dispensed without it; and in making this determination he is authorized to adjudge the efficacy of drugs, in addition to their safety. The vast scope of this authority is indicated by saying that it reaches all drugs, except habit-forming drugs under section 502 (d) and new prescription drugs under section 505 as provided in amended section 503 (b); and the only restraint on its exercise in that made by the provisions for a public hearing and court review, which can have a limited effect. The conclusive question however is not how the exercise of this authority should be restrained, but whether it should be granted at all; and it manifestly invites three basic objections, at least.

The first objection to this administrative authority is that it empowers the Government to decide the therapeutic value of drugs, in a controlling sense; whereas this decision is and always has been and always should be the clinical function of the medical profession instead. It is no answer to say that in making this decision the Government will consult the medical profession, because it may significantly override the opinion of that profession or instead be guided by the advice of its employed physicians, who are not engaged in active practice and may have a questionable opinion in the circumstances, as we have had good reason to learn in the past. It is also no answer to say that the danger of a wrong decision is removed by a court review of it. For drug therapy is not an exact science generally and the Government could probably manage to prevail in such a review, as a rule and because of its favored position therein. Moreover the fact that drug therapy is not an exact science is also effective to give the Government an important latitude of administrative decision, in the first instance.

It is likewise no answer to say that sections 506 and 507 of the FDC Act now authorize the Administrator to decide both the safety and efficacy of insulin and certain antibiotic drugs. For they are placed under an exceptional batch-certification regulation and such decision with respect to them-that is to say the decision as to efficacy is strictly limited to an analytical basis, which is a different situation.

The second objection to this administrative authority is that it vests in the Government significant bureaucratic control of the drug industry and medical profession, which the FDC Act does not contemplate and is repugnant to its philosophy; and which is inherently undesirable. The significance of this control is indicated by saying that it is a life-and-death control of nonprescription drugs and a dominating control of prescription drugs; that it may be directed or slanted to achieve a government concept of medical care; that it is an important step toward socialized medicine; and that control will be exercised by an executive who is the Government leader for socialized medicine.

But aside from these serious considerations such a Government bureaucratic control of the drug industry and medical profession is wholly inconsistent with the philosophy of the Federal Food, Drug, and Cosmetic Act, because it is instead designed to regulate the marketing of drugs by appropriate and sound objective standards of conduct, which must be complied with at the risk of a drastic penalty for failure to do so.

This is the legislative philosophy of a Government dedicated to free institutions and therefore we should not depart from it here, as a

matter of fundamental public policy. In short: the present objective definition of a prescription drug exactly conforms to that philosophy; whereas the proposed substitute flagrantly violates it.

The third objection to this 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 prescribtion ones; and there is a wide area for its marginal exercise, which is open for infinite Government exploration.

I would like to add to my prepared statement three observations based upon the testimony of the representatives of the National Association of Retail Druggists given yesterday.

In their testimony they made statements and offered exhibits which were designed to establish that pharmaceutical manufacturers are using labels on drugs that are erroneous, confusing, and violative of the existing provisions of the drug law of the FDC Act, because such labels either contain an unwarranted prescription restriction or fail to contain an indicated prescription restriction.

This testimony invites two conclusive replies: the first reply is that this label situation is an exception to the general rule to the contrary and that is certainly so as to the dangerous drugs which H. R. 3298 is designed to place on a prescription basis.

I can say from my own close contact with the pharmaceutical manufacturers for nearly 40 years, and since long before the FDC Act was enacted, that they have been scrupulously careful to label any dangerous drug with a prescription restriction where it is indicated; and if and to the extent this has not been done, that is a very exceptional situation.

And, we should keep two facts in mind here: One fact is that all new prescription drugs must bear a prescription restricted label under section 505 of the FDC Act.

The other is that there are border-line cases where there is a legitimate question, whether such a prescription restricted label should be used on the drug. This last situation calls for both industry remedial action and official advice by the FDA, and you may rest assured that the pharmaceutical industry will respect this advice when it is given.

As to industry remedial action in this exceptional situation, I am recommending to my own organization of pharmaceutical manufacturers that the three national associations of drug manufacturers institute such action in remedial consultation with the FDA, which should be effective in the circumstances.

