In our opinion paragraph C of this section does not go far enough in formula disclosure. We would prefer to see this rewritten to require the disclosure on the label of all therapeutically active ingredients of all drugs. For the purpose of properly protecting the originator or discoverer of a drug, we believe that a statement of quantities of therapeutically active or other ingredients should not be required.

Senator COPELAND. I am not quite clear, myself, as to how far you are intending to go. Are you intending that there should be formula disclosure on all drugs?

Dr. JORDAN. Yes; of therapeutically active ingredients.
Senator COPELAND. All?

Dr. JORDAN. Yes.

Senator COPELAND. Not those that are necessarily habit-forming? Dr. JORDAN. Yes, sir; but the quantity is not given, in order to protect those who have originated preparations.

Section 8, paragraph D, lines 1 to 3: We are offering a suggestion there as to wording. We believe this statement will be improved by changing the article "a" in line 2 to "the" and the elimination in line 3 of the expression "if such there be ", so that this paragraph will read:

If it is not designated solely by a name recognized in an official compendium and its label fails to bear the common or usual name of the drug.

That is just a suggestion of wording.

In section 8, paragraph I, the question of antiseptics: We believe that it is a mistake to write into a law a specific test, because future investigation may prove the test to be false or inadequate, and better tests may be developed.. So far as we know, there has not yet been devised a satisfactory test for the so-called "antiseptics and germicides." We, therefore, recommend that further consideration be given to this section.

I am sorry to say, sir, that we have not a suggestion as to how it can be bettered. We are just raising some objections to the thing as it stands.

Senator COPELAND. May I say in that connection, if there is any one part of the bill which has had a tremendous amount of consideration, it is this. We know perfectly well that it is unscientific to classify in one list germicides, bactericides, and all the other "cides" that are included in this paragraph. We had long discussions and conferences with experts in this field. The final conclusion of the group that to me was particularly impressive was headed by Dr. Wright. He said that this was not satisfactory and Professor Prescott, from M.I.T., made the same statement. Yet this group appeared to be reasonably satisfied because the test methods could be carried, by section 22, to a scientific body, so that whatever faults appeared could be met.

There was at one time the thought that we would take a given germ, like the straphylococcus aureus and make the death of that germ the tests of the merits of a germicide. But, of course, with a growing science like bacteriology, you might have a definition which would not be standard 5 years from now or 10 years from now when there might be recorded five or six strains or types. One might be so resistant that it would be like the anthrax spot which

could not be killed. So, it was deemed wise to accept the phenol If you have a better test, we shall be glad to have it.

Dr. JORDAN. We question the advisability of writing a test into the law. I am frank to admit the difficulty there. Wouldn't it be well to leave that with regulation, rather than putting it into the body of the law?

Senator COPELAND. All testing methods for the purpose of this paragraph shall be prescribed by regulation. That is exactly what is done. You will find that at the bottom of page 14.

Dr. JORDAN. Evidently I overlooked that.

Senator COPELAND. Yes; you overlooked that, because that was the saving grace with Dr. Wright and the other men.

Dr. JORDAN. That can be interpreted to mean that legislation can change this test?

Senator COPELAND. Yes.

Dr. JORDAN. That was not quite clear to us.

Section 9, paragraph C: We are heartily in accord with any legislation which has for its objective the prohibition of the advertisement of drugs for diseases in which self-medication may be especially dangerous or contrary to the interest of public health. We believe that drugs should not be advertised for the treatment or cure of certain of the diseases named in this paragraph, but it is our opinion that this list should not include any diseases which cannot be specifically defined. We, therefore, suggest that this paragraph be given further study before it is finally written into law.

Senator COPELAND. Have you got additions to make or subtractions to suggest?

Dr. JORDAN. I am just raising this one question. What is blood poison? I think that term is used in there. Is that a specific disease?

The point I am raising there is that I think there are some diseases there which are not specific enough to be so included.

What page is that?

Senator COPELAND. That is on page 16.

Senator OVERTON. Second line.

The CHAIRMAN. I suppose that would mean septicemia.

Dr. JORDAN. That is the only think that would be included under blood poisoning. We thought that the term was rather general.

