Mr. DOLLIVER. The legal basis for this kind of legislation comes from the Sullivan case and other cases similar to that which preceded it in the courts; is not that true?

Mr. EWING. Yes.

Mr. DOLLIVER. And this legislation would establish or tend to establish uniformity of regulations with respect to the dispensing of prescription drugs; would it not?

Mr. EWING. My understanding of the legal situation on that is that if you have a Federal law and have a State law-take a druggist in Michigan, we will say; if his State law is more strict than the Federal law, he has to obey the State law; on the other hand, if the Federal law is more strict than the State law, he has to obey the Federal law. He has to obey the one that is more strict.

This would establish a rule for those States that have no laws on this problem.

Mr. DOLLIVER. It would set minimum standards in some States and maximum standards in others?

Mr. EWING. Yes.

Mr. DOLLIVER. Do you have any knowledge, Mr. Ewing, as to the attitude of the pharmaceutical profession generally about this legislation, or will we hear from them?

Mr. EWING. You will hear from both the big national pharmaceutical organizations-the Retail Druggists Association and the American Pharmaceutical Association.

Mr. DOLLIVER. Of course, we all recognize the profession of pharmacy is a learned profession with high standards of professional conduct with respect to the distribution of drugs

Mr. EWING. Completely.

Mr. DOLLIVER. Either drugs that are dangerous or otherwise.
Mr. EWING. Completely.

Mr. DOLLIVER. They have very high standards of professional education and professional conduct.

Mr. EWING. Completely.

Mr. DOLLIVER. I may say in closing that the question of these telephone prescriptions is of very great importance in the rural area I represent. I have some communities in my district which have no doctors in them at all, and the doctors in an adjacent town will call the druggist in that town and say "This person needs this kind of a drug," and it may be an emergency situation which requires the use of the telephone. So I am completely in sympathy with the idea that telephone prescriptions should be permitted.

Mr. EWING. Yes.

Mr. CARLYLE. Mr. Ewing, I have studied this bill of Mr. Durham's, and I find on page 2 of the bill, line 14, two words that are a little confusing to me, namely, the two words "or ineffective.", Do those two words add anything to the bill?

Mr. EWING. The way that is drafted, it is—

unsafe or ineffective for use without the professional diagnosis or supervision of a practitioner licensed by law.

Mr. CARLYLE. What value do those two words have in that connection?

Mr. EWING. Well, you have the problem, Mr. Carlyle, of drugs being sold under representations that they are cures for everything

on earth, and very often they will prevent a person from going and getting proper professional help on those things until it is too late.

My associate here says that this was designed to meet a case, for instance, of penicillin, which has no toxicity; yet it is a type of drug that should not be dispensed or used except under the supervision of { physician.

Mr. CARLYLE. Would not "unsafe" cover that?

Mr. EWING. Not necessarily. It might, but not necessarily.

Mr. CARLYLE. "Which is unsafe" means a drug that is ineffective and would it not be difficult always to define what would be effective at one time on some person and ineffective at another time or what would be effective when applied to one person and ineffective when applied to another?

Mr. EWING. We think this adds something to the protection of the bill, but it is nothing I would die for.

Mr. SCOTT. Following up Mr. Carlyle's question, how would you answer this question: What drug is effective in the treatment of the common cold?

Mr. EWING. I do not think this deals with the effectiveness of the drug so much as merely that it is ineffective except under the proper direction of a physician.

Of course, going back to your cold question, I once asked my doctor for a good cold remedy, and he said there are a thousand of them, and if there was any one of them that was worth a damn, there would be no reason for the other 999.

Mr. SCOTT. But I do not want him to prescribe 14 handkerchiefs and 14 days in bed. [Laughter.]

Mr. HARRIS. Following up that same question, it is a fact that in many instances if the proper dosage is not given, it is ineffective; is it not?

Mr. EWING. That is just the point.

Mr. HARRIS. I do not know enough about it to indicate the effectiveness of it, but I used to hear if a person took an overdose of strychnine, it would not bring about death. Certainly that would be ineffective. Is that true or not?

