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We are strongly in favor of the Stephens bill, S. 2355, which would amend the present Food and Drugs Act of 1906, including within its scope cosmetics and the illegal advertising of food, drugs, and cosmetics. We trust that you will use your efforts in behalf of the Stephens bill, Very truly yours,
SCHLOTTERBECK & Foss Co.,
CHICAGO, ILL., March 8, 1934. Hon. HUBERT D. STEPHENS,
Chairman Commerce Committee, Washington, D.C. HONORABLE SIR: During my testimony before your committee on Saturday, March 3, I was asked by Senator Overton whether or not we had any suggestions regarding amending said Copeland food and drug bill. We respectfully suggest that the committee exclude “conditioned air" being defined as a drug, and submit following clause for consideration :
“ Conditioned air and devices for producing same shall be excluded from the operation of this act where common usage over a long period of time has proven said air harmless to animal life.”
When 25,000 people have breathed the vapor as made from the Terpezone generator it would seem proven harmless. Let false claims in advertising be severely condemned and prohibited, although there will always be an argument over what constitutes “substantial medical opinion.” Failing the inclusion of the above clause dealing with conditioned air, we urge attention to the following paragraphs as either being impossible to comply with or unnecessarily drastic.
Section 8, paragraph A.-A drug shall be deemed to be misbranded-(a) [suggested change) if its labeling bears the name of any disease which has not shown beneficial results with the application of said drug, in the majority of cases where so used, and a drug advertised as a specific cure for any disease must be substantiated by competent medical opinion, demonstrable scientific facts or confirmed by reputable licensed physicians who have been in charge of cases using said drug.
Paragraphs I and J.-It being impossible to determine how long it would require a germicide to act within the body, any clause dealing with suppositions is ambiguous.
Section 9, pargraph B.-The American public are fairly intelligent and know the limitations of most of the drugs on the market. It is absolutely unfair to bar the advertising of a drug just because it is not admitted to be a specific” by the medical profession. The medical profession have but very few specifics for any disease themselves, and should not wish to bar others.
Paragraph C.-This is the worst paragraph in the entire bill. Its inclusion will prevent progress in scientific discovery on over 40 different diseases, except by medical men. Pasteur was a chemist but his work was originally ridiculed by the medical powers. The inventor of the microscope was called “crazy." Harvey, who discovered the circulation of the blood, was put in jail. The history of vaccination reveals that Thomas Jefferson was unable to secure recognition of vaccines, and the fine doctors who introduced vaccination to this country were persecuted.
It is preposterous to assume that mention of any one of these 40-odd diseases is necessarily false. It is ridiculous to suppose that any mention of treatment will be “contrary to the interests of public health”, or “especially dangerous.' What specific or even relief has the medical profession for those 40 diseases? Is it intended that one must secure medical help or no help? It is a grant to the medical profession giving exclusive rights to treat these diseases even though they have been trying to help for the past hundred years without much more success today than the day they began.
Terpezone is extensively used and with extraordinary results, in at least 10 of this prohibitory list.
Section 14.-Under this clause the Government or any other interested parties could secure for ulterior purposes a copy of customers' lists and others using the food, drug, or cosmetic.
Section 16, paragraph 1.—(2) Isn't this too much authority to give any officer?
Section 17, paragraph 4.-A manufacturer will fear to write a letter regarding his product as it can be considered as “inducing indirectly the purchase of food, drugs, or cosmetics."
At the conclusion of our testimony before your committee we submitted the Terpezone green book and the black book, containing many records and data pertaining to Terpezone vapor. These records of Terpezone are left with you as chairman and hope that you and your committee will have the opportunity to inspect same. I wish to thank you for the great opportunity extended to present just a few of the Terpezone fact, and if there is anything further that we can do to display the generator or to show its results in operation, we will hope to be called upon. Respectfully yours,
F. L. ROGERS, President. The CHAIRMAN. Is Mr. Clinton Robb in the room? Mr. ROBB. Yes, Mr. Chairman.
STATEMENT OF CLINTON ROBB, COUNSEL FOR THE UNITED
MEDICINE MANUFACTURERS OF AMERICA, INC.
Mr. Robs. I am speaking on behalf of the Drug Institute of America and the United Medicine Manufacturers of America. My remarks will deal mainly with sections 9 and 22 of Senate bill 2800, not that these are the only sections to which I have objection, but rather because I regard sections 9 and 22 as fairly typical and as tending to support my position that the bill as a whole is objectionable both in principle and form.
