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FOOD, DRUGS, AND COSMETICS
Another argument, from the standpoint of the proprietary manufacturer, is that the printing of the forinula on the label will have the effect of piracy, permitting piracy. Some unscrupulous druggist will Bay, whon the customer coinos in and asks for a bottlo 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 niy bottle for 49 cents."
That is a valid objection from the proprietary man, a roally valid objection, which we should tako into considoration, although it should not be a controlling incident in this.
There are some considorations which have been very genorally overlookod both by tho friends and by the ononies of the formula disclosures, but that is the gonorul efl'ect that it would have upon the classification of propriotary remedios.
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 thoso formulas, they will discover to their surprise that they are all in the United Statos Pharmacopain 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 liko to seo a pharmacist get a fair doal. The physician can, in a measure, protect himself against it, but where does tho pharmacist come in, who tries to make a living by compounding physicians' prescriptions?
If tho public will bo materially benefited, there is only one answer. If we are certuin that the public will be materiully benefited, the only answer is to put the formula on the packngo.
Senator COPELAND. Well, did you heur nie ask a question of Mr. Campbell this morning?
You may remember that during my administration of the health department, we tried the sanitary code, and we had this argument, and I see many fanıiliar faces here, and we finally roached the conclusion that if the formula wero filed with the comniissioner of boulth, we could then determine whether or not thoro wore any incompatibles in it, or poisons, or improper drugs, and then by giving the serial number, we would bo 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 tho 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 stato, out of your wide exporionce, how you think the public would be best protected. That is what we as a Sonato comınittee aro hore 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 protectod and the goneral good will be best bonefited by disclosing the formula to some adninistrative board, with proper provision that that board shall not publish it gonorally, and permit thom to pass upon it and say whether it is a safe remody for the purpose for which it is intended.
FOOD, DRUGS, AND COSMETICS
In other words, to disclose it to the adininistrative body instead of giving it wido 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 inean, 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 tasto Nuid extract of bucui, and if you have tasted it onco, you will never forget that flavor. It is the most dificult of all finvors to overcome or hide or disguise. If I know 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, "Ilere, I have something and I have invented it myself. It is nn invention; it is a now thing. It is a useful thing."
They would sny, "What is it?''
I would say, "It is making flavoring agents in suid extract of bucui 80 ns to concealits nauseous Bavor."
“No; you cannot have a potent on that. If you could prove that you had administered something to the Quid extract of bucui which had made an entirely differont compound out of it, changed its nature, then we might give you a patent.'
But if I did something to the Muid extract of bucui which changed the nature of it altogether, it would no longer produce the desirable effects of huid extract of bucui on the human system.
So there is some excuse in certnin 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 porngraph contains the term "physiologically active ingredients." Senator COPELAND. Where is that? Dr. BEAL. On page 11. Senator COPELAND. Yes; on line 4.
Dr. Bral. Now, I nosume that the professor who composed this bill, by the use of that langunge, mount to say something which had considerablo physiological activity, that he meant that there should bo placed on the packnge the namos of those substances on which the proprietary relied to substantiate his claim for therapeutic value. That was iho 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 anid that lie can subinit the rest of his address in writing, and let, ine say to the witness that, after all, this is a bearing and we are simply making a record, and this record will ho used by every inember of the Senate who desires to participate in the debate. is no particular ronson why all of the arguments should be made for the benefit of Senator ('ariwny and myself, and if the Doctor is willing to put the rest of lois paper into tho 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, bocause I think that the attitude of our present witness is to be helpful and constructive, but there are some, I think thut would like to tour tho bill apart.
So I think that, without the slightest desire to cut you off, we will accept your proposal and put the reinainder of your remarks in the record, but in the meantiine you may tako 5 or 6 minutes to close your argument.
Senator CARAWAY. Are his idens--what he wants to suy--included in his paper thoro?
Dr. Bwan. Wo have included our ideas in the forın of ninendments to the present act.
Senntor Callaway. And they are included in your paper?
Senator COPELAND. Furthermore, Doctor, if upon further considoration there is any further inaterial 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 ontirely certain whether that function can be best dischargod by the Federal Trade Commission or by the authority, provided for here. That is a board which has done some
remarkable work under some very disturbing circumstances, but, in spito of a good deal of adverse criticism, I think that if that board were given sufficient authority and adequate support, it could accomplislı alınost an ontire revolution on the subject of medical advertising, or, as they state, advertising medicinals. For iny part, I would like to see this false advertising exterminated altogether. I love my tomper every evening whon I try to got some music over the rudio and my ears aro Assaulted with somo 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 troutmont of. That is not so bad, because most of tho disonses named there are such as should not be self-tronted by the pationt.