Mr. EWING. I do not know. I am not going to try it. [Laughter.] Mr. HARRIS. It is true that if some people, at least, take an overdose of penicillin, it is very effective; is it not?

Mr. EWING. I do not know that I can answer that.

Mr. HARRIS. I know I took a dose of that at one time given to me by a doctor for about 3 days, and I was just broken out all over. Mr. EWING. A small dose might have done the same thing to you, because maybe you happen to be allergic to it.

Mr. HARRIS. I have not taken any since; I know that.

Now, you were talking a moment ago about the responsibility of the doctor, and I thoroughly agree that there should be some responsibility on the doctors. Is there any way you can tell where the responsibility of the doctors ends and the responsibility of the pharmacist begins?

Mr. EWING. I think if you have this list as Mr. Durham's bill proposes, you would pretty much put the entire responsibility on the doctor and, to me, that is where it belongs, for prescribing what the patient should take, the quantities, the dosage, the times, and all that.

Mr. HARRIS. In carrying out the orders of the doctor, there is a vast responsibility on the druggist; is there not?

Mr. EWING. Oh, certainly 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 of a drug that must be dispensed on a prescription, namely, if

such 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, is 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 understand it.

Mr. EWING. I did not make this regulation myself.

Mr. HARRIS. I know. I was talking about the responsibility of labeling, strictly. I am just asking for information. I cannot see why there should be such a burden on the druggist to have to write out a label and put it on the prescription. Is that what you are trying to relieve?

Mr. EWING. Oh, no. You see, under the law, a drug is misbranded unless its label bears (1) adequate directions for use.

Mr. HARRIS. That is right.

Mr. EWING. That is one thing the Administrator is authorized to waive by regulation-then (2) that it contains adequate warning against the use in those pathological conditions, and so forth, that I read awhile ago, and then, to go on, "even though it is being dispensed under the direction of a physician." And we do not think there is any point in requiring this warning and all that if the doctor is taking the responsibility for prescribing the medicine.

Mr. HARRIS. You say on page 3 "The Administrator may by regulation remove drugs subject to section 502 (d)." That has to do with certain habit-forming drugs; is that right?

Mr. EWING. Yes.

Mr. HARRIS. Does that give the Administrator authority to remove by regulation any restrictions with reference to narcotics?

Mr. EWING. No. We do not deal with narcotics.

Mr. HARRIS. I wanted to be sure you did not, by this language. Mr. EWING. Oh, no.

Mr.HARRIS. It has been called to my attention that no representative of the medical profession is presently scheduled to appear as a witness on this proposed legislation. Of course, knowing how well you always get along with the medical profession, I thought you could advise us as to whether or not that profession is going to be represented or how they feel about it.

Mr. EWING. They have not notified me, Mr. Harris. [Laughter.] Mr. HARRIS. Is there any way you have learned of any particular opposition of the organized medical profession; have you heard any expression one way or the other about it, or do you know?

Mr. EWING. No; I do not. I understand some of the witnesses will be able to answer that.

Mr. HARRIS. Thank you very much.

Mr. BEAMER. I have just one question for information that follows along Mr. Harris' comment. On page 3 you refer to the fact of when a caution label is required. Could you tell me some caution labels that are not required? Are not caution labels required under the present act to bear the statement "Caution: Federal law prohibits sale or dispensing without prescription"? I know I have been given bottles and prescriptions that have had caution labels on them. Is this a new prohibition you are suggesting in this bill?

Mr. EWING. I will ask Mr. Goodrich to answer that.

Mr. GOODRICH. The present caution label for prescription items is "Caution: To be dispensed only by or on the prescription of a physician."

The CHAIRMAN. Suppose you give your name for the record.

Mr. GOODRICH. My name is William W. Goodrich. I am attorney for the Federal Security Agency.

That is the only caution legend, as such. There are certain warnings on prescription drugs; there are also certain warnings on other drugs in accordance with section 502 (f) (2). That is a warning against misuse or a warning against the use in pathological conditions where it may be dangerous. It varies from drug to drug, but the standard caution label now on all prescription items is the one I quoted.