Senator COPELAND. That is the only one I think of. I would have no objection, personally, to changing it from blood poisoning to septicemia. A lot of this particular section we inherited, and it might be well to do that, to take out blood poison and put in septicemia.

Dr. JORDAN. Our suggestion was that that be given careful consideration by someone who knows. We are not pharmacologists and we cannot do that.

Senator COPELAND. That has been given a tremendous amount of consideration, that list.

Dr. JORDAN. I thought the words "blood poison" was rather poorly selected there.

Senator COPELAND. I think you are right.

Dr. JORDAN. In section 22, paragraph A, lines 7-11: Inasmuch as this Committee on Public Health is to advise with evidently I haven't the same thing you have

Senator COPELAND. B-1, you mean.

Dr. JORDAN. Inasmuch as this Committee on Public Health is to advise with the Secretary in the promulgation of regulations for the control of drugs and cosmetics, it is believed that it should be constituted as is the Committee on Food Standards, and that the groups most affected should be represented on the committee. Therefore, we recommend that the committee be composed of 2 members representing public health, 2 representing pharmacy, and 1 representing the Department of Agriculture.

Senator COPELAND. I do not like to comment, but this witness is so fair that may I say we have had experience in New York State where we have tried to have the members of the medical board of licensors named by the State medical society, that is, that the Governor should select a list of names, and the courts held that he was not under obligation to do that, that you could not require him to delegate his authority.

Dr. JORDAN. But you do that in the next clause.

Senator COPELAND. I do not know whether that would be wise or not. I thought we might trust the President to select such a group, and certainly your profession would be fully justified in making them feel that somebody from the pharmaceutical organization should be one of the representatives.

Dr. JORDAN. I think in your other committee on foods you make that distinction there.

The CHAIRMAN. In the following paragraph.

Senator COPELAND. Just as soon as you say that, the dentists will say they want a man, and the veterinarians will say they want a man. You know how it would go. You would have a list so great that you could not include all the groups in the selection of a committee of five.

Dr. JORDAN. Our experience has been that pharmacy has been very often left out when we think they should be represented. Senator COPELAND. It ought not to be.

Dr. JORDAN. Very frankly, that is our reason. I think I can point to cases where pharmacy has been left out. We want a representative from the pharmacists on that. We think they should be there. Senator MURPHY. You think that the bill does that in the paragraph designating how it shall be selected?

Dr. JORDAN. Thank you, gentlemen.

Senator COPELAND. I would not personally have the slightest objection to it, except that you would have a multiplicity of professions to deal with. We treated the pharmacopoeia pretty fairly, didn't we?

Dr. JORDAN. I think so. I have no complaint, sir.

The CHAIRMAN. I want to call Prof. Harry F. Smyth, of the University of Pennsylvania, Philadelphia.

STATEMENT OF PROF. H. F. SMITH, LABORATORY OF HYGIENE, UNIVERSITY OF PENNSYLVANIA, PHILADELPHIA, PA.

Prof. SMYTH. Mr. Chairman and Senators: I am appearing before you today in the interests of a group of manufacturers of materials designated in this bill under consideration, Senate 2800, as "germicides, bactericides, disinfectants, and antiseptics."

My purpose is to consider specifically section 8, (i) and (j), of the latest Copeland bill, Senate 2800.

Reviewing briefly the requirements of those paragraphs, section 8 (i) concerns itself with the above substances. It requires their labeling, if for use on or within the body, stating specific use or uses, strength or dilution for use, manner of application, and duration thereof.

These materials shall be tested by methods simulating as nearly as practicable the conditions of use.

They must have a germicidal effect, within the duration of such use, equal to that of 1 to 80 phenol in 10 minutes when tested by a standard method. This means that in the space of time that they are in contact with tissues, they shall, whether it be for a minute or less, or 30 minutes or more, kill all germs, not only all staphylococci but all other germs of any type.

We have mentioned the resistance of some of these organisms, germs, but have notes of all, and we know that resistances vary very, very greatly.

Section 8 (j) considers such materials for use specifically as “inhibitory antiseptics" in wet dressings, ointments, dusting powders, and so forth. The labels must state such use, giving strength or dilution, manner of application, and duration of the same.

