1951.

Clerk, Committee on Interstate and Foreign Commerce,
House of Representatives.

In regard to H. R. 3298 we wish to go on record as being in favor of modification of this bill in the manner suggested by Leslie D. Harrop as general counsel for the American Drug Manufacturers Association. We believe that limiting the dispensing of any drug on prescription only may best be accomplished by definition in the law in language like that now in administrative regulation (sec. 2.106 (B) (1)) applying to section 502-F of the Federal Food, Drug and Cosmetic Act rather than by placing upon the Food and Drug Administration the responsibility to prepare and keep up to date a continually changing list of drugs identified by specific names we also believe the proposed reference in (B) (1) of bill to habit forming drugs is completely unnecessary in the light of section 502 (D) of the present act and the application of now effective narcotic laws and regulations.

PARKE DAVIS & Co.
KENNETH D. MCGREGOR,
Secretary and General Attorney.

The CHAIRMAN. The next witness is Mr. Clutter.

STATEMENT OF RAYMOND O. CLUTTER, ELI LILLY & CO.,
INDIANAPOLIS, IND.

Mr. CLUTTER. My name is Raymond O. Clutter, and I am representing Eli Lilly & Co., one of the larger pharmaceutical manufacturers, located in Indianapolis, Ind. I have here a prepared statement which was written by Mr. W. M. Wheeler, Jr., our secretarygeneral counsel. Unfortunately, he was not able to attend this hearing and so first I am going to read his statement, after which I will be glad to answer any questions that any of you gentlemen may have.

Mr. WOLVERTON. Before the witness proceeds, may I inquire as to what position he holds with the Eli Lilly Co.?

Mr. CLUTTER. I am an attorney for Eli Lilly & Co. and I am Mr. Wheeler's assistant.

Since 1876 Eli Lilly & Co. has been engaged in the manufacture and sale of medicinal products for use under the direction of a physician. It opposes the legislation now under consideration by this committee because it feels that to place in the hands of any administrative agency the broad powers of drug classification contemplated by H. R. 3298 would be against the best interests of the public. Its reasons may be stated briefly as follows:

1. H. R. 3298 will amount to an abdication by Congress of its legislative powers and a delegation of such powers to an administrative agency.

2. When it is considered that there are many thousands of drug products and many thousands of diseased conditions for which one or more of them may be indicated in the treatment the endless task of administrative classification becomes apparent. Some drugs may be safe and efficacious without medical supervision when recommended for certain conditions and at the same time be quite dangerous for use without medical supervision in the treatment of other conditions. The question of safety and efficacy accordingly depends upon countless factors, among the most important being the nature of the drug, its dosage, method of administration, frequency of administration, the precise condition for which such drug is being administered, et cetera. An administrative classification would accordingly require that consideration be given to each of these factors for each drug with respect to each intended use. Such administrative classification would involve hearings, the attendance of experts, and the taking of testimony. Is it possible for anyone to foresee the end of these proceedings? 3. As opposed to the proposed administrative classification, the existing statute now simply requires that drugs bear "adequate directions for use." This simple statutory mandate is designed to protect the user of medicinal products. It would be difficult to improve upon the present system. In enacting the Federal Food, Drug and Cosmetic Act of 1938 Congress did not attempt to protect the consumer against his own foolishness or against his own willful disregard of label directions. There is no need to do that now. Under the present system, if a drug manufacturer deems that his product requires medical supervision he is at liberty to state that fact clearly on his label and the purchaser is thus given adequate information as to how the product should be used. If the nature of the product and the claims made therefor are such that medical supervision is required, the existing statute makes its own classification. This is a legislative classification and wherever a doubt arises as to the proper labeling of a product the courts have jurisdiction to decide the issue. We are opposed to substituting a system of administrative classification for the legislative classification now embodied in the statute.

