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Senator COPELAND (interrupting). What you are saying now, Doctor, is because of the fact that your name was used yesterday and this is in reply!

Dr. FISCHELIS. Yes, sir.

Senator COPELAND. Because I could not keep faith with Senator Clark if I permitted you to make a new statement, but you have been referred to and you feel that you should make a statement regarding that, and certainly I could not object to its being received. Dr. FISCHELIS. I can confine myself then to this matter entirely. Senator COPELAND. I wish you would.

Dr. FISCHELIS. Mr. Bigelow, who spoke for the American Drug Manufacturers' Association yesterday, when asked to comment by Senator Copeland on the opinion expressed by several witnesses before the committee, including myself, with respect to the variation clause stated that Dr. Beal, who is a member of the council of the American Pharmaceutical Association, disagreed with my stand that lines 10 to 18 at page 14 of Senate 5, Committee Print 3, should be eliminated. That is the variation clause.

Dr. Beal is a highly respected and most able member of our association. In this instance, however, if Mr. Bigelow is quoting Dr. Beal's opinion correctly, and I presume he took pains to ascertain Dr. Beal's opinion, before quoting him, Dr. Beal does not speak for the American Pharmaceutical Association, for the American Pharmaceutical Association expressed itself very definitely on the subject by resolution at its convention in 1926 as follows:

It is noted that there is an increasing disposition on the part of manufacturers to use labels which are similar to U. S. P. and N. F. titles for preparations, both sub-standard and above standard, whereas such practice is not only deceptive for the buyer but carries potential dangers for the user; we emphatically protest against the use of U. S. P. and N. F. titles for any preparations excepting those which are prepared exactly according to U. S. P. and N. F. formulas.

No official expression since 1926 has been recorded by the association to alter its stand on this question, and therefore, while in this instance I have also expressed my own views on the subject, I really placed before the committee the expressed view of the association, and I speak for it as its president. In this connection, and in view of the fact that the committee will have before it the record of the hearings last year when considering this year's legislation, I deem it necessary to point out that the testimony given by Dr. Beal last year was given as spokesman for the National Drug Trade Conference and not as spokesman for the American Pharmaceutical Association.

The American Pharmaceutical Association did not have a separate spokesman last year at the hearings on S. 1944 and S. 2800. The National Drug Trade Conference made up of delegates from the American Pharmaceutical Association, National Association of Retail Druggists, National Wholesale Druggists Association, Federal Wholesale Druggists' Association, American Association of Colleges of Pharmacy, National Association of Boards of Pharmacy, Amer ican Drug Manufacturers' Association, American Pharmaceutical Manufacturers' Association, and Proprietary Association, appeared in opposition to these bills last year, although a separate statement

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favoring S. 2800, with certain modifications, was made on behalf of the American Association of Colleges of Pharmacy. It is conspicuous by its absence this year, a fact which can probably be best explained by the president of that organization who is also secretary and executive vice president of the American Drug Manufacturers' Association, the same association of which Mr. Bigelow is the general counsel.

Incidentally, Mr. Bigelow referred to Dr. Beal as chairman of the revision committee of the United Stataes Pharmacopoeia. This was an error. Dr. Beal is not chairman of the revision committee which produces the Pharmacopoeia. He is chairman of the board of trustees of the U. S. P. Revision Convention. This board has charge of the fiscal affairs and not of the revision.

Now, Mr. Chairman, the balance of what I have to say bears on the variation clause and is in reply to Mr. Bigelow's statement with regard to its effect upon manufacturers.

Senator COPELAND. That you will prepare for us and we will put it in the record.

Dr. FISCHELIS. If you prefer to have it done that way, I will do so. (The matter referred to is as follows:)

It seems to me that in view of a number of conflicting and possibly erroneous statements made at these hearings in behalf of interests representing professional pharmacy and the drug industry, the committee should be informed as to the type represented and the extent to which they reflect pharmacal opinion in the matters under discussion.

The American Pharmaceutical Association, of which I am president, is the oldest pharmaceutical association in the United States. It was organized in 1851 and is all-inclusive in its membership. Manufacturers, wholesalers, retailers, college professors, law enforcement officers, and pharmacists in Government services are all eligible to membership in the association. The association was organized primarily to cope with the problem of adulterated drugs, which was a very serious matter in the days before State and Federal legislation on the subject. Although its individual membership list is not large, it is very representative. Resolutions passed by the association are the expression of its house of delegates, which is made up of delegates from the 48 State pharmaceutical associations, the national associations representing wholesale, retail, and manufacturing interests, Government services, and various separate groups organized to serve the specialized interests within the profession and the industry. All are entitled to send delegates.

Its expression of policy, therefore, reflect as nearly as possible the composite of all shades of opinion within the profession and industry.

In addition to the American Pharmaceutical Association, we have a variety of national organizations representing specific interests within the profession and industry.

The American Association of Colleges of Pharmacy, the National Associa tion of Boards of Pharmacy, together with the American Pharmaceutical Association, are the groups within the profession and industry that compare with the American Medical Association, the American Public Health Association, and similar bodies in their interest in the legislation before your committee from the publc health standpoint.

