« ForrigeFortsett »
FOOD, DRUGS, AND COSMETICS
Another argument, from the standpoint of the proprietary manufacturer, is that the printing of the formula on the label will have the effect of piracy, permitting piracy. Some unscrupulous druggist will say, when the customer comes in and asks for a bottle of, say, Dr. Jones' Hair Preparation, "Why, Dr. Jones' Preparation costs you a dollar, and here is my own; look at it, and you will see that the formula is exactly the same, and you can have my bottle for 49 cents."
That is a valid objection from the proprietary man, a really valid objection, which we should take into consideration, although it should not be a controlling incident in this.
There are some considerations which have been very generally overlooked both by the friends and by the enemies of the formula disclosures, but that is the general effect that it would have upon the classification of proprietary remedies.
Proprietary remedies are now divided into two classes, those of secret composition and those of open composition, and if we are going to have them all open compositions, we shall have only one class. In the estimation of the consuming public, they will all be put in the same class; in other words, when people read those formulas, they will discover to their surprise that they are all in the United States Pharmacopoeia and the United States Formulary, and that the written prescriptions which their physicians give them bear a very close resemblance to the formulas printed on the proprietary drugs.
I am a pharmacist, and I like to see a pharmacist get a fair deal. The physician can, in a measure, protect himself against it, but where does the pharmacist come in, who tries to make a living by compounding physicians' prescriptions?
If the public will be materially benefited, there is only one answer. If we are certain that the public will be materially benefited, the only answer is to put the formula on the packago.
Senator COPELAND. Well, did you hear me ask a question of Mr. Campbell this morning?
You may remember that during ny administration of the health department, we tried the sanitary code, and we had this argument, and I see many familiar faces here, and we finally reached the conclusion that if the formula were filed with the commissioner of health, we could then determine whether or not there were any incompatibles in it, or poisons, or improper drugs, and then by giving the serial number, we would be prepared to administer the law.
Mr. Campbell this morning took a strong ground against that, said that that was not sufficient, that it was right for the public to have this information because the man is self-prescribing, that he is his own doctor and he is entitled to know what he is taking.
I would like to have you state, out of your wide experience, how you think the public would be best protected. That is what we as a Senate committee are here for. Regardless of any profession that I may have, my duty here is to do what we can to protect the public, and I would like to have you present your views on it.
Dr. BEAL. My personal feeling, expressed in various papers written and various talks, is that the public will be best protected and the general good will be best benefited by disclosing the formula to some administrative board, with proper provision that that board shall not publish it generally, and permit them to pass upon it and say whether it is a safe remedy for the purpose for which it is intended.
FOOD, DRUGS, AND COSMETICS
In other words, to disclose it to the administrative body instead of giving it wide publication.
Some people say, "Why, that is a valuable preparation; why don't the man get a patent on it?" The patent law says that he shall have a patent for a new and useful invention. That law is like the Food and Drugs Act. It is not what we say the words mean, but it is the interpretation which the officer gives to it, and they have interpreted that to mean that a man can make something very useful and not get a patent on it.
To give an illustration, many of you have had the opportunity to taste fluid extract of bucui, and if you have tasted it once, you will never forget that flavor. It is the most difficult of all flavors to overcome or hide or disguise. If I knew how to disguise it so that it would not be so revolting, I could sell the secret tomorrow for $1,000.
But suppose that I went with that secret to the Patent Office and I said, "Here, I have something and I have invented it myself. It is an invention; it is a new thing. It is a useful thing.”
They would say, "What is it?”
I would say, "It is making flavoring agents in fluid extract of bucni so as to conceal its nauseous flavor."
"No; you cannot have a patent on that. If you could prove that you had administered something to the fluid extract of bucui which had made an entirely different compound out of it, changed its nature, then we might give you a patent.'
But if I did something to the fluid extract of bucui which changed the nature of it altogether, it would no longer produce the desirable effects of fluid extract of bucui on the human system.
So there is some excuse in certain cases for a certain degree of secrecy in medicine, but it in no case should be permitted to interfere with the general public interest.
Now, another statement in this paragraph contains the term "physiologically active ingredients.”
Senator COPELAND. Where is that?
Dr. BEAL. On page 11.
Senator COPELAND. Yes; on line 4.