The materials are to be tested by methods simulating as nearly as practicable the duration of application and other conditions, and they must prevent growth of microorganisms, or germs, as popularly called, and not stated whether of all germs or most or of what proportion, so presumably all is meant, within the entire time of such duration.

My objections to these provisions as written in the bill are various. The paragraphs as now worded are unscientific in that they do not and cannot set up a standard equivalent or equivalents, equivalent to the varied uses of the materials in practice, nor does it define all materials sufficiently. I object to the grouping of these four materials and using the same yardstick to measure germicides and bactericides, which, according to their names, must kill, with disinfectants and antiseptics, which, according to their names, need only be inhibitory of cell growth or even only of the production of harmful substances. Disinfectants render infective material noninfective, and antiseptics prevent sepsis or pus formation, the harmful action of the pus-forming organisms. Neither of them need kill, and neither may affect nonpathogenic organisms which may decompose dead materials and organic solutions, and so forth. Yet they are subject to the same measurements, the same yardsticks, as the germicides and bactericides, which must kill, according to their names. One strength of a material may kill while a weaker strength may merely inhibit, and an inhibitory substance need not kill in any dilution to meet the accepted definition of an antiseptic. A disinfectant or an antiseptic need not kill. A germicide or bactericide in weaker dilution is practically always antiseptic. Disinfectants in a stronger solution may kill, but your disinfectant and your antiseptic need not kill, according to the derivation of the name, if they prevent growth. In actual practice in the body, germicides rarely if ever kill all organisms, nor need they do so to be useful remedies.

Senator COPELAND. They kill those with which they come in contact?

Prof. SMYTH. Complete disinfection or germicidal action in vivo

The CHAIRMAN. Just a minute. Senator Copeland asked you a question.

Prof. SMYTH. I am a little hard of hearing. I am sorry. Senator COPELAND. They are to kill those with which they come in contact?

Prof. SMYTH. Yes.

Senator COPELAND. You are not expecting any more of them?

Prof. SMYTH. Antiseptics are supposed to inhibit the action of organisms with which they come in contact, but, according to the derivation of the word-my interpretation of it, at least-they need not kill those organisms. Their effect may remain as long as they are in contact with the organisms, but if that contact is broken up, if the contact has not been too long, the organisms may revive. That is possible even with bichloride of mercury, which is usually considered as a germicide. Bichloride of mercury acts on bacteria entering into chemical_combination, forming the so-called "albuminate of mercury." If that combination does not last too long, further chemical treatment may break that up, and your organism may still be alive, even though the material came intimately in

contact.

Complete disinfection or germicidal action in vivo is not necessary or always possible. Nature can and does care for comparatively heavy infections. It may be hindered rather than helped by relieving it of all responsibility; for example, as people grow in strength and resistance, and the body grows in its resistance to microorganisms by overcoming that resistance. To produce immediate death in the first application may prevent the development of desirable reactions, and that is the natural way for the body to recover and remain healthy after an infection, by the development of the immune reaction material, killing or inhibiting the majority of the organisms, and the infection, but not all may leave sufficient cells there to act as stimulators to the body cells to produce immune reaction to enable the body cells to overcome other invasions.

My point is that if we by the use of some materials kill all of the organisms at once, as may be required by the provisions of this bill, we may interfere with nature rather than help nature, so-called.

Again, it is impossible, with our present technique, to set up in vitro laboratory test conditions even simulating the conditions in open wounds with the presence of dead tissue shielding germs or buffering chemical action, and the continued diluting effect of secretions, let alone conditions in body cavities and deep sinuses, and yet the bill says that we must use tests testing by methods simulating as nearly as practicable the conditions of such use.

My point is that it is not practicable as yet. No standard tests have been developed that do approach these conditions.

Senator COPELAND. Doctor, read the rest of it.

Prof. SMYTH (reading):

Or, in the absence of such methods, when tested by a standard method, it does not have the germicidal effect within the duration so prescribed of a 1 to 80 dilution of phenol used by a standard testing method for 10 minutes at 37° Centigrade.