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such as barbiturates or something like that, normally in his request, would he not, whereas if it was just for a harmless tonic, there would be no reason why the druggist should not fill it.
“Mr. WARNACK. That is true. I do not think there is any reason why the druggist should not fill any request of the physician if he uses the proper care and consideration in accepting it and translating it in the proper terms. The druggist knows the doctor's language and it would be very difficult for a person to attempt to speak fraudulently in that language without the druggist being able to detect it. There is something fishy or something wrong about it.
“Mr. WILLIAMS. As for getting a confirmation in writing from the doctor, I think you will agree with me when I say that is virtually impossible nowadays."
“Mr. WARNACK. It is quite difficult to do. As I said before, I cannot see how it would serve any useful or practical purpose.”
In this connection it is important for this committee to understand that professionally as well as legally, the retail druggist is primarily responsible, in every detail, when he dispenses drugs on a doctor's prescription-this whether it is confirmed or not. Also that confirmation will not cure errors, nor void fraud, and accordingly will serve no purpose. The druggists are willing, as they have been in the past, to assume and retain their professional and legal responsibilities in dispensing drugs on prescription, provided, however, their responsibilities are clearly defined, as is sought to be accomplished by amending the present law by H. R. 3298.
In the face of these glaring facts, it is hard to understand how anyone could sincerely and logically maintain that this measure seeks to increase the cost of medical care by converting nonprescription drugs into more expensive ones. Nor can we understand the logic and the purpose of the statement by Mr. Dunn that the members of the National Association of Retail Druggists will be very much interested in extending the list of drugs to be sold on prescription only when, as a matter of fact, the retail druggists' chief complaint and grievance under the present law is that there are already too many simple and safe drugs without reason or purpose restricted to sale on prescription only. As this witness for the proponents in his original prepared statement to the committee, dealing with the present promiscuous and unwarranted restrictions of simple drugs and compounds to sale upon prescription only, emphatically stated (p. 4, top of page of prepared statement):
"In effect and in practice here is what this prescription legend regulation brought about. Manufacturers, large and small, distributing any kind of a drug, no matter how simple or how potent, for any reason or no reason at all, promiscuously labeled Their products with the prescription legend, thereby relieving themselves from the liability of proper and adequate labeling as is required by the act, passing on this liability and burden to the retail druggists. By this process of uncontrolled and promiscuous use of the prescription legend label, many simple drugs were thereby restricted to sale upon a physician's prescription only, with the consequent results of increased costs of medical care, much confusion among the retail druggists because the same product coming from different manufacturers, may or may not carry the prescription-legend restriction."
In the second paragraph on the same page of the prepared statement I stated: “Moreover this uncontrolled, promiscuous, and unjustifiable restrictive method of labeling confused, inconvenienced, and harassed the public as well as impeding the medical and pharmaceutical professions in serving them more effectively and more economically.”
This charge was substantiated not only by mere statements, but by dozens of exhibits, proving without a doubt that the aim and purpose of proponents of this measure is to so amend the present act as to enable them to serve the public with medicaments, more economically and more efficiently.
In further support of the proponents' aim and assertion that H. R. 3298 will decrease the cost of medical care, your attention is directed to the questions of Representative Wolverton and the answers of Mr. Warnack, a practicing pharmacist, appearing as a proponent of this measure (pp. 88 and 93, both inclusive), and the material contained on page 217 of the record, in which Mr. Wolverton asked Mr. Larrick, an Associate Commissioner of the Food and Drug Act, this question:
“Mr. WOLVERTON. Would this legislation increase the necessity for obtaining prescriptions? “Mr. LARRICK. My own view is that it would not
Now, in my opinion, the ultimate effect of this list would be to require directions for use on many items which now bear the prescription legend. I can't see into the future with enough certainty to know precisely what would happen, but I do not agree
or believe, as Mr. Dunn appears to believe, that the net effect of this would be to increase prescription practice
I honestly think that this bill would accomplish the objective that you so succinctly stated this morning when you said that you wanted a bill which will protect the public health fully, but which will not unnecessarily burden the patient and will not unnecessarily add to the cost of his medical care. To some extent, that is a matter of opinion, but that is our honest effort."
We believe that enough has been clearly shown to resolve without any doubt, that the innuendos to the effect that this bill will raise the costs of medical care are intended for no other purpose than to confuse and mask the issues involved, and to detract from the real aim of this measure.
