on the far larger number of legitimate users. I think perhaps a solution of this problem might be found by permitting telephoned prescriptions for limited quantities, to meet situations where use of written prescriptions is impractical, such as permitting a telephoned prescription, say, for a couple of days' supply rather than for an unlimited amount. The only other major point I wish to make about the bill is to urge you most strongly to reconsider the anomalous, and I think unconstitutional, provisions it contains in the respect to judicial review of orders listing prescription drugs. I firmly believe in judicial review in matters such as this, for I am only too well aware that we bureaucrats can make mistakes as well as anyone else; but I am equally convinced that the traditional pattern of such review, expecially as it has recently been restated in the Administrative Procedure Act, affords adequate means of correcting such mistakes without injecting the courts into areas inappropriate to the judicial process, in which they cannot in the nature of the case have the expertness of an administrative organization. To amplify that a little, this bill permits an appeal to the circuit court of appeals from the action of the Administrator in putting a drug on the list that would require it to be dispensed only by prescription, or refusing to do so, or taking it off, or refusing to take it off. The act as it is drafted provides that in the circuit court of appeals there shall be no presumption but that it would be, in effect, a trial de novo. I personally do not think that there is any question but that that would be regarded as an unconstitutional delegation of power and I would urge that the bill be amended to bring it within the terms of the Administrative Procedure Act, the constitutionality of which has been upheld. Mr. DOLLIVER. A delegation of power to whom? Mr. EWING. To the courts. Article III of the Constitution places. the judicial power of the United States in the courts and the second sentence of that article requires that there be a case-in other words, there has got to be an adjudication of existing legal rights. The act does delegate certain matters to the Executive, but these are executive powers which are prescribed, because the act gives the outline of the legislation and lays down the rules to govern the action of the administrative body. This is merely filling in details and that has been held to be an administrative act which is properly vested in an administrative officer. In several respects the bill lacks something of clarity, and I feel sure you will wish to examine its wording with care. Our technical staff will, of course, be at the committee's service for any aid it can render in this process. In conclusion, gentlemen, let me say that the more I have studied. this problem, the more I am convinced that legislation is called for. The bill before you would strengthen the legal controls which prevent abuses at the expense of the public, and at the same time would remove unnecessary and annoying restrictions on the practice of pharmacy. While in some points the bill is a compromise, I believe it is a good compromise. I recommend its enactment. The CHAIRMAN. Are there any questions? Mr. BECKWORTH. How large is that twilight zone that you were talking about? Are there vast numbers of drugs that would fall in that category? Mr. EWING. I think it is pretty big, Mr. Beckworth. There are any number of drugs that you could say are clearly on one side or clearly on the other, but many are in the intermediate category, and as to them it is very difficult to say. Mr. BECKWORTH. What would constitute the routine by which you could cause that twilight zone to become smaller? Mr. EWING. I think this bill provides the routine for eliminating the twilight zone. That is why I like its approach; that is, the definite listing of the drug, putting it on either the required prescription list or saying that it can be sold over the counter. Mr. BECKWORTH. I should assume that some drugs are made up with more than one ingredient. Mr. EWING. Oh, yes. Mr. BECKWORTH. Might there be a situation where if a given drug contains a certain percentage of a certain ingredient it would be in one zone and if it had a different percentage, it would be in another zone? Mr. EWING. I think that is definitely possible, yes. Mr. BECKWORTH. Would that provide an excellent opportunity for evasion by changing the percentages? Mr. EWING. I would not think it was an evasion if it were changed; in other words, under the narcotic laws you have exempted preparations that have such a small percentage of narcotics in them that the Government does not feel there is any necessity for a prescription as to those. But if you increased those percentages, it would put them over on the other side of the fence. Mr. BECKWORTH. What I have in mind is that there may be some concerns that would dislike their drug being placed in one category and therefore they would undertake to make up the drug in such a way that it would get into another category. I am wondering if that could become a great problem? In other words, would this really do the job in regard to the kind of problem that I am posing here? Mr. EWING. I should think it would. Experience might prove otherwise. But certainly our best guess today is that this would do the job certainly far better than under existing law. Mr. BECKWORTH. With reference to the matter of telephoned prescriptions, you feel that there is no foreseeable problem of any great consequence that would develop by that change? Mr. EWING. No; I do not, Mr. Beckworth. I have not a doubt that there will be some abuses, but when you balance the advantages against those, when you balance the ability of the doctor to take care of an emergency situation by telephone in thousands of legitimate cases as against a few cases of abuse, I think the first far outweighs the second. Mr. BECKWORTH. Would you restate your opinion as to the necessity of the doctor's confirming the telephone prescription within 72 hours? Mr. EWING. Our reason for that is this. I think it is a protection to the pharmacist if the doctor confirms the prescription, for the simple reason that the druggist can compare it then with his copy, with what he put down on the basis of the telephone conversation. If there is any mistake, he could get hold of the purchaser of the prescription and make the correction. Furthermore, it seems to me that we ought to put a little responsibility on the doctors in connection with these telephone prescriptions. Of course, the real danger probably is, Mr. Beckworth, of the barbiturate addicts, or one of them, getting on the telephone and saying, "I am Dr. Smith, will you send me these particular pills," whatever they may be, "to such and such address; it is an emergency." There