2. It specifies in detail the conditions under which pharmacists may refill prescriptions. At present no prescription may be refilled without the specific written authorization of the physician. The proposed act would permit refilling without authorization except in the case of dangerous or habitforming or new drugs. This change we favor and support. These two provisions of the Humphrey bill were the fundamental reasons for the legislation and these purposes have been universally approved by all parties and groups concerned. Were the bill confined to these purposes, we would support it. The bill as presently drawn, however, does not stop with the treatment of the prescription refill problem. Instead, that problem is availed of for the advancement of a plan to regulate the drug industry in a manner and to an extent not heretofore proposed. Rather than the manufacturer of a drug being allowed, on the basis of a statutory standard, to make a determination as to whether its product should be sold by prescription or over the counter, this bill provides that three types of drugs will be limited to prescription sale. These are: habit-forming drugs, "dangerous" drugs, and new drugs. The Federal Security Administrator will determine which drugs are "dangerous" and must be sold by prescription. There is at present no difficulty in determining which drugs are habit-forming or new. It is claimed by the proponents of the bill that the determinations of the Administrator as to which drugs are dangerous will be made on the basis of a statutory standard and that they will be subject to judicial review. It is this feature of the Humphrey bill which we vigorously oppose. We feel that the determination of which drugs may be sold only on prescriptions should be left to judicial determination on the basis of a statutory standard in court proceedings instituted by Federal enforcement officials. The power of the Administrator under the proposed legislation to decide, by the issuance of regulations, drugs which could be sold only upon prescription, we believe would be a dangerous and unnecessary delegation of authority. Moreover, instead of solving the problems of the public, the retail druggists, and the physician as the bill purports to do, it will add to present difficulties by increasing bureaucratic regulations. The use of this power by the Administrator would, in time, amount to an over-all control of the manufacture, distribution, and administration of drugs. And, of equal if not greater importance, the Administrator in the exercise of his power would have greatly to do with the practice of pharmacy and medicine. The bill as reported jeopardizes the traditional right of self-medication and choice of remedies, and will increasingly restrict the number and nature of drugs available in over the counter sales, and will, therefore, increase the cost of medical care. As medical costs rise because of fees to physicians for prescriptions and because of perscription prices, there may well be a demand by the public for governmental relief. This would be one of the last steps toward socialized medicine. We know of no occasion when a grant of administrative power as wide in scope and as far reaching in effect and implication as that of the Humphrey bill has been proposed for the regulation of the drug industry. We, therefore, respectfully request that you give consideration to an amendment of this bill as follows: Strike out all the language in subparagraph (B) of subsection 9 (b) (1) of section 503 of the Federal Food, Drug and Cosmetic Act, and insert in lieu thereof the following: "(B) because of its toxicity or other potentiality for harmful effect or the method of its use or the collateral measures necessary to its use is not safe for use except by or under the supervision of a practitioner licensed by law to administer such drug." The adoption of this language, we believe, sets up a proper standard and gives it statutory authority. With subparagraph (B) so amended, we support the bill. Very truly yours, BRISTOL LABORATORIES, INC., Treasurer. Hon. JAMES P. KEM, PHI BETA SIGMA FRATERNITY, INC., United State Senate, Washington, D. C. DEAR SENATOR: Please be advised, that as president of the Mound City Pharmaceutical Association, I have been instructed by said body, representative of the 50 Negro pharmacists of Greater St. Louis to urge you to support and work toward the passage of the Durham-Humphrey bill. Your favorable action in this matter will be highly appreciated by all members of this professional group. Hoping to hear from you at your earliest convenience, I am, Respectfully yours, S. EDWARD GILBERT, President, Mound City Pharmaceutical Association. SEPTEMBER 10, 1951. Hon. THEODORE FRANCIS GREEN, Senate Office Building, Washington, D. C. DEAR SENATOR: The druggists of Rhode Island desire the passage of Senate bill No. 1186 introduced by Senator Humphrey written to give the retail druggists of the Nation relief from a condition that has grown increasingly intolerable. Under present law pharmacists are not permitted to receive oral prescriptions from a practitioner. We ask privilege of accepting telephoned or oral prescriptions. No. 1186 gives authority to