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objections which this association desires to point out to your committee. In so doing, this association wishes to make it clear that there are many other features of S. 2800 which appear to be open to criticism, but which, because they do not immediately and directly affect the broadcasting industry, are not specified in this memorandum.
1. Page 3, lines 15–17. This paragraph defines advertising as "all representations of fact or opinion disseminated in any manner or by any means other than by the labeling."
Such a definition, if taken literally, is manifestly absurd. It is not an arhvertisement if A tells B that he thinks X Remedy cured his headache, yet such a statement falls absolutely within this definition. Further, under the terms of section 9, paragraph (b), it is, or may be, a false advertisement, in that it refers to X Remedy as a cure and not a palliative, and therefore, under the terms of section 17, paragraph (b), the speaker is technically “subject to imprisonment for not more than 1 year, or a fine of not less than $100 nor more than $1,000, or both such imprisonment and fine.”
Vor is it an advertisement if a scientific speaker or writer, discussing matters relating to health, happens to refer to a particular food or drug, when his object is manifestly not to promote the sale of such food or drug.
It is therefore, urged that this paragraph be amended by the addition of a phrase borrowed from the copyright laws, so that the paragraph as amended shall read as follows:
* (j) The term 'advertisement includes all representations of fact or opinion disseminated publicly and for profit in any manner or by any means other than by the labeling."
2. Page 15, lines 15–20: This paragraph provides that "An advertisement of a drug shall also be deemed to be false if it contains the name of any disease for which the drug is not a specific cure but is a palliative and fails to contain a plain and conspicuous statement, so placed as to be readily observable where such pame occurs, indicating that the drug is å palliative and how the palliation is effected."
Regarding this paragraph three specific points should be considered :
(a) The paragraph apparently includes oral or broadcast advertising, and yet it is absolutely impossible to apply to such advertising the provision contained in the clause “so placed as to be readily observable where such name occurs." This difficulty can be obviated by striking out, in line 18, the words * and conspicuous", and in lines 18 and 19 the phrase “ so placed as to be readily observable." ; (b) It should be pointed out that both popular and scientific opinions vary widely as to what is actually a “cure" and what is a “palliative". For instance. do certain familiar remedies “cure” headaches or are they merely - palliatives "? In view of the apparent impossibility of securing any adequate and accurate definitions of “ (ure and “palliative", it appears that this paragraph should be stricken out.
(c) The clause “and how the palliation is effected " appears to present a condition with which it would be impossible to comply. Such a statement would, in effect, require every advertisement of a "palliative” to include an essay or technical treatise on the manner in which the drug in question affects the system. Such a treatise may be possible on a label, though even there it seems difficult, but how is it to be included on a signboard or in a radio announcement? It seems clear that this clause should be stricken out.
3. Page 15, line 25. Paragraph (c) of section 9 is “ to discourage the publie advertisement-of drugs for diseases wherein self-medication may be especially dangerous.” To this end, the section provides that “any advertisement of a drug representing it to have any effect in the treatment of any of the following diseases shall be deemed to be false." Then follows a long list of diseases, including diphtheria, measles, mumps, pneumonia, scarlet fever, and whooping cough.
There is plenty of medical opinion to support the contention that certain drugs do have at least a palliative effect in the treatment of these and other specified diseases, if only to the extent of relieving pain or discomfort, redueing fever, or inducing restful sleep. The phrase “ have any effect in the treatment of", therefore, seems altogether too broad, and it is suggested that this phrase be stricken out, and replaced by the word “cure."
4. Page 22, lines 12–1.7: Section 1.1 provides for examinations and investigations of alleged violations of the provisions of this act. Paragraph (a) authorizes the Secretary of Agriculture to conduct such examinations. Paragraph
(c) provides that the Secretary, before reporting any violation of this act to a United States attorney for institution of criminal proceedings thereunder, shall provide for hearings for all interested persons.
Paragraph (b) of this section conforms to paragraphs (a) and (c) so far as the Secretary's activities are concerned, but in lines 12–15 it adds a mandatory provision that proceedings shall be instituted by each United States attorney to whom any health, food, or drug officer of any State or Territory, or political subdivision thereof, presents evidence satisfactory to the United States attorney of any such violations."
The Secretary of Agriculture cannot report a violation of the act until after a hearing, but any local health, food, or drug officer may do so without giving anyone a chance to be heard. They do not even have to report such alleged violations to the Secretary of Agriculture.
