clerk, Mr. Layton, from Parke, Davis & Co. of Detroit; and further, that Parke, Davis & Co. may have permission to submit a statement for the record following the testimony of this witness.

The CHAIRMAN. That will be done.

Mr. PRIEST. You pointed out a short time ago that a list will be constantly out of date because of changing experience, and I think quite logically so. And near the last of your prepared statement you suggest that

* * * we urge that a legislative standard be created to classify the drugs that may be refilled without limit. Such a standard earnestly enforced will clear up this problem.

There may be no inconsistency in the position with reference to a list and a legislative standard, and it occurred to me that for the very same reasons that you advanced as to why a list would not be up to date, might also apply to writing into legislative form a standard such as you suggest, a standard to classify this. Would that be true or would it not?

Mr. HARROP. The standard to which I am referring, Mr. Priest, is the one that would substitute for section (b) (2). That would prevent the refill without the doctor's authority, of any drug which— because of its toxicity or other potentiality for harmful effect, or the method of its use or the collateral measures necessary to its use, is not generally recognized among experts qualified by scientific training and experience to evaluate the safety, as safe and efficacious for use except by or under the prescription of a practitioner licensed by law.

That is the standard by which you would measure any and every drug that came along. The standard wouldn't change, but the drugs. will keep changing all of the time. You will measure the drugs against the standard.

Mr. PRIEST. That was the point that I wanted clear in my mind, because I felt that there was a possibility there that the drugs would be changing, and experience today perhaps would not be the same as a week from now, and you might take them out of one category and place them in another. But the standard would remain the same, as you say.

Mr. HARROP. The standard would remain the same. It would be the measuring stick against which you would place every drug as it came along.

Mr. PRIEST. And you think the language that you suggest there would be a standard adequate to control the situation?

Mr. HARROP. I think it would. It is the standard that is now applicable in the regulations of the Food and Drug Administration. It is lifted bodily from the regulations under section 502 (f) (1). It is the standard that the Food and Drug has set up now to decide which drugs must be limited to prescription sale. I think it is adequate.

Mr. PRIEST. Well, just one further question. Would it likely develop, or could it develop, that maybe a court decision under such a standard might later become out of date because of experience that is developed subsequent to a particular court decision?

Mr. HARROP. I don't believe that the experience would alter the legislative standard as it might be interpreted by a court. You might have to again amend the law if an adverse decision came along, but I can't see where the legislative standard as interpreted by the

court could be modified by any scientific change. It might be indicated, but it wouldn't be modified.

Mr. PRIEST. In other words, any drug that has toxicity, as we call it, remains the same.

Mr. HARROP. Toxicity is a scientific standard of pharmacologic determination. It is the relation between the effective and the minimum and the lethal doses of a drug.

Mr. PRIEST. I believe that is all for the time being, Mr. Chairman. Mr. BECKWORTH. Will you state in brief words what this standard is that you consider adequate?

Mr. HARROP. If a drug can only safely and efficaciously be administered under a doctor's supervision, it may not be sold except on prescription, and that prescription may not be refilled without a physician's authority.

Mr. BECKWORTH. Now, what, as you understand it, is the primary argument that is advanced rather often against that standard?

Mr. HARROP. I don't know of any argument advanced against that standard, unless it is the question of how you are going to interpret the word "efficacy." I don't know of any dispute about the standard. It is a proper standard for a drug that should be administered under a physician's care.

Mr. BECKWORTH. And accepted as such by everybody?

Mr. HARROP. Yes.

Mr. BECKWORTH.. As Mr. Priest indicated, I think one of the most interesting points you made is the fact that as experience is gained with reference to a drug, it may be changed as far as the use that is allowed is concerned.

Mr. HARROP. That is quite true. You will start out with a new drug, which must be filed, under the law, under section 505, and the evidence that you have from the clinical studies that have been done will show that it is useful in the treatment, maybe, of three disease conditions; 5 years later you may have 15 or 20 disease conditions for which it is then known to be useful. The only way you can prove that is to try them and see whether it will produce good results. Then you may find ultimately that some of the toxic side effects of it, of which you were aware, prove to be worse in the long run than you expected they would, and you may have to put some drastic limitations on it.

Maybe it would be of some assistance, and I can give rough figures, but more than 50 percent of the drugs sold today were not on the market 10 years ago; they are new drugs. That is how fast the development of drugs has taken place.

