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between one of them having either full directions or partial directions, and the other having the prescription legend, that to litigate all of that on a case-to-case basis, making each one of them a separate lawsuit, would take us 10 or 15 years. That is the whole purpose
Mr. WOLVERTON. Do you know whether the different methods which the different companies have in dealing with the same drug are based upon a difference in sales policy?
Mr. LARRICK. I have an opinion on that which I would be glad to state, and that opinion is based on having read, over the years, the comments which drug firms have made to us at various times about these regulations. There are many fine drug firms in this country who historically and from a business standpoint cater to physicians, and their principal business and their outlets and their sales drive and all of their business outlet is to promote sales to doctors.
Now, many doctors don't think well of self-medication, so in my opinion, those firms who are seeking to maintain the highest standing with the medical profession do everything that they can to convince the doctor that they are preparing drugs for the doctor and that they don't want to prepare them for self-medication.
Now, there are other firms whose sales set-up and whose organization and plans are quite the reverse, and they, too, are fine firms, but they aren't set up commercially to get business from the doctor. They are trying to deal with the general public, and so they label their merchandise in a manner that is most likely to catch and keep that business. And I think that the two commercial approaches condition the thinking of those people to some extent.
Mr. WOLVERTON. During the hearings, I have made some inquiry as to whether the medical associations will be represented here by witnesses, and I have been told that they would not. That rather surprises me, in a matter that so directly concerns the medical profession, and I would assume that they had some opinions on these controversial matters that appear here. The druggists are represented by their association, and the manufacturers by their representatives, and you appear on behalf of the Department. It seems to me that there is a link that is missing when the physicians themselves do not come in here and express some opinions.
Do you know any reason why that should be? Mr. LARRICK. I can explain it in part, Mr. Wolverton, I believe. This is, of course, a highly involved, technical question, so when the American Medical Association undertook to consider it, my understanding is that it delegated the initial responsibility for the inquiry to the Council on Pharmacy and Chemistry of the American Medical Association, which is made up of a group of scientists. That council invited before it representatives of the American Drug Manufacturers, the American Pharmaceutical Manufacturers, the National Association of Retail Druggists, the American Pharmaceutical Association, the Food and Drug Administration, and perhaps others, and these representatives of these different groups made their statements and stated their respective viewpoints.
Well, the council is an organization that doesn't sit continuously, and I understand that it considered the problem by mail, and I understand that some weeks ago it came to a conclu ion and made a recommendation. But the officer of the council to whom I spoke said that in the protocol and the procedure of the American Medical Association on a matter affecting legislation, the Council on Pharmacy and Chemistry of necessity had to make its report to the legislative committee, and that a report was made to the legislative committee, and he did not advise me what the report was, but said that it is now pending before the legislative committee.
I do not think that there is any reluctance on the part of the doctors to appear, and I think it is more the cumbersome machinery that is perhaps necessary in a large organization to go through the formal proceedings that they do go through before they pass on a bill.
Mr. WOLVERTON. Would this legislation increase the necessity of obtaining prescriptions?
Mr. LARRICK. My own view is that it would not. If you get a prescription today for some pose drops, you will use up that first prescription for those drops and probably you won't know what is in it. If
you did know what is in it and if you wrote it down and translated it into language that lay people can understand, probably you could walk back to the drug store and call for it by a brand name. But you wouldn't do that, probably. You would go back and you would get your prescription refilled; and every time you got it refilled you would take the prescription back, and you would never call for it by its advertised name.
Now, in my opinion, the ultimate effect of this list would be to require directions for use on many items which now bear the prescription legend. I can't see into the future with enough certainty to know precisely what would happen, but I do not agree or believe, as Mr. Dunn appears to believe, that the net effect of this would be to increase prescription practice. I have in my pocket a letter that we just received. One of the large chain drug stores has written to a lot of its doctor-customers about the changes in prescription practice that are being brought about by more enforcement of this law, and the conversation before this committee, and what not. It asks the doctors' opinion of putting on each prescription form a little box, down in the left-hand corner, which will say,
Refill zero times, (blank) 1 time (blank), 2 times (blank), for your convenience in indicating your wishes, and we comply with these instructions.