Dr. BEAL. Now, I assume that the professor who composed this bill, by the use of that language, meant to say something which had considerable physiological activity, that he meant that there should bo placed on the package the names of those substances on which the proprietary relied to substantiate his claim for therapeutic value. That was the intention, but it does not state it.
Physiological activity will comprehend any degree of activity from the most minute degree to the most potent activity, so that that language should be modified or changed.
(After an informal discussion as to how much longer the doctor cared to speak:)
Senator COPELAND. The doctor has said that he can submit the rest of his address in writing, and let me say to the witness that, after all, this is a hearing and we are simply making a record, and this record will be used by every member of the Senate who desires to participate in the debate. is no particular reason why all of the arguments should be made for the benefit of Senator Caraway and myself, and if the Doctor is willing to put the rest of his paper into the record, it would help us a lot, because there are many others here who
FOOD, DRUGS, AND COSMETICS
take the same position in opposition to the bill, and even more violent opposition, because I think that the attitude of our present witness is to be helpful and constructive, but there are some, I think that would like to tour the bill apart.
So I think that, without the slightest desire to cut you off, we will accept your proposal and put the remainder of your remarks in the record, but in the meantime you may take 5 or 6 minutes to close your argument.
Senator CARAWAY. Are his ideas-what he wants to say-included in his paper there?
Dr. BEAL. We have included our ideas in the form of ainendments to the present act.
Senator CARAWAY. And they are included in your paper?
Dr. BEAL. They are submitted with the statement.
Senator COPELAND. Furthermore, Doctor, if upon further consideration there is any further material that you want to put into the record, you may do so.
Go ahead and finish, then.
Dr. BEAL. The only thing I will say in addition is this, that we are heartily in favor, 100 percent in favor of the proposition to control, and to effectively control, false or fraudulent advertising.
We are not entirely certain whether that function can be best discharged by the Federal Trade Commission or by the authority provided for here. That is a board which has done some very remarkable work under some very disturbing circumstances, but, in spite of a good deal of adverse criticism, I think that if that board were given sufficient authority and adequate support, it could accomplish alinost an entire revolution on the subject of medical advertising, or, as they state, advertising medicinals. For my part, I would like to see this false advertising exterminated altogether. I lose my temper every evening when I try to get some music over the radio and my ears aro assaulted with some outrageous mass of nonsense concerning some medicinal preparation.
There is one other thing I wish to call attention to, in respect to the list of diseases which might not be mentioned on the label, or concerning which you may not or shall not advertise a preparation in treatment of. That is not so bad, because most of the diseases named there are such as should not be self-treated by the patient.
I want to call your attention to the fact that there are not as many of those preparations as you have been led to believe, perhaps. Suppose that you go to your drug store and say, "I want you to give me a patent medicine for tuberculosis or consumption."
You would be told, "I have not anything of that kind."
I do not know any patent medicine of that kind. If you were to ask, "Give me one for Bright's disease," you would be told, “I do not know anything of that kind," and so as you go down the list, it is not there. There are not half-way as many as the public has been led to suppose that there are. Propaganda has been carried on to make the general public believe that the shelves of the average drug store are loaded down with alleged cures for these diseases for which there is no exact cure.
Then the provision goes on and gives the Secretary of Agriculture the power, whenever he deems it necessary, to add to the list of
FOOD, DRUGS, AND COSMETICS
diseases or ailments for which nobody may advertise a medicine. Think of that.
Now, psychologically speaking, this is one of the most adroit sections of the bill. If this section started out with the last provision put first, that the Secretary of Agriculture should have the right to prescribe by regulation what medicines might not be advertised, you would hoot at the proposition, so it is cleverly covered up by introducing this list of twenty-five afflictions, beginning with albumin uria and ending with whooping-cough, nearly all of which are such that they cannot be treated with self-medication; and this provides that he shall have the authority to put others on this list, and there is no limit. He can say that it is patently contrary to the public interest that a man should treat himself when he can be treated so much better by a physician. I agree. If I had my way about it, every case of illness would be diagnosed and prescribed for by a competent physician, who would write a prescription and take that prescription to a competent pharmacist and have it filled by a pharmacist, but that is impossible.
