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Mr. Ewing. That is true. My objection to it fundamentally is a constitutional objection, because I think if you would check up on those decisions you would agree with me that the procedure provided here with respect to a trial de novo in the circuit court of appeals would probably be unconstitutional.
Mr. O'HARA. I would be very interested if your counsel would care to file some citations of authority on that question.
Mr. GOODRICH. I think I can state those now. Keller v. Potomac Electric Co. (261 U. S. 428); Federal Radio Commission v. General Electric Co. (281 U. S. 464); Federal Radio Commission v. Nelson Bros. Co. (289 U. S. 268).
Mr. O'HARA. That is on the question of certain things which the administrative department is charged with doing?
Mr. GOODRICH. Those are on the constitutional question-the permissible scope of review by a constitutional court. The leading case under the present law, I suppose, is Federal Security Administrator v. Quaker Oats (318 U. S. 218), which interprets the present law under section 701 (f).
Mr. O'HARA. But that is under a provision which does not permit a trial de novo in the circuit court of appeals?
Mr. GOODRICH. That is correct. I should say that recently the Third Circuit has held in Creamwipt Salad Dressing v. Federal Security Administrator that the Universal Camera decision recently decided by the Supreme Court is applicable to the present law.
Mr. O'HARA. As I stated before, it has completely changed the preexisting notion of the Supreme Court. There was very little review, as a matter of fact, but they placed greater responsibility on the Circuit Courts of Appeals in the Camera case.
Mr. GOODRICH. The point I am making is that there has already been a Third Circuit Court decision holding that the Supreme Court's decision in the Universal Camera case was applicable under section 701 (f) of the present law.
Mr. WOLVERTON. Mr. Ewing, I realize the complications in this act. It is very difficult to understand it in all of its details. But looking at it from the standpoint of the over-all objective, would this bill, if enacted, increase the necessity of getting refill prescriptions, or decrease it?
Mr. EwIng. It would increase the necessity of getting refill prescriptions very much.
Mr. WOLVERTON. I am looking at it from the standpoint of the patient or the consumer or whatever you wish to call him. If he had to go back to the doctor to get a refill in every instance, which would mean an additional fee, I can see how it might be highly desirable from the physician's standpoint, but it would not be so desirable from the standpoint of the patient and probably not from the standpoint of the druggist. So that there is an economic question that enters into it, as to whether it will increase or decrease the necessity of getting refill prescriptions.
Mr. Ewing. This bill has tried to meet that question, Mr. Wolverton, by specifically providing that the doctor can put on the prescription, the first prescription he gives, that this can be refilled. Then there is no limit to the number of times it can be refilled.
Mr. WOLVERTON. But if he does not put that on, then it would be necessary to go back and cousult the physician again.
Mr. EWING. That is true.
Mr. WOLVERTON. And it might require the payment of a fee to get it refilled.
Mr. EWING. That is, of one of the dangerous drugs which, by definition, was a type of drug that should only be dispensed and taken under a doctor's supervision.
Mr. WOLVERTON. That is where the complication comes in so far as I am concerned-in determining what is a dangerous drug. How is it determined to be dangerous and which ones would be permitted to be refilled without a physician's direction that it might be. I am interested from the standpoint of the patient and the trouble he must go to to get a refill and if it necessitates additional expense to him.
Mr. Ewing. I think you have a very real point and one that was brought out the other day when I saw that some publication reported that some doctors had a long dissertation on how dangerous it was to take aspirin except under the direction of a doctor. I think it is a thing where I do not know what you can do but leave it to the good judgment of someone whom you believe would try to act fairly and honestly on the thing; but you are certainly right. Whichever way you move, you have possible dangers.
Mr. WOLVERTON. Take a very simple case. Using aspirin as an illustration, in the case of the average patient, there is an absolute lack of ability to read prescriptions. Sometimes I wonder how the druggist reads them from the handwriting that appears on the prescription; but, aside from that, they may use a technical name. I would not know whether they can for aspirin or not, whether that is the accepted name of the chemical or whether it has several ingredients which you could prescribe which, in effect, would be aspirin.
Now, suppose a physician gave aspirin tablets to someone. Is there any possibility under this bill, that it would require the patient to get another prescription for a refill?
Mr. Ewing. Well, as of today, I would say "No," but I think you have to recognize that under this bill you might have an Administrator who would call a hearing to put aspirin on the list of dangerous drugs. If he held that aspirin was a dangerous drug and that was appealed to the circuit court of appeals and they upheld it, then you would be in that situation.
