The purpose of the administration, stated repeatedly and frankly, is to preserve the profit system, which, in my previous talks, I have attempted to show is outworn.

Then there is just one more:

Gandhi is a mere piker in the technique of nonviolent coercion compared with the American ruling class in its use of educational agencies to prevent the frustration of its will to rule, or for that matter to prevent even the discovery of it unfitness to rule. The police power or the class-owned state is only the second line of defense for entrenched privilege which may in times of social turbulence be driven back from its educational outposts by a desperate enemy class of consumer-workers that has become educated, really educated, by the deprivations to which exploitation subjects it. In the last analysis the business state must either educate or shoot its despoiled subject masses. In either case its purpose is only to achieve stability for its rule.

Mr. CHAPMAN. We thank both of you very much.

STATEMENT OF HORACE BIGELOW, GENERAL COUNSEL AND CHAIRMAN, COMMITTEE ON LEGISLATION, AMERICAN DRUG MANUFACTURERS' ASSOCIATION

Mr. CHAPMAN. Please state your name, place of residence, profession, and business connection.

Mr. BIGELOW. Mr. Chairman, my name is Horace W. Bigelow, and I reside in Detroit, Mich. I am immediately connected with Parke Davis & Co. and am its general attorney. I am also general counsel and chairman of the committee on legislation for the American Drug Manufacturers' Association, which is composed of those manufacturers of medicinal products which are used by druggists in compounding physicians' prescriptions, and also by physicians who dispense direct to their patients. I have a list of membership here.

Mr. CHAPMAN. Will you file the list of all those you represent? Mr. BIGELOW. Yes. Included in the membership of our association are some of the largest and oldest manufacturers of that type in the country, who have not only a Nation-wide but an international distribution of their products. I refer to such firms as Squibb, Parke Davis, Sharp & Dohme, Frederick Stearns & Co., the Upjohn Co., and many others. Our association has always been mindful of the fact and in complete accord and full sympathy with the proposition that the safeguarding of the public health is paramount to any commercial interest. However, when the public interest can be properly safeguarded and at the same time the commercial interest fully protected, this should be done. Consequently, we are in full sympathy with the underlying principles and purposes of S. 5 as it was passed by the Senate and is now being considered by your committee. In other words, we endorse this measure and urge its early passage in the form in which it passed the Senate, with one or two minor exceptions to which I will address myself.

The first is the question of the language found in line 18 on page 16, which declares a drug misbranded if its labeling fails to bear plainly and conspicuously complete and adequate directions for use.

This particular question was very fully and ably discussed by Mr. Warren N. Watson, representing the Manufacturing Chemists' Association, and it was also referred to by Mr. Dunn in his statement.

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We believe the use of the words "complete and " places an unwarranted and unjustified burden on the manufacturers with respect to labeling, and the requirement, in many instances, I believe, would be contrary to the public interest. We believe that those words should be stricken from line 18, and after the word "use", in line 18, the following language inserted: "Under the conditions for which it is recommended."

I might say in this connection that Mr. Phillip, who was the last speaker this morning, referred to one drug which I believe had five different uses; that is, used in five different conditions. My point is that if manufacturers are recommending it for one of those conditions they should give adequate directions for that use, and that should be sufficient.

Mr. KENNEY. Do you favor the Watson amendment or the Phillip amendment, or do you have a separate amendment?

Mr. BIGELOW. I have just suggested my amendment, Mr. Kenney. I can read it again if you wish.

Mr. KENNEY. Your amendment is something different from the other two?

Mr. BIGELOW. It is a little different from Mr. Phillips' and Mr. Watson's, but they are all trying to accomplish the same purpose. I am giving it to the committee as a suggestion, and whatever the committee does to correct the situation will be satisfactory to us. The provision would then read, " adequate directions for use under the condition for which it is recommended."

Dr. George W. McCoy, Director National Institute of Health of the Treasury Department, appeared before your committee and recommended an amendment to this measure, the purpose of which is to completely eliminate from the provisions of the bill the regulation of those biological products already controlled and regulated under the Biological Act of 1902.

We wish to endorse that amendment, because a number of the members of this association are engaged in the manufacture and distribution of biologicals of the kind which I have mentioned.

I understand that the Food and Drug Administration has no objection to the amendment.