is certainly a danger of that. On the other hand, you have got to balance that danger against the good that may come from permitting telephone prescriptions. We think even as to those barbiturates, that particular class of dangerous drugs, if a telephone order can be placed only for a limited supply, the total amount of which would not be a lethal dose, then there is not any great danger and it would be a practical way of meeting that situation. Mr. BECKWORTH. That is all. Mr. HELLER. Mr. Ewing, with reference to the last observation that you made, that somebody might get on the telephone and say, "I am Dr. So-and-so and I want some sleeping pills," I get the impression that thereafter, within 72 hours, there would be a requirement that there be a confirmation of that prescription; is that so? Mr. EWING. Yes; that is our suggestion. That is not in the bill. Mr. HELLER. Would it not be too dangerous to wait that long a period of time for a confirmation? I am looking at it from the practical standpoint; that is, if you get a call and there is no confirmation required for 72 hours after the call is made, is that not too great a lapse of time? Mr. EWING. Well, it is just a matter of judgment, as to whether it ought to be 24 hours, or 36 hours, or 48 or 72. That was in Mr. Durham's original bill. It was in the bill in the last Congress. For that reason we accepted it. But if the committee made a change either way, that would be all right. Mr. HELLER. There is a good deal of danger involved there, though, is there not? Mr. EWING. I do not know; I think it is about right. That would be my feeling. By the way, that is a provision in the New York State law now and I do not think they have had any great difficulty with it. Mr. HELLER. I do not have a definite recollection of the law, but I did not think that it permitted confirmation after 72 hours. Mr. EWING. That is what I am told. Mr. HELLER. Is that so? Mr. GOODRICH. Yes, sir. Mr. HELLER. Just one or two other questions. You referred in your statement to drugs that can be safely dispensed; is that correct? Mr. EWING. Dispensed or sold without a prescription. Mr. HELLER. How can that be decided? Mr. EWING. It is just a matter of someone's judgment. Mr. HELLER. And whose judgment would that be? Mr. EWING. That would be the Administrator's judgment after a hearing and the taking of evidence. Mr. HELLER. The taking of testimony? Mr. EWING. Yes, sir. Then there would be an appeal if the procedure of the Administrative Procedure Act is followed, and there would have to be substantial evidence in the record to support the finding. Mr. HELLER. Would there be findings of fact made and submitted to a court for review; is that the idea? Mr. EWING. As I recall, the Administrator makes a finding and an order a finding of fact and an order, what we call in New York a finding of fact and conclusions of law. Then the party may appeal on that record and the whole record then goes up, all the evidence taken at the trial and the exhibits. Mr. HELLER. Where would that go, to the United States district court or the circuit court of appeals? Mr. EWING. It goes to the circuit court of appeals. Mr. HELLER. Without any hearing in a Federal court, is that the idea? Mr. EWING. Yes. Mr. HELLER. You said, I believe, that you have received numerous objections to this bill; am I correct in that understanding? Mr. EWING. I have understood that there were; yes, sir. Mr. HELLER. Briefly, could you tell the committee what was the tenor of those objections? Mr. EWING. I think the matter of the list is the most controversial provision in this bill. I think I am right in that. Some of the manufacturers have indicated that they were not happy about it. They will be here, Mr. Heller, to express their views. 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 with respect to 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 prepared 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 bill provides machinery that would make that whole procedure much better and eliminate the so-called twilight zone. Mr. HELLER. Is the determination in the case of United States v. Sullivan, which you quoted in your statement, one of the reasons for sponsoring this bill? Mr. EWING. No. The effect of that decision was this, Mr. Heller. Up to that time there was a question whether Federal law applied after a drug had got into the hands of a pharmacist when he had bought it from a local wholesaler in the same State; there was a question whether the Federal law still applied and the Sullivan case held that it did. Mr. HELLER. Do you not feel at the present time that the Administrator has broad enough discretion to cope with this problem? Mr. EWING. No, sir. Mr. HELLER. You do not think so? Mr. EWING. No; not to do the job that should be done. Mr. HELLER. According to the decision of this court at page 690- Mr. HELLER. The Sullivan case, yes; it says: The broad discretion given the Administrator to excuse minor violations with a warning and to issue regulations exempting many articles from the labeling requirements when compliance is impractical. In other words, it says that you do have that discretion at the present time and if you do, would it not seem unnecessary for this bill to be brought before the Congress? Mr. EWING. I will tell you, Mr. Heller; it is perfectly true that in the Food and Drug Act there is a provision that permits the Food and Drug Administration to overlook minor violations of the law and not prosecute, but to me, as a lawyer, that is a provision that I do not like at all. That is a bureaucrat's dream-of deciding whem he will prosecute and whom he will not prosecute. It is revolting to every concept of justice that I have. To me the law or certainly the regulations, so far as possible, should make it perfectly clear on which side of the line a particular action falls. Mr. HELLER. In other words, it resolves it into a definition of terms? Mr. EWING. Yes, sir. Mr. HELLER. Thank you, sir. Mr. DOLLIVER. You have alluded to the fact, Mr. Ewing, that in the State of New York there is a 72-hour regulation on telephone prescriptions. Is it not true that every State has a large volume of laws and regulations on this subject? Mr. EWING. Not every State. Many of them do. Offhand, I would say about two-thirds of them do and about one-third of them do not, but do not hold me to that. Mr. Durham says 32 States have laws; so I was not far wrong. Mr. DOLLIVER. Would your organization be able to furnish the committee with a summary of those laws? Mr. EWING. Yes. Mr. DOLLIVER. Would it be permissible to insert that in the record, Mr. Chairman? I think that is quite important to have in this discussion. The CHAIRMAN. Without objection, it is so ordered. Mr. DOLLIVER. You will see that that is done? Mr. EWING. Yes, sir. (The information requested follows:) |