STATEMENT OF HORACE W. BIGELOW, GENERAL COUNSEL AND CHAIRMAN OF COMMITTEE ON LEGISLATION OF THE AMERICAN DRUG MANUFACTURERS ASSOCIATION The members of this association (list of members attached) are representative of manufacturers of prescription products which are the medicines used by pharmacists in compounding physicians' prescriptions and by dispensing physicians who supply medicines direct to their patients. By the very nature of their business, the members of this association have always been mindful of the necessity for the proper protection of the public health, the safeguarding of which is recognized by the members of this association as paramount to commercial or other considerations. Consequently, their attitude toward Senate bill 1944 has been governed by the necessity of the proper protection of the public health, as well as the safeguarding of the consumer. We are in accord with the proposition that false advertising of medicinal products must be eliminated and that there is also a necessity for the control of the so-called cosmetic products. It has been our hope that these purposes could be accomplished by the amendment of the existing Federal Food and Drugs Act. This hope has been entertained because it is felt that a repeal of the existing law would result in the recall of many interpretative decisions of the courts, which have been handed down during upwards of the 25 years which have elapsed since the enactment of the present act. Moreover, every member of this association has a Nation-wide distribution of its products, which brings them more or less under the jurisdiction of the food and drugs acts of the several States, which acts have been enacted over a period of years and to a greater or less degree in their form and substance follow the Federal act. It necessarily follows that if the present act is repealed, there will follow a period of years during which the several States will attempt by legislative enactment to bring their various laws into line with any Federal act which may be passed by the Congress of the United States. The turmoil and uncertainty resulting therefrom would, we believe, be detrimental to the manufacturers and producers of prescription medicinal products without serving the public interest. We have, therefore, been inclined to the view that if it were at all possible, the existing Federal Food and Drugs Act should be amended to accomplish the proper control of false advertising and the other matters which seem to require better supervision. The proposed legislation which is now under consideration, does not amend the present act but completely repeals it, and is susceptible to the sound objection that by its terms it is an unwarranted and unjustified delegation of legislative power to administrative officers. Provision after provision and section after section contain powers of regulation with respect to specific problems, and finally in section 23 the Secretary of Agriculture is given additional broad powers of regulation which would enable him to write regulations at will having the full force and effect of law, thus submitting the drug industry to the whim and caprice of administrative officials. In making this statement, we are not in any way reflecting on the present administrative officers, but are advocating the continuance of 30390-34-29 the sound principle that no Government administrative officer should have the power and authority to legislate by regulation. We do not deny the necessity of conferring upon administrative officers regulatory powers limited to the proper enforcement of the law under which such powers may be exercised. It is believed that there has never before been a measure introduced in the Congress of the United States, granting such wide legislative powers to an administrative agency as Senate bill 1944. It hardly seems necessary to advance any further reasons for the necessity of the complete revision of this proposed measure than the sound objection which we have already enunciated. However, there are many specific objections to particular provisions of the proposed measure and we will attempt to enumerate some of the more important. Section 4 (a) provides that a drug shall be deemed to be adulterated-(a) if it is or may be dangerous to health under the conditions of use "prescribed in the labeling thereof." Almost any drug may be dangerous to health. Even a normal dosage when administered to a patient with idiosyncrasies for certain drugs which appear to be free from possible danger, may be found overnight to be dangerous to certain individuals as in the case of Cincophen, and the careful use of antitoxins and serums which may be accompanied by unavoidable reactions. This form of definition might open the door to unjustifiable lawsuits against reputable manufacturers by designing individuals, even though there is no adulteration in fact within the commonly understood meaning of the term. Also under this clause the physician may be deemed by the administrative officers to be liable under the prescriptions which he writes. Section 4 (b) repeals the deviation clause as it is now found in the present Food and Drugs Act. The repeal or change of this clause has been consistently opposed by this association for years. At the third annual meeting of this association, held in 1914, Frank G. Ryan, then president of the association, made the following significant statement in his address: During the past year indications have appeared that an attempt will be made to amend the Pure Food and Drugs Law with a view of doing away with the socalled variation clause. To those who have not given careful study to this subject