food and drug administrators to determine after a hearing if requested which drugs should carry legend, viz, "CautionFederal law prohibits sale or dispensing without prescription." The bill provides that when a drug is safe for lay use the manufacturer must indicate by preparing adequate directions. For across-the-counter sale, we ask your support for the bill as reported favorably by the House committee without the O'Hara amendment. CHARLES F. GILSON, Secretary, Rhode Island Pharmacists Association. Hon. H. H. LEHMAN, Washington, D. O. GUARINO FOR PRESCRIPTIONS, Richmond Hill, N. Y., August 15, 1951. HONORABLE SIR: I wish, Honorable Sir, that you support S. 1186 because this bill will correct detrimental provisions (1) That make it illegal for a pharmacist to recognize an oral prescription (telephone) from a physician; (2) That require a written prescription from the prescriber for every refill, despite the fact that many of the drugs called for are safe to use; (3) That allows a manufacturer to confine a medicine he makes to a prescription though it be nothing more than charcoal or molasses; (4) That include restrictions on numerous medicinals without the slightest justification; (5) That make the pharmacist alone liable for mislabeled drugs sold in packages over the counter though the responsibility belongs to the manufacturers of the packaged medicinals; (6) That contribute serious confusion through uncertainty and the inability of the pharmacist to determine limitations in a large number of instances. The S. 1186 (the Durham-Humphrey bill) this proposed measure is in the Senate there, it is in the Committee on Labor and Public Welfare, hearing on this bill is expected quite soon. Won't you please support S. 1186? Respectfully yours, MICHAEL GUARINO. NEW YORK, N. Y., September 13, 1951. Senator LEHMAN, Washington, D. C. DEAR SENATOR: I oppose the prevention of receiving medicines by mail. My sister would be involved in this respect, and we have all the faith we can toward the medication she has been receiving from Chicago. She has had no spells epilepsy since she is taking pills sent by her doctor. This can be proven in her case and many more there. I am very much opposed to the DurhamHumphrey bill amendment. Very truly yours, Mrs. CEILA GUCITI. SUMMIT, N. J., September 17, 1951. Hon. HERBERT H. LEHMAN, Washington, D. C.: On behalf of this company and personally we recommend that you give your support as a member of the Labor and Public Welfare Committee to H. R. 3298, Durham bill, as passed by the House with the two amendments embodied in the September 7, 1951 agreement addressed to your committee by the National Association of Retail Druggists, American Drug Manufacturers Association, American Pharmaceutical Manufacturers Association, and the Proprietary Association. H. R. 3298 appears to us to best preserve the objectives of the Food and Drug Administration, the retail pharmacists, and the pharmaceutical manufacturers of this country in their services to the American public. CIBA PHARMACEUTICAL PRODUCTS, INC., Hon. HERBERT H. LEHMAN, NEW YORK PHARMACEUTICAL CO., United States Senate, Washington, D. Ơ. Bedford, Mass., August 13, 1951. DEAR SENATOR LEHMAN: The Durham-Humphrey bill, H. R. 3298, as it passed the House, is a constructive measure. In the original bill, in subparagraph B of paragraph 1, there was a bad feature, giving as it did arbitrary powers to the Federal Security Administrator to determine whether or not medicines should be sold over the counter or only by prescription. The Administrator already has the power to control dangerous drugs, and with this we have no quarrel. The additional powers conferred under the above paragraph would only be a step in the direction of socialized medicine which we all wish to avoid. * We suggested that all of the language in B beginning with line 6, page 5 of the bill, and extending through line 16 be stricken out and the following inserted: "(B) because of the toxicity or other potentiality for harmful effect or the method of its use or the collateral measures necessary to its use except by or under the supervision of a practitioner licensed by law to administer such drug." and this amendment was accepted by the House. We understand that the Humphrey bill, S. 1186, now before your committee, is identical with H. R. 3298 before it was amended by the House. We strongly urge that you amend S. 1186 to make it identical with the bill which the House approved. Very truly yours, NEW YORK PHARMACEUTICAL CO., Hon. HENRY CABOT LODGE, Jr., THE MASSACHUSETTS MEDICAL SOCIETY, The United States Senate, Washington, D. C. DEAR SENATOR LODGE: The committee on national legislation of the Massachusetts Medical Society is of the opinion that S. 1186 should be amended to conform with H. R. 3298 as amended on the floor of the House. As you know, the House struck out that portion of the bill empowering the Federal Security Agency to prepare and administer a list of drugs which would require a prescription for dispensing. This bill has been scheduled for hearing before the Senate Subcommittee on Health starting September 11, 1951. Respectfully submitted by direction of the president. CHARLES