The attention of the committee has been directed to paragraph (d), which will be found on page 14, lines 13 to 15, and the statement has been made that this paragraph invalidates the variation clause, which will be found in paragraph (b), page 13, lines 21 to 25.

I have discussed the question with Mr. Campbell, and he advises that the intent and purpose of this section is to cover those drugs and preparations for which no standards are fixed; in other words. the so-called "unofficial drugs."

In view of the fact that this question has been raised, and for the purpose of clarifying the situation, I respectfully request that your committee, in its report on this measure, declare the legislative intent and purpose of paragraph (d), page 14, making it absolutely clear that this paragraph in no wise affects the variation clause as found in paragraph (b) of section 401, page 13, lines 21 to 25.

Mr. Campbell has advised me that he is agreeable to such a declaration.

As I have stated before, we endorsed S. 5 as it was passed by the Senate, with the exceptions which I have brought to your attention.

Mr. KENNEY. Did you appear before the Senate committee?
Mr. BIGELOW. I did; yes, sir.

Mr. KENNEY. Did you read those amendments?

Mr. BIGELOW. Which amendment? You mean the one with respect to adequate directions?

Mr. KENNEY. Yes.

Mr. BIGELOW. I believe I did. I know that matter has given manufacturers a great deal of concern.

Mr. CHAPMAN. Mr. Bigelow, can you give some concrete example of some product manufactured by one of your clients that will illustrate that variation problem to which you refer and show how it would operate?

Mr. BIGELOW. Yes. I think, for instance, Parke Davis & Co.I am depending on my memory now-introduced sometime in the seventies or eighties a product called "cascara sagrade ", which is a laxative preparation. Later, when the Food and Drugs Act was enacted, the U. S. P. and the N. F. were set up as official standards, this product, having been included, I believe, in the U. S. P., with a little different formula, without the variation clause we would have been compelled to change the name of the product or else conform our own formula to that set-up in the U. S. P.

Mr. CHAPMAN. How long has Parke Davis & Co. manufactured cascara sagrada?

Mr. BIGELOW. Well, I am just guessing at it. But my recollection is that it was around 1880; somewhere along that time.

Mr. CHAPMAN. Am I correct in my recollection that that drug was first used by the Indians, and that the Spanish priests in the early days, in the far West, got it from the Indians?

Mr. BIGELOW. I think Parke Davis got the drug through an expedition that they sent to South America. Upon further consideration, I believe the drug brought back by that expedition was cocillana.

Mr. CHAPMAN. Isn't the first record of any scientific publication, to the effect that there was any medicinal value to this product, the published account of Dr. J. H. Bundy, of Caloosa, Calif., in 1876?

Mr. BIGELOW. That I can't answer, Mr. Chairman. As I have explained, I am a lawyer and not a scientist.

Mr. CHAPMAN. You don't know whether Parke Davis & Co. got it from Bundy, or how they got hold of it and began bottling it and selling it?

Mr. BIGELOW. I think you are giving an unfair impression there. Mr. CHAPMAN. I don't mean to reflect on the quality of the medicine at all, or on the

company.

Mr. BIGELOW. I am not certain about the source from which it was obtained.

Mr. CHAPMAN. Does anybody else manufacture this product?
Mr. BIGELOW. Oh, yes. It is not a patented product.

Mr. CHAPMAN. Under the same formula, or do they use some other formula?

Mr. BIGELOW. Other manufacturers may make it in a little different standard or strength.

Mr. CHAPMAN. Is it a fact that Parke Davis & Co. has frequently changed that formula, so that it has passed through numerous variations during the period that company has manufactured it?

Mr. BIGELOW. I would not be surprised if that were true, Mr. Chairman, because Parke Davis & Co. is constantly trying to improve its products. We maintain a research department, I think one of the finest and largest in the country, just for the advancement of that sort of thing.

Mr. CHAPMAN. I was interested--I also know that this is a reputable company, and I do not mean any reflection on it at all-but isn't it also true that in manufacturing a product like this, in addition to maintaining or even improving the quality of it, there is another motive frequently with business firms to work out a formula by which that product can be marketed as cheaply as possible and at the same time maintain a standard high enough that it can still be sold?

Mr. BIGELOW. Are you speaking of pharmaceutical manufacturers generally?

Mr. CHAPMAN. Yes; and also of manufacturers of other products; but I am speaking particularly of cascara sagrada now. Is that the one that has passed through these variations of formula?