The second reply is that in any event the FDA now has full authority successfully to enforce the existing prescription-drug law of the FDA Act against any misuse of a prescription restricted label on a drug or any failure to use such a label where it is actually indicated.

Now, the second observation is this: we must not permit any. testimony about this incidental situation to divert our attention from the basic purpose and need of the prescription drug amendment of the FDC Act proposed by H. R. 3298. The purpose is to write a strong basic prescription drug law into the FDC Act itself, as distinguished from one made through regulations thereunder, which will effectively prevent retail druggists from dispensing dangerous drugs originating

in interstate commerce on a nonprescription basis or from refilling prescriptions for such drugs without medical authority.

The seriousness of this situation is indicated by the fact that we are here dealing with drugs which, while they are safe and necessary when used under medical supervision, are potentially killers when they are not used under such supervision, and the need for such law is demonstrated by the fact that druggists have incidentally dispensed dangerous drugs on a nonprescriptive basis with fatal results.

This grave fact has been documented by the United States Commissioner of Food and Drugs, Dr. Paul B. Dunbar, and by his administrative associates. Therefore, the National Association of Retail Druggists is to be commended for sponsoring a remedial bill; but I am surprised, very much surprised indeed, to hear one of its representatives suggesting to you yesterday that an essential provision of it is unnecessary. It is a provision requring the written confirmation of an oral prescription for a dangerous drug.

This confirmation is manifestly an essential restraint on a crooked or erroneous oral prescription which endangers public health, since it provides a written confirmation for the record and enforcement purposes.

I should go on and say here that a registered pharmacist who is trained in the science of drugs knows full well what is a dangerous drug that should be dispensed only on a prescription basis, and he cannot escape his own responsibility to dispense such a drug only on such a basis because the manufacturer improperly fails, if he exceptionally does so, to use the prescription restricted label for it.

Take the case of dangerous barbiturate, a drug for producing sleep, which is the one that is the principal cause of the amendment proposed by H. R. 3298. The dispensing pharmacist knows full well that it should only be dispensed on a prescription basis and, therefore, if he dispensed this drug on a nonprescription basis, he certainly is fully responsible and the law should be enforced against him for doing so. The third observation is that this prescription drug amendment of the FDC Act, proposed by H. R. 3298, unnecessarily and unwisely contains a provision which makes it have a bad side effect.

This bad side effect is contained in the administrative definition of a drug which has been explained and to which there are the fundamental objections that I have cited. This side effect is that such a definition is certain to be used progressively and extensively to convert old nonprescription drugs into prescription drugs. This will practically result in increasing the profit of the retail druggist, and we cannot assume that they are unmindful of the beneficial effects of this to them. And I direct your attention to the fact that the main emphasis that their witnesses have laid upon this bill in discussing it before you is upon that very administrative definition of a prescription drug. And this will constantly increase the cost of medical care of the American people to the extent that drugs are shifted from nonprescription to a prescription basis.

Now the FDA is a very efficient administrative agency for which I have the fullest admiration and respect; but it has never yet failed to make full use of any administrative power vested in it. Therefore, if Congress enacts this definition in the amendment before us and thus in effect directs the FDA to place drugs on a prescription basis, we must expect that it will do so to a very large extent in the long and

broad view. And it must be borne in mind that the guiding standard of "safe and ineffective" and especially the latter standard of "ineffective" has a broad scope of discretionary administrative application, depending entirely upon the approach.

Moreover it must be borne in mind that the vast field of old drugs contains a large opportunity for the exercise of this administrative discretion by the FDA to convert nonprescriptive drugs into prescriptive drugs. For it may be said, as it is often said, that most drugs should be used only under medical supervision, and that many old drugs contain inherently dangerous ingredients.

I will state in conclusion that while the effect of an administrative definition of a prescriptive drug will have the tendency to force drugs from a nonprescriptive to a prescription basis, the present objective definition in the act has just the reverse tendency.

Mr. WOLVERTON. Mr. Chairman?

The CHAIRMAN. Mr. Wolverton.

Mr. WOLVERTON. On page 8 of your statement, No. 4, you say, "If and to the extent they have any doubt about this in exceptional border-line cases, it may be clarified by official advice or industry action."