One serious objection to this bill is that in general structure and plan it follows the original or so-called “ Tugwell” bill, known as S. 1944, which, in the language of Senator Copeland, in introducing Senate bill no. 2800, placed in the hands of the Secretary of Agriculture "too great arbitrary power.” In some respects I regard S. 2800 as more objectionable than either S. 1944 or S. 2000, for reasons to be outlined.
Unless new legislation dealing with foods, drugs, and cosmetics takes the form of amendments to the present Food and Drugs Act and follows the general plan of the original statute, all the decisions of our Federal courts construing and applying that statute during the last 27 years will be set at naught, with complete sacrifice of the views and ideas of some of the country's best legal minds respecting the problem of regulating the manufacture and sale of food and drug products. For example, such as as "therapeutic” and “curative should be preserved in any new statute because the courts have been at great pains to define them with exactness.
The passage of S. 2800, instead of clarifying the present Food and Drugs Act and giving more definite scope to its terms, would reopen and subject to protracted litigation many questions regarding selfmedication and proprietary medicine which already have received the exhaustive consideration of our courts, thus adding to the general confusion and uncertainty.
The first specific objection to S. 2800 relates to subsection 9 (b) which requires remedies that are not specific cures to bear labels to that effect and which explain “how the palliation is effected.” In the first place, no medicine can cure any disease for nature is the only curative agent. Physicians cannot cure, although we do not expect them to so inform their patients before they accept money for their services. But, even if it be fair to impose such a requirement on manufacturers of proprietary remedies, this is not a practical matter. In many instances where medicines are composed of several ingredients it is absolutely impossible to determine what particular ingredient or ingredients are responsible for the beneficial result or exactly how that result is achieved. A medicine may contain no ingredient that is recognized by the medical profession as particularly effective in and of itself, yet that ingredient in a compound may be the very therapeutic agent that makes the medicine effective.
Another serious objection to S. 2800 is that, in subsection 9 (c), it in effect would amount to legislative finding or decision that all self-medication is dangerous and contrary to public health, but “especially" or "patently” so in the 42 enumerated diseases, many of which diseases either are not of a communicable nature or ordinarily present no serious danger of contagion or epidemics. Throughout the history of the United States and up to the present time both the legislative and judicial branches of our Government have always respected the inherent right of the individual to treat his own ordinary ailments with remedies of his own choice, save only in cases where the facts warrant reasonable apprehension as to danger to the public through the spread of disease.
The passage of Senate bill 2800, containing the present subsection 9 (c), would establish the principle that a citizen may be deprived of the opportunity to buy a proprietary medicine for self use in the relief of a noncontagious ailment, or to purchase a proprietary remedy for a contagious disease in a case in which there is no reasonable ground for anticipating the spread of disease, thus making it possible for the Secretary of Agriculture under the provisions of this bill gradually to extend the application of that principle until all proprietary medicines were driven from the market and the right of self-medication thereby rendered empty and valueless. What the Secretary would be likely to do in this connection is revealed by the fact that while the first draft of the Copeland bill or S. 1944 enumerated 34 diseases as outside the permissible scope of self-medication, S. 2000 mentions 38 diseases and S. 2800 lists 42. Thus the forbidden list of diseases has jumped from 34 to 42 in a few weeks, making it possible for one to forecast the life expectancy of self-medication under this proposed law with almost mathematical certainty.
Senator VANDENBERG. Could he increase this list under the terms of the bill?
Mr. ROBB. He could.
The third and perhaps most serious of the many objections that may be made to Senate bill no. 2800 is with respect to the committee on public health created by subsection 22 (b). This committee would consist of five members designated for their “ distinguished scientific attainment and interest in the public health” and, as explained by Senator Copeland in introducing this bill, would consist of physicians interested in public health.
Inasmuch as the interests of the medical profession necessarily conflict in some degree with those of manufacturers of prepared medicines, and since the profession under the leadership of the American Medical Association is publicly committed to the theory
that all self-treatment is inherently dangerous unless under the supervision of some physician, the average physician naturally is more or less prejudiced against the sale of prepared medicines to laymen, although that prejudice may be unconscious. Therefore, and since it is fundamental that no man should be the sole judge of cases in which he has even an indirect interest, it is respectfully submitted that any committee or board of review created by new legislation pertaining to drugs and medicines should not be composed exclusively of physicians. Specifically, it is felt by the industry that such a committee or board should include a physician, a chemist, a pharmacist, a person with practical experience as a manufacturer, and an attorney.
