test case, still it may be the case which is a signal for others to do likewise, and surely the Food and Drug Act is not enforced by having an inspector or a policeman constantly in attendance upon the manufacturer. We obey that law just as we obey the criminal and civil laws of the country by the various coercions, the moral code, the fear of apprehension, the fear of punishment, the love of our Government, all the things that make it possible for us to live in an organized society without multiple litigation.

Let me say something else in telling you about the number of drugs. A few years after this law was passed, the Food and Drug Administration issued a statement saying that it had been asked to supply a list of drugs which should be sold only on prescription. It answered that, according to its own written statement, by saying that the law imposes upon the manufacturer the responsibility of properly labeling drugs, meaning by that that it is his responsibility, and if he does not live up to it he is subject to apprehension and prosecution at the hands of the enforcement agency. And the agency said-the statement said—this:

Obviously it is impossible to list all drugs which may be dangerous since not only the compositions but also the directions for use and the conditions in which their use is recommended may have a very definite bearing on the question of safety or danger.

So a few years after enactment of the law the Food and Drug Administration said that it would be impossible to make a list of the kind it now asks you to empower it to make.

The Administrator would not dispute, rather he would agree, that years would be required to promulgate the regulations contemplated by this power. I have for my authority on that the statement of Mr. Charles Crawford, Deputy Commissioner of Food and Drugs. I do not know whether he is here this morning or not; he was yesterday. He appeared before the council on pharmacy and chemistry of the American Medical Association in Chicago on November 10, 1950, when the council invited representatives of the interested groups to appear before it and state their positions on this legislation, or rather on the bill which was then pending, which included the same provisions to which I am now addressing myself.

I appeared at that time on behalf of the Proprietary Association; Mr. Harrop on behalf of the American Drug Manufacturers' Association; Mr. Dowling on behalf of the American Pharmaceutical Manufacturers Association; Dr. Fischelis on behalf of the American Pharmaceutical Association; Mr. Crawford and his counsel, Mr. Goodrich, on behalf of the Food and Drug Administration; and Mr. Dargavel and Mr. Waller on behalf of the National Association of Retail Druggists. During the course of that discussion, Mr. Crawford said-I do not have the quotation, but I recall distinctly what he said that he thought the Durham bill should be amended to allow for at least 2 years in which to make the regulations applicable to the drugs then existing on the market.

I think that was a conservative estimate. I think he would need a decade. It has been 13 years since this law was passed, and we are still in the midst of food standards-and I intend no criticism by that at all, but simply to illustrate the magnitude of the task of holding administrative hearings on all of the literally thousands of drugs, to use Mr. Larrick's term, which would be subject to this power. And

I come back again, Mr. Chairman, to remind you that the use of the word "list" is a misnomer.

I think Mr. Ewing said in his testimony-and I believe a question about it was asked here yesterday-something with respect to the Canadian law. For my part it does not matter what Canada may have. That is not the criterion for what we shall have in this country of 150 million people as compared with a small country of 12 or 15 million. But the proponents have absolutely no suggestion in their own minds that what they are asking here is a list similar to the Canadian list.

In Canada there is a list. The list includes 18 drugs, the most serious drugs that could be mentioned, drugs as to which there could be no possible division of opinion between the manufacturers and the Food and Drug Administration, some of which are not even sold in this country because the Administration has threatened litigation if one dare to sell them.

One, from memory, is dinitrophenol, a very dangerous drug, which the Food and Drug Administration clamped down on immediately after the passage of the Food and Drug Act in 1938. And, if it is on sale anywhere in this country now, it is subject to immediate seizure and to multiple seizures and drastic criminal action.

Another one is aminopyrine. It was on sale in this country at the time this law was passed. At one time it was thought to be a good drug; it had a good reputation; but it developed that it was capable of harm, and serious harm; and the Food and Drug Administration took the position first that it had to be drastically labeled with warnings and afterward that it should not be sold at all; and it is not sold today unless in some isolated instance in which there is ample law to control it, if so.

The other drugs are not in my memory, although I have a list of them. They are the drugs, the chemicals, not preparations, not compounds. Cinchophen is another one. I should not speak to you knowingly about drugs; I am not a druggist. But I know what is the situation in this country in the sale of cinchophen. It has been on the taboo list for years.