The National Association of Retail Druggists is the trade association of those engaged in the retailing of drugs and medicines and the compounding of prescriptions. Its membership has a dual interest in pharmaceutical affairs. It cooperates actively with the American Pharmaceutical Association in professional matters, and in addition it maintains its own bureaus and committees which look after trade interests.

The American Drug Manufacturers' Association, as Mr. Bigelow stated, represents manufacturers of products used in the compounding of prescriptions and by physicians in their dispensing. Mr. Bigelow, however, neglected to point out that some members of his association are dealers in crude drugs which are sold to patent medicine manufacturers for the compounding of their

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products, and that it also includes chemical manufacturers who furnish the patent medicine industry with the crude materials entering into their preparations. Furthermore, some of the members of this association manufacture patent and proprietary medicines for those engaged in the patent and proprietary medicine business.

The American Pharmaceutical Manufacturers' Association consists largely of manufacturers preparing medicines for dispensing by physicians, although it also includes specialty manufacturers whose products are supplied to pharmacists for prescription compounding and who also manufacture medicines for others.

The National Wholesale Druggists' Association includes the so-called “service jobbers." They are the independent wholesale druggists who supply retail druggists with stocks of patent medicines and other drug-store commodities. A very large part of the business of the members of the National Wholesale Duggists' Association is, naturally, in advertised medicines, and they are the distributors to the retail drug trade of practically all patent medicines. The Federal Wholesale Druggists' Association is the association of cooperative wholesale drug houses. These cooperatives are, in many cases, owned by retail druggists as stockholders, and they, likewise, act as distributing organizations for patent medicines and other drug-store commodities.

The Proprietary Association and the United Medicine Manufacturers' Association are national organizations representing manufacturers of medicines advertised and sold to the public, usually without medical advice. They represent the so-called “patent medicine industry." Some of the members of these associations are actually manufacturers of the preparations which they market. Others merely package, advertise, and distribute their remedies and have them manufactured by members of the American Drug Manufacturers' Association or similar concerns. Still others are merely advertisers and distributors of the remedies which are manufactured for them.

In speaking for a specific group in the industry, a representative may refer to the number of units represented or the volume of business represented. The largest group in the profession and industry is made up of registered pharmacists who either own retail drug stores or are employed to carry on professional pharmaceutical activities in laboratories of retail pharmacies. manufacturing houses or in Government laboratories. They total about 130,000 individuals. There are about 55.000 retail drug stores. Their interests are represented largely by the American Pharmaceutical Association and National Association of Retail Druggists, and they distribute roughly 90 percent of all drugs and medicines consumed by the public. They are, therefore, closer to the public than any other group in the industry and most interested in the health and welfare of the average citizen as far as the sale of drugs and medicines is concerned. Their viewpoint as to the need for the public control of the industry is, therefore, an important one and less tinctured with selfinterest insofar as this particular legislation is concerned. May I remind you that they favor S. 5 with advertising under the jurisdiction of the Food and Drug Administration, formula disclosure and no variation clause in the case of the American Pharmaceutical Association.

Mr. Bigelow, in his testimony yesterday, quoted from correspondence with Mr. Lynn, of Eli Lilly & Co., whom he referred to, incorrectly I believe, as president of that firm. According to my information, Mr. Eli Lilly is the president of that company and Mr. Lynn is its general manager. In this correspondence it was asserted that the U. S. P. and N. F. originate nothing and there was at least a strong intimation that formulas and names originated by manufacturers had been appropriated by the compilers and revisers of the U. S. P. and N. F. This is a gratuitous insult to the medical and pharmacal professions, for it is a well-known fact that many of the drugs and preparations now listed in these official standards were there before any drug manufactur ing firms, such as Mr. Bigelow represents, came into existence. The policy of the U. S. P. and N. F. revision committees is to include no drugs in these books which have been patented, unless the patents have expired. It is a further policy not to list drugs in these standard works under registered trade-mark names, even though the patents on these drugs have already expired. Thus in the case of acetyl-salicylic acid, now listed in the U. S. P. since the patent on it has expired, it is not listed under the name of aspirin or any other trademarked title, but under its chemical name only.

Mr. Bigelow also alluded to the fact that Eli Lilly & Co. had donated to public use its patent for compounding a solution of ephedrine in mineral oil