the suggestion may seem desirable; but when carefully exmained it will be found that its effect will be very far-reaching, and in fact will prohibit the sale of large classes of medicinal products, such as the mother tinctures of the homeopathic physician and specific tinctures of the eclectics, and any improved pharmaceutical or chemical product not conforming to the standards of the Pharmocopoeia or National Formulary, thus stifling all progress in the manufacture of medicinal substances until such time as those in authority may see fit to recognize such improvements. With the few exceptions where the public are purchasers direct, pharmaceutical products are sold through the drug trade, or used by physicians who certainly should be able to read labels and decide for themselves what product is wanted, and a definite statement of the exact strength of a product distinctly on the label should be all that should be required. I recommend that this association go on record as opposed to any change in the Food and Drugs Act which will repeal the so-called "variation" clause. Acting upon Mr. Ryan's recommendation, the association passed a resolution recording its opposition to any change in the act which would repeal the so-called "variation" or "deviation" clause. Section 4 (b) also gives the power to the Secretary of Agriculture to change the tests laid down in the United States Pharmacopoeia and the National Formulary. This question was very ably discussed by Dr. James H. Beal in his address before the committee yesterday. We are convinced that the present system of revision of these official standards is sufficient to meet the requirements of enforcement officers, particularly in view of the expeditious manner in which the two revision committees may issue supplements changing, modifying, or adding to the official standards. Attention is directed to section 6 (a) and the interpretation of what constitutes ambiguity or inference. This particular section was quite fully discussed and it is believed that the committee is thoroughly aware of the possibilities of drastic and dangerous interpretations under this paragraph. The provisions of section 8 (a) have also been forcefully brought to the attention of the committee and we wish to emphasize the fact that there are exceedingly few medicines recognized by the medical profession as specifics in the treatment of any disease in the medical sense of the word, and it is entirely out of place in this paragraph. Certain drugs that are exceedingly useful cannot be classed as anything but palliatives. Just what would be considered a cure and what would be considered a palliative, is evidently left to the discretion of the Secretary of Agriculture. Also, under this same section, it is provided that a drug shall be misbranded if its labeling bears any representation directly or by ambiguity or inference concerning the effect of such drug which is contrary to the general agreement of medical opinion. The chairman. of the committee has evinced considerable interest in this particular provision and apparently has been asking some revision of the language of this section whereby a fair interpretation could be obtained. Section 8 (i) attempts to cover the labeling of germicides, bactericides, disinfectants, and antiseptics. By his own statement Mr. Campbell made it perfectly clear that it would be impossible for the manufacturer of a germicide, bactericide, disinfectant, or antiseptic to comply with the provisions of this paragraph. It is obvious that it would be impossible for a manufacturer to market one of these products under the provisions of this paragraph, and we wish to emphasize the necessity of the elimination of this paragraph, not only from the proposed measure, but from any measure which Congress may enact. This type of product and the proper labeling thereof should fall under the general provisions of any act which the Congress of the United States may enact. Sections 12 (a), (b), and (c) place in the hands of the Secretary of Agriculture unlimited, unjustified, and unwarranted power; but, if in the public interest and as a matter of sound public policy it is deemed necessary to include in the law provisions of this type and character, the power conferred upon the Secretary of Agriculture should be limited in its exercise to those cases in which after proper showing before a court of competent jurisdiction he has obtained an order from that court authorizing him to proceed to exercise such power. In other words, manufacturers should have their day in court. As to section 13, providing for factory inspection, there may be need for such a power in the Secretary, but as in the case of section 12, we do not believe such a power should be exercised until and after the Secretary has been authorized by an order of a court of com petent jurisdiction to proceed with such an inspection. Section 16 enables an administrative officer to make seizures when he has probable cause to believe that a drug is so adulterated as to be imminently dangerous to health. The placing of such a power in the hands of an administrative officer would subject manufacturers to the constant danger of having their products seized without having an opportunity of protecting themselves from the prejudice, whim, or caprice of such an official. Moreover, this section protects an administrative officer who abuses his authority by providing that any judgment which may be obtained against him for illegal acts shall be paid by the Government. Section 16 (c) leaves the matter of furnishing samples to the discretion of the court. It should be mandatory and the court should upon application