So I say to you, when they come here and cite Canada as an example, they should tell us whether what they want is a list such as Canada has. If that is what they want, there is no objection to making a list of 18 drugs. Do not hold me too strictly on this, but I do not think there is anything on the Canadian list right now that is being sold in this country except under the strictest supervision of the Govern

ment.

They have used the term "list." It is a convenient one to use, and we have been given the picture of the druggist being able quickly and conveniently just to look at a list and to run his eye down it. Gentlemen, believe me, that is not what is involved in this case at all. The druggist would go to something as large as the United States Dispensatory, which would stand high on this table and, given a few more years, he would go to a library, because the so-called listing must encompass all the variations, from time to time, in medical opinion and in dosages and the directions and the other material that I went over with you. That is the breadth of this provision. And it would grow with the succession of administrators and the passage of

time. That is usually the case with powers granted to Government bureaus.

If I appear to be speaking feelingly and vehemently about this, I do not want to be understood as being critical of the Food and Drug Administration. I have great respect for that Administration, and I have personal affection and regard for the officials of it, and I prize the so-called first-name relationship which I enjoy with them. I speak objectively and not subjectively.

That is the way I think legislation ought to be considered and the way this bill ought to be measured; not by the high purposes and the fine traditions of the gentlemen who now run this agency, but looking into the future as to those who may come, whom we now do not know.

The Administrator at the present time has power under the existing law to proceed against products for which unfounded therapeutic claims are made for effectiveness. He should not now be given this additional power-the power not only to proceed against, but the power, himself, to adjudge, the effectiveness of drug products.

I do not think it has been pointed out here the power which now resides in this Department for regulating the sale of drugs; it would tax my time if I tried to go into all of it, but let me remind you of a few of the outstanding provisions of the misbranding section, 502. What we are asking for and I do not believe I have yet said in so many words, although I indicated at the outset the issue between us and the proponents-is this: We subscribe to the suggestion which was made here by Mr. Harrop yesterday, and a few days ago by Mr. Dunn. The three manufacturing organizations are unanimous in the position which they have taken with respect to that suggestion. Whether we like the particular wording of that suggestion or not, we have chosen it, because it is the wording composed by the Food and Drug Administration itself under its regulations. And our suggestion of adopting that standard and writing it into the law would thus bring this area of regulation into the same philosophical background and operation as pertains to the rest of the law.

What we propose is no departure from the philosophy of this law. What the proponents propose is a radical departure. I say to you deliberately that it represents a request for the greatest power that has ever been asked under the Food and Drug Act, and a power far greater than any now in that act.

I go back to the Tugwell bill, so-called, of 1933, when this started, where in almost every section the power was to be left to the Administrator, and the fight which industry made was to keep the door to the courthouse open, to have the food and drug law state the definitions, the prohibitions, to lay down the boundaries and the rules by which business might be carried on by manufacturers, with them carrying the responsibility which is their lot and, I think, under our system of Government, their due.

Now, the Administrator, acting through the Food and Drug Administration, has the following among other controls of drug products. In the first place, no new drugs as defined in the act can be sold without obtaining release from the Food and Drug Administration. And a new drug, gentlemen, can be an old drug which has new use. That is, it can be an old drug for which new uses and new directions have been advanced in the labeling.

In other words, if you have an old drug that has been used for a generation for one thing and you suddenly project it for another use which has not been known to medicine, so that its use in that regard is not generally recognized as safe, it becomes under the definition of this law a new drug. If you take two old drugs and put them together in a new combination, which was not known, and which was not generally recognized as safe, it becomes a new drug.

Now, no new drug, whether it is an old drug or the old drug so transformed, or whether it is an entirely new substance like the sulfas when they came, can be sold in this country today until it is filed with the Food and Drug Administration, with a report of all the research which has been done to determine its safety, with the labeling under which it is proposed to be sold, and various other detailed material required by section 505 of the Federal Food, Drug, and Cosmetic Act. So that is the first area of control.

Even then, gentlemen, the Government has nothing to do with effectiveness. The question is safety. The question is toxicity.