G. HAYDEN, M. D., Chairman, Committee on National Legislation. INDIANAPOLIS, IND., September 14, 1951. Senator LEHMAN, Senate Office Building, Washington, D. C.: Indiana pharmacists urge approval of H. R. 3298 as amended in committee September 12. INDIANA PHARMACEUTICAL ASSOCIATION, Hon. HERBERT H. LEHMAN, DIRECT LABORATORIES, INC., BUFFALO, N. Y., September 10, 1951. Senate Office Building, Washington, D. C. MY DEAR SENATOR LEHMAN: It is our understanding that you are on the Committee on Labor and Public Welfare, and that an act, H. R. 3298, to amend section 503 (b) of the Federal Food, Drug, and Cosmetic Act has been referred to the Committee on Labor and Public Welfare. We feel that the act as now written should be clarified and changed at least in one minor way. The act, H. R. 3298, now states on page 3, lines 12 to 17, that a drug subject to the act shall be labeled: "Caution: Federal law prohibits dispensing without prescription." We feel that this should be changed to read: "Caution: Federal law prohibits dispensing except by a physician or dentist, or on prescription." It is customary for many physicians to give or dispense various drugs to their patients. The new act, as now written, seems to prohibit the physician from this very common practice. We do not believe that the act intended to prohibit the physician from giving drugs to his patients, nor do we believe it is for the general good that a law should be enacted prohibiting physicians from giving drugs to their patients. Therefore, we respectfully request that you make the indicated changes in act H. R. 3298. Yours very truly, Hon. HERBERT H. LEHMAN, Senate Office Building, Washington, D. C. ARTHUR C. HERZOG, FERD. T. HOPKINS & SON, New York, N. Y., September 6, 1951. DEAR SENATOR LEHMAN: This is to urge your most vigorous opposition to the Humphrey bill, S. 1186, now pending before the Committee on Labor and Public Welfare. Our objection is to subparagraph (B) of paragraph (1) which empowers the Federal Security Administrator to determine the drugs that can be sold only on the prescription of a physician. The Administrator would thus This have the power to restrict all proprietary drugs to sale by prescription. would be disastrous not only to the proprietary drug industry but also to the consuming public, which would suffer greatly in the time, cost, and inconvenience then required to obtain common necessities of this kind. Most families have in their medicine chests a variety of proprietary remedies such as aspirin tablets, laxatives, nose drops, antiseptics, and bandages. Those who travel and are subject to motion sickness also carry a supply of Mothersill's. All remedies of this type are used for minor ailments without the supervision of a physician. Consumers demand that such products be readily available to them and the proprietary drug industry has sought to satisfy that demand. If a physician's fee for writing a prescription and a pharmacist's fee for filling it were added to the cost of such remedies, the price the consumer would have to pay would be prohibitive. It would then be necessary for the Government to subsidize the consumers either through some form of socialized medicine or through direct subsidy. A similar bill was before the House of Representatives, H. R. 3298. After extensive debate, the subparagraph to which we object was deleted and the bill was amended so as to be entirely satisfactory. As passed by the House, subparagraph (B) of paragraph (1) reads: "(B) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; or" We therefore respectfully urge that you oppose S. 1186 in its present form and support a bill containing the provisions of H. R. 3298, as it passed the House. Respectfully yours, FERD. T. HOPKINS & SON, Distributors, Mothersill's Travel Remedies. WEST HILL PHARMACY, Ilion, N. Y., August 27, 1951. Senator HERBERT H. LEHMAN, Washington, D. C. DEAR SENATOR LEHMAN: May I urge you to vote for bill S. 1186 and include subsection B left out by the House of Representatives? This subsection will not only protect the public but it will relieve the pharmacist from the constant worry of violating the law due to the selfish actions of manufacturers. We must be free to handle and accept oral prescriptions from physicians and to refill said prescriptions when we deem it advisable. To be able to do this sometimes means that with prompt medication the patient makes a faster recovery than if a period of time elapses between the doctor's call and the time the store receives the written prescription. Please vote for bill S. 1186 and include subsection B. ROLAND M. JORDAN. WILLIAM W. LEE & CO., INC., Watervliet, N. Y., August 22, 1951. Hon. HERBERT H. LEHMAN, The United States Senate, Washington, D. C. DEAR SIR: On September 11 hearings will begin on bills S. 1186 and H. R. 3298. Our company vigorously opposes bill S. 1186, particularly subparagraph (B) of paragraph (1), which grants such unnecessary and arbitrary power to our Federal Security Administrator, Mr. Oscar Ewing. Your full support of a bill containing the provisions included in H. R. 3298 as it passed the House is earnestly requested and will be sincerely appreciated. Very truly yours, WILLIAM W. LEE & Co., INC., |