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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. 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
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 be 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 witb 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
a 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 Government.
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, bas 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.