The result would inevitably be flagrant injustice and a complete overturning of the orderly and rational procedure set up in the rest of section 15. It is, therefore, strongly urged that the entire clause just quoted be stricken out. In view of the fact that the greater part of the advertising coming under this act is national or at least interstate in scope, it would manifestly be impossible to provide that any local officer shall hold hearings, as is provided in the case of the Secretary of Agriculture.
5. Page 27, line 15: This paragraph provides that certain persons shall not be “ deemed in violation of paragraphs (b) or (c) of this section.” The prohibited acts, however, are all listed in paragraph (a), while paragraphs (b) and (c) set forth the penalties for violation of any of the provisions of paragraph (a). It is obvious, therefore, that line 15 should be amended to read “ deemed in violation of paragraph (a) or subject to any of the penalties set forth in paragraphs (b) or (c) of this section."
6. Page 28, lines 16-20: The following new and extraordinary provision, not included in any of the previous drafts of this bill, has been added to section 17, paragraph (e) :
* No retail dealer shall be prosecuted under this section for the dissemination, other than by radio broadcast, of any advertisement offering for sale at his place of business any product which is not distributed or sold in interstate commerce."
Apparently the sole purpose of this sentence is to discriminate among advertising media, and to say to the retail dealer that he may safely use the United States mails or any other medium with the single exception of radio broadcasting.
If the commodity offered for sale is actually not“ distributed or sold in interstate commerce ”, why should the retail dealer be warned by act of Congress against the use of radio broadcasting whereas the United States mails are left open to him?
If the commodity is distributed or sold in interstate commerce, the provi. sions of section 17, paragraph (a) (5) immediately apply. Otherwise the situation is fully covered by the provisions of section 17, paragraph (a) (4).
This deliberate and, in view of the language of the two subparagraphs just cited, absolutely uncalled-for attempt to discriminate against radio broadcasting as an advertising medium marks a new departure in the field of Federal legislation. The Congress might with equal logic declare an advertiser criminally liable for false advertising in a periodical but guiltless if he inserts the same copy in a newspaper. The principle underlying such discrimination, which is in effect a deliberate effort to dictate to advertisers what media they shall use, is so utterly foreign to all established legislation that it is not surprising that this sentence was not introduced in time to be subject to scrutiny at the hearings on the earlier draft of this bill.
In common fairness, and still more in maintenance of the principle that it is not a function of Federal legislation to tell advertisers what media they shall or shall not use. it is urgently requested that this recently added sentence be stricken out.
As has already been stated, the National Association of Broadcasters, in setting forth these specific suggestions for amendment of S. 2800, does not thereby imply that with these amendments the bill will be satisfactory to the broadcasting industry. The points herein covered are those which seem to the broadcasters the most obvious and self-evident defects in the measure as now drafted, and it is urged that your committee give careful attention to the suggestions here set forth.
BRIEF OF DR. John F. ANDERSON, VICE PRESIDENT OF E. R. SQUIBB & Sons, 745
FIFTH AVENUE, NEW YORK CITY
Mr. Chairman and Members of the Committee on Commerce:
My name is John F. Anderson. I am a physician, vice president of E. R. Squibb & Sons of New York City, and director of the research and biological laboratories of that company. I appeared before the subcommittee of this committee at the time was holding hearings on S. 1944, and presented a brief approving in general the purpose of that bill and making suggestions which we felt would improve it.
E. R. Squibb & Sons are glad to see that in drafting S. 2800 many suggestions which were made on my first appearance have also appeared advisable to the committee. A few suggestions which we still deem of considerable importance were, however, either not adopted at all, or only partially adopted in S. 2800. We are, therefore, calling these again to the attention of the committee.
At the outset we wish to reemphasize the necessity for Congress to adopt some legislation to counteract the serious abuses which were referred to in my original statement to this committee regarding the dangerous practice of counterfeiting drug, cosmetic, and food products. We are prepared to recede from our original position that these dangerous abuses be covered in the Federal Food and Drugs Act but as a necessary supplement to the present bill we respectfully urge the adoption of legislation in the form of S. 783 introduced by Senator Wagner on behalf of Senator Copeland in the first session of the Serenty-third Congress. The present bill does not purport to cover the counterfeiting evil yet, in our judgment, at least as great, if not greater, dangers lie in this field than in the field covered by the present bill. We speak from experience when we say that some of the most dangerous and vicious elements of racketeers are devoting themselves to the counterfeiting of drugs and nationally advertised products.