The two safeguards you have really, the main safeguard you have is the judgment and fairness of the Administrator, because in the appeal to the circuit court of appeals, if there was substantial evidence in the record to sustain the Administrator's finding, I do not see how the circuit court of appeals could do anything about it. The difficulty is that these are problems that are inherent in any situation where you have to control trade of any kind, and it is unfortunate and very difficult to frame legislation to prevent abuses and at the same time not set up a cumbersome machine that might
Mr. WOLVERTON. The statement you have made to the committee leaves no doubt as to your viewpoint on an over-all plan. However, I am concerned a little bit, and maybe more than a little bit. I do not want to do anything in the name of protecting the patient that unnecessarily might add to the expense incident to his obtaining that particular prescription. The cost of medicine today is such that I think we ought to take that into consideration, because it is getting
go too far.
into such realms now that it does seriously interfere with the average person getting the medical treatment he wishes on his own responsibility.
Mr. Ewing. Certainly, for my own part, I think there is definitely a field for self-medication, but where the line is between that and where it should not be permitted is not easy to draw. About the only way you can do it is to take a particular drug and have a hearing on it and try to make an honest decision on it in that case.
Mr. WOLVERTON. Fundamentally, my thought is that I do not want to do anything by legislation that is going to increase the necessity of the patient obtaining a prescription to get a refill of a particular medication,
Mr. EWING. I think this, Mr. Wolverton: The thing that has caused most of the trouble is the barbiturate situation, because there have been grave abuses there. There have also been some abuses in connection with hormones.
Mr. WOLVERTON. In that connection, I was wondering if our difficulties in that respect are not in a large measure removed. For instance, I read an advertisement last night in one of our Washington papers-I am sorry I do not have it all with me, but I was interested in this hearing when I cut this part of it out. I was intrigued by the promises it makes.• It says “Sleep tight every night. No prescription needed for the nonhabit-forming”-I will not mention the name "sleep capsules.". And it goes on to say it eliminates all of these sleepproducing drugs that are looked upon as dangerous and contains none of them and that there are no opiates, barbiturates, or anything in it, except that it will put you to sleep. If that drug can do just what this says, maybe there won't be any need for taking barbital, and so forth, for sleeping.
The CHAIRMAN. It is necessary for the committee to suspend at this time, as there is a call of the House.
I understand there are a number of manufacturing druggists in the room, and I just want to say to them it would be very much better if they could agree on one or two spokesmen for any general aspect instead of trying to hear everybody, because otherwise we will never get through.
Mr. WOLVERTON. For the purpose of making the record as complete as possible, would it be appropriate to have made a part of the record the elaborate regulations which have been testified to?
Mr. EWING. Yes, sir.
Mr. WOLVERTON. Put it in your statement at the point where you refer to them, which is in the third paragraph, second line.
The CHAIRMAN. I think it would be a very good idea, and it is so ordered.
The committee will stand adjourned until 10 o'clock tomorrow morning.
(The committee thereupon adjourned until tomorrow, Wednesday, May 2, 1951, at 10 a. m.).
FEDERAL FOOD, DRUG, AND COSMETIC ACT
WEDNESDAY, MAY 2, 1951
Washington, D. C. The committee met at 10 a. m., Hon. Robert Crosser (chairman) presiding.
The CHAIRMAN. The committee will come to order.
Give your name and whom you represent for the benefit of the record.
STATEMENT OF ROY S. WARNACK, RETAIL DRUGGIST,
LOS ANGELES, CALIF.
Mr. WARNACK. Gentlemen of the Interstate and Foreign Commerce Committee, my name is Roy S. Warnack. I operate the Warnack Pharmacy at 1000 South LaBrea Avenue, Los Angeles, Calif. I have been a drug-store owner for 33 years and a licensed pharmacist since 1910.
I am a past president of the California Pharmaceutical Association and for 15 years I served the organization as executive secretary. My own experience and extensive acquaintance with druggists Nationwide enables me to know their problems and to understand them.
I come here today to support H. R. 3298. The bill is important to public health and the vital services of pharmacy.
The law as it is now contains six provisions that are obstructive to the efforts of the druggists to provide the medicinals available for the treatment of diseases.
The Food, Drug, and Cosmetic Act includes provisions:
(1) That make it illegal for a pharmacist to recognize an oral prescription from a physician:
(2) That require a written prescription from the prescriber for
(3) That allow a manufacturer to confine a medicine he makes to a prescription though it be nothing more than charcoal or molasses;
(4) That restrict numerous medicinals and many of them without the slightest justification;
(5) That make the pharmacist liable for mislabeled drugs sold over the counter;
(6) That contribute serious confusion through uncertainty and the inability of the pharmacist to determine limitations in a large number of instances.