The letter adds
If a refill is not indicated and we are requested to refill a prescription, we must contact you, preferably by telephone, and we will refill the prescription or not, as directed.
In other words, here is a big drug chain trying to fit into this picture and trying to make it easy for the patient and easy for the doctor, and if the doctor anticipates when he gives the prescription that it should be refilled three times, he writes that on the prescription. And from our standpoint, under this bill and under the present law, that would be quite all right.
On the other hand, if the doctor doesn't write it down and the patient comes back to the drug store, this chain doesn't send him back to the doctor for a new prescription. The pharmacist picks up the telephone and asks the doctor if it is all right to refill it. And under this bill that you have before you, that would be legal; under the law now it is illegal. We haven't brought any cases on it but it is illegal.
I honestly think that this bill would accomplish the objective that you so succinctly stated this morning when you said that you wanted à bill which will protect the public health fully, but which will not unnecessarily burden the patient and will not unnecessarily add to the cost of his medical care.
To some extent, that is a matter of opinion, but that is our honest view.
Mr. WOLVERTON. Has any effort been made to iron out these differences with reference to these controversial matters between the manufacturer and the druggist, as to labeling, and so forth? Do you know whether it would be possible to come to some decision that would make it a matter less complicated than it would seem to us, as laymen, on the committee.
Mr. LARRICK. I should like to preface this statement by saying that, by and large, the relationships between industry, retail pharmacists, and the Food and Drug Administration, are quite cordial. Many of the men in this room who will take a position quite contrary to the position that we have taken here have been on a first-name basis with us for many years.
I do not believe that, so long as the lawyers who represent these firms honestly and conscientiously entertain a forthrightly different view from ours about what this law requires, that we can get together in a satisfactory way, sir.
Mr. WOLVERTON. I did not hear your last few words.
Mr. LARRICK. I say, I don't believe that under those circumstances we can—and I don't want to say it is impossible, because we have solved many, many difficult problems before—but we have been working with this problem now, in one way or another, since 1938, and we have not reached a satisfactory solution yet.
Mr. WOLVERTON. Well, looking at this from a layman-purchaserpatient standpoint, and seeing these different exhibits that you have put here in duplicate, marked “A and B,” where one requires a prescription and the other does not, it would seem to me that it cannot be based upon danger to the patient.
Mr. LARRICK. It isn't based exclusively upon that.
Mr. WOLVERTON. Or that there is a difference of opinion in that respect. Then it would seem to me to be a matter for the Department to act and require the prescription.
Mr. LARRICK. This bill would really facilitate that. And as it is now, it would take us 10 to 15 years in case-by-case litigation.
Mr. WOLVERTON. How will the bill help that, and what is the provision in the bill that would meet that situation?
Mr. LARRICK. The bill would permit this: Here is the way I would visualize the list would work. We would start out at the beginning, and we would obviously have to allow some time in the bill for the manufacturers to make a change-over from the old practice to the new; and then we would take a list of the drugs that are the most clean-cut from the standpoint of the fact that they should not be distributed otherwise than on prescription, and we would start with that list and we would try to get a list that would be as noncontroversial as we could, and make it as small as necessary to accomplish that objective, and get that list on the records and in the regulations.
Then we would take the next batch of drugs, and work our way progressively, as our facilities would permit, down to that area where there is a genuine right to honest differences of opinion about whether it should go one way or whether it should go the other way.
Our thinking is that considering the legislative history of the Food, Drug, and Cosmetic Act, and the many references in this statute to the fact that the Congress does not wish to outlaw self-medication, but does want to make self-medication safe and effective, that we, in making this list, should always bear in mind that the Congress has instructed us not to unnecessarily restrict self-medication.
Mr. WOLVERTON. Then this bill does not seek to give you the authority to direct a manufacturer to place upon it a label that would indicate that a prescription was not necessary?
Mr. LARRICK. I am not sure that I get that, Congressman.
