It has been pointed out a number of times in these hearings that the situation leading to this bill was precipitated by a speech of the Commissioner of Food and Drugs, Dr. Dunbar, when he appeared on the program of the National Association of Retail Druggists in Atlantic City in 1948.

In that speech, as you have been told, he announced that refills of prescriptions were in violation of the law unless specifically authorized in writing by the prescribing physician. In effect, he announced that without such specific permission, a refill was not a prescription at all but an over-the-counter sale. I point out to you that was not a ruling published in the Federal Register; it was not official in any character that lent itself to attack or review by any process provided generally by law, or particularly by the Administrative Procedure Act. It was a speech on that occasion.

This represented a newly announced, if not a changed, administrative interpretation of the prescription-exemption law. It is not for me to say whether the Department held that view always or not; I do not know, but it came as a surprise and represented at least a newly announced administrative position.

The statute is silent with respect to refills. The prescription exemption is contained in section 503 (b), and, as the law is now written, a drug dispensed on a written prescription-no mention of oral one way or the other is exempt from the requirements of section 502 (b) and (e), and in the case of an article marked "Not refillable," or its refilling is prohibited by law, then section 502 (d).

Section 502 of this act is the general misbranding section of the law, and the (b) from which they were exempt is that part of the Misbranding Act which requires that you put the name and address of the manufacturer on the label, and state the contents in terms of numerical count or weight or other forms of measurement; (e) is that part of section 502 which provides for a disclosure of the active ingredients of the drug, and (d), which is exempted only if the prescription is nonrefillable, is the so-called narcotics and hypnotics part of section 502.

Now, the exemption as thus provided in the present law does not include section 502 (f), and I am inclined to think that is the only major point that was left out. That is the section which requires adequate directions, and adequate warnings against misuse of drugs.

That puts the druggist in this position, and however practical it may have been, I do not know, but at least on the face of the act it put him in this position: that if he sold the drug on prescription he was required to put adequate directions on it.

Now it may be a question, which we need not debate here-but I raise it for illustrative purposes-whether or not the directions of the physician put upon the label of the prescribed article are "adequate" directions. We may say that they are "adequate" directions. But, the druggists, to say the least, were left in a state of uncertainty.

So, the situation which was created by the Commissioner's speech at Atlantic City is the background upon which this bill, sponsored by the Food and Drug Administration and the National Association of Retail Druggists, has been proposed. The bill is described as defining an exemption, and it is referred to as a prescription exemption. But the core of it is a compulsion. Exemption implies an optionyou can do one or the other-but in the main feature of this bill, the grant of this power, there is no option; there is only compulsion.

That does not appear too clearly upon the face of the bill, but it is definitely the position which the sponsors of the bill have taken before you, and that is what it is intended to do. It is intended to empower the Federal Security Administrator, acting through the Food and Drug Administrator, to restrict to prescription sale all articles included within the broad definition of the word "drug" which he may determine to be "unsafe or ineffective for use without the professional diagnosis or supervision of a practitioner licensed by law."

Let me hestitate a moment to call your attention to the word "diagnosis," as it appears there. I imagine it must be important to all manufacturers. It is particularly important to those for whom I speak. I suppose it is commonly known that there is a substantial body of medical opinion to the effect that the layman is not competent to diagnose for himself in anything. And certainly, in our courts, the rule of evidence frequently, if not always, forbids a layman, a lay witness on the stand, to testify as to what was the matter with him when he took the drug, and for what purpose he took it.

Now, I think that I will not be controverted in that; that doctors, shall I say generally, think that a layman is not able to diagnose for himself, perhaps beyond the most simple thing.

It is very important that at the outset we get into our minds the definition of the word "drug.' we talk about a list, of which I shall speak later. That word is of great importance, as

The word "drug," I think, to lay people often suggests narcotics, but usua ly we think in terms of chemicals, the substances which go to make up a preparation. But we look to the Food and Drug Act for the definition of the term "drug," and it is clearly defined in section 201 (g) briefly as this:

"Drug" means, one, articles recognized in the United States Pharmacopeia, the Homeopathic Pharmacopeia, and the National Formulary. They are the three so-called official compendia under this law. Each one of them, especially the U. S. P., as the Pharmacopeia is usually called, is a sizable volume. Those volumes contain all manner of substances. According to this definition, sugar and salt are drugs because sugar and salt are listed in the Pharmacopeia. I suppose we should read in that they are for medicinal use, but the law does not say so. Of course, sugar frequently has a medicinal use; "confections," they are called sometimes and may be for the palatability of the substance, but my point stands that these many substances are in the Pharmacopeia.

