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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 byMr. WOLVERTON. You need not mention the name; sir. Mr. HESELTON. I excluded names in my question.
Mr. CLUTTER. One of the products, 5X, 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.
Mr. WOLVERTON. Which one do you think is misbranded?
Mr. CLUTTER. I don't know which one is misbranded. It is so 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 some
a what 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 ilb?
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 1la 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 ila 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
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 1la 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. 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?
Mr. CLUTTER. That is right. Mr. Hale. Do you think there is no necessity for any amendment of any kind?
Mr. CLUTTER. We think that that is right, there is no necessity for any amendment of any kind. I know that one group of the drug manufacturers feel that there is some confusion as far as prescription refills are concerned. I don't think we care to comment too much on that. That is a problem of the druggist more than it is of the manufacturer. The main thing we are against is giving the power to the Food and Drug Administration to classify our drugs.
Mr. HALE. What is your attitude about the oral prescription, about which so much has been said in these hearings?
Mr. CLUTTER. I think an oral prescription if properly safeguarded can serve a very useful purpose.
Mr. Hale. What do you mean when you say properly safeguarded? Mr. CLUTTER. Well, reduced to writing by the pharmacist. Mr. HALE. You mean if a pharmacist gets a prescription over the telephone from a physician, he ought to write it down as it comes in; is that what you mean?
Mr. CLUTTER. Reduce it to writing for his files, yes. That is either then, or right away afterward.
Mr. Hale. That does not give the patient any protection, does it? I can well see that it might give the pharmacist some protection.
Mr. CLUTTER. Of course it is the duty of the pharmacist, and his professional duty, to determine that the prescription is a bona fide one. If he has any doubts about it, why certainly I think he ought to check with the doctor where it came from. I don't propose or I am sure no reputable pharmacist would just dispense drugs indiscriminately to anybody that says "I am a doctor," and send over so many tablets of some drug.
Mr. Hale. At the present time, as I understand it, the oral prescription is definitely banned, is it not?
Mr. CLUTTER. That is the Food and Drug Administration's interpretation, that all prescriptions must be in writing.
Mr. HALE. Then, if you think that oral prescriptions properly safeguarded should be permitted, and they are not now permitted, then how ca you say that you are content with the present law?
Mr. CLUTTER. Well, I was thinking of it from the standpoint of the list problem more than I was this other. It is the labeling of the products and the list, and that problem rather than the refill problem was what I was thinking about. The Eli Lilly & Co. is content with the law as it is and the refill problem is a real problem with the pharmacist.
Mr. Hale. But it is not quite the same as the oral prescription problem, is it?
Mr. CLUTTER. That is tied up with it, the whole problem of prescription.
Mr. HALE. I wouldn't have thought it was.
Mr. CLUTTER. I wouldn't object to that, Mr. Hale. I will go along with that, and I will withdraw my statement and say that we have no objection to the law being amended to provide for that.
Mr. Hale. Then you will concede, will you not, that there are two problems, the oral prescription problem and the refill problem as to which the existing law leaves something to be desired?
Mr. CLUTTER. Yes, I will agree with that.
Mr. HALE. Now, I am not quite sure exactly what you mean by the brief paragraph on page 1 of your statement where you say that I. R. 3298 will amount to an abdication by Congress of its powers and the delegation of those powers to an administrative agency. I suppose you are referring to the Food and Drug Administration?
Mr. CLUTTER. Yes, sir. I meant by that that at the present time we have legislative standards, that if the drug is not labeled properly under a legislative standard the Food and Drug Administration can bring legal action against the manufacturers of that drug. If the law were changed, and H. R. 3298 were enacted, then Congres 3 would not be furnishing the standard, they would be telling the Food and Drug Administration, “You go and determine what drugs shall carry what labels."
Mr. HALE. I am not particularly familiar with the Food, Drug, and Cosmetics Act of 1938, but was not there considerable delegation of power to the Food and Drug Administration in that legislation?
Mr. CLUTTER. They were given the power to set up regulations under a legislative standard that a drug should not be misbranded or adulterated, and they have enforced these regulations of course under this law, this legislative standard. But H. R. 3298 would allow them to determine what drugs were toxic, too toxic or could not be efficaciously administered except under the prescription of a physician.
Mr. HALE. Your objection to 3298 is that the bill enlarges in your opinion unduly the discretion conferred on the Food and Drug Administration?
Mr. CLUTTER. That is right.
Mr. Hale. And even with the amendments suggested by the American Drug Manufacturers Association, you still think that that is true?
Mr. CLUTTER. No, I don't think it is true, I think it eliminates that objection. The standard is then a legislative standard.
Mr. HALE. Then, the amendments suggested by the Association completely eliminate your first objection to H. R. 3298.
Mr. CLUTTER. Yes, it eliminate it.
Mr. BEAMER. Mr. Chairman, I would like to ask Mr. Clutter just a few questions. I gathered that you, representing your company, would favor certain clarifications probably of the existing law, but you feel that this present H. R. 3298 might go a little too far, is that correct?
Mr. CLUTTER. We think it goes very much too far.
Mr. BEAMER. And then Mr. Harrop's suggestion would probably be a mild compromise, is that right?
Mr. CLUTTER. That is right. Mr. BEAMER. In other words, it might do something to clarify and still not give that undue authority to some one taking away from legislative authority? Mr. CLUTTER. That is right.
Mr. BEAMER. I think, Mr. Clutter, that I could help you answer Mr. Hale's question on the statement numbered 1 in your statement,