They have learned much that is helpful in distributing their wares from their experiences in the liquor bootlegging business. They are experts at false labeling and, of course, the sources from which their products come are subject to no supervision, are very difficult to locate and the dangers to the public health are obvious. Established manufacturers with well-known brands even without the passage of the present bill are subject to the very effective administratiton of the food and drug department and of the Department of Agriculture. They will be even more so, we hope, after the passage of the present bill, and it is quite anomalous that such manufacturers will be subject to the stringent requirements of the present bill and these other elements to which we refer will not. We do not wish, however, to confine our arguments to the public health aspect alone. Although this is, no doubt, the paramount consideration, the Government, we submit, should also be desirous of protecting its citizens in the establishment of honest business and against such patently dishonest practices. We think the Food and Drug Administration will be among the first to acknowledge that many manufacturers have cooperated with them in their attempts to bring about pure food and drug dissemination and to eliminate improper methods of distribution, and it seems only fair that the powerful instruments of the Feileral laws be applied to protect such manufacturers from this evil. Many States have adopted laws along the lines of S. 783 but, without the control of interstate commerce of these goods, which only the Federal Government can effect, such laws can only be partially effective.
We are aware of the thought and time which has been given to the preparation of S. 2800 and we know that this Committee is loath to take the time necessary to adjust the proposed legislation to fit the abuses of which we are now speaking, but this is, of course, wholly unnecessary as the other legislation (S. 783) is designed only to cover counterfeiting. is along lines which have already been laid out by State legislation, and if the Committee in its report will likewise urge the adoption of a bill along the lines of S. 783, as a complement to this bill: to which we believe no honest objection can be raised, the ('ommittee will, in our judgment, have covered the entire field. In our judgment, it will have rendered a great service to the public and to the cause of honest business.
The following are the specitic suggestions which we made at the time of my previous appearance before the subcommittee which have not been incorporated in S. 2800 and which we deem of such importance that they should be again presented to the committee with the request that it give them its serious consideration in connection with any bill that it recommends to the Senate.
Page 6, section 4, paragraph (bi, subdivision (2), beginning with line 5, reads as follows:
“No drug shall be deemed to be adulterated under subdivision (2) 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, ani purity set forth in the appropriate official compendium, as determined by the tests or methods of assay applicable under this paragraph.
While this language has been changed somewhat in detail its meaning is the same as in S. 1914. We still believe that this paragraph will be improved if amended to read as follows:
" No drug shall be deemed to be adulterated under subdivision (2) of this paragraph if (1) its label bears immediately following the principal name of the preparation a plain and conspicuous 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 or (2) if its label bears immediately following the principal name of the preparation a plain and conspicuous statement indicating wherein the preparation fails to meet the definition, formula, or description, set forth in such compendium, provided that the variation from such official definition, formula, or description does not either materially affect the efficacy of such preparation or substantially alter its identity."
As stated at the time of my previous appearance, this amendment is designed to cover a very definite need which now exists under the present law, There are many articles which are defined in the United States Pharmacopeia, Homoeopathic Pharmacopeia, or National Formulary, which because of their viscosity or unsuitable form require the introduction of some nonactive in. gredient to improve their availability for consumption. To introduce such an ingredient is sometimes deemed to alter the identity of the product and thus preclude the use of the designation referring to that product in the official compendium. As we previously pointed out, a very good example of this is the case of castor oil. Castor oil is defined in the United States Pharmacopæia substantially as extract from the castor bean. Everyone knows that the high viscosity of pure castor oil makes it unpalatable and disagreeable to take. The introduction of certain oils render castor oil much more agreeable to the taste and thus promote its use. The amount of oil which is added is inconsequential so far as the efficacy of the product is concerned.
Again, elements are introduced into products to keep them from freezing or dissolving under certain temperatures so that they may be constantly available for consumption. Their introduction does not affect the real identity or efficacy of the product but on the contrary most definitely improves it. As previously pointed out, it is no answer to say that the manufacturer may designate his product by a name other than the official name for the official name is the one the public is used to and readily recognizes. The expenditure of large sums of money in advertising the product under the new name would be necessary to familiarize the product to the public even in the most general way. The provision which we have suggested which would require that the variation does not materially affect the efficacy or substantially alter the identity of the product will, we believe, check abuse of this provision. As previously pointed out, we urge the provision for the further reason that it will permit and encourage the introduction and use of definite pharmaceutical improrements in existing specifications in the United States Pharmacopoeia, Homoeopathic Pharmacopoeia or National Formulary.