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by the intervention of oleic acid as a solvent in the form of a vegetable oil. He did not point out, however, that the effect of this patent, if enforced, might have been to prevent the compounding of physicians' prescriptions for ephedrine in mineral oil by the method covered in this patent and that the indignation of the pharmacal profession in learning of this possible restriction had reached the point, in some quarters, of considering a court test of the validity of the patent. The action of Eli Lilly & Co. in surrendering its patent to public use was, therefore, not only timely in their own interest, but fair. as well, to the profession. The issuance of a patent on this process by the United States Patent Office was of doubtful legality in the opinion of many members of the pharmacal profession. In making available its patent on the ephedrine spray solution, Eli Lilly & Co. did not surrender the trade name of its product. The fact is that practically every one of those manufacturers who develop some kind of a formula gives it a trade name which is registered, if possible. As soon as one firm brings out a formula like that of the ephedrine spray, the others supply a similar formula with another trade name. A mere glance at the trade-name list issued by the American Drug Manufacturers Association will convince anyone that these manufacturers have been given every opportunity to protect their special formulas by trade marks. It is simple justice and fair play for the American people to keep the names under which standard formulas are listed in the U. S. P. and N. F. exclusively for the designation of those products which comply absolutely with such standards. The elimination of the variation clause is in the interest of honest manufacturing and dispensing of drugs and medicines. It will harm no one except the manufacturer who insists on trading on an official and recognized name without supplying the official formula.

If the manufacturer wants to vary the official formula he may do so but he should then select a new name for the product. The U. S. P. and N. F. titles should be a guaranty of identity, purity, and strength, in conformity with official standards from coast to coast and from border to border.

It is regrettable that Mr. Bigelow introduced the correspondence and other references to Eli Lilly & Co. into this record, as this firm has been one of the outstanding contributors to pharmaceutical and chemical research, and has made available, on a commercial scale, some of the most valuable medicinal products of the University Research Laboratories. It is at least doubtful that the principal officers of this firm hold the views expressed by Mr. Bigelow and the gentleman he quoted with regard to the U. S. P. and N. F.

In Senator Copeland's State (New York) I believe no variation is permitted and nobody has been put out of business on account of it. Professor Cook raised the question of the constitutionality of the U. S. P. if no variation clause is included in S. 5. If Congress is delegating power illegally by adopting the U. S. P. and N. F. as official standards, it is doing so regardless of the variation clause.

Changes can be made in the organization of the revision convention and committee if necessary to preserve the present status.

Congress could issue the call for the U. S. P. revision convention and make it an arm of the Government if necessary. The revision committee, as now organized, could readily become a revision commission with a proper set-up under governmental auspices and retain the present democratic principle of selecting the committee.

To hold that the constitutionality of the U. S. P. and N. F. cannot be questioned as long as there is a variation clause in the food and drug law is specious reasoning and to threaten to question the constitutionality of these standards, if a variation clause is not inserted in S. 5, is to inject cheap politics into a public-health question.

Senator GIBSON. Mr. W. G. Campbell!

STATEMENT OF W. G. CAMPBELL, CHIEF OF THE FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF AGRICULTURE

Senator COPELAND. Do you represent the consumers, Mr. Campbell!

Mr. CAMPBELL. I hope so.

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Mr. CHAIRMAN. I spoke at length at both of the previous hearings. Most of what I said before, and then, if not everything that I said is applicable in substantial measure to a consideration of the present bill S. 5. I have no desire to repeat the statements I have already made. The committee has indicated that it does not care to have a mere repetition of statements. I have no desire either to speak for the purpose of hearing the sound of my own voice.

I am perfectly willing to submit a statement if that is what the committee prefers, or I am willing to undertake to discuss the various matters that have been brought up as briefly or as exhaustively as the committee wishes.

Senator GIBSON. We feel that if you will submit a statement for the record, that that will be ample.

Mr. CAMPBELL. Very well. That will suit me entirely.
Senator COPELAND. Was Mr. Crawford to be called?

Mr. CAMPBELL. I understand not.

Senator GIBSON. His name is on the list.

Mr. CAMPBELL. I did not understand that he was to be called. Senator COPELAND. Now, after all of these hearings, have we finished?

Mr. J. B. MATTHEWS. Mr. Chairman, my name was on the list and was not called.

Senator GIBSON. Yes; Mr. Matthews.

STATEMENT OF J. B. MATTHEWS, REPRESENTING THE
CONSUMERS RESEARCH

Mr. MATTHEWS. I represent the Consumers' Research with headquarters in Washington, N. J., an organization which does in a very real sense speak on behalf of the ultimate consumer, numbering some 50,000 of them. We have been classified at this hearing by some witnesses as professional crusaders, with such adjectives as silly" and "hysterical" used to characterize us. If the interested parties testifying on this bill must be reduced to two classifications and I do not concede that they must be-we prefer to be counted among the professional crusaders who speak on behalf of the consumers rather than to be found among the agents of the modern Borgias of the patent-medicine racket. This bill is, as Senator Copeland has stated repeatedly, a measure designed to protect the consumers. It is that if it has any meaning at all. Yet it is perfectly clear that there are industries who would like to prevent the consumers' case from being presented here. I have before me a copy of Business Week of February 23, 1935, a responsible business organ published by the McGraw Hill firm-I believe the most powerful business publishers in America. This journal has the boldness, the audacity, to claim the support of this senatorial committee in such suppression. I think it highly important, that the statement from Business Week be brought to the attention of the committee if the committee has not seen it.

Commenting on the choice of Senator Clark as chairman of this committee-this is not my comment, but I wish only to read the statement of Business Week with regard to the way in which this hearing is to be conducted [reading]:

He