of any party to any proceeding criminal or otherwise, as a matter of right obtain an order for the delivery of a sample to the applicant party. Section 19 is objectionable because it would permit injunction proceedings against manufacturers involving products, the adulteration or misbranding of which had not been passed upon by a court of competent jurisdiction. Such proceedings should not be had until the question of adulteration or misbranding has been finally determined by the court. Section 22 provides for a voluntary inspection service, and on the face of this section it might appear to be a very wise provision in the public interest; but upon careful analysis it will immediately be seen that every manufacturer would eventually be compelled to accept this voluntary inspection service in order to be placed upon a fair competitive basis with other manufacturers who accepted it and labeled their products in accordance with these provisions. This entire section should not be included in any measure which may be enacted by the Congress. The foregoing are a few of the most objectionable features of S. 1944, but there are many more which we could bring to the attention of the committee. However, we believe that what we have said will suffice to convince the committee that the amendment of S. 1944 in order to make it a measure sound in principle, in law, and in public policy, is impossible. If this conclusion be correct, there remain open but two courses for the committee to pursue in meeting the legislative problem now before them. The two courses are: (1) Amend the existing law in such a manner as to strengthen it to the extent that it will meet present requirements, or (2) Strike out everything after the enacting clause in S. 1944 and rewrite it in such a manner as to make it sound in principle, in law, and in public policy. With respect to the first course, there has been offered by the National Drug Trade Conference, of which this association is a constituent member, suggested amendments of the existing law. These amendments deal only with the drug provisions of the existing law and in no manner attempt amendment of the food sections. These proposed amendments, as we understand them, are merely suggestions subject to revision. With respect to the second course, we have not had the time or opportunity to prepare and submit a complete revision of S. 1944, but we stand ready to render such assistance to the committee or to the Department of Agriculture as may be required to accomplish the proper amendment of existing law, if that be deemed to be the proper course, or to prepare a complete revision of S. 1944, if that be deemed the proper course. Respectfully submitted. MEMBERS OF THE AMERICAN DRUG MANUFACTURERS ASSOCIATION Abbott Laboratories, North Chicago, Ill. Armour & Co., Union Stock Yards, Chicago, Ill. Bauer & Black, 2500 South Dearborn Street, Chicago, Ill. W. J. Bush & Co., Inc., 370 Seventh Avenue, New York, N.Y. G. W. Carnrick Co., 20 Mt. Pleasant Avenue, Newark, Ń.J. Citro Chemical Co., Maywood, N.J. Cole Chemical Co., Inc., 3727 Laclede Avenue, St. Louis, Mo. The Cutter Laboratory, Berkeley, Calif. Davies, Rose & Co., Ltd., 22 Thayer Street, Boston, Mass. The Dow Chemical Co., Midland, Mich. The Drug Products Co., Inc., 26-32 Skillman Avenue, Long Island City, N.Y. Fairchild Bros. & Foster, 70-76 Laight Street, New York, N.Y. Fritzsche Bros., Inc., 78-84 Beekman Street, New York, N.Y. Heyden Chemical Corporation, 50 Union Square, New York, N.Y. Hynson, Westcott & Dunning, Baltimore, Md. Johnson & Johnson, New Brunswick, N.J. Mead, Johnson & Co., Evansville, Ind. Lederle Laboratories, Inc., 511 Fifth Avenue, New York, N.Y. Eli Lilly & Co., Indianapolis, Ind. Lloyd Brothers, Pharmacists, Inc., 300 West Court Street, Cincinnati, Ohio. Magnus, Mabee & Reynard, Inc., 32 Cliff Street, New York, N.Y. Mallinckrodt Chemical Works, 3600 North Second Street, St. Louis, Mo. The Maltbie Chemical Co., 246–250 High Street, Newark, N.J. The Maltine Co., 30 Vesey Street, New York, N.Y. Maywood Chemical Works, Maywood, N.J. Robert McNeil, 2900 North Seventeenth Street, Philadelphia, Pa. The Wm. S. Merrell Co., Cincinnati, Ohio. Monsanto Chemical Works, 1724 South Second Street, St. Louis, Mo. The National Drug Co., Inc., 4679 Stenton Avenue, Philadelphia, Pa. Nelson, Baker & Co., 1301 West Lafayette Boulevard, Detroit, Mich. The New York Quinine & Chemical Works, Inc., 99-117 North Eleventh Street, Brooklyn, N.Y. The Norwich Pharmacal Co., Norwich, N.Y. Parke, Davis & Co., Detroit, Mich. The E. L. Patch Co., Stoneham Post Office, Boston, Mass. S. B. Penick & Co., 132 Nassau Street, New York, N.Y. G. D. Searle & Co., 4737 Ravenswood Avenue, Chicago, Ill. Sharp & Dohme, Broad and Wallace Streets, Philadelphia, Pa. G. H. Sherman, M.D., Inc., 14600 Jefferson Avenue, East, Detroit, Mich. Smith, Kline & French Laboratories, 105 North Fifth Street, Philadelphia, Pa. Upsher Smith Co., 529 South Seventh Street, Minneapolis, Minn. E. R. Squibb & Sons, 745 Fifth Avenue, New York, N.Y. Frederick Stearns & Co., Detroit, Mich. R. J. Strasenburgh Co., 195 Exchange Street, Rochester, N.Y. Tailby-Nason Co., 49 Amherst Street, Kendall Square Station, Boston, Mass. The Tilden Co., New Lebanon, N.Y. The Upjohn Co., 223 East Lovell Street, Kalamazoo, Mich. Henry K. Wampole & Co., Inc., 440 Fairmount Avenue, Philadelphia, Pa. Wm. R. Warner & Co., Inc., 113 West Eighteenth Street, New York, N.Y. The Wilson Laboratories, 4221 South Western Avenue Boulevard, Chicago, Ill. John Wyeth & Brother, Inc., 1118 Washington Avenue, Philadelphia, Pa. The Zemmer Co., 3943-47 Sennott Street, Oakland Station, Pittsburgh, Pa. |