The second part of the definition of "drug" is "articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals."

I can tell you how far that goes by illustrating what was true under the old law. The new law has a definition for a so-called device, but under the old law the Food and Drug Administration asserted, and was upheld in the courts, that bandages were "drugs" for the logical reason that they were used in the cure, mitigation, and prevention of disease. The Administration was also upheld in the assertion that prophylactic devices were "drugs" because they were used in the prevention of disease.

As just said, the new law covers such things by defining the word "device," but you see how broad at this point is the definition of "drug."

In the third place, the definition includes "articles (other than food) intended to affect the structure or any function of the body of man or other animals," and finally in the fourth division, "drug" includes all articles intended for use as a component of any of the foregoing articles.

Thus this definition includes substances, compounds, mixtures, and fabrications of all forms used for the purposes stated.

If we have in our mind here that we are talking of some "list" which can be pasted on the door, or put under the glass covering of a desk, we are mistaken. If there are any who think that is what is proposed, they are in for a rude awakening. Restrictive regulations in this broad field would apply to a great number and variety of "drugs" as defined by the law.

Now, the inclusion of the word "ineffective" opens a door to almost unlimited control of therapeutics and the sale of drug products. In addition, it jeopardizes the traditional right of self-medication and choice of remedies. In the sense in which it is used in this bill, "effectiveness" has not been a matter of Federal control. Let me make that clear again so that there will not be any possible misunderstanding the Federal law now has abundant power, frequently exercised, against any false or misleading representation as to the effectiveness of a drug, but as it stands now, and I say in the sense in which the word is used here, the Government does not have the power, administratively, to regulate effectiveness of drugs as to the prescription of them and as to the use of them in treatment of disease. Up until this time and at present, people have been free to use any drug product desired so long as it is safe and so long as there are no false or misleading representations made about it, and the law is very severe in the regulation of those things.

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The committee report which accompanied this bill in 1938, or accompanied the bill that was passed in 1938, stated that it was not purpose of the act to restrict self-medication but to make it safe. Now, consider this other aspect of the power to determine the effectiveness of drugs-to determine that drugs are not effective unless sold under a prescription, which is the way that the bill reads: The leverage of such proposed control in regulating the composition and the labeling and the distribution of drug products would be enormous. The power to restrict any drug to prescription sale would coerce the manufacturer to submit to any labeling demand of the Government which had any semblance of support. No one can predict, sitting here today, the full extent of this power as it would take form and growth with each passing year.

In my own opinion, based upon experience, there is no doubt whatever that it would increasingly restrict the right of self-medication and the citizen's choice of remedies. I think that I am borne out in that by some of the implications of the Administrator's testimony before you last Tuesday. Administrator Ewing said when he was asked about aspirin that there were those who thought that aspirin should be restricted to prescription sales; that as of this time, meaning, I suppose, in the present views of the Department, aspirin would not be put on a restricted list; but he said candidly and truly that we must realize that future Administrators with views that aspirin should be put on the list might put it on, and that if they had sub

tantial evidence for doing so they would be upheld by the courts and nothing could be done about it.

In fact, Mr. Ewing said that the safeguard is the reasonableness of the Administrator from time to time in the future.

Yesterday Mr. Harrop mentioned to you the attitude of the Food and Drug Administration that ear drops must be sold on prescription because they might mask some more serious condition. There are all sorts of theories held now, and what will be held in the future we cannot possibly tell, whereby safety and effectiveness may be determined in the mind of the Administrator.

Let me say this: I have been speaking of self-medication. I have no reference to any special interest. True, the manufacturers for whom I speak do sell for self-medication. The manufacturers who have already been before you do the same thing, though they do not advertise direct to the public. I have no reference to any particular product or class of product, or any particular manufacturer or group of manufacturers. For present purposes there is no distinction whatever between over-the-counter articles advertised to the public and advertised to the profession.