4. It is said that H. R. 3298 is necessary to establish the rules for refilling of prescriptions. These rules, by custom and usage of long standing in the pharmaceutical and medical professions, are established by the physician. In writing a prescription, it is his responsibility to give instructions as to the refilling thereof if he contemplates

that the prescription will be refilled. In the absence of specific directions to the contrary, it has been the custom of the pharmaceutical profession to refill prescriptions except in cases where, by the exercise of sound professional judgment, the pharmacist feels that injury may result. There should be no legislative interference with the exercise of this professional judgment.

5. Abuses respecting the refilling of prescriptions are confined to a relatively few retail pharmacists. Where dangerous drugs are involved the Food and Drug Administration has already demonstrated its ability to correct the situation under existing law. Where nondangerous drugs are involved there is no situation requiring correction. For the foregoing reasons we are opposed to H. R. 3298.

For a discussion of the provisions of the present act as it relates to the problem of refilling prescriptions, reference is made to an article entitled "Prescription Refills" appearing in the November 1950 issue of the Food and Drug Cosmetic Law Journal published by Commerce Clearing House, Inc. Reprints of this article are available to the members of the committee.

This is the article that I have referred to and I am able to supply reprints if anyone would care to have a reprint made available to them. This concludes the prepared statement which I have.

Mr. HESELTON. Will you look at these two packages, 5A and 5B.. Will you comment on these? 5A does not have a cautionary label on it, and the other does.

Mr. CLUTTER. Exhibit 5A is a product made by

Mr. WOLVERTON. You need not mention the name; sir.

Mr. HESELTON. I excluded names in my question.

Mr. CLUTTER. One of the products, 5A, has the directions, adult does, one or two tables as directed by the physician, and exhibit 5B has the legend "Caution, to be dispensed only by or on the prescription of a physician."

As these two products sit on the druggist's shelf, he can tell by looking at the label that he can sell 5A over the counter, and he cannot sell 5B except under the prescription of a physician..

Mr. HESELTON. They are both the same product, are they not? Mr. CLUTTER. I presume they are, they are both methenamine. I think they are the same.

Mr. WOLVERTON. They were offered to the committee as being the

same.

Mr. CLUTTER. I think that they are the same product or practically the same product.

Now, the manufacturer of product 5A and its staff has decided that this product is of such a nature that under the law they can write adequate directions for use, and so they have so labeled it that way; but the manufacturer of the other product, product 5B, has apparently determined that they do not know how to write adequate directions for us and therefore they have put the caution legend on it.

Now I would like to point out first of all that there is no confusion as far as the durggist's concern goes, whether he can sell this product or not. That is which way he has to handle these products. There may be some confusion as to whether he can refill the prescription for the product that is labeled 5B, because it has a caution legend and this bill would eliminate that confusion. Perhaps one or the other product is misbranded.

It is so

Mr. WOLVERTON. Which one do you think is misbranded? Mr. CLUTTER. I don't know which one is misbranded. written in the regulation that any product which can bear adequate directions for use should bear adequate directions for use. All drugs, because of their dangerous character, that are not safe to sell over the counter should carry the caution legend.

Mr. HESELTON. Now, will you look at exhibits 11a and 11b. Apparently the same kind of a label is used on 11a as on 5a, and somewhat the same sort of a label on 11b as used on 5b. Is your argument or your explanation with reference to 5a and 5b the same in terms of 11a and 11b?

Mr. CLUTTER. Absolutely. Let me see, this is a larger package here. This is apparently the same thing.

Mr. HESELTON. Then if I understand you correctly, you suggested to us that the maker of 5a and 5b has sufficient experience and sufficient knowledge through an expert staff which the manufacturer of 11b and 5b does not have, so that the manufacturer of 5a and 11a can take more chances with its product being sold over the counter and the public is adequately protected.

Mr. CLUTTER. No, I don't know anything about the status of them. We have to look merely at the law and the law says that you must carry adequate directions for use if such directions can be written and apparently one drug house has determined in this case that they can be written. Now if that is true, and I don't know whether that is true--and I am not commenting upon that-but if it is true that adequate directions can be written, then the other product would violate the law whether they had a large staff or no staff, because it is the public we are thinking about and we want the public to have the drugs that comply with the law, and we are not thinking about the staffs.