Page 10, section 8, line 18, reads as follows:
* SEC. 8. A drug shall be deemed to be misbranded (a) if its labeling bears the name of any disease for which the drug is not a specific cure but is a palliative, and fails to bear a plain and conspicuous statement, so placed as to be readily observable where such name occurs, indicating that the drug is a palliative and how the palliation is effected."
This paragraph has also been modified, but our suggestion to amend the paragraph by inserting or does not constitute specific substitution therapy" after the word
has not been adopted. Medical science has produced and is at this time producing specific glandular extracts containing hormones which are recognized by physicians as specific substitution therapy. These
preparations are capable of replacing deficiencies of such hormones when properly administered to patients. We believe that the peculiar efficacy of these preparations in the treatment of certain diseases warrants their recommendation in the treatment of these conditions without the necessity of explaining in detail how they accomplish palliation of the manifestations of the disease. It is our suggestion, therefore, that this paragraph be amended to read as follows:
“ SEC. 8. A drug shall be deemed to be misbranded
“ (a) If its labeling bears the name of any disease for which the drug is not a specific cure or does not constitute specific substitution therapy but is a palliative, and fails to bear a plain and conspicuous statement, so placed as to be readily observable where such name occurs, indicating that the drug is a palliative and how the palliation is effected.”
Pages 13 and 14, section 8, paragraphs (i) and (j) beginning, respectively, at line 18 on page 13 and line 13 on page 14, read as follows:
SEC. 8. A drug shall be deemed to be misbranded-.
“(i) If it purports to be or is represented as a germicide, bactericide, disinfectant, or antiseptic for any use on or within the body and its labeling fails to bear a plain and conspicuous statement of such use, including the strength or dilution, manner, and duration of application, and when tested by methods simulating as nearly as practicable the conditions of such use, or in the absence of such methods, when tested by a standard method, it does not have the germicidal effect within the duration so prescribed of a one to eighty dilution of phenol used by a standard testing method for ten minutes at thirty-seven degrees centigrade. All testing methods for the purposes of this paragraph shall be prescribed by regulations as provided by section 22: Provided, That no drug shall be deemed to be misbranded under this paragraph by reason of failure of its labeling to bear a statement of any advertised use if such advertising is disseminated to members of the medical and pharmaceutical professions only, or appears in scientific publications of these professions.
“(j) If it purports to be or is represented as an inhibitory antiseptic for any use as a wet dressing, ointment, dusting powder, or such other use as involves prolonged contact with the body and its labeling fails to bear plain and conspicuous statement of such use, including strength or dilution and manner of application, and when tested by methods simulating as nearly as practicable the duration of application and other conditions of such use, or in the absence of such methods when tested by a standard method, it fails to prevent the growth of micro-organisms within the entire time of such duration. All testing methods for the purposes of this paragraph shall be prescribed by regulations as provided by section 22: Provided, That no drug shall be deemed to be misbranded under this paragraph by reason of failure of its labeling to bear a statement of any advertised use, if such advertising is disseminated to members of the medical and pharmaceutical professions only, or appears in scientific publications of these professions."
Paragraph (j) which has been added takes care of one of our objections to section 8 (i) in S. 1944. However, as more closely meeting the situation than the modifications which appear in S. 2800 and in the interest of accurate scientific evaluation of the properties of germicides, bactericides, disinfectants, and antiseptics, we wish to repeat the amendment suggested at the previous hearing and urge its adoption in lieu of the above paragraphs (i) and (j) in S. 2800. That amendment is as follows:
“(i) If it purports to be or is represented as a germicide, bactericide, disinfectant, or antiseptic for any use on or within the human or animal body and its labeling fails to bear a statement clearly indicating its phenol coefficiency and the dilutions in relation to time of exposure in which it kills recognized test micro-organisms; provided that any preparation may be labeled as an antiseptic if its directions for use provide for continuous contact with the part treated and in the strength used and in such contact and strength it is capable of preventing the growth of recognized test micro-organisms with which it comes in contact. The Secretary may establish after notice and hearing bacteriological tests, including the various types of test micro-organisms, to be used in determining phenol coefficiency, the strength of killing dilution in relation to time and growth inhibition."
Page 19, section 13, line 8:
This section provides for factory inspection with the exception of methods and processes. We object to this provision on the ground that we do not see