The significant thing about this is that if self-medication is prevented, or if it is severely restricted something must be put in its place. The people must then have medical care to a greater extent and at lower cost, and so I say that a power like this in the proposed bill would become a handmaiden of socialized medicine. If we compel people to prescription purchase, with consequent physician and pharmacist fees, of an ever-lengthening list of medicaments, I think we shall see that in time the Government would have to ease the burden.

In order to determine "effectiveness" or "safety"-because the term "safety," as applied to drugs, Mr. Chairman, is a relative termit depends upon many considerations, and there is hardly anything known to us in the medical field, and perhaps in the food field, that cannot become dangerous if used improperly, or in improper amountin order to determine "effectiveness" or "safety," many things have to be considered.

The Administrator would have to take into consideration every condition and circumstance pertaining to the use of every drug product under his consideration. He would have to take into consideration the dosage; the route or method of administration, whether external, internal, oral, or injection; he would have to take into consideration the frequency and the duration of use, the age of the patient, the sex of the patient, perhaps the social and economic environment of the patient; the time of use with respect to meals or symptoms-and, gentlemen, I am using now material taken from the regulations which pertain to the adequacy of directions.

With them I have no complaint so long as the Food and Drug Administration does not have arbitrary power to enforce its will in these particulars. In the present state of the law it is good and it is helpful to have these things set out in the regulations as guideposts by which a manufacturer may steer in trying to get his labeling to conform with law and, if you please, to conform with the views of the Administrator, for whom we have respect and with whom we would much prefer to live in peace and harmony than in litigation.

So these things that I am telling you are not of my origination. I have taken them from the regulations. I do not think that the Food and Drug Administration thinks that it has exhausted the considerations, because the regulations say that these criteria are "among other reasons" why directions may be "inadequate."

Now, doubtless, comparative considerations would also be involved if the Administrator received the power sought in this bill; that is to say, would a certain drug be as effective in the various conditions and according to the foregoing criteria as some other drug or some other form of treatment?

For instance, it is almost impossible now to sell over the counter any worm medicines. To my knowledge, there is only one permitted. The others have been forbidden. The manufacturers in most cases yielded to the administrative attitude without litigation that either the medicines were not safe or that the worm situation was not a matter for medication but a matter for sanitation; that the circumstances in which people live are the real controlling considerations. I mention that not to criticize the position but simply to let you know that I am not conjuring out of my imagination any of these things which I am trying to say to you.

Mr. Ewing in his testimony laid down a criterion which is not new. We have heard it at the Food and Drug Administration for at least a decade, perhaps two. Mr. Ewing, when questioned by some of you gentlemen as to how he would go about determining "ineffectiveness, gave this illustration: He said, "The taking of such a medicine might prevent a person going and getting proper medical care." Perhaps sometimes that might be true, but it is a rather farfetched criterion for determining "ineffectiveness" of drugs by and large. The same criterion could be applied to "safety"; that perhaps the drug is not safe because if you take an aspirin tablet for your headache you may prevent yourself going to a physician and discovering that instead of a headache due to some simple cause you have a headache due to some serious condition.

Now, the magnitude of this task, Mr. Chairman, is illustrated by considering what will be involved in dealing with drugs now on the market.

First, you will remember the definition which I just gave you from the law; and then, in the paper filed by Dr. Hugo Schaefer, of the Brooklyn College of Pharmacy, on behalf of the American Pharmaceutical Association, he says there are approximately 30,000 drug items.

Mr. Larrick, the Assistant Commissioner of Food and Drugs, in his testimony this week said, and I quote from his statement, "There are literally thousands of different drug items on the market." He said that in connection with the exercise of this power. He followed that by saying, and he used that as a premise for saying, unless he had this power he would have to enforce the standards by thousands of lawsuits. With the greatest respect to Mr. Larrick-and I enjoy that first-name relationship that he referred to on the stand herelet me say that is not a realistic approach or statement. No provision of the Food and Drug Act today-and there are many-is enforced by thousands of individual cases. In that field, as in all fields of regulation in a democracy, one case may be the bellwether for people following. One case may well be a test case, and, if not a friendly