I want to call your attention to the fact that there are not as inany of those preparations as you have been lod to believe, perhaps. Suppone that you go to your drug store and say, “I want you to give me
patent medicine for tuberculosis or consumption.".
I do not know any patont medicino of thut kind. If you were to ask, "Give me one for Bright's disenso,” you would be told, “I do not know anything of that kind,” und so as you go down the list, it is not there. There are not half-way as many as the public has boen led to suppose that there are. Propaganda has been carried on to make the general public boliovo that the shelves of the average drug storo are loaded down with alleged cures for those disossos for which there is no exact cure.
Then the provision goes on and gives the Secretary of Agriculture the power, whenever he deems it nocessary, to add to the list of
FOOD, DRUGS, AND COSMETICS
dincases or ailments for which nobody may advertise & 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 tho authority to put others on this list, and thore is po limit. He can say that it is patently contrary to the public interest that a man should trent 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 bo diagnosed and prescribed for by a competent physician, who would write a prescription and tako that prescription to a competent pharmacist and have it filled by a pharmacist, but that is impossible.
Suppose that you aro living way out in the country, 42 miles from the nearest registered pharniacist and 18 miles from the nearest physician? If I had time I would tell you an interesting experience
i This licensing of factories and laboratories may possoss the same element of value, but also it presents a very great monaco. Consider the thousnnds and thousands of factories, of manufacturies and laboratories which can be inspected with no control over the nppointment of the inspector except the discretion of the Secretary of Agriculturo. To police all of this would mean a party of political appointeos approxi. mating the United States Army in number, with real authority, with the authority of lifo and death over every establishment that they inspocted, and sometime they might exorcise that authority unwisely.
Just a low words with reference to penalties. I won't take up your time by ronding them all, but I want to call your attention particularly, Mr. Chnirman, to paragraph 5 in section 17 relating to penaltios. That reads:
The introduction into interstate commerce of any food, drug, or cosmetic, If the manufacturer, processor, or packor does not hold a valid permit whon 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, thon you have committed a crime; and if you commit this crime, it is evidontly one that you must havo committed voluntarily, and in that caso you will be subject to the full ponnlty of the law, namely, $10,000 fino nnd a maximum of 3 yenrs in the Federal penitentinry, and not for violating the Inw. Your product can rate 100 percent in purity or in tho manner of branding or in the manner of advertising, but if you havo dared to send that in interstnte 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 sny that thnt is fundamentally the crontion of a crime by action of tho Socrotnry of Agriculturo, becauso unless ho presos such a rogulation the crimo doos not exist. Ho croates it whonover ho passes tho regulation, and you violate the regulation and then you are due for a fine and a penitentiary sentenco.
FOOD, DRUGS, AND COSMETICS
Just ono other point and then I will sparo you, and thut is with relation to the general administrative provisions in Section 23. Now, with any statute of an administrativo character, it is almost always provided that the administrutive officer shall have authority to mako Buch rules and rogulations as may be nocossary to carry the provisions of the law into effect. It is the court which determines what regulutions 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 henrings. A hearing is in the nature of a judicial proceeding. A hoaring before the Secretary of Agriculture bears tho same relation to the procoodings of a Foderal District Court. That is roughly analogous to the proceedings in a magistrato's court, in its relation to the court of comnion ploas, or a grand jury
Now, consider how these preliminary proceedings are to be carried out. We do not expoct, of course, that in the hoarings in magistrate's courts the procedure shall be with the same formality that is required in courts of record, but we do expect, and tho law demands, that the procedure shall be such that the substantial riglits of the act used uro proporly protectod, that you can appear in person, or can have u legul representative.
But here we find a set of regulations which, if they are sustained by the courts, croate an entirely different situation. I'or instanco, by considering parngraph 5, Section 17, wo discover it is an offensú to violato a rogulation, and, secondly, we discover that certain provisions set forth in such general terms that tho specific acts necessary to constituto an offense must of nocessity be prescribed und defined by rogulation, in other words, that the roul obligations for which ponulties may be imposed shall be created by the administrative ollicor.
Then we find that in questions not susceptible of exact proof, by exporimental evidence, as, for example, whut shall be accopted us contrary to the goneral agreement of medical opinion, the opinion of the agent who conducts tho 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 ho muy doen necessary for the efficient enforcernent of the functions vested in hiin”-not such as are necessary to carry into effect tho provisions of the law, but such as he may doem necessary to discharge offectively the functions vosted in him as he interprets ihese functions.
Wo 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. Tho Socretary has power to decide whethor the accused inay be represented by legal counsel, or must present his own defense, and can decide the method of proceduro, 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 couclusions that an article is adulterated, misbranded, or contrary to the general agreement of medical opinion, further than the report of an analyst who inay have made an assay, and he muy reject the opinions of standard modicul