I might remind you that in the Administrative Procedure Act passed by this Congress, in the review section it has been made. necessary for the circuit courts of appeals to go as far as this: You have said to us: So far as necessary to decision and where presented the reviewing court shall decide all relevant questions of law, interpret constitutional and statutory provisions, and determine the meaning or applicability of the terms of any agency action. It shall (A) compel agency action unlawfully withheld or unreasonably delaved; and (B) hold unlawful and set aside agency action, findings, and conclusions found to be (1) arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law; (2) contrary to constitutional right, power, privilege, or immunity; (3) in excess of statutory jurisdiction, authority, or limitations, or short of statutory right; (4) without observance of procedure required by law; (5) unsupported by substantial evidence. viewed on the whole record. So we do have, imposed by you, a solemn responsibility, and I assure you we discharge it with deliberation and pains. I I thank you very much for your attention. Before I close may express the regret of my colleague, Judge Biggs of the Third Circuit Court of Appeals, at not being able to be here today. Chief Justice Vinson asked both of us to come to be of assistance to the committee. Judge Biggs was unavoidably detained by judicial duties. He is familiar with my views. He has read my statement and participates in it. The CHAIRMAN. We appreciate your statement. Mr. DOLLIVER. Mr. Chairman? The CHAIRMAN. Mr. Dolliver. Mr. DOLLIVER. I just want to clear up one point of perhaps a misunderstanding in my mind. Actually what you are saying here is that you are not in favor of a trial de novo either in the district court or in the circuit court of appeals. Judge STEPHENS. That is right, sir. Mr. DOLLIVER. But you have no particular objection to a review? Judge STEPHENS. Not at all. Mr. DOLLIVER. You think that would be a proper procedure, to review the decision of this or any other administrative group? Judge STEPHENS. Of course that is a matter of congressional policy, but since you asked me I would be glad to answer you frankly. Mr. DOLLIVER. I would like to have you do so. Judge STEPHENS. I think that the ultimate orders of all administrators ought to be subject to judicial review. Mr. DOLLIVER. Would you say that they should go to the district court or to the circuit court of appeals? Judge STEPHENS. I think that the pattern already established by Congress of having the Administrator hold a hearing, if his action is adjudicatory or of a quasi judicial character, having him hold a hearing and make a record and take evidence and make findings of fact, and then having the review go immediately to the circuit court of appeals, just as the district court decisions go to the circuit court of appeals, is sufficient. Mr. DOLLIVER. In other words the record would be made by the administrator for review by the circuit court of appeals? Judge STEPHENS. That is right. Mr. DOLLIVER. Thank you. That is all. 84416-51-15 Mr. CARLYLE. Mr. Chairman? The CHAIRMAN. Mr. Carlyle. Mr. CARLYLE. Judge Stephens, a jury trial is never allowed in the circuit court of appeals, is it? Judge STEPHENS. I have never heard of one, sir. It is anomalous to have any trial in the circuit court of appeals. There is a minor exception, to be quite explicit. Sometimes when a particular type of case comes into the circuit court of appeals pendente lite relief must be allowed. It is extremely rare, but, for example, in the Circuit Court of Appeals for the District of Columbia Circuit, of which I am the chief judge, because Congress has the power to legislate for the District as well as the country generally, we have all the power of a circuit court of appeals and also the power of the common law courts, because there are no State courts. We perform both functions. Therefore, we get cases such as a divorce appeal, from the United States district court, which also has both common law and the Federal functions, in the circuit court of appeals. If such an appeal reached us, there might be an application to the court of appeals for support money for the wife pending the appeal. We would have to act upon it. In that event we might have to receive some evidence in the form of affidavits. That is as close as we ever get to a trial, except in a contempt proceeding originating in a court of appeals, and that is a rare occurrence. Mr. CARLYLE. If a trial de novo should be written into this statute where would the jury come from? Judge STEPHENS. It is not understandable where it would come from. I think I ought to preface my answer by saying this: The action of the Administrator under this bill is not, I think, in the nature of action in a criminal proceeding. It is true, of course, that the violation of the Food, Drug and Cosmetic Act may be followed by criminal prosecution, but so far as the Administrator's action under this bill is concerned, it is not in the nature of a criminal proceeding, and, therefore, a jury would ordinarily not be contemplated at all. But if the jury were required I do not know where we would get it. We have no witness facilities. We have no court reporter. It is utterly an anomalous proposition to have a de novo trial in the usual sense of that term in a circuit court of appeals. Mr. CARLYLE. You do not have a jury box. Judge STEPHENS. We have no jury box. We have no witness chair. We sit and listen to arguments. We read records and we read briefs, and we write opinions. Perhaps I should say that both Mr. Waller, the attorney for the Retail Druggists Association, whom I have been told is one of the proponents of this Act, and Mr. Goodrich, one of the counsel for the Administrator, have indicated to me that they have no interest at all in the de novo provision in the circuit court of appeals. I think Mr. Ewing in his statement made a similar declaration. I am sorry to have taken so much of your time, gentlemen, but from the standpoint of the Judicial Conference of the United States it is extremely important that we do not have a precedent established by Congress of having trials in the circuit courts of appeals. The CHAIRMAN. We appreciate your statement. Mr. HESELTON. It is my recollection, Judge, that you said the other day the Universal Camera case was an unanimous opinion. Judge STEPHENS. I believe so. I have it here. Mr. HESELTON. In view of the importance of the decision I did want this fact in this record. Judge STEPHENS. Yes; Congressman Heselton. It is the unanimous opinion in the subject with which we are now dealing. There was a separate opinion by Mr. Justice Black and Mr. Justice Douglas on one aspect of the case, but it does not have to do with the subject we are now discussing. Mr. HESELTON. Thank you. The CHAIRMAN. Thank you, Judge, for your fine presentation. Judge STEPHENS. Thank you, gentlemen, for the privilege of coming here. The CHAIRMAN. The committee will stand adjourned until further order of the Chair. Mr. WOLVERTON. The witness who preceded Judge Stephens stepped aside after his statement without opportunity for the committee to question him. I am wondering whether any members desire to do so. The CHAIRMAN. If there are no questions, this will conclude the hearings on this bill. Mr. WOLVERTON. Mr. Chairman, I would request that Mr. Fischelis be allowed to submit for the record certain material which has a bearing upon the bill. I understood he had made the request when he gave his testimony. I assume he will have the right to do so. I ask that it be granted. I have had an opportunity to look over it, and it is very important material. The CHAIRMAN. That will be allowed. (The information referred to appears on p. 132.) Mr. HALE. Mr. Chairman, I have a very brief letter here from Pierce's Proprietaries, Inc., in reference to this bill, which is succinct and helpful. I would like to have unanimous consent to include it in the record. The CHAIRMAN. That will be all right. (The letter is as follows:) Re: Durham bill, H. R. 3298. Representative ROBERT HALE, PIERCE'S PROPRIETARIES, INC., House Office Building, Washington, D. C. DEAR MR. HALE: H. R. 3298 by Mr. Durham would authorize the Food and Drug Administration to place practically any drug on the list that must be sold only on prescription. The Food and Drug Administration should not have this life-and-death power to prevent drugs from being sold over the counter to consumers, and this authority isn't necessary. The present food and drug law adequately protects the consumer and I urge you to oppose the Durham bill and particularly this provision. Sincerely yours, R. V. PIERCE, President. The CHAIRMAN. This will conclude the hearings on this bill. Hon. ROBERT CROSSER, Chicago, May 8, 1951. 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. D. 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. I 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 convert 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 a 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, a 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, |