mation. I would not like to do that. I cannot estimate it. It would be an immense sum of money-I think several millions of dollars.

Senator OVERTON. All throughout the United States?

Mr. MILLER. Yes, sir. I think so.

Senator OVERTON. That is not very much these days.

Mr. MILLER. There is a feature of that, that I want to discuss with you. There have been different recommendations on that. It has been recommended that it be 18 months. I recommend that you give consideration to this thought. Any food which has been prepared under the present law, which, when this law becomes effective, has been prepared and is legal under that law, and any label which is applied to such food and was a legal label when it was applied, should not be restricted in interstate commerce at all. Why should it be? If it is legal under the present law, it is good, wholesome food. If the label is legal under the present law, it does not misrepresent the product. If the label is illegal, we have no recommendation for it, and we have no recommendation for any product that has been illegally prepared. We want nothing, we want no favors, but I submit to you, as reasonable men of experience, as reasonable people, whether we are not correct in that position.

Senator OVERTON. Well, I think you are pitching your objection on firmer ground now, provided there is very much food that will still be on the market 6 months after the time of the enactment of this bill.

Mr. MILLER. Well, there will be many, many millions of dollars of it.

Now, just let me cite you an example. You take the principle industries in this country, in the food line. They are reliable people, and they are placing their products in the hands of distributors every day, and they will continue to do so until this bill becomes a law. Those products will go out in car lots. The distributors cannot turn around and dispose of them, except when there is a consumption demand. What are they going to do with them under this bill? I say that if they are legal now, they should be forever legal until they go into interstate commerce and are consumed. If there is any question about the legality of the goods or of the label we want no favors for them, however; but how will the distributors of goods, who kept them from the packers and the manufacturers today and up until this bill becomes a law-how are they going to handle the goods, in six months? They cannot do it in a year, and they cannot do it in two years. We know that there will be a lot of them left on hand, and under this bill they will be criminally liable for disposing of those goods and we beg of you to give that feature of this matter most careful and, as we know you will, candid consideration. That is all we ask. This thing of putting in a 6 months' clause here, we regard as a great mistake, good intention, but a great mistake, and a year would be a great mistake, and 18 months would be a great mistake, because the people cannot handle these goods, and cannot dispose of them except as there is a demand for them. Then what are they going to do with them? The safe plan is to adopt a straight course and say that if these

goods are wholesome and if they are legal under the law of 1906, the present law, if the labels are legal, no objections should be raised to the going into interstate commerce at any time. I thank you for your attention.

The CHAIRMAN. All right, sir.

Mr. MILLER. Mr. Chairman, I may desire, on behalf of the people whom I represent, to file a brief, if that is agreeable to the committee. The CHAIRMAN. Entirely, so; yes.

Mr. MILLER. I also desire to suggest the following amendment: "Amend paragraph (a), section 25, page 38, by inserting, after the word "approval" in line 9, the following words:

"Provided that foods and labels for the same prepared prior to the approval of this act which comply with all the provisions of the Federal Food and Drugs Act, approved June 30, 1906, when such labels are affixed to the containers of said foods, may continue to be transported in interstate commerce."

The CHAIRMAN. Dr. Cook.


Dr. Cook. Mr. Chairman and members of the committee, I have listened to the proceedings here up to this time and throughout the previous discussions of the food and drug bill S. 1944, and have not personally participated, thinking that probably it would not be necessary or desirable; but as the hearings have proceeded it would seem desirable that someone should speak for the Pharmacopoeia. Every bill which is before this committee and the Congress has included the United States Pharmacopoeia as one of the books of standards. There would seem to be no question on the part of the Congress or those who were interested in drug legislation, including the officers of the Food and Drug Administration, concerning the suitability of the Pharmacopoeia for maintaining this very important, very unique position in the establishment of drug standards. That, in itself, I think, is evidence of the position which the Parmacopoeia has established for itself and maintained through 115 years of service to this country.