For the purpose of properly deciding border-line cases, what would you think of an advisory group as being helpful; a group probably composed of manufacturers, of druggists, physicians, and possibly consumer representatives?

Mr. DUNN. We have that very situation in effect now. The American Medical Association has a council on pharmacy and medicine which deals with the problems of this sort and gives advice as to how drugs ought to be labeled and sold.

Furthermore we have in the pharmaceutical industry right now what we call a joint contact committee which is a committee that was created years ago between the two organizations of pharmaceutical manufacturers, to cooperate with the FDA in settling questions of this sort; doubtful questions about the application of the law. I am sure that Dr. Dunbar will testify to you what he has said repeatedly that this has been one of the most valuable developments in the regulatory field of the FDC Act and through this cooperative action we can accomplish the very purpose we have in mind.

Furthermore, it is customary for the FDA to issue constantly advisory announcements Right now, within the last 2 or 3 weeks, they have issued a statement suggesting that the manufacturers of antibiotic drugs use a certain warning in their labeling. Now, that suggestion will be complied with throughout the length and breadth of the pharmaceutical industry in the manufacture of those drugs.

Mr. WOLVERTON. Do you think it would be advisable or not to have a provision in the law creating an advisory group such as had been indicated?

Mr. DUNN. I think it would probably be inadvisable for this reason, that the insertion of that provision for an advisory committee signifies that the FDA is given the controlling decision in the final analysis, whereas my contention is, and this is the basis on which we have always operated, that these border-line cases can be very well taken care of, both on the basis of advisory notices, by the FDA and/or on the basis of cooperative action by the industry and the medical profession with the FDA.

Mr. WOLVERTON. I have been very much interested in your statement. It certainly has been analytical. And, I like the frankness with which you express your opinions for or against the bill before us. Without indicating my agreement with what you have said, I am certainly impressed with the fact that you have definite thoughts with respect to this bill, and I think that you have been helpful to the committee in having presented your viewpoint as you have.

Now, I was impressed with the point that you were making with respect to the increasing necessity for prescriptions, which would add to the cost of the consumer-patient.

Do I understand from that that it is the general practice-if you are not in the position to say, you may so indicate-for druggists to require a prescription in order to sell a medicine with certain ingredients which are already a part of-well, I do not know what you would call it but we will call it a proprietary medicine-an over-thecounter sale in packages, for instance.

Now, is it your idea that if that had to be sold on a prescription that it would increase the cost to the patient?

Mr. DUNN. Well, I am not going to undertake to answer a question relating to the conduct of the retail drug business, but I do know this fact, which is common knowledge. You all know it as well as

I do. Prescription drugs cost more than over-the-counter drugs. There is no doubt about it.

Mr. WOLVERTON. Would it in addition to increasing the prices which would have to be paid for the drugs, would it not also involve the cost of obtaining the prescription?

Mr. DUNN. Of course. If I understand what you have said, you have got to pay a doctor as well; you have got to pay the doctor's fee and pay for the drugs.

Mr. WOLVERTON. You have to pay for the prescription.

Mr. DUNN. You have to pay for the prescription.

Mr. WOLVERTON. And to the amount which the patient paid for the drugs would be added the amount that he would have to pay his physician for the prescription.

Mr. DUNN. Of course. That is obvious.

Mr. WOLVERTON. Well then, it does increase the cost all along the line, does it not?

Mr. DUNN. Exactly. We have got to have prescriptions for the sale of dangerous drugs, but I say if you enact this proposed administrative definition of a prescription drug, it will be used in this vast field of old drugs, where there is a question as to whether or not they should be sold on a prescription or a nonprescription basis, with a vast increase in the sale of prescription drugs, and the result will be an increased medical cost to the American people.

Mr. WOLVERTON. Well, I asked that question, if I recollect correctly of Mr. Ewing, and he said he did not know whether it would increase the cost.

Mr. DUNN. Well, I will say this that if Mr. Ewing is true to his position, advocating socialized medicine, this will be one of the finest instruments he ever had to accomplish that purpose-this Government definition of prescriptive drugs in his own Agency; under his own control.

Mr. WOLVERTON. You have already pointed that out in your statement. If you would care to expand your views on that point in your