Next: No adulterated drug can be sold. An adulterated drug is defined in numerous ways, but briefly, and I think the most comprehensive one, is that an adulterated drug is one which differs from the standard, differs from the identity or the standard of purity and quality which is set out in the official compendia if it is listed, and if not listed there, which is claimed for it on its label.

If an adulterated or misbranded drug is offered on the market it is subject to seizure in an in rem action, by libel. For adulterated drugs there may be multiple seizures. It is permissible to seize wherever found and as many times as found.

A misbranded drug is subject to a single seizure unless the Administrator finds that it is dangerous to health or is, in material respects, grossly misbranded. And then, of course, after a judgment in favor of the Government, a misbranded drug is subject to seizure multiply, just as though it were adulterated.

The misbranding section is broken down into many parts. I shall not go into all of them, because time forbids and also because some of them are not as illustrative as those I wish to pick out.

In the first place, a drug is misbranded if its labeling and you know, under the cases, labeling has been held by the Supreme Court to include not only the label which goes around the bottle and is affixed to it, but any circulars with it, or any cartons on the outside; and beyond that, the cases have held that if one ships separately from the drug any advertising material, circulars, or the like, which eventually meet that drug in the marts of commerce, no matter that they travel separatelyI think one of the cases had an 18-month lapse between the shipment of the drug and the shipment by express or parcel post, however it was, of the descriptive material-that is held labeling. If the package which travels in commerce is as pure as Ivory soap says it is, and material sent by mail or otherwise to dealers and users of the article is false and misleading, the drug is misbranded.

Now, it is subject to seizure, as I said, and the purveyor is subject to criminal prosecution except, as Mr. Harrop pointed out yesterday, the act provides a guaranty for the retail or wholesale purveyors who receive and distribute the drugs in good faith.

The fines and imprisonment under criminal prosecution are severe and they were made so by this committee when you took up con

sideration of it in 1935 and finally reported it out for passage in 1938; There are jail sentences and there are fines.

In addition, there is the remedy of injunction. The Government may secure injunction temporarily and permanently against the distribution of an adulterated or misbranded drug and against any drug that has not gone through the new drug section if it is subject to

it.

If the drug is narcotic or hypnotic under section 502 (d), it must be labeled "Warning-May be habit forming." It is misbranded if the ingredients are not disclosed on the label and the quantities of certain named ingredients, such as alcohol and chloroform.

Then there is the broad provision which has figured here a great deal. The drug is misbranded if it does not bear adequate directions for use. That was a very signal development under this act. There was nothing comparable to it under the 1906 act. I have always had great respect for that provision. I have always thought that it was one of the most salient provisions in this law for the protection of the public. And I may say to you that my position for years has been that the Federal Food and Drug Act on this point is no respecter of persons. The Food and Drug Act has said to the manufacturer that drugs must have adequate directions for use. If sold through the channels of the profession, they must have either adequate directions for use or be exempted under regulations for prescription sale.

We have had no complaint or criticism of the Food and Drug Administration dividing drugs into two classes: over the counter, with full directions for using, and prescriptions. They are doing that now administratively. What they ask here now is the power to adjudge. We have accepted the construction of the law which they have given. We have no objection to writing into the law the standard which they have administratively adopted for enforcing section 502 (f). And let me illustrate to you how this fits into the philosophy.

The command is that there shall be adequate directions for use. It is a very sensible command. What is "adequate" is a question of fact. The same article which contains an identical drug with this other article may need different directions because the proportions of the drug are different, because the recommendations are different; one may be for external use, another one for internal use; one may be for frequent use, another may be for occasional use; one may be for prolonged contact with the body, if it is an external ointment or salve, and another may be for short contact or limited contact.

A drug must have adequate warnings against use in pathological conditions or by children where its use would be dangerous.

That illustrates, Mr. Chairman, the position we hold here today. When this bill was before this committee in the years of 1935 to 1938 the Department wanted to write that provision in this way, that a drug shall be misbranded unless it bears warnings against use in pathological conditions and use by children, wherein its use may be dangerous, in such manner and form as may be promulgated by regulations.

In other words, they wanted power then to write the warning so that we would have to adopt it and we should have no relief except that which they propose here now of this involved administrative

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