Mr. WOLVERTON. Having in mind in these exhibits that you have given to us that in each case you have given us two cases, one, where for the same drug a prescription is required, and the other where, for the same drug, a prescription is not required based upon the statement that is contained on the label.
Mr. LARRICK. That is right.
Mr. WOLVERTON. Now, is there anything in this bill that would give the Department the authority to direct the manufacturer not to place a legend upon the bottle that requires a prescription, when you know that a prescription is not necessary?
Mr. LARRICK. This bill would leave intact the requirement of section 502 (f) (1) of the Food, Drug, and Cosmetic Act, which says that à drug is misbranded if its label fails to bear adequate directions
Now, this bill would only take out of the class that must have that complete label, the drugs that are unsafe for self-medication or cannot be used effectively for self-medication without medical supervision.
Mr. WOLVERTON. So that, in these exhibits that you have given to us, you would have authority under the bill to call them misbranded, when they require a prescription?
Mr. LARRICK. That is right; after going through the formal procedure and the lapse of time for an appeal to the courts, and that sort of thing, we would have the power to do a direct job on it.
Mr. WOLVERTON. Naturally, the thought that I had in mind is that the question of medication has become one of major proportions from the standpoint of expense; and it seems to me to be unfair to be permitting labeling that would indicate that you had to have a physician's prescription when, as a matter of fact, you know it is not necessary.
Mr. LARRICK. We agree with that 100 percent. I have four children, and I have to pay all of their doctor bills and buy all of their medicine.
The only drugs that would have the prescription legend on them would be those that are on the list.
Mr. WOLVERTON. Would be what?
Mr. LARRICK. Would be those that were on the list and which had, after a hearing, been determined to require a prescription.
Mr. STANLEY. Mr. Chairman.
Mr. STANLEY. I would like to ask this question: Since the doctors have not been heard from or have not been requested to be heard from, do you think it would be wise to postpone action on the part of the committee until they may be given further opportunity to be heard?
Mr. LARRICK. Mr. Stanley, I would leave that entirely to the committee.
Mr. STANLEY. Do you have any feeling as to whether or not they would like to be heard?
I do not believe they høve made a request, as I recall, Mr. Chairman, to be heard. No request has been made on the part of the doctors.
Mr. LARRICK. Mr. Waller tells me that he has had some conversations with executives of the American Medical Associations, and he may be able to answer that question. I think that they want to be beard, and I think that the only reason they are not represented here is that their organization is big and the bill hasn't been reviewed by their legislative committee.
Mr. STANLEY. I might say that I haven't heard anything from the American Medical Association of my State as to whether they do or do not. I just have not heard from them.
The CHAIRMAN. I have the information that they received the same notices that all of these other groups have had. I also understand that they have a representative in the room as an official or unofficial representative. Mr. STANLEY. So they have had an opportunity to be heard. The CHAIRMAN. Yes. Mr. STANLEY. That is all, Mr. Chairman. The CHAIRMAN. Mr. Mack? Mr. Mack. No questions, Mr. Chairman.
Mr. Wolverton. Would it be possible, Mr. Chairman, to inquire from the representative of the American Medical Association who is present as to when we may expect there will be a report made by the legislative committee and when it will be acted upon by the American Medical Association or when it will be possible to have the benefit of their advice? Will the gentleman who is present, if he is not too modest, please stand up and acknowledge his presence.
The CLERK. He is not here this afternoon, although he was here this morning.
Mr. HESELTON. Mr. Chairman.
Mr. HESELTON. Mr. Larrick, possibly this is not a question that should be directed to you, but I noticed on page 4 of your statement that you seem to indicate that you are in favor of having prescriptions given by telephone or orally.
Mr. LARRICK. But confirmed in writing:
Mr. HESELTON. Yes, confirmed in writing. Am I correct about that?
Mr. LARRICK. Yes, sir; that is right.
Mr. HESELTON. When that question first arose, I believe there was some provision by the United States Public Health Service for treatment at sea by means of radio instructions, even including directions for operations. What is that requirement, if any, if you know?