Mr. BIGELOW. Are you referring to Parke Davis & Co. particularly? Mr. CHAPMAN. Yes. You stated they had varied that formula a number of times, and I wondered if the question of profit might have entered into their minds in changing this formula.

Mr. BIGELOW. Mr. Chairman, you misunderstood me. I did not say they had varied it, because I don't know. It is very possible they might have varied it.

Mr. CHAPMAN. Let me ask you this: Did the United States Pharmacopoeia accept this formula of Parke Davis for cascara sagrada as a standard formula?

Mr. BIGELOW. I am not sure about that. I was merely trying to illustrate this point; if a manufacturer introduces a preparation, has it on the market and well established for 5 or 10 years, then the revision committee of the United tSates Pharmacopoeia or the National Formulary takes that as a good product and sets an official standard for it, they may set a standard that is different from the one which has been established by the manufacturer who originally introduced it. If that is done, then the manufacturer either has to change the name of his original preparation or he has to adopt the formula fixed by the revision committee. The variation clause is put in for the purpose of taking care of such situations in the interest of progress in pharmacy and chemistry and to protect the rights of the manufacturer who has introduced and established a product of that type.

Mr. CHAPMAN. When the hearings on this bill started I got from the Congressional Library a United States Pharmacopoeia to be used as a reference work and have checked and investigated a number of well-known medicines. My understanding and recollection is that the Pharmacopoeia refused to accept your company's formula as a standard, and I have wondered if that was due to the fact that it had been, as I am advised, varied materially on numerous occasions, and I was wondering also if that might be one of the underlying reasons for your advocacy on behalf of Parke Davis & Co. of this variation clause?

Mr. BIGELOW. No; that is not true, Mr. Chairman. The variation clause has been in the existing law ever since it was enacted. You will find substantially the same language in the measure before you. I would like to read it to you. It will take but a moment.

Mr. CHAPMAN. All right.

Mr. BIGELOW. The existing law provides:

That no drug defined in the United States Pharmacopoeia or National Formu lary shall be deemed to be adulterated under this provision if the standard of strength, quality, or purity be plainly stated upon the bottle, box, or other container thereof, although the standard may differ from that determined by the test laid down in the United States Pharmacopoeia or National Formulary.

That is the existing law.

S. 5 has this language:

No drug shall be deemed to be adulterated under this paragraph because it differs from the standard of strength, quality, or purity therefor set forth in an official compendium

And, of course, "official compendium" is defined as including the United States Pharmacopoeia, the Homeopathic Pharmacopoeia of the United States, and the National Formulary

if its standard of strength, quality, or purity be plainly stated on its label.

The old act said" on the label, box, or container thereof." It is not necessary to use that under this act, because labeling is defined and includes the container, the box, and other packages.

Mr. CHAPMAN. Now, Mr. Bigelow, I know that Parke Davis is one of the outstanding manufacturers of drugs. Now, does that company also manufacture patent medicines for other people?

Mr. BIGELOW. I don't understand

Mr. CHAPMAN. I mean do they manufacture formula that they do not sell themselves but manufacture for other people who do put them on the market, as do many other manufacturers?

Mr. BIGELOW. I think that every pharmaceutical manufacturer, including Parke Davis & Co., maintains what they term usually a private formula department. For instance, if you, Mr. Chairman, had a formula that you wanted made, and you brought the formula to us, we would make it and ship it to you.

Mr. CHAPMAN. Can you estimate about what proportion of the total business that amounts to?

Mr. BIGELOW. You mean in the industry?

Mr. CHAPMAN. Yes; and your company, if you can't speak for the industry.

Mr. BIGELOW. I am speaking for the industry not particularly for my company, but I can say for the record that my company is the only one I know about, and the percentage is so small that it is practically nothing.

Mr. CHAPMAN. A comparatively small part of the total business. Mr. BIGELOW. Yes.

Mr. CHAPMAN. Do you know who manufactures Banbar?

Mr. BIGELOW. No, sir.

Mr. CHAPMAN. That is this $12 a bottle diabetes cure.

Mr. BIGELOW. The horsetail remedy?

Mr. CHAPMAN. The horsetail; yes. You don't know who manufactures that?

Mr. BIGELOw. No, sir: I do not.

Mr. CHAPMAN. You have supplied the clerk, I believe, with a list of all those for whom you speak?

Mr. BIGELOW. Yes.