For that reason, it might seem unnecessary for me to speak for the Pharmacopoeia at this time, simply have it accepted as the contribution of an altruistic, highly professional group, serving this country and the consumer in a very remarkable way. When this book was established to serve the community, or more exactly the consumer, it must be remembered that it was not the ordinary consumer but the sick, a special class of consumers, who should have the utmost consideration. For its entire history of over a century its record is such that it receives nothing but respect and commendation. Its purpose has always been to establish uniformity in the quality, purity, and the strength or potency of medicines; that the patient may always obtain the therapeutic action which was intended by the physician.

That the pharmacopoeial standards should meet this purpose fully, there has been called, every decennial year, in the city of Washington, what is known as the "pharmacopoeial convention."


To this pharmacopoeial convention are invited, on a volunteer basis, without expenses paid, representatives of the medical groups connected with the Government of the United States-the Surgeons General of the Army, Navy, and the Public Health Service.

The officers of the Food and Drug Administration of the Department of Agriculture are also invited to send delegates, and have participated in the convention since its establishment. Also the Bureau of Standards. In addition to this, the medical profession is invited to send delegates from many organized bodies, including national associations, such as the American Medical Association, and in addition the State associations and the colleges of medicine. The scientific and professional pharmaceutical groups are also invited to send delegates from the national associations, from the State associations, and from the colleges of pharmacy.

This convention, meeting in Washington on the decennial year, constitutes a group of from 500 to 700 delegates who discuss the basic principles upon which to establish the foundation for the new revision of the Pharmacopoeia, and select a board of trustees to handle the business and a committee of revision, to handle the technical side of the revision. The members so selected serve for 10 years, on a volunteer basis, with the exception that their expenses are paid when called into conference and the chairman is paid a salary. Research work is also paid from the treasury of the convention. The Government has at no time contributed directly towards the support of this group, but it has given its service freely and continuously through the Food and Drug Administration, the National Institute of Health, and the Bureau of Standards.

This Pharmacopoeial Board and Revision Committee includes many of the most eminent medical men of the United States, also representatives of the Government, and representatives of the pharmaceutical profession, and it is considered a distinct honor to be permitted to serve in this capacity. Many scientific and professional men devote years of service to this cause without pay, loaning the facilities of their laboratories, the help of their assistants, and extensive personal participation to perfect the revision.

I particularly wish to speak of the provision of this bill which calls for cooperation with the Secretary of Agriculture and the officers of the Government who are entrusted with the enforcement of this act.

The Pharmacopoeia endeavored to do for medicine and pharmacy the very service which this bill establishes, long before there was a Food and Drugs Act, in fact, for over 80 years. The book was first published in 1820. It is true it did not have legal authority to enforce its provisions, but there was a wide volunteer compliance with its standards, and the physicians and pharmaceutical organizations of the country accepted it as the standard for medicine in the United States.

When the Food and Drugs Act was proposed, the pharmacopoeia group supported it and was one of the groups actively assisting Dr. Wiley in the securing of the present act. Since the Pharmacopoeia was already well established, it was accepted in the Food and Drugs Act by the Congress as the basis for the medical standards in the United States, Insofar as they are covered by the Pharma


copoeia. I might say that the Pharmacopoeia takes precedence over all other standards in that its committee of physicians select those medicines which, in their opinion, are the most important, in each decade, for the treatment of disease. There must be necessarily a selection, as some new drugs become available and should be added, while some older drugs become obsolete and should be omitted. the enforcement of the Food and Drug Act is in charge of the officials of the Food and Drug Administration, there has, of necessity, come about a very close relationship between the pharmacopoeial committee of revision and the officers of this department.


The fact that for 28 years these officers have worked with the revision committee and that they have approved the inclusion of the Pharmacopoeia as one of the standards recognized by the law is an indication that the revision committee has established its integrity and its high ideals and equally its efficiency.