Mr. BECKWORTH. It would almost become an impossibility, then, to keep them labeled up to date, would it?

Mr. HARROP. As far as a list is concerned; yes, sir. The label has to be up to date, but the label itself has to keep changing as you get newer and better knowledge of the drug.

Mr. BECKWORTH. But to keep every druggist apprised of the change in the listing would be quite some task, would it not?

Mr. HARROP. I think it would, sir.

Mr. BECKWORTH. Do you know what those who have different points of view to what you have expressed in that connection, say in answer to that criticism that you have advanced?

Mr. HARROP. The only argument I have heard for the list is based on the idea there is going to be a small list that the druggist can paste back of his prescription counter, and all he has to do is turn there and say, "No, it is on there, and I can't refill." If that were true, I would be for the list, too, but that isn't going to be true. He is going to have to paste a book on the counter that is about like the Washington telephone directory, and begin leafing through it. Then he is going to have to look at last week's supplement, and the supplement of the week before; unless they adopt the lawyers' method of using cumulative supplements to keep him from looking through 25 volumes, it is going to be very large, and it is going to be extended all of the time.

In the exhibits that Mr. Larrick put in yesterday, there were 11 exhibits, and if you will remember, those are the ones where the same drug is labeled by one manufacturer to be sold only on prescription, and the other one has directions. I asked Mr. Larrick if he would be willing to tell me the views of the Food and Drug Administrationand incidentally, those all hinge on the question of efficacy, and they are not dangerous drugs, per se. Of the 11 drugs that he put in in his exhibits, the Food and Drug Administration, if they had the power, would change 6 of those to a "Caution" or prescription limitation right now. I have great difficulty, myself, in making that fact reconcile itself with Mr. Larrick's statement that if this list were given to them, there would be fewer drugs on prescription than there are now. I just don't believe that, if I may be allowed to express the

doubt.

Mr. DOLLIVER. It is just at that point that I was very much interested, and I wish you would take these two exhibits here, and I cannot even pronounce the name of the drug.

Mr. HARROP. Maybe I can't, either.

Mr. DOLLIVER. Hyoscyamus; each of those bottles contains an identical tincture of that drug, is that correct?

Mr. HARROP. Yes, sir.

Mr. DOLLIVER. One is a prescription label and the other is not; is that true?

Mr. HARROP. No. These are both prescription labels, Mr. Dolliver, and I think the objection that Mr. Larrick has is the fact that the average dose is put on this one. The regulations say that if you use the prescription legend, you are not allowed to put anything of any character on there that would indicate dosage. You must put just the caution legend and nothing else. But these are both limited to prescription use.

Mr. DOLLIVER. One of them applies only to elderly patients, however, does it?

Mr. HARROP. I beg your pardon. I looked at the word "Caution," and didn't read it through. That is right. This one is Pilot Laboratories, and it is with directions, and this is with caution, and is made by Wyeth, Inc., of Philadelphia.

Mr. DOLLIVER. Now, maybe that is not confusing to somebody in the drug business, but it certainly is confusing to a layman such as I am. You have two identical drugs, one where the manufacturer says "Should be dispensed only with a physician's prescription," and the other says "It can be sold over the counter without prescription." Now, if we are talking about protecting the consumer, it seems to me that there is an area of confusion which ought to be cleared up by this legislation.

Thank you, Mr. Beckworth.

Mr. HARROP. Would you like me to comment on that?

Mr. BECKWORTH. Let him comment on that, because that is something I was pursuing yesterday, and I did not quite comprehend the answers received.

Mr. HARROP. Either one or the other of those drugs is in violation of the present law. That really hasn't got anything to do with H. R. 3298. It is under the present Food, Drug, and Cosmetic Act. Either one or the other of those products is misbranded, and should be proceeded against.

There always are going to be people-and I don't care what kind of a law you write-there are going to be people violating it. I am not going to express an opinion as to which one is misbranded, but one or the other of them is misbranded. They can't both be right.

Mr. DOLLIVER. This is not a prosecutory investigation, and we are not interested in finding that out; but I am glad to have that comment. Now, would you say that that would apply in each instance in which there is that disparity in the labels?

Mr. HARROP. Yes, sir.

