Dr. ROBINSON. Some years ago I wrote to the A.M.A. and stated our case as frankly as I could, and the answer was if I would come to Chicago and give them my formula and process of manufacture they would be perfectly delighted to approve my preparation. My answer was: That is the most valuable piece of property I possess; and when you give all of your property and your income to the people generally, then come to me, and we will consider the advisability of my giving you my property." 66 I can get their approval overnight, so this letter said, if I give them my property. But, gentlemen, I have to make a living the same as they do. You may find people who criticize us, but you certainly cannot find them among our patients. Thank you, gentlemen, very much. The CHAIRMAN. Mr. George W. McCoy. STATEMENT BY GEORGE W. McCOY, NATIONAL INSTITUTE OF HEALTH, UNITED STATES PUBLIC HEALTH SERVICE, WASHINGTON, D.C. Mr. McCoy. I am only here to call your attention to one feature in S. 2800, and that is that the permit factories, on pages 18 and 19, which is in effect, provides for a system of factory permits which would permit complete duplication of the work carried out by the Public Health Service under the provisions of the act of July 1, 1902, entitled "An act to regulate the sale of viruses, serums, antitoxins, and analogous drugs in the District of Columbia, to regulate interstate traffic in said articles, and for other purposes." This S. 2800 provides for a similar system of licenses under the name of permits to be enforced through the Agricultural Department, and I can readily see it would bring about a situation which would be a duplication of work and effort and perhaps some conflict of authority. I have no further comments to make on it. I wanted to bring this to the attention of the committee. I thank you. The CHAIRMAN. Do you have anything you want to file? Mr. McCoy. Nothing that I want to file. The CHAIRMAN. All right. Mr. J. T. Snyder. STATEMENT BY J. P. SNYDER, NORWICH, N.Y., OF THE NORWICH PHARMACAL CO. Mr. SNYDER. My name is J. P. Snyder. I am chief chemist for the Norwich Pharmacal Co., and as such I am called upon to serve in the position of controlling a complete line of pharmaceuticals according to the Food and Drugs Act. Consequently, I have been extremely interested in the various bills that have been presented before the different bodies, and at the outset I would say that I am extremely favorable to the McCarran-Jenckes bill. However, I understand we are here today to discuss S. 2800, and I want to point out one or two things in S. 2800 and offer constructive amendments which I think you will be inclined to adopt. Section 4 (b) of S. 2800, introduced by Senator Copeland, lines 5 to 11, on page 6, reads as follows: No drug shall be deemed to be adulterated under subdivision (g) of this paragraph if its label bears, in juxtaposition with the name of the drug, a statement indicating wherein its strength, quality, and purity differ from the standard of strength, quality, and purity set forth in the appropriate official compendium, as determined by the tests or methods of assay applicable under this paragraph. The paragraph, although expressed in somewhat different words, does not differ materially from a similar provision in the present Food and Drugs Act. It is an excellent provision of the law and one which has served the people of the United States admirably since in many instances it has placed in their hands medicinals of a higher quality or purity than would otherwise have been possible. Numerous illustrations of this situation might be related. However, I will not burden you with but one, as this will probably suffice. Shortly following the introduction of one edition of the Pharmacopoeia, manufacturers of antitoxin were able to greatly improve their process for the production of diphtheria antitoxin. Not alone were they able to greatly increase the potency of the product but they devised means of getting rid of certain impurities, thereby making it less dangerous when injected. The variation clause in the present law permitted manufacturers to at once place the improved diphtheria antitoxin upon the market, labeling it to show the difference from the official product of the Pharmacopoeia. If the law had not wisely provided for this advance in the science. of medicine, it in all probability would have been lost for some time to the American public since probably years would have elapsed before the change could have been incorporated into the Pharmacopoeia. It would seem that the intent of S. 2800 was to permit the public to obtain full advantage of any improvements in the science of medicine without waiting years for the Pharmacopoeia or National Formulary Committees to act. Unfortunately, however, we find the variation clause as given in section 4 (b) of S. 2800 is entirely voided by section 8 (f) on page 12, lines 16 to 18, which reads: SEO. 8. A drug shall be deemed