However, I have talked to senior members of the staff engaged in the investigation of matters, and they tell me that this has not been a problem insofar as complaints being filed at the Commission. Mr. MEADER. How long have you been with the staff? Mr. KINTNER. I have been with the Commission 10 years. Mr. BLATNIK. You may proceed, Commissioner.

Mr. ANDERSON. You have asked, also, that I discuss the Commission activities with respect to tranquilizers.

When undertaking to discuss tranquilizers, it is first necessary to define the term, even at the risk of repeating what has been discussed more comprehensively by previous witnesses before this subcommittee. The term "tranquilizer" was introduced into the medical literature some 5 or 6 years ago as a designation for a heterogeneous group of drugs which have the ability to calm an individual, usually without making him sleepy, and which, more importantly, bring out significant selective changes in mental attitudes and behavior, rendering patients with emotional disturbances and certain kinds of mental illness more manageable and amenable to treatment. The medical literature distinguishes tranquilizers from the older sedative or somnifacient drugs, such as barbiturates, bromides, and so forth. The older drugs tend to produce drowsiness, as well as having a calming or sedative effect, and they do not bring about the changes in mental attitude and behavior which characterize the newer tranquilizers.

Since the compounds designated as tranquilizers are newly introduced into medicine in this country, they are all subject to the newdrug provisions of the Federal Food, Drug, and Cosmetic Act, which is enforced by the Food and Drug Administration. Because of their potent effect, the sale of tranquilizers is restricted to their use by or on the prescription of physicians, and dissemination of the advertising to promote the sale of tranquilizers has, insofar as we are aware, been confined to members of the medical profession. No instances have come to the attention of the Commission where the advertisement fails to truthfully disclose the formula of the drug or contains a false representation of a material fact. Therefore, the Commission has found no occasion to investigate or institute legal action with respect to the advertising of tranquilizer drugs in medical journals or otherwise disseminated to the medical profession. I have mentioned that our filing system does not index matters according to the profession of the applicant, but the staff members charged with handling this type of work recall no instance where a physician has complained about the advertising of a tranquilizer.

With respect to advertising to the general public, the Commission's Bureau of Investigation has encountered three instances in which combinations of the older sedative drugs, such as bromides, were being advertised in a manner which might lead the public to believe that they were obtaining one of the new tranquilizers. It has been necessary to distinguish such advertising from that involving merely the offering of the older sedative drugs for their long-recognized effects. In two of these instances, namely, Tranquil, Alva Laboratories, we have been advised that action has been instituted by the Food and Drug Administration; and North American Stevens Corp., by the Post Office Department; and, in conformity with the working arrangements with these agencies, no formal action has been taken with respect to these drugs. It is felt that for the Commission to institute proceed

ings at this time would involve unnecessary duplication of effort and expenditure of funds. In the third instance, dealing with Pasitabs, Broco, Inc., the Bureau of Investigation expects to reach a definite decision with respect to the institution of appropriate action in the very near future.

Surveillance of advertising for the purpose of detecting instances where the older drugs are being represented as the equivalent of tranquilizers will be continued.

In connection with our continuing surveillance of drug advertising addressed to the general public, we have taken corrective action against nine advertisers of the older sedative drugs which have misrepresented the therapeutic or palliative effects of the drugs.

Mr. BLATNIK. Thank you, Commissioner Anderson.

Commissioner, you state there is no instance where a physician has complained about the advertising of tranquilizers, and your investigators have not uncovered any advertising which could be considered false on their inquiries. May I ask if that indicates that no problems exist in this field of advertising the tranquilizers to the medical profession? In short, what is the attitude of the Commission on that? Do you feel that there is no problem, that the matter is being satisfactorily taken care of?

Mr. ANDERSON. Well, the Commission, which as you know, Mr. Chairman, from your knowledge of this regulatory body, is loaded down with such a tremendous amount of work and operating with a shortage of personnel and having a very wide area of jurisdiction where the pressures are tremendous and where the matter of finding a case is certainly a lot easier than in this small area where the medical profession, possessed of tremendous expertise, and I think we can say that, with full knowledge, that the Commission has not been in that field.

Now, that is not to say that there might not be some problems in there, but at least, the medical profession has not come to the Commission and called it to our attention as saying that here is an area that you should look into and that requires attention.

