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The CHAIRMAN. This will conclude the hearings on this bill. (The following matter was submitted for the record:)
AMERICAN MEDICAL ASSOCIATION,
Chicago, May 8, 1951, Hon. ROBERT CROSSER, Chairman, Committee on Interstate and Foreign Commerce,
House of Representatives, Washington, D. C. DEAR SIR: I am informed that the House Committee on Interstate and Foreign Commerce desires an expression of opinion from the American Medical Association concerning H. R. 3298, a bill introduced by Congressman Durham, to amend section 503 (b) of the Federal Food, Drug, and Cosmetic Act.
This bill has been given consideration by our committee on legislation. Some members of the committee feel that the proposed legislation has implications not readily apparent and for that reason the committee, at its recent meeting, deferred action pending further study. It is expected that the committee will again consider the bill at a meeting to be held at Atlantic City, June 13. Yours truly,
ERNEST B. HOWARD.
SUPPLEMENTAL STATEMENT OF HERMAN S. WALLER, LEGAL COUNSEL FOR THE
NATIONAL ASSOCIATION OF RETAIL DRUGGISTS The principal proponents of H. R. 3298 are the 35,000 members of the National Association of Retail Druggists. Every one is an independent owner of one or more drug stores. Together they employ about 70,000 pharmacists. The N. A. R. Ď. was mandated in convention assembled on two occasions to seek a solution of Federal restrictions on prescriptions through legislation. Hence the reason the N. A. R. D. appeared before the Committee on Interstate and Foreign Commerce in support of H. R. 3298.
Because of the confusing statements and issues raised by the opponents to this measure, we feel impelled to make this supplemental statement to the committee, in order to clarify and reveal the real issues involved, so that the committee may be thoroughly apprised of the existing problem. H. R. 3298 seeks to solve.
First and foremost, the opponents tried to infuse a scare in the minds of the committee by the remarks made by Mr. Charles W. Dunn, who represents the American Pharmaceutical Manufacturers' Association, in his prepared statement (p. 172 of the record) he said: “The third objection to the administrative authority is that it is certain to increase the cost of medical care to an important extent that cannot be measured now; for this authority is bound to be progressively exercised; it can only be exercised to converi nonprescription drugs into more expensive prescription ones, and there is a wide area for this marginal exercise, which is open for infinite Government exploration. And I may say that the members of the National Association of Retail Druggists will be very much interested to cooperate with the FDA in the extension of this prescription-drug law to place more drugs on a prescription basis, where there is a greater profit to them.'
Representative Charles W. Wolverton of New Jersey was justifiably apprehensive of this statement when he said in a question put to Mr. Dunn, as well as to other witnesses, "Now, I was impressed with the point that you were making with respect to this increasing necessity for prescriptions, which would add to the cost, to the consumer patient.”
Analysis of H. R. 3298 clearly and unequivocally shows that each provision thereof, on the contrary, aims directly at reducing and eliminating in a large area, the need for
a doctor's prescription for the sale of many well-known household remedies. The present law requires a written prescription each time a prescription for these simple remedies is refilled. H. Ř. 3298 would repeal this requirement.
H. R. 3298 will decrease the necessity for prescriptions and thereby decrease the cost of medical care.
First, H. R. 3298 amends the present law to permit the druggist to dispense drugs upon a prescription if phoned in by the physician. This not only obviates the inconvenience to the patient and physician, but affords quicker and more adequate service to the sick. It materially reduces the cost of the medication
by eliminating the expense entailed in calling for the prescription from the patient's house. This provision will also permit the doctor to tell the patient to purchase a certain drug or compound without the need of writing a prescription for it.
Second; H. R. 3298 will also so amend the present law as to permit the druggist to refill a prescription without consulting the doctor if the prescription called for drugs which are not specifically restricted to be dispensed on prescription only. And even if the drug is restricted to prescription sale only, the proposed measure specifically provides that the druggist may dispense the drugs upon the oral authority of the doctor, providing the druggist himself reduces such authority to writing and files it. In each instance under this provision, the only aim and purpose of the proponents of the measure is to reduce to an absolute minimum the need for a doctor's prescription when such is not necessary for the protection of the public health, a practice which will materially reduce the cost of medication, and afford more adequate service to the public by the medical and pharmaceutical professions.
Third; H. R. 3298 further reduces the requirements for a doctor's prescription, since it provides a means of limiting the number of drugs to be sold on prescription only. It authorizes a legally constituted governmental agency to select the list of drugs to be so restricted. And as a further public protection the provision limits the selection of the list so restricted to those drugs which are habit forming, and those drugs which, after investigation and an opportunity for a public hearing, have been declared to be unsafe or ineffective for use without the diagnosis and supervision of a licensed practitioner.
Fourth; H. R. 3298, to further carry out the aims and purposes of reducing the cost of medical care, also provides on page 3 in lines 3 to 6, inclusive, authority for the Administrator of the law to relieve from restrictions the sale of drugs upon a doctor's prescription even though such drugs may be habit forming or new drugs when dispensed in small dosages when a prescription is not necessary for the protection of the public health.
Fifth, another vivid and real demonstration that the aim of the proponents, the retail druggists, in urging the passage of H. R. 3298 is not, as is asserted, to increase medical costs, but instead to reduce the costs, is evidenced by their opposition to the suggestion that the measure provides that an oral prescription or å refill for a restricted drug be confirmed within 72 hours by the doctor's written confirmation. This objection on the part of the proponents rests not only on the fact that such a provision will serve no practical purpose or public good, but primarily also because such a requirement would without purpose and public benefit increase the cost of getting a written confirmation of a prescription for medication which has already been dispensed and probably has served its purpose. This cost of getting a written prescription to confirm on oral authority to dispense the drugs would further be augmented by the additional cost reflected in the expense incurred by the druggist chasing such confirmations, as well as the added cost of unnecessary recordkeeping.
As was aptly stated by Mr. Warnack, a retail druggist from Los Angeles, à witness in behalf of the measure (on pp. 80 and 81 of the transcript), in reply to Representative O'Hara's question:
“Mr. O'HARA. With reference to the suggestion that has been made that the doctor, within 72 hours, confirm the telephone prescription, what are your comments on that? Is that too long a time, or what is your thought on that?
“Mr. WARNACK. My comment on that is that it is too long a time; that any requirement for a written confirmation is unnecessary and serves no useful purpose. As a matter of fact, if the prescription is bona fide, and there is every reason to believe that it would be, confirmation would serve no useful purpose. If there was fraud, 24 hours, 48 hours, or 72 hours would be too late to do any good, and if there was any possibility for fraud one could not get confirmation.”
Again on pages 93 and 94 of the transcript, of interest is Mr. Warnack's reply to Representative Williams' question.
“Mr. WILLIAMS. Mr. Warnack, perhaps I might be a little biased in my consideration of this legislation; I have a little personal or selfish interest in it, being the son of an old-time druggist.
"In regard to what the gentleman from Minnesota (Mr. O'Hara) asked you a few minutes ago about the 72-hour provision on taking prescriptions over the telephone from doctors, I think possibly you might clear that up for him if you would tell him that the fraudulency of a prescription given over the telephone would be immediately suspected by the druggist, would it not, because of the very make-up of the drugs which would be ordered?' In other words, if a person was going to order a prescription fraudulently, he would include some narcotics,
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. WARNACE. 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 anyoue 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 poient, 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 prom.iscuous 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 ühe aim and purpose of proponents of this measure is to so amend the preseno 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 praciicing 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 out 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.”