Mr. BEAMER. In other words, this would throw the burden back on the pharmacist-to require this particular label?

Mr. GOODRICH. This particular label would be required for the protection of the pharmacist, so that he could look at the bottle and know, if it had that legend on it, it was a prescription item and was not to be sold over the counter.

Mr. BEAMER. It only protects him where he is asked to refill it? Mr. GOODRICH. Yes. It will say on there "Caution: Federal law prohibits sale or dispensing without a prescription."

Mr. BEAMER. Would that extend back to the manufacturer of the product?

Mr. GOODRICH. Yes. The manufacturer would be required, if he sells a drug listed in that list, to put this statement on. Then the druggist would be in a position to rely on that statement.

Mr. O'HARA. Mr. Ewing, in the light of Mr. Harris' question, there is no claim that there is any socialized medicine in this bill; is there? Mr. EWING. Not by us.

Mr. HARRIS. Certainly there is no implication of that on my part. [Laughter.]

Mr. O'HARA. Of course, the dispensing of medicines or drugs is extremely important to three groups of people-the doctor, the druggist, and the person who is taking them. In the past, Congress and your agency and the public generally have been concerned with the protection of the public. I suppose it is true that the average layman does not have any knowledge of drugs. I know I do not have. I go to my doctor and he gives me a prescription which is something I cannot read. I take it over to the druggist, and I have great confidence in him tha the is going to transcribe onto the label on my bottle what I am supposed to do.

Do I understand that this bill in any way relieves the druggist of placing on the label on the bottle the instructions which I should have?

Mr. EWING. Oh, no; in no sense. He must put on the prescription drug, if the drug is one that can only be dispensed on prescription, a label containing the name and address of the dispenser, the serial number and date of the prescription or of its filling, the name of the prescriber, and, if stated in the prescription, the name of the patient, and the directions for use and cautionary statements, if any, contained in such prescription.

Mr. O'HARA. I want to make sure the procedure which I rely on fundamentally is still going to continue insofar as the druggist is concerned who is filling the prescription and turning it over to the layman who does not know anything about it. I want to make sure that continues.

Mr. EWING. I think that is amply taken care of.

Mr. O'HARA. Violations of the present Food and Drug Act are prosecuted in the Federal courts; are they not?

Mr. EWING. Yes, sir.

Mr. O'HARA. That means it is a complete trial de novo in the Federal court?

Mr. EWING. Absolutely.

Mr. O'HARA. I notice you objected to the judicial review section of this statute. Would you have any objection to a judicial review of one of the orders which might be issued under this proposed legislation in the Federal district court?

Mr. EWING. I think the present Administrative Procedures Act sets forth that there would be an appeal, as we would recommend, from the Administrator to the circuit court of appeals. The only thing we think is doubtful in the bill as drafted is the provision which says it should be a trial de novo in the circuit court of appeals. That is the only thing that troubles us.

Mr. O'HARA. That would be the three-judge court?

Mr. EWING. Yes, sir.

Mr. O'HARA. Have there been in the past any attempts to review by court action the regulations of the Administrator?

Mr. EWING. Oh, yes. The present act, Mr. O'Hara, in section 701 (f) (1), provides in a case of actual controversy-you see, they are shooting there to get it within the constitutional authority-"in a case of actual controversy as to the validity of any order under subsection (e), any person who will be adversely affected by such order if placed in effect may at any time prior to the ninetieth day after such order is issued file a petition with the circuit court of appeals of the United States for the circuit wherein such person resides or has his principal place of business, for a judicial review of such order." That is in the present law.

Mr. O'HARA. You recognize in that provision for appeal it is practically a question of the construction of the law. The Administrator, having disposed of the questions of the fact, it is just a question of law for the court under the provision you just read. If there was a trial de novo, in the circuit court of appeals, you recognize there would be an opportunity for the triers of the fact there to determine what the facts were, and it would be quite a different situation than under existing law; is not that so?