I am a lawyer, and therefore I can criticize my own profession. It is our business. But it is what the industry is doing that counts and the industry has all of these drugs labeled with the caution legend.

Now, in this field of efficaciousness, and whether a harmless drug should be kept from being available to the public at large on the theory that, since they don't know what is wrong with them, they can't possibly administer it to themselves efficaciously, you are getting into a very speculative field. It is just as dangerous to the public one way as it is the other. Because you may deny the public some very proper medication on the theory that they don't know what is wrong with them. And yet, I will have to admit that I am very much nonplused and perplexed as to what a doctor's prescription does to make, let us say, aluminum hydroxide jell effective. The drug is exactly the same, and it will counteract acidity in the stomach when you take it, and it probably will do just as much counteracting without the doctor's prescription as it will with it.

However, if you are talking about a drug that is dangerous, that may injure the patient, there isn't any difference of opinion at all. If there is any question of safety, we would rather lean over backward and say don't let him have it without the doctor's permission. But where it is not toxic, and you are talking about the theoretical possibility of masking symptoms, for example, you are getting out to the limits where you may put everything on a doctor's prescription and have nothing available for sale over the counter.

I think, in closing, that we would like to summarize by saying that it seems to us that this calls for a proper compromise. That is what we are trying to propose here. We are giving up something that we are a little doubtful about, in fact quite doubtful, and that is that word "efficacy," hoping we could propose something that would be acceptable to this committee and would satisfy pharmacy at large and would serve the public, because really, it is not what we want or what the retail pharmacists want; it is what the public should have that should guide this bill. In those interests we think we should give up on the word "efficacy," here, and we think that the National Association of Retail Druggists should give up on their idea of a list. It is going to work out the same way, anyway. There are a lot of objections to the list from an administrative standpoint; but we think both parties should give up something, because the public has got to be protected, and they have got to be able to buy these drugs on proper refills and not have to keep going back to the physician. He doesn't want to be bothered. He doesn't want people calling him up, druggists or patients, all times of the day and night to get permission to refill a prescription that could have been bought across the counter in the first instance.

Thank you.

(The list of members of the American Drug Manufacturers Association follows:)

MEMBERS OF THE AMERICAN DRUG MANUFACTURERS ASSOCIATION

Abbott Laboratories, North Chicago, Ill.

The Armour Laboratories, Armour & Co., Chicago, Ill.

J. T. Baker Chemical Co., Phillipsburg, N. J.

Bauer & Black, division, The Kendall Co., Chicago, Ill.
E. Bilhuber, Inc., Orange, N. J.

Bristol Laboratories, Inc., New York, N. Y.

Buffington's, Inc., Worcester, Mass.

Burroughs Wellcome & Co. (U. S. A.), Inc., Tuckahoe, N. Y.

W. J. Bush & Co., Inc., New York, N. Y.

Calco Chemical Division, American Cyanamid Co., Bound Brook, N. J.

G. W. Carnrick Co., Newark, N. J.

Chilcott Laboratories, division, The Maltine Co., Morris Plains, N. J.

Ciba Pharmaceutical Products, Inc., Summit, N. J.

Citro Chemical Co. of America, Maywood, N. J.

Cole Chemical Co., St. Louis, Mo.

Commercial Solvents Corp., Terre Haute, Ind.

Cutter Laboratories, Berkeley, Calif.

Davies, Rose & Co., Ltd., Boston 18, Mass.

Difco Laboratories, Inc., Detroit 1, Mich.

Distillation Products Industries, Division, Eastman Kodak Co., Rochester 3,

N. Y.

The Dow Chemical Co., Midland, Mich.

Fritzsche Bros., Inc., New York 11, N. Y.

Gelatin Products Division, R. P. Scherer Corp., Detroit 13, Mich.

Heyden Chemical Corp., New York 1, N. Y.

Hoffmann-La Roche, Inc., Nutley 10, N. J.

Hyland Laboratories, Los Angeles 27, Calif.

Hynson, Westcott & Dunning, Inc., Baltimore, 1, Md.

Mead Johnson & Co., Evansville 21, Ind.

Johnson & Johnson, New Brunswick, N. J.

Lakeside Laboratories, Inc., Milwaukee 1, Wis.

Lederle Laboratories Division, American Cyanamid Co., New York 20, N. Y. Eli Lilly & Co., Indianapolis 6, Ind.

Lloyd Brothers, Pharmacists, Inc., Cincinnati 3, Ohio.

Lloyd & Dabney Co., Inc., Cincinnati 2, Ohio.

Magnus, Mabee & Reynard, Inc., New York 13, N. Y.

Mallinckrodt Chemical Works, St. Louis 7, Mo.
Maltbie Laboratories, Newark 2, N. J.
Maywood Chemical Works, Maywood, N. J.
McNeil Laboratories, Inc., Philadelphia 32, Pa.
Merck & Co., Inc., Rahway, N. J.

The Wm. S. Merrell Co., Cincinnati 15, Ohio.
Monsanto Chemical Co., St. Louis 4, Mo.

The National Drug Co., Philadelphia 44, Pa.

The New York Quinine & Chemical Works, Inc., Brooklyn 11, N. Y.
The Norwich Pharmacal Co., Norwich, N. Y.

Parke, Davis & Co., Detroit 32, Mich.

The E. L. Patch Co., Stoneham 80, Mass.

S. B. Penick & Co., New York 7, N. Y.

Chas. Pfizer & Co., Inc., Brooklyn 6, N. Y.

Pitman-Moore Co., Division, Allied Laboratories, Inc., Indianapolis 6, Ind.
Reed & Carnrick, Jersey City, N. J.

G. D. Searle & Co., Chicago 80, Ill.

Sharp & Dohme, Inc., Philadelphia 1, Pa.

Sherman Laboratories, Detroit 15, Mich.

Smith, Kline and French Laboratories, Philadelphia 1, Pa.

Carroll Dunham Smith Pharmacal Co., New Brunswick, N. J.

E. R. Squibb & Sons, New York 22, N. Y.

R. J. Strasenburgh Co., Rochester 4, N. Y.

Tailby-Nason Co., Cambridge 42, Mass.
The Upjohn Co., Kalamazoo 99, Mich.

Valentine Co., Inc., Richmond 9, Va.

Henry K. Wampole & Co., Inc., Philadelphia 23, Pa.

Warner-Hudnut, Inc., New York 11, N. Y.

White Laboratories, Inc., Newark 7, N. J.

The Wilson Laboratories, Division, Wilson & Co., Inc., Chicago 9, Ill.
Winthrop-Stearns, Inc., New York 18, N. Y.

The Zemmer Co., Inc., Pittsburgh 13, WM

Mr. BENNETT. I merely would like to ask permission to have inserted in the record, following the testimony of the present witness, a copy of a telegram which I received this morning, addressed to the

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.