Mr. HESELTON. Would you yield for one question on this?
Mr. BECKWORTH. All right.

Mr. HESELTON. I notice that prominently placed on one bottle is the word "Poison," and an antidote is given. On the other one there is no mention of it. Can you account for the difference there?

Mr. HARROP. I can only say that the question of what is a poison. is one of the most perplexing and confused questions that there is in pharmacy today. Nobody has been able to define a poison satisfactorily. They have been trying for 30 years to do it. Hence, you will find all sorts of statements on it. It is not regulated by any law, with the exception of one or two State laws. California has the most elaborate poison law. Each State that has a poison law has different standards. The usual practice among the better manufacturers is to take a rather toxic preparation and put "Poison" on it as a warning. Some put an antidote on and some do not.

Mr. BECKWORTH. What do you feel would be the most forward step that could be taken to remove the confusion that would characterize some member of the public in accordance with what has been brought out by Mr. Dolliver a moment ago?

Mr. HARROP. Well, the member of the public shouldn't be able to buy a thing like that. I believe that the Food and Drug Administration deserves a very high tribute for the work they have done educationally in the last 2 years. I think if you will go in drug stores throughout the length and breadth of this land today, you will find in a great many of them signs near the prescription counter, "Please do not ask your druggist to violate a Federal law by selling you a prescription item without a prescription." They were not aware of it and the druggists generally were not aware of that requirement of law until this educational campaign was undertaken. Today they are very much aware of it, and I think that the public is becoming brought aware of it.

Mr. BECKWORTH. One more question. Back to the list that you were talking about, do you foresee less protection for the public because of, we will say, lack of an up-to-date list being in a given drug store, or carelessness that might attend the keeping up to date of

that list-do you see the possibility for more harm to the public than exists today because of that kind of a situation?

Mr. HARROP. Mr. Beckworth, I think I do. One of the difficulties that I foresee with a list is where the druggist has his list back of the counter, and he has this product-let us assume that this is a new drug that he received on Monday of this week, and it is a toxic drug, and it has a caution legend on it, and he has a prescription for it. The question of refilling comes up. He looks on his list. Of course it isn't on the list-he just got it Monday, and the list is a week old and this new drug is only a day old. He goes ahead and refills that. He is violating the law. You haven't kept him out of law violation. You have given him a sort of phony guide because you have given him a feeling of assurance of protection, but he hasn't got it at all.

Mr. BECKWORTH. That is what I am talking about; and proposed protection, if accompanied by carelessness, might even be injurious to the patient, because the druggist would be looking at one list as his main standard, whereas he might perhaps get careless in regard to secondary standards.

Mr. HARROP. There really shouldn't be any substitute for the careful reading of the label on a drug at any time. There are no tricks, and no devices, and no colors or any shaped bottles (people from time to time want you to put out a bottle shaped this way for one drug and shaped another way for the other drug) that will serve. There is only one way to keep drugs straight, and that is to carefully read the label, because you have to print a lot of very useful information on there. for them.

Mr. BECKWORTH. I was interested in your comment along that line, and it is not a conclusion that I have reached, but I simply wanted to get what your thinking is.

That is all, Mr. Chairman.

Mr. HALE. Returning, if you please, Mr. Harrop, to these two bottles of Hyoscyamus tincture, would you say one of them is misbranded there? Now, one bottle bears a "Caution" in red ink, and below that in red ink the word "Poison," and below that in red ink "Antidotes," and some further reading matter.

Bottle B simply bears a "Caution" in red ink, and you say one of them is misbranded. Must not the misbranding be in bottle B? Mr. HARROP. May I look at the exhibits?

Mr. HALE. Yes.

Mr. HARROP. I think bottle B is the one misbranded; yes, sir. Mr. HALE. In other words, it cannot be misbranding to be a little overcautious, can it?

Mr. HARROP. That preparation should not be sold except on prescription, and the one that can be sold across the counter is, in my opinion, misbranded.

Mr. HALE. What is that again, please?

Mr. HARROP. That preparation is so toxic that it should not be sold except on prescription, and the one that can be sold across the counter, your product "B," is misbranded because it is so labeled. I am expressing my professional views now.

Mr. HALE. Of course, a cautious and honorable pharmacist might not sell bottle B without a prescription, despite the fact that there is not anything on the label to that effect, is that not true?