Secondly, and probably just as illogically, the opponents of H. R. 3298 have injected in their testimony before this committee, the bugaboo that this measure will lead to socialized medicine. We just cannot understand the basis nor the logic for such conclusion. Socialized medicine, as it is generally understood and practiced, is a procedure whereby the Government furnishes its citizens with medical care without cost, the cost being defrayed by a special or general over-all tax. If anything, the reverse premise is a more logical and reasonable conclusion.
Is it not strange that the patent medicine manufacturers and not the physicians of this country raise the cry of "socialized medicine”?
If this measure, as was conclusively pointed out, accomplishes the aims of its proponents-namely, to reduce the cost of medication and thereby enable the medical and pharmaceutical professions to serve the public more effectively and more economically—the need for socialization of medical care will become unnecessary and impractical. If reducing the cost of medical care, as is sought to be accomplished by H. R. 3298, be socialized medicine, the proponents of this measure emphatically say, let's have it, no matter what else the opponents may term such an effort.
For the edification of this committee, let it, however, be emphatically understood that the members of the National Association of Retail Druggists, the proponents of this measure, on more than one occasion in convention assembled, have, by a unanimous resolution, recorded their opposition to socialized medicine, as it is now understood and practiced in England under a socialistic form of government. Also that the members of this association, representing the great majority of retail druggists of the country, have twice by resolution unanimously adopted and approved the provisions of H. R. 3298, as a means of clarifying the provisions of the present law as enacted in 1938, in order to better enable them to safeguard the public interest and serve it more adequately and more economically.
Thirdly, the opponents of H. R. 3298, in one form or another, assert without explanation that this measure is unnecessary for the reason, as is alleged by them, that the Administrator of the act under the present law may by regulation solve the problems sought to be corrected by this measure.
The chief advocate of this erroneous argument is the American Pharmaceutical Association.
Mr. Robert P. Fischelis, secretary of the American Pharmaceutical Association, in the statement he submitted to the Committee on Interstate and Foreign Commerce, tried to leave the impression that the American Pharmaceutical Association is a spokesman of the druggists of the United States. Accordingly, it is important to explain that the American Pharmaceutical has a conglomerate membership. Mr. Fischelis revealed the status of the membership in the statement he submitted to you. We quote him as follows:
“Its members practice their profession in retail establishments, in hospitals, in manufacturing laboratories, in colleges of pharmacy, in the medical facilities of the Armed Forces, the Public Health Service, research institutions, and other places requiring professional pharmaceutical services.”
The official records show that only about 14,000 pharmacists are active members of the American Pharmaceutical Association and only a fraction of them are proprietors of drug stores or employees who deal with the public.
It is obvious from these facts that the American Pharmaceutical Association cannot speak for the drug store owners of the country
and it does not in any sense represent them. The National Association of Retail Druggists
is the only organization that is in a position to serve as the spokesman of the proprietors of the independent drug stores Nation-wide.
Mr. Fischelis also tried to leave with the committee the impression that the American Pharmaceutical Association represents the druggists of the country because the State pharmaceutical associations are affiliated with his association. As a matter of fact, State, city, metropolitan, and county pharmaceutical associations throughout the United States are also affiliated with the National Association of Retail Druggists. Representatives of each of these local groups who are also members of the National Association of Retail Druggists, have on two separate annual occasions, in convention assembled, by a unanimous resolution mandated the National Association of Retail Druggists to seek a solution of the Federal restrictions dealing with prescriptions and the sale of simple household remedies which are unnecessarily restricted to sale by prescription via the socalled prescription legend. However, Mr. Fischelis in reply to a question by a member of this committee, upon what authority he makes his representations, answered that his authority is based upon the action of the council of his association.
In behalf of the vast majority of the druggists, we disagree with the premises of the American Pharmaceutical Association. First, because of the very emphatic statement of Mr. Oscar Ewing, the Administrator of the Federal Security Agency, in charge of the enforcement of FDC Act (as is pointed on p. 18 of the record) when speaking of this problem said:
“Frankly, I feel very strongly that this is a question that should be dealt with by legislation rather than by regulation of the Administrator. I feel that for two reasons. In the first place, I am sure that under the law the Administrator cannot do some of the things that ought to be done; and secondly, I feel that this is so far-reaching that it is important that it be done by legislation and not by regulation of the Administrator.” The Administrator went on further to say on the same page:
"On the other hand, some of the things that we are authorized to do, I think could be done better by legislation.
