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sored by a group, as a standard. There would be no question as to that, but when it says that for all time in the future, the author of the book, a private citizen or corporation may make changes in it and change those standards, I think you are passing beyond limits of valid delegation of legislative authority.
Senator COPELAND. Yes; but, doctor, the provision is made that if the Secretary wants to set up another standard, and so indicates to the pharmacopeia board, and the board does not, within a reasonable time, respond, the Secretary may promulgate his own standard under section 22.
Dr. WOODWARD. That has reference to methods of assay. The bodies to which it is proposed thus to delegate authority are composed of the United States Pharmacopæial Convention, the American Institute of Homeopathy, and the American Pharmaceutical Association, each engaged in formulating the standards, the limits within which they may operate not being defined, the memberships not being defined.
Now, it may be advisable to delegate to corporations or a poration, the right to formulate the standards, but my suggestion is that if that is to be done, then the Congress set up its own corporation, defining the terms of membership, defining the method of procedure and saying how the finding shall be promulgated. That is the only way in which it can properly be delegated, it seems to me.
Senator COPELAND. That would require a separate bill, wouldn't it ?
Dr. WOODWARD. Yes. The formulation of standards by such a Government corporation might proceed along the lines adopted in the formulation of codes under the National Industrial Recovery Act. Those codes, as you may remember, must be approved by the President before they are effective. As it is proposed in this bill, there would be no one to whom you could refer for authoritative information regarding drug standards except the executive officers of the three private corporations named, for each of those corporations would be at liberty to change standards from day to day and there is nothing in the bill that would prevent anyone of those corporations from fixing standards for any given drug that might differ from the standards fixed for the same drug by one or both of the other corporations. This bill proposes to say to the Secretary of Agriculture that before he fixes a standard of any kind he must give notice of a hearing, hold a hearing, and then promulgate his standard, which cannot take effect until the expiration of a statutory period. The United States Pharmacopæial Convention, the American Institute of Homeopathy, and the American Pharmaceutical Association, however, are to be authorized under this bill to fix standards without notice, and without hearing, and to promulgate them to take effect instantly, and then to change them from time to time at their pleasure.
I am not criticizing the corporations named. I think that the work they have done has been done admirably. My objection lies in the delegation of power to these private corporations to fix standards for the entire country. But with respect to the proposed recognition of the Homeopathic Pharmacopoeia—and I want Senator Copeland to hear what I have to say-it seems to me that its adoption now as law would be a backward step. The latest edition of that Pharmacopæia that I have been able to find was published in 1914 and certainly some progress has been made in therapeutics since that time.
Senator COPELAND. You see, we found the perfection of medicine in that day and it was not necessary to make any changes.
Dr. WOODWARD. One word more, with respect to these regulations. There should be some provision whereby the Secretary of Agriculture can, if necessary, promulgate a regulation without a hearing and without waiting 90 days. If the Secretary, after conference with his boards, has promulgated a regulation, some one takes it into court, and it is wiped out. It isn't every time that one can wait 60 or 90 days for a new regulation, but as was provided in a bill that I drafted some little while ago, to regulate the promulgation of regulations, the President ought to be authorized, in an emergency of that kind to waive those periods, and let a temporary regulation be put into effect immediately.
I shall be very glad to file a brief. I appreciate very much the courtesy that you have extended me, and I apologize most sincerely that I have exceeded my time, it was quite without knowing it.
Senator COPELAND. I want to ask the doctor one question. You have made very helpful suggestions, Doctor, and we are very much obliged to you. Some of them may sound critical to the public, but I think you did not intend to be critical of the bill, but to be helpful, and you have been.
I want to ask you this question: By and large, is this a good bill ?
Dr. WOODWARD. It is; rather than oppose the bill, we would see it go through.
Now, I would like just one minute more. With respect to your permit' factories, there is a possible compromise. The objection to the permit system, as I see it, is the possible revocation of the permit. It is a valuable asset to a health officer to be able to require persons who. are engaging in the manufacture, distribution, and sale of goods, to have a proper equipment before they can do so, and to register, so that they will be brought under inspection. I should certainly require that even though you do not authorize the summary revocation of the permit, but that sometimes that is necessary, as Senator Copeland, · I know, can tell from his experience. Ï thank you gentlemen.
Dr. ROBINSON. The gentleman has criticized me, personally. May I ask him one other question?
The CHAIRMAN. You have that privilege.
Dr. ROBINSON. If I should take apple juice and ferment it until it contained 14 percent of alcohol, I would then have to sell it under the alcohol laws. If I then add acetic acid bacilli to it and the alcohol is oxydized to vinegar, would I then have to sell it under the alcohol laws! That is exactly similar to what occurs in my preparation.
Dr. WOODWARD. There is a statute that regulates the distribution of narcotic drugs. In my judgment, the gentleman is not complying with it.
Mr. Ben C. Marsh. May I ask a question? I understood Dr. Woodward to say that the American Medical Association has a list of quacks and fake nostrums, and I would like to ask whether that could be read in the record for the edification of the victims?