The large amount of time that doctors are required to spend in preparation for their degrees, and subsequently, is such as to make them pretty well acquainted with the preparations that are offered to them for sale, and I believe that that represents, in a fair way, the attitude of the Commission on this score.

Mr. BLATNIK. Since this is such a highly specialized technical and complex field come to light only in recent years, and since the Food and Drug Administration has to, apparently, go into great detail on the safety and the effectiveness of these drugs, and they do have at least the professional staff of doctors, which you do not have because of limitation of the budget, what would be your comment to the proposals that have been made by some of the witnesses that perhaps the jurisdiction of this type of advertising in the field of tranquilizers be transferred over to the Food and Drug Administration?

Mr. ANDERSON. Well, any answer on that score, Mr. Blatnik, would have to be made as a policy statement of the whole Commission. Coming here today and not having had this question posed to the Commission at a regular meeting, it would be very difficult for me to make a statement which would be other than a curbstone opinion of my own. But I believe, Mr. Blatnik, that the fine relations that

have existed and do exist between the Food and Drug Administration and the Federal Trade Commission, which has worked, I believe, very admirably and the liaison arrangement we have is such as to make it a pleasure to work with that agency of the Government.

This little provision that we are wrestling with at the moment apparently has caused a lot of legal scholars to wonder what the thing really means. Somebody facetiously once said that it is a little bit like a burl in a maple tree; it just kind of grew up there all by itself. We know that is not the case. There must have been, in the first instance, a reason for it, but it may have been at the time that there was a reason, but if there had been a continuing reason, surely the members of the medical profession would have come to our agency and said now here is something that you should look into. It never has and now, for instance, we do have a certain amount of joint jurisdiction with the FDA, but that has worked out in such a way that there is no real overlapping of actual functions. So, after having made my short story long, I would say that I don't believe-my own opinion now-that it would serve any useful purpose in having a divestiture of the Federal Trade Commission's functions over to the FDA.

Mr. BLATNIK. What liaison arrangements do you now have in this field of tranquilizers with the Food and Drug Administration?

Mr. ANDERSON. Mr. Blatnik, the gentleman who is in charge of that liaison is Mr. Frederick Irish, who is on Mr. Babcock's staff, or at least he was until yesterday when Mr. Babcock was promoted to be the executive director of the Commission, and hence his statement to you that he was no longer in this particular bureau.

This is Mr. Irish.

Mr. BLATNIK. Mr. Irish, you are in the Division of Scientific Opinion?

Mr. IRISH. That is right.

Mr. BLATNIK. In the Bureau of Investigation?

Mr. IRISH. That is correct.

Mr. BLATNIK. Would you give us an answer to the question of what liaison arrangements now exist in this matter of tranquilizers between the FDA and the Federal Trade Commission?

Mr. IRISH. We have a liaison arrangement with the Food and Drug Administration. In fact, I have acted as the Commission's liaison officer in connection with that arrangement. It runs, of course, to food and drugs and therapeutic devices and cosmetic work, generally, although much of it is in the field of proprietary drugs.

However, as some of my colleagues have pointed out, we have not been proceeding on complaints in the field of ethical drug advertising. Consequently there has been very little occasion for liaison on any of the ethical drugs, in general, or tranquilizers, in particular. That is the way the situation is. The procedural setup is available, but it has not been utilized in the tranquilizer field.

Mr. BLATNIK. Could you give us any reason why it has not been utilized? Would that indicate there is no problem in that area? Mr. IRISH. Well, I would not say that there is no problem, but there has been no problem brought to the Commission's attention through any type of complaint, and consequently there have been no investigations instituted which would provide us with the necessity to utilize our liaison arrangement with Food and Drug.

Mr. BLATNIK. Would that indicate, then, Mr. Irish, that you are satisfied that there is no problem and that the health and welfare of the public in the field of tranquilizers is adequately protected?

Mr. IRISH. I have not studied the problem of tranquilizer advertising because, as I said before, it is advertising of ethical drugs and we have had no cases initiated by complaining physicians or anyone else in the case of tranquilizers that we would have any occasion to

process.

Mr. BLATNIK. Mr. Babcock, did you wish to make a comment?

Mr. BABCOCK. I have in a way been placed in a position of being opposed to the opinion of the General Counsel, and I would like to clarify my thinking, for whatever use it may be to the committee.