Moreover, it is clear that the act, in section 503 (b), by its very phraseology, plainly provides that only a written prescription signed by the prescriber is exempt from certain labeling provisions of the act. Also that according to a justifiable interpretation of that provision of the present law, Dr. Paul Dunbar, the FDC Commissioner, declared that a refill of such a prescription must likewise be authorized by the prescriber in writing. That a sale of drugs which were once the subject matter of a prescription, without the written authority of the doctor, is in fact a sale of the drugs over the counter and must bear such labeling information as is required by the act. With this conclusion few can reasonably disagree.
No regulation, however written, can change the plain import of the words contained in the law as far as it may deal with oral prescriptions and refills thereof. Also equally as important for the public good, we mention that no ruling can solve the present prescription legend labeling abuses without a clear authority from Congress, as is provided in H. R. 3298. And finally, no regulation could relieve the pharmacist from the responsibility of placing warnings on prescription packages, contrary to his ethics in dealing with physicians.
Of particular interest in this connection is the concern of certain members of the committee as is reflected by their questions to Mr. Ewing:
First, on page 36 of this record-question by Representative Heller:
“Mr. HELLER. I see. We shall get those views later. Just one more thing. You made the general statement that the Government should only act when necessary.
What conditions exist that make action on the part of the Congress necessary for the passage of this bill?
“Mr. Ewing. I feel that the present law is ambiguous to a certain extent; for instance, those warnings under the law that the pharmacist has to put on a bottle, even though it is dispensed on the prescription of a doctor. I think that is an unnecessary thing. I think that this legislation, if it is adopted in the form suggested here, would eliminate this twilight zone. We have been in our regulations trying to get a definition; we have proposed a definition of what we call drugs that would require a prescription and those that do not; and work as we may, we are not satisfied or happy with that definition. I think that this (referring to H. R. 3298) provides machinery that would make that whole procedure much better and eliminate the so-called twilight zone."
Second, quoting from page 51 of the recorda question by Representative Harris:
"Mr. HARRIS. In carrying out the orders of the doctor, there is a vast responsibility on the druggist, is there not?
“Mr. Ewing. Oh, thoroughly—to properly label it in accordance with the prescription, and all that.
“Mr. HARRIS. As I understand it, you are endeavoring here to relieve the pharmacist of some of the labeling responsibilities.
“Mr. Ewing. Yes, you are quite right. But the point of it is, that under the existing regulations we have a definition where a drug can be dispensed on a prescription if such a drug or device, because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, if not generally recognized among experts qualified by scientific training and experience to evaluate its safety and efficacy as safe and efficacious for use except by or under the supervision of a physician, dentist, or veterinarian.
"If that does not leave a whale of a twilight zone, I do not know what does, That is why we do not like that definition given there at all; yet it is probably as good as we can get.
"Mr. HARRIS. I thoroughly agree with you. If the Administrator cannot understand what the law means, then I do not see how you can expect the public to.
"Mr. Ewing. I did not make this law myself.”
All of which clearly supports the proponents' position that the confusion, uncertainty and ambiguity created by enforcing the provisions of the present Food, Drug and Cosmetic Act cannot be obviated by a regulation of the Administrator, and that only an amendment to the act, such as is reflected by the provisions of H. R. 3298 will serve to solve the problems experience has revealed.
It is because of this uncertainty in interpreting the provisions of the present law, even by so-called experts, that prompted this witness, in behalf of the retail druggists of the country to make the assertion in his prepared statement:
“It is signifanct, too, that the proponents of this bill, the pharmacists of the country, do not, for themselves, seek any special privileges nor any exemption
All they ask, as is simply provided in the bill before you for consideration, is that the present provisions of the act with regard to the labeling requirements be modified so as to promote uniformity in labeling, to afford proper compliance, to provide an authorized means of standardizing the present promiscuous and inconsistent labeling restrictions engaged in by numerous and varied persons or groups, and generally to enable them to better serve the public.”
Fourth, the opponents of H. R. 3298 further and vehemently contend that this measure will vest in the Government significant bureaucratic control of the drug industry and the medical profession. However, this assertion, when exposed to an analysis of the existing facts, and experiences, is likewise without merit or logic. From an analysis of the testimony this assertion seems to be directed only to that provision of H. R. 3298 which authorizes. the Administrator to list the type of drugs which, for the protection of the public health, ought to be restricted to sale on prescription only.
Analyze, if you will, the provisions of H. R. 3298 in that respect in the light of public health and welfare:
1. The measure provides (p. 2, lines 10 and 11) that habit-forming drugs shall be dispensed upon prescription only. Can anyone conscientiously maintain that it ought not be so? Moreover by section 502 (d) the act already so provides. This measure makes no significant change in this respect, except when on pages 3 to 6, inclusive, it provides that, “The Administrator may be regulation remove drugs subject to section 502 (d) and section 505 from the provisions of this subsection when such requirements are not necessary for the protection of the public health.”. No one reasonably will quarrel with this provision, a provision, by the way, which was inserted by the proponents of this measure to obviate the need for getting a doctor's prescription, thereby reducing the cost of medication for a compound containing such drugs when such requirements are not necessary for the protection of the public health.