Mr. HESELTON. Now, Mr. Clutter, will you look at these two, 3a and 3b. I notice they are to be used in cases of heart irregularities, so I assume that there is potential danger in their use unless under proper conditions. And I call attention to the fact that on 3a there is absolutely no precautionary label, while on 3b, and it is identically the same product. There is "caution, to be dispensed only by or on the prescription of a physician.' Can you explain why those two should be treated differently?

Mr. CLUTTER. The same facts are presented on all of these cases, that is true.

Mr. HESELTON. There is a difference between the label on 11a and the one on 3a, in that it says that the dose, one or two as prescribed by a physician, and there is at least the suspicion that they should be handled under a physician, while on the other one there is absolutely no notation.

Mr. CLUTTER. There is a direction for use, it says adult dosage here. Mr. HESELTON. What interests me, and without naming the manufacturer, you have one type of warning to the public or to the druggist or anyone using one of the products, and then it is put over on the side of the other one. Is there any reason for it?

Mr. CLUTTER. Well, it is a different size bottle. Some drugs come in very small bottles and you have to have certain things on the label and in this case there was room to put it all on the front, and in

84416-51——12

this case there was not room to put it on the front because it is a smaller bottle.

Mr. HESELTON. You are not going to argue that that cannot be put on that bottle, that the label on 11a could not be put on the front of 3a.

Mr. CLUTTER. Perhaps it could, but where the label is placed so long as it is conspicuous complies entirely with the law and there is nothing that violates pure food and drug law as far as the place where this direction is. As a matter of fact on a lot of aspirin tablets, I saw some last night in the drug store, it is on the back. You will find that the law provides that the direction must be stated and it must be conspicuous, but it does not say whether it has to be on the front or the back or where it has to be. They comply as far as the place is concerned.

Mr. HESELTON. That is all.

Mr. HALE. Did you hear the testimony of Mr. Harrop this morning? Mr. CLUTTER. Yes, I did.

Mr. HALE. He represents the American Drug Manufacturers Association.

Mr. CLUTTER. Yes, I heard that testimony.

Mr. HALE. Have you given any consideration to his proposed amendments to H. R. 3298?

Mr. CLUTTER. Yes, sir; I have. I have given them a lot of consideration.

Mr. HALE. Will you tell the committee what your opinion would be of the bill with the amendments suggested by Mr. Harrop?

Mr. CLUTTER. Yes, I feel that the amendments suggested by Mr. Harrop are in the nature of a compromise measure. Eli Lilly & Co. believes that this law does not need to be amended, that it is perfectly satisfactory the way it is at the present time. However, as some one mentioned this morning, the various groups of the drug industry have always been very close. We work together and we try to do the best job we can for the public. We generally get along pretty well. So Mr. Harrop and others have worked with this bill and in the nature of a compromise, and it goes further than we would like for it to go, but it doesn't provide the list which we are violently opposed to.

Mr. HALE. It does not do what?

Mr. CLUTTER. It does not allow the Food and Drug Administration to set up a list which we are very much against, so that as a compromise measure if the committee feels that something is necessary, we would much rather have the measure that Mr. Harrop suggested than the Durham bill in its present form. So that my answer, I suppose is yes, we are in favor of the measure Mr. Harrop suggested if something has to be enacted.

Mr. HALE. Eli Lilly & Co. is a member of the American Drug Manufacturers Association?

Mr. CLUTTER. That is right, and I, representing them, helped draw this amendment.

Mr. HALE. You helped draw the amendment suggested by Mr. Harrop?

Mr. CLUTTER. Yes, sir; that is right.

Mr. HALE. But as far as you personally are concerned and I take it as far as your company is concerned-you are happy with the law today, is that right?