I do not say we do not have jurisdiction over advertising to doctors. Indeed I say positively we do. I think it goes to the kind of representations made to doctors in advertising published in medical journals, or perhaps anywhere. We do have jurisdiction over false claims made to doctors.

For example, here is an advertisement which represents that a product has been clinically tested and is now in common use in Johns Hopkins University for the cure of, let's say, arthritis, and it is false from beginning to end. I would take that and we could and would summarily deal with it. There is no sanctuary in this section for that type of advertising.

Let's take a second illustration, where the formula of a product is misrepresented as containing many ingredients which are not there, or which are claimed to be there falsely. I would attack that as quickly. But if you want me to evaluate claims made for the curative properties or the therapeutic or palliative effects, then we are way over in the area that the learned doctor here gave such a fine talk about a little while ago. I think if the section means anything, it means that in that area we are not supposed to function, and it is more or less moot, as you heard here, because we have not been asked to function.

But this committee asked outright would we or could we. In my opinion, this section gave sanctuary from our jurisdiction of that type of claim made in medical journals on the condition prescribed in the statute, and I would like the committee to consider my thinking. It is that type of claim where we are not supposed to function. We are not to tell the doctor what he can and cannot do in the practice of his profession.

Thank you.

Mr. BLATNIK. Supposing a claim in the professional literature, Mr. Babcock, is incorrect. As a material fact, they comply with the law. They cite all of the beneficial responses or reactions to the drug, but omit any contrary indications.

Mr. BABCOCK. Well, since they are still in the area of the clinical claims of beneficial effects, in my judgment, we would be excluded from taking action.

Mr. PLAPINGER. Governor, and Mr. Kintner, in Dr. Dowling's statement he referred to the fear that an attempt to enforce a code of ethics among the manufacturers might be considered to be a violation of the antitrust laws. Would you comment on the antitrust implications of these codes?

Mr. KINTNER. Well, we have issued guides for cigarette advertising; we have issued tentatively guides for rubber advertising. Those guides were issued by the Commission on the advice of the lawyers on the staff. The Commission had no fear of getting into an area where the antitrust laws might be affronted.

Mr. PLAPINGER. I think the doctor was referring to voluntary codes among the manufacturers themselves, rather than the Government responsibility.

Mr. KINTNER. The danger there is that they get together and discuss advertising and then they go into perhaps pricing and other related topics. That is the danger of industry issuing such guides. I think that there is a safeguard where the Government agencies participate in issuing the guide and consult with industry as to the meaning of the advertising, the meaning of the terms used by the industry and then determine what is lawful and what is not lawful. Mr. PLAPINGER. But a voluntary code of ethics promulgated by the industry itself, without the concert with respect to prices

Mr. KINTNER. I wouldn't see any antitrust problem with respect to a voluntary code promulgated by the industry on the advertising. It is only when you get into the other areas that you have antitrust implications. So long as the industry promulgates its code of good taste with respect to advertising, I don't see any antitrust problem. Indeed I think the industry should be encouraged to study this problem and to voluntarily clean its house.

Obviously, with the limited staff of both our agency and the Food and Drug Administration, much voluntary adherence to the law must be secured from industry. All violations can't be on an involuntary basis.

Mr. ANDERSON. May we point out at this time that the broadcasting and telecasting association has not long since prepared a so-called code, a code of ethics. And coming back to Mr. Kintner's statement here as to the actions by the Commission, I believe that we have around 160 trade practice conference rules in effect now with the various industries in the United States that in the main have come to us and said we have problems in our industry and they are bad; and, before they get too bad and things go to pieces, let's sit down and talk them over and maybe we can get a set of rules; and we have around 160 of those in effect now. So I don't think that they are looking at that as having insuperable qualities.

Mr. PLAPINGER. The fact that it has been under discussion indicates that there is some concern in the industry concerning the quality of the advertising, and this is also reflected in articles that have appeared in the various medical journals that will be in the committee's records, and there are references in the committee's records.

Mr. KINTNER. I see no reason why the industry could not promulgate a code of good taste with respect to advertising. If they get into areas involving restraint of trade, that is a different thing altogether. Mr. PLAPINGER. But your offices or the Commission would be available to promulgate a code of fair trade practices?

Mr. KINTNER. We definitely would assist in that respect.

Mr. ANDERSON. We are doing it every day in the Bureau of Consultation.