Dr. WOODWARD. Gentlemen, it is entirely too long. I could say something about the exemption of publishers. I have taken from a recent issue of a local journal some advertisements which need not go into the record that show what a publisher may do, and that there certainly must be some restriction placed on the publisher. These are from a journal that is published in the Nation's Capital under the Blue Eagle.
Senator OVERTON. What do you mean by placing some restriction on the publisher? What have you in mind in particular?
Dr. WOODWARD. I think when a publisher has knowledge of the false character of the advertisement, or when he might, by reasonable diligence acquire that knowledge, he should be held guilty. I say that, because we have had reference to the B. & M. remedy case that was prosecuted successfully by the Department of Agriculture a short time ago. In 1921 or 1922, when I was health commissioner of Boston, I prosecuted them, not under the pure food law, but I prosecuted them and when I say prosecuted, I do not mean I referred it to the district attorney, I went into court as prosecuting counsel myself—I prosecuted them under the fraudulent advertising law, and under the law of that State, if we could show that they knew or by reasonable diligence might have ascertained the false and fraudulent character of the representations, they were guilty. So, backed with a provision of that kind, we found them guilty. There is no reason why anyone, when he knows, or by reasonable diligence can know, that the article that he is putting out is adulterated and misbranded, should be allowed to continue it.
What does “ publisher” mean? A publisher once published a little sheet that he called the “United States Health Reports." He claimed to have a testing laboratory of his own. He would publish advertisements indicating that the articles advertised had been tested in his laboratory and would vouch for their virtues. The name of the sheet gave the entire transaction the semblance of governmental authority. Reprints of items published were circulated for advertising purposes. And the "publisher” of that sheet was legally just as much a "publisher” as was the publisher of the New York Times or the Ladies' Home Journal. It seems to me that we shall have to recognize some distinction among “ publishers.”
Senator OVERTON. Have you a medical phrase that would cover that suggestion?
Dr. WOODWARD. I will submit one. (The brief subsequently submitted is as follows :) The time available for the preparation of this brief has been so limited as to render it impracticable to submit it to the individual members of the board of trustees of the American Medical Association, by which the policies of the association are determined in the intervals between the annual meetings of the house of delegates of the association. Criticisms and suggestions contained in it are to be considered, therefore, as made by counsel, and not criticisms and suggestions made by the board of trustees or by the association.
The American Medical Association played a leading part in the movement that led to the adoption of the Food and Drug Act of 1906. It has been the vanguard of every effort that has been made since that time to improve such legislation. It is pledged by a resolution of its board of trustees to support present efforts looking toward the formulation and enactment of effective national food and drug legislation.
Within the meaning of the resolution adopted by the board of trustees, S. 2800 represents in the main effective national food and drug legislation. It proposes to extend the existing legislation so as to make it cover more effec
tively foods and drugs, and it extends it so as to make it cover cosmetics. To safeguard the people with respect to all of these foods, drugs, and cosmeticsit proposes to extend the law so as to make it cover advertising pertaining to them. The enactment of sound legislation along the lines laid down in this bill should go far toward protecting the people against fraud and against injury to health.
The suggestions and criticisms supported below are, as even a casual inspection will show, not designed to weaken the bill, but to strengthen it. The methods proposed for strengthening it are, it is believed, fair to the food, drug, and cosmetic industries, and to the advertising interests, and are believed to be necessary to accomplish the purposes of the bill. They are respectfully submitted for consideration by the committee.
The page and line numbers given throughout the brief refer to S. 2800 as. pending before the Senate Committee on Commerce, February 27, 1934.
Definition of the term “diug."-Section 2, subsection (b), in defining the term “ drug says (p. 2, 4-5):
“ The term 'drug', for the purposes of this act and not to regulate the practice of medicine, includes
The phrase "and not to regulate the practice of medicine" should be eliminated. Its apparent purpose is to protect drugless healers against the use of this act to prevent them from using “ devices intended for use in the cure, mitigation, treatment, or prevention of disease in man or other animals”, and “ devices intended to affect the structure or any function of the body
, (p. 2, lines 9–13). It has apparently been conceived that since such devices are declared to be drugs under this bill, efforts might be made in case of its enactment to prevent their use by persons who hold State licenses to practice only without the use of drugs. The fear of the use of the Federal Food and Drugs Act for that purpose is in my judgment remote, but if it is regarded as a substantial fear, then it can probably be best met by adding at the end of subsection (b), section 2, (p. 2, line 13) after the word “body”, some such language as
“ Provided, That the foregoing definition of the word 'drug' is not to be construed as attempting to define the limits of authorized practice by persons authorized by law to use drugs and persons authorized by law to practice the healing art only without the use of drugs.”
Definition of “medical profession” and “medical opinion.”—Subsectio:1 (k), section 2 (p. 3, lines 18–22) reads:
“(k) The term “medical profession' means the professions of physicians, pharmacologists, dentists, and veterinarians; and the term 'medical opinion means the opinion of physicians, pharmacologists, dentists, or veterinarians relating to the fields of their respective professions.”