Suppose that you are living way out in the country, 42 miles from the nearest registered pharmacist and 18 miles from the nearest physician? If I had time I would tell you an interesting experience I had, but I want to pass on to the next.
This licensing of factories and laboratories may possess the same element of value, but also it presents a very great monaco. Consider the thousands and thousands of factories, of manufacturies and laboratories which can be inspected with no control over the appointment of the inspector except the discretion of the Secretary of Agriculturo. To police all of this would mean a party of political appointees approximating the United States Army in number, with real authority, with the authority of life and death over every establishment that they inspected, and sometime they might exercise that authority unwisely.
Just a few words with reference to penalties. I won't take up your time by reading them all, but I want to call your attention particularly, Mr. Chairman, to paragraph 5 in section 17 relating to penalties. That reads:
The introduction into interstate commerce of any food, drug, or cosmetic, if the manufacturer, processor, or packer does not hold a valid permit when so required by regulations under motion 12.
In other words, you are required to hold a permit by a regulation issued by the Secretary of Agriculture, and if you don't have a permit, then you have committed a crime; and if you commit this crime, it is evidently one that you must have committed voluntarily, and in that case you will be subject to the full penalty of the law, namely, $10,000 fine and a maximum of 3 years in the Federal penitentiary, and not for violating the law. Your product can rate 100 percent in purity or in the manner of branding or in the manner of advertising, but if you have dared to send that in interstate commerce without having a permit from the Secretary of Agriculture, you are just in bad. You have not violated a law, but you have violated a regulation.
I say that that is fundamentally the creation of a crime by action of the Socrotary of Agriculture, because unless he passos such a rogulation the crime does not exist. Ho creates it whenever he passes tho regulation, and you violate the regulation and then you are due for a fine and a penitentiary sentence.
FOOD, DRUGS, AND COSMETICS
Just one other point and then I will spare you, and that is with relation to the general administrative provisions in Section 23. Now, with any statute of an administrative character, it is almost always provided that the administrative officer shall have authority to make Buch rules and regulations as may be necessary to carry the provisions of the law into effect. It is the court which determines what regulations are necessary, but here we see an evident intent to go to the extreme limit of whatever authority can be vested in the making of regulations in the Secretary of Agriculture.
Take the matter of provisions for hearings. A hearing is in the nature of a judicial proceeding. A hearing before the Secretary of Agriculture bears the same relation to the proceedings of a Federal District Court. That is roughly analogous to the proceedings in a magistrate's court, in its relation to the court of common pleas, or a grand jury.
Now, consider how these preliminary proceedings are to be carried out. We do not expect, of course, that in the hearings in magistrate's courts the procedure shall be with the same formality that is required in courts of record, but we do expect, and the law demands, that the procedure shall be such that the substantial rights of the act used are properly protected, that you can appear in person, or can have a legul representative.
But here we find a set of regulations which, if they are sustained by the courts, create an entirely different situation. For instance, by considering paragraph 5, Section 17, wo discover it is an offense to violate a regulation, and, secondly, we discover that certain provisions set forth in such general terms that the specific acts necessary to constitute an offense must of necessity be prescribed and defined by regulation, in other words, that the real obligations for which penalties may be imposed shall be created by the administrative ollicer.
Then we find that in questions not susceptible of exact proof, by experimental evidence, as, for example, what shall be accepted us contrary to the general agreement of medical opinion, the opinion of the agent who conducts the hearing will control, since he will designate the particular authority which will be accepted.
We find in paragraph (a), section 23, that "The Secretary of Agriculture is authorized to prescribe such regulations as he may deem necessary for the efficient enforcement of the functions vested in him"-not such as are necessary to carry into effect the provisions of the law, but such as he may deem necessary to discharge effectively the functions vested in him as he interprets these functions.
We find, finally, that the Secretary's regulations are to be imbued with the force and effect of law as to the notice and conduct of hearings. Under this, the notice of hearing may be 30 days or 24 hours. The Secretary has power to decide whether the accused may be represented by legal counsel, or must present his own defense, and can decide the method of procedure, the kind of evidence to be admitted or rejected. The Secretary is not required by the law to specify the authority upon which he relies to support his conclusions that an article is adulterated, misbranded, or contrary to the general agreement of medical opinion, further than the report of an analyst who may have made an assay, and he may reject the opinions of standard medical