2. The measure provides (p. 2, lines 17 to 19, inclusive) that if the drug is a new drug and its effective application under section 505 limits its use under the professional supervision of a practitioner licensed by law, shall continue to carry such restriction. This the present law already so provides. H. R. 3298 makes no significant changes except as is provided in the provision contained on page 3, lines 3 to 6, inclusive, to permit sales without a prescription when such requirements are not necessary for the protection of the public health.
With this provision of H. R. 3298 the opponents likewise can find no quarrel, because it is proper and just as is borne out by experience that such precautions are necessary for the protection of the public welfare.
So far even the opponents of this measure seem to raise no serious objection. The strenuous objection, however, is evidently aimed at that provision of H. R. 3298 which provides (p. 2, lines 12 to 16) that a drug be restricted to sale by prescription only if the drug
“(2) has been found by the Administrator, after investigation and opportunity for public hearing, to be unsafe or ineffective for use without the pro
fessional diagnosis or supervision of a practitioner licensed by law." No one with reason will dare maintain that drugs which are unsafe or ineffective for use without professional diagnosis or supervision of a licensed practitioner should be placed in the hands of a layman for unsupervised use. The very aim, purpose, and philosophy of the Food, Drug, and Cosmetics Act, as enacted in 1938, was to curb this practice as it then existed.
It is, therefore, conclusively apparent, and without argument to the contrary, that drugs that are unsafe or ineffective without medical supervision ought not to be permitted to be sold without some definite, clearly recognizable, and legal restriction.
The objection, therefore, must resolve itself to the single issue-namely, who should choose the drugs to be so restricted. For nearly 12 years, since the enactment of the present FDC Act, the manufacturers have chosen which drugs are to be regarded as unsafe or ineffective and restricted to sale by prescription only by using the so-called prescription legend label which reads: "Caution: To be dispensed only by or on the prescription of a physician, dentist, or veterinarian, or otherwise used only for manufacturing purposes.' The proponents in their testimony have clearly and profusely demonstrated to this committee by dozens of exhibits and practical experiences, the confusion, the ambiguities, and the laxity the prevailing practice has brought about, not only to the detriment of the public, but even to the inconvenience and the disrepute to the pharmaceutical profession engaged in the distribution of drugs and drug devices.
The practice as is now followed with respect to the choice of drugs to be restricted, permits every Tom, Dick, and Harry to so label a drug or device as would permit him to say or create the condition or situation when a person who distributes such a drug may be branded a violater of the law and subject him to the penalties provided: namely, 1 year in jail and/or $1,000 fine. In other words, as it is now, the right to declare a druggist a criminal for breaking a prescription legend label, instead of it being delegated to an authorized constituted body or person, is left to every Tom, Dick, and Harry—this without a public hearing, investigation, or an appeal, as is provided for in H. R. 3298.
The practice and manner of choosing unsafe or ineffective drugs to be limited to sale by prescription only, as is now followed by the manufacturers under the exemption rule of the so-called prescription legend label, as has been shown by numerous exhibits, has been selfishly abused and flaunted by the manufacturers to the detriment of the public welfare. The present practice impedes the pharmaceutical as well as the medical professions to serve the public with medicaments more economically and more adequately. The practice as it is now followed by the manufacturers under the present law is unfair, confusing, impractical and illegal. The present practice of restricting drugs to be sold on prescription only results in hardships and is contrary to the welfare of the public, as well as to those who serve them-particularly the pharmaceutical and medical professions. The present practice warrants and demands correction, which can be accomplished only by a precise legislative enactment.
This witness in behalf of the proponents maintains that the provision of H. R. 3298 in this respect, in the face of experience, provides a practical, legal, and democratic approach to the problem of choosing the types of unsafe or ineffective drugs and devices which ought to be restricted to sale upon a prescription only.
The opponents have vehemently and repeatedly shouted that H. R. 3298 is a bureaucratic measure. This witness in fairness and logic asks:
Is it bureaucratic for those charged with compliance of a law to ask that its provisions be clarified as to obviate confusion and uncertainties.
Is it bureaucratic to ask that the designation of conditions and situations which brands one a violator of law be placed in an authorized and legally constituted