The word physicians” is sometimes used to include chiropractors, osteopaths, naturopaths, naprapaths, and others whose practice is based on dogmas, most of which hold that the use of drugs, using that word in its ordinary sense, is not necessary. If, then, the term “medical opinion” with respect to drugs and medicines is intended to mean the opinion of naprapaths, naturopaths, chiropractors, and osteopaths, as well as the opinion of doctors of medicine, it is obvious that there will be no limit to the resulting confusion.
Probably this entire subsection had better be omitted, and provision be made for the use of reputable medical books and periodicals and of the testimony of competent medical witnesses in determining matters that depend on “medical opinion."
Section 4 (p. 5, line 11, to p. 6, line 18) provides that a drug shall be deemed to be adulterated if its name is the same as, or simulates, a name recognized in an official compendium, or if it purports to be a drug the name of which is so recognized (p. 5, lines 14–16). The term “ official compendium " is defined as meaning the United States Pharmacopeia, the Homeopathic Pharmacopæia of the United States, the National Formulary, or any supplement thereto, official at the time any drug is introduced into interstate commerce (p. 3, line 23, to p. 4, line 3). And for the purposes of the act, all substances and preparations recognized in the United States Pharmacopoeia, the Homeopathic Pharmacopeia of the United States, the National Formulary, and supplements thereto are recognized as drugs (p. 2, lines 4-9). No test or method of assay.
prescribed by the United States Pharmacopeia, the Homeopathic Pharmacopeia of the United States, the National Formulary, or supplements thereto, can be changed by the Secretary of Agriculture under his general authority to make regulations, even though he deems those tests and methods insufficient, until the Secretary has brought the insufficiency of such tests and methods to the attention of the appropriate body charged with the revision of the United States Pharmacopæia, the Homeopathic Pharmacopeia of the United States, the National Formulary, and supplements thereto, and that body has failed after a reasonable time to prescribe tests or methods of assay which are sufficient (p. 5, line 20, to p. 6, line 4). This bill defines a drug as misbranded if its name is the same as, or simulates, a name recognized in the United States Pharmacopæia, the Homeopathic Pharmacopoeia of the United States, the National Formulary, or supplements thereto, if it is not packaged and labeled as prescribed therein (p. 12, lines 16-18). The sale of any drug that is adulterated or misbranded within the meaning of the terms stated above is unlawful (p. 26, line 2, to p. 27, line 12).
The bill thus undertakes to make the United States Pharmacopoeia, the Homeopathic Pharmacopeia of the United States, the National Formulary, and supplements thereto, the law of the land. There is no question as to the power of Congress to recognize as statutory authorities the volumes named and supplements to them that are in existence at the time of the passage of this bill, if it should be passed. In fact, as a practical matter, it may be necessary so to recognize the United States Pharmacopæia, the National Formulary, and supplements to them, pending the establishment of standards by some duly constituted Government authority. The recognition of the Homeopathic Pharmacopoeia of the United States, however, would be at best of questionable propriety, for the latest edition of that volume was copyrighted in 1914, and the adoption of the standards laid down therein as the legal homeopathic standards for the year 1934 and the years to follow seems hardly consistent with progress.
As a matter of fact, however, it is commonly understood that the proponents of this bill have sought and are seeking to have recognized as the law of the land not only the United States Pharmacopæia, the Homeopathic Pharmacopoeia of the United States, the National Formulary, and supplements to all of them, existing at the time of passage of this bill, but also all future editions of the volumes named and all future supplements to them. This is clearly shown by the provision of section 2, subsection (1) (p. 3, line 23, to p. 4, line 3) which reads:
“ The term 'official compendium' means the United States Pharmacopæia, Homeopathic Pharmacopoeia of the United States, National Formulary, or any supplement thereto, official at the time any drug to which the provisions thereof relate, is introduced into interstate commerce.”
The purpose of the proponents of this legislation to obtain continued legal recognition of the United States Pharmacopæia, the Homeopathic Pharmacopæia of the United States, the National Formulary, and all supplements thereto, as the law of the land insofar as drug standards are concerned, can probably not be accomplished by the language of this bill. Probably the purpose sought by the proponents of the bill cannot be accomplished at all. For the courts, in order to sustain the constitutionality of the act, might well hold that the volume or supplement
at the time any drug is introduced into interstate commerce is the volume or supplement made official” by the act itself, namely, that relevant volume or supplement that was in existence when the act was passed.
The ordinary rule of statutory construction is that where one construction will support the constitutionality of a statute and another possible construction will not, that construction will be adopted that favors constitutionality. In the present instance, to accomplish what is believed to be the purpose of the proponents of the bill, the bill must be construed as delegating to the editors and authors of the United States Pharmacopæia. the Homeopathic Pharmacopæia of the United States, the National Formulary, and supplements thereto, the right to make changes in drug standards from time to time, at their pleasure. But the editors and authors of these volumes and supplements are in no way officers or agents of the Government. They are persons selected from time to time by certain private corporations and are accountable only to those corporations. The corporations are the United States Pharmacopoeial Convention, the American Institute of Homeopathy, and the American Pharmaceutical Association. Each of these corporations determines its own rules of member