The new provision herein, that the Secretary, through the advice no doubt of his technical assistants, should establish tests, if necessary, should they not be found in the Pharmacopoeia is a provision with which I personally have entire sympathy. I do not see, through my cooperation for a number of years with the officers of the Department, that this will in any way lessen the efficiency of the Pharmacopoeia. The primary object of the Pharmacopoeia is to select the medicines which, in the opinion of the committee, are of primary importance in the treatment of disease. Some, of course, are not available, as they are recently patented or controlled by trademarks, but as these patents expire, then the Pharmacopoeia, if the medicine justifies it, will recognize such products. The drugs recognized in the Pharmacopoeia represent from 70 to 80 percent of the medicines prescribed by physicians in the United States today, as has been demonstrated by repeated investigations. In the establishment of the standards of these medicines, it is perfectly obvious that scientific development and changes in conditions necessitate the changes in the standards and even in the additions of new medicines to the Pharmacopoeia. Therefore, it is perfectly proper that there should be a recognition of the need for changes in the United States Pharmacopoeia from time to time. The Pharmacopoeia has been revised decennially during the century of its existence, although the convention has always authorized a change of these standards, between revisions, should it become necessary. It has happened that within the last 2 or 3 years, the necessity for what is termed “interim revision", changes between the decennial period have become very marked. The pharmacopoeial committee, in cooperation with the officials of the Food and Drug Administration, or at least in consultation with them, have taken such steps as are necessary to make these modifications in the standard.

The committee of revision is fully in sympathy with this program. They are instructed by the convention to perform such functions. They are therefore legally performing their duty, and the provision that is herein embodied is entirely in harmony with that policy of the revision committee. I want to make it quite clear, that so far as I personally, as chairman, can speak for the committee, and, as far as the recent action of the committee would indicate, we are fully in sympathy with this program. It is particularly happy

that this revision of the law advises or directs that the Secretary shall first refer these proposed standards to the committee on revision for their consideration.

Senator OVERTON. To what page of the bill are you addressing yourself?

Dr. Cooк. On page 5, section 4, where the provision is set forth that

Whenever tests or methods of assay have not been prescribed therein

That is, in any of the books of standards, and I am referring to the Pharmacopoeia

and such tests or methods of assay as are prescribed are insufficient for determining whether or not such drug complies with such standard, the Secretary is hereby authorized to bring such fact to the attention of the appropriate body charged with the revision of such compendium, and if such body fails within a reasonable time to prescribe tests or methods of assay which are sufficient, then the Secretary may prescribe such tests.

This is the provision which is new, but which is strictly in harmony with the present procedure of the committee of revision and the officers of the Food and Drug Administration. It introduces a proviso which is not at all out of harmony with the ideals of the Pharmacopoeia. The Pharmacopoeia does restrict to itself first the right to select the medicines to be included. That is a medical function, or a professional function. That is not distributed by this proviso. The Pharmacopoeia reserves for itself the right to set standards, the degree of purity and this is again a matter of great importance, because the medical group and the scientific professional group should know what quality is available and what strength is necessary for therapeutic use. The determination of whether this quality and standard set up by the Pharmacopoeia is maintained by those who produce these medicines, is a third function. The Pharmacopoeia establishes these standards, these tests to determine the quality; but should those not prove satisfactory in the light of new scientific development, then the Secretary of Agriculture has the right under this act to call the attention of the committee on revision to the need for revision of those methods, and the committee of revision has the privilege of discussing them, and making such changes as they consider necessary. Should they not do so the Secretary has the right ultimately to set up such standards. But in my experience of many years, I have found that this group, the committee of revision and the Department of Agriculture, working together, have always been able to reach harmonious agreements, and it does introduce this possibility that the one is a check upon the other; that, should the committee of revision, for some reason at some future time, introduce some test which was not of a satisfactory character, the Secretary can alter that, if it prove necessary. It keeps the committee of revision very definitely rendering a high type of service. It equally prevents something being done by the Secretary which might not be wise, because it gives the opportunity for this wide consideration.

I do want to speak of just this one point, additionally, in connection with this pharmacopoeial work. It is unique in that it has brought, through this developed program, the cooperation on a very large scale, of the scientific representatives of the medical profession

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