to be misbranded (f) If its name is the same as, or simulates, a name recognized in an official compendium and it is not packaged and labeled as prescribed therein. Accordingly, while it is evidently the intent of this law to permit variation such as was illustrated with diphtheria antitoxin, article (f) of section 8 prohibits such improvements in medicinal products by providing they must be labeled as prescribed in an official compendium, if it bears the same or a similar name. Article (f) of section 8 should be amended so that it will conform to the variation clause as given in section 4, article (b). This can be accomplished by adding on page 12, line 18, after the word "therein ", the following: Except as provided in section 4 (b). It will then read— SEC. 8. A drug will be deemed to be misbranded— (f) If its name is the same, or simulates, a name recognized in an official compendium and it is not packaged and labeled as prescribed therein, except as provided in section 4 (b). I would like to submit that for your consideration, and I have just one other point in reference to what was discussed yesterday that I think is worthy of some further consideration. I refer to page 5 of S. 2800, line 17: And it fails to meet the definition, formula, and description. There seemed to be some discussion on the floor yesterday with reference to what was the meaning of the word "formula", and it was thought that it might be interpreted as meaning the chemical formula, the symbol for a compound or an element. It is my opinion that the writers of this bill, in placing this word "formula" in there, had in mind that when a person bought a U.S.P. or a N.F. preparation they were entitled to receive a produce that was made from the ingredients as specified in the United States Pharmacopoia or National Formulary. I feel that it is very essential that the law retain this word "formula." If it is not clear what is meant by "formula", then it should be modified by "working formula" or "ingredient formula." I can illustrate what I have in mind by how possible it will be if you do not retain that word "formula" for unscrupulous manufacturers to adulterate the United States Pharmacopoeia and National Formulary products. If we turn to the United States Pharmacopoeia under "fluid extract of cascara" and we refer to the test defined in the law, it says it must correspond to the test given in the Pharmacopoeia, but the United States Pharmacopoeia does not give any test for bona fide fluid extract of cascara, it simply requires in the formula that it must be made from cascara bar. Therefore, it is important to keep that formula. I have here a fluid extract of cascara, I can label it such, if you do not get that word "formula" in, and the product does not contain one bit of cascara. It is made out of buckthorn. The therapeutic activity of buckthorn may be similar to cascara, but I believe if a person specifies he wants fluid extract of cascara, he should get fluid extract of cascara made according to the United States Pharmacopoeia. The test in the Pharmacopoeia simply is an alcohol test: it must contain an average of 23 percent of alcohol. There is no other requirement. So we must retain this formula, or we will be subject to adulteration and sophistication of the official products. Here is another one, a very important product of the United States Pharmacopoeia, powdered extract of nux vomica. The United States Pharmacopoeia does give some test, but it is a simple and easy process, just so it contains a certain amount of alkaloids. If we do not retain the word "formula ", I or nobody else can manufacture it. These are big propositions, and the Department of Agriculture will have to pass these products because they comply with the law. You take the powdered extract of nux vomica; that product is made out of ginger mock. By "ginger mock" I mean ginger that is exhausted with some solvent and simply powdered, and I have added to it alkaloids of nuxin, brucin, and strychnin. In the preparation given in the Pharmacopoeia they answer all of the official tests, but surely a physician or anyone asking for powdered extract of nux vomica is entitled to obtain a preparation made from the drug and not from some exhausted mock treated up with some alkaloids. In fact, I wouldn't even have to use the alkaloids specified in nux vomica; I might use the palliative alkaloids and use them in the correct molecular proportion, and it would answer the requirements of the Pharmacopoeia. I would therefore stress that that law should retain this word formula ", and if you want my suggestions as to how it can be done, I would again refer to the McCarran-Jenckes bill, which so ably takes care of the situation, wherein it states, "and which differs from the standard of strength, quality, and purity." If we get the words "quality and purity" there won't be any question regarding the formula, because then it must comply with the official