The discrimination in this connection against manufacturers of drugs and medicines is emphasized by the fact that under the provisions of subsection 22 (c) two of the seven members of the “Committee on Food Standards are to be selected from the “ food producing, processing, and manufacturing industry” and three from the public. The provisions for representation of the industry in the case of foods and the absence of such a provision in the case of drugs and medicines indicates an intention on the part of the authors of Senate bill no. 2800 to place the future of the proprietary medicine industry entirely in the hands of the members of a profession whose representatives have publicly declared that all selfmedication is dangerous unless under the supervision of physicians. Accordingly, the enactment by the Congress of Senate bill no. 2800 containing the subsection 22 (b) would have the effect of dooming to certain destruction a great industry which represents the investment of hundreds of millions of dollars and employs many thousands of men and women.
This subsection 22 (b) is further objectionable in that it makes provision for the review by the committee it creates of only the promulgation of new regulations and leaves out of consideration the review of administrative acts. If any committee or board of review is to be created by the Congress, it is respectfully urged that such committee or board be given authority to review and make summary decision of questions of dispute between manufacturers and the Food and Drug Administration growing out of alleged violations of the Food and Drugs Act, thus correcting a very serious fault in the present statute.
Under the Food and Drugs Act now in effect the provisions for judicial review are inadequate in that in a case involving honest differences of opinion between representatives of the Department of Agriculture and of a manufacturer valuable good will may be destroyed while the manufacturer is vindicating his position in the courts. In such cases it should be possible either for the Department or the manufacturer to appeal to a board of review, constituted as just outlined, and secure summary decisions which should be binding upon both parties unless and until set aside or modified by the courts.
The so-called "Dunn bill", or Senate bill 2858, provides a board of review with power to pass upon administrative rulings and decisions, as well as new regulations, but the bill makes no mention of the qualifications of the five members of that board. For reasons already set forth, section 19 (1) (a) of the Dunn bill should be
I think so.
amended to provide that this board of review shall include a physician, a chemist, a pharmacist, a person with experience as a manufacturer of drugs and medicines, and an attorney.
Other objections to Senate bill no. 2800 may be summarized in the statement that the authors of this bill have attempted to effect a complete rewriting of the Food and Drugs Act instead of the addition of amendments to that statute. The underlying principles and general plan of the original statute have been abandoned entirely, notwithstanding that the Supreme Court of the United States, in U.S. V. 95 Barrels, 265 U.S. 438, said of the present Food and Drugs Act:
The statute is plain and direct. Its comprehensive terms condemn every statement, design, and device which may mislead or deceive. Deception may l'esult from the use of statements not technically false, or which may be literally true. The aim of the statute is to prevent that resulting from indirection and ambiguity, as well as from satements which are false.
Senator VANDENBERG. What year was that decision rendered?
Mr. Robb. The Drug Institute is a general trade association, and I may explain that I was asked to speak here today, presumably because I happen to be counsel for the United Medicine Manufacturers of America, many of whose members are also members of the institute, and supposedly with some practical experience in connection with food and drugs, too.
Senator VANDENBERG. Is the Institute thoroughly representative of all organizations? Mr. Robs. It is thoroughly representative of the industry; yes.
Senator VANDENBERG. You mentioned one objection to the McCarran bill. Have you endorsed, or are you satisfied with the subject in that respect ?
Mr. ROBB. Well, Senator, I would like to see the right of appeal made to the board of review absolute. In its present form the bill provides that there may be review where an appeal is granted. I appreciate the necessity of heading off frivolous appeals, but upon reflection I am convinced that the right of appeal should be absolute. I think it should be a matter of right on the part of the manufacturer.
Senator VANDENBERG. Would you concede that the existing Food and Drug Act requires any amendments in behalf of consumer protection?
Mr. Robs. I think, Senator, that the present Food and Drugs Act-and I speak with all sincerity–has been unusually effective. Frankly, I am unable to think of any other statute that has been more effective. Perhaps something should be done about advertising, but it seems to me that it is questionable whether the Congress should single out manufacturers of foods and drugs, and cosmetics, and impose restrictions as to advertising upon them and make no general provisions as to the advertising of other commodities. It seems to me that such action would be justified only if the manufacturers of these three classes had shown a greater propensity in that direction, but the facts are to the contrary.
The records of the Federal Trade Commission, which as you know, now has jurisdiction over the advertising of foods, drugs, and cosmetics, indicate that manufacturers of foods, drugs, and