requirement. Senator OVERTON. It has been suggested that the word "formula" be clarified by the adjective "chemical ", so it would read "chemical formula." Do you think that covers your objection? Mr. SNYDER. No, sir; I don't think it wants to be "chemical formula." It wants to be so specified that it is the actual working formula of the National Formulary or the Pharmacopoeia. There are many products in the Pharmacopoeia and the National Formulary for which it would be impossible to give a chemical formula, because they are not pure substances. Thank you. The CHAIRMAN. Now, there are two gentlemen who want to leave the city, and I understand they have asked to be allowed to speak 10 minutes. We have just 20 minutes to adjournment, so I trust each gentleman will stay within the 10 minutes. Mr. R. M. Allen. STATEMENT BY R. M. ALLEN, NEW YORK CITY, REPRESENTING THE AMERICAN PURE FOOD LEAGUE Mr. ALLEN. I appear to represent the American Pure Food League, with a telegram from Mrs. Harvey W. Wiley, the president, as follows: ROBERT M. ALLEN, New York City: Please represent league hearing Tuesday. Have arranged Commerce Committee for you to speak. Mrs. HARVEY W. WILEY. I think, Senator, I said to you a little while ago I wished I had been heard over in the Commerce Committee room. In 1903, shortly after I was just out of college, we had a hearing then, I remember, before Senator McCumber on the then pending pure food bill. Yesterday afternoon I recalled the Members of the House and Senate committees, the food commissioners that were with me then, and I happen to be the only one living. During those intervening years I have had charge of the food and drug control work in Kentucky. For some 16 years I was secretary of the National Association of Food Control Officials, from 1902 to 1906. I served as a special assistant, although from the staff, to Attorney General Bonaparte in the final enforcement of cases arising under the Food and Drug Act. When I read the Senate bill, Senate bill 1944, I said to myself it is an honest bill; it has been written out of the best experience that we have had during the last 30 years. It should be taken as a model by the committee to construct this very difficult piece of legislation that you gentlemen have. I heard a suggestion yesterday from Dr. Jordan. By the way, he made a splendid talk, an honest talk, a helpful talk. He represented the college, as I understand, of pharmacy. The suggestion was very much akin to the way I handled the thing in Kentucky. Our pharmacists did not want the State board of health to have it. The State board of health did not want the pharmacists to have it, so the State board of pharmacy appointed a member on the committee, the State board of health a member on the committee, and the director of the experiment station. We worked it out splendidly that way. The American Pure Food League, Mr. Chairman, was organized back in those days, out of the senate of conference which came together from the different groups, the General Federation of Women's Clubs, the National Consumers' League, the State food commissioners. They all organized themselves into the American Pure Food League, and it later served as a clearing house for information back of the bill and for the bill. It has been reorganized here, and may I put into the record-I won't put any dynamite in, if you will trust me-may I put into the record the letter that was sent, the statement that has been sent to the members of the league? Dr. Carl L. Alsberg, who is regarded a rather conservative professor, wrote that he held up accepting the invitation until he looked the bill over. Here is his letter that he is in support of its general provisions: Miss ALICE LAKEY, FOOD RESEARCH INSTITUTE, STANFORD UNIVERSITY, American Pure Food League, Cranford, N.J. DEAR MISS LAKEY: If I have not replied to your letter of October 31 at an earlier date, it is not because I do not believe the Federal Food and Drugs Act needs strengthening. I simply wanted to secure a copy of the bill and examine it. I have now done so, and find myself in sympathy with its aims. I am, therefore, glad to accept your invitation to serve on the advisory board of the American Pure Food League. Very truly yours, CARL L. ALSBERG. Mr. Charles D. Howard, who was with us in those old days, the chief chemist and State food and drug control official of the State board of health of New Hampshire, and a member of the advisory board of the American Pure Food League, has written in the bulletin of the New Hampshire State Board for January 1934, a comprehensive and not too long review of that. I would like to have that included in the record. (The review mentioned above follows:) THE FEDERAL FOOD AND DRUG BILL The anticipated bombardment on the part of the well-known "interests " against the pending much-needed Federal food and drug law revision has been in full force for some time. Those of us who have reason to be familiar |