validity except as a record of the transaction. Is the Administration correct in its contention that a prescription is an expression of the will of the physician that a particular patient receives a particular quantity of a particular drug to be taken over a particular period of time, and that a refilling of a prescription without specific approval of the physician is equivalent to a sale over the counter and is beyond the scope of the exemption conferred in section 503 (b)? The answer to this question may not be entirely free from doubt but most of the persuasive arguments appear to line up in opposition to the view of the Administration. PRACTICE OF REFILLING RECOGNIZED BY CONGRESS In the first place, the language of section 503 (b) shows affirmatively that Congress recognized the practice of refilling prescriptions. This is clear from the specific provision exempting prescription labels from bearing the "Warning-May be Habit Forming" statement (applicable to section 502 (d) drugs) if the prescription is marked nonrefillable or if its refilling is prohibited by law. This special provision for section 502 (d) drugs would not be necessary if the view of the Administration is correct that no prescription may be refilled without the approval of the physician. We should not assume that in writing this special rule for habit-forming drugs Congress was indulging in a futile pastime. On the contrary, we must recognize that Congress was well aware of the custom of refilling prescriptions, that it acknowledged the validity of this practice, and that it approved the refilling of prescriptions even for habit-forming drugs provided the warning statement was emploved on the label. It is quite difficult, if not impossible, to understand the basis for the Administration's view in the face of the clear and plain language of section 503 (b). PERCENTAGE OF REFILL BUSINESS But there are other arguments. Of the total prescription business, approximately 40 percent represents refills.5 While the percentage may have been either lower or higher in 1938, when the act was passed, it was nevertheless substantial. The legislative history fails to assist in ascribing a meaning to the word "prescription" as used in the act, and Congress must therefore have intended that the word have the meaning usually and customarily ascribed to it in the appropriate professional channels. The percentage of refill business to total prescription business is adequate proof that it was customary in the pharmaceutical profession to regard prescriptions as refillable unless marked nonrefillable by the physician. This custom was apparently recognized by the Commissioner in explaining the new prescription policy. VIEWS OF THE MEDICAL PROFESSION From time immemorial it has been the practice of pharmacists to refill prescriptions unless otherwise directed by the physician. The medical profession has had knowledge of and. it must be assumed, has acquiesced in this custom. If this practice has resulted in the dispensing of medication not intended by the physician, it is the responsibility of the physician, not the pharmacist. The physician knows that a prescription marked "nonrefillable" will not be refilled. He is taught this in school and he is reminded of it in medical journals. Thus in the textbook Practical Therapeutics by Rehfuss, Albrecht & Price, in the section on prescription writing, the following rule appears: "If you do not want a prescription refilled write on the prescription 'Ne Repetatur' or its abbreviation 'Ne Re' or simply in English 'Do Not Refill'. " Again, in an article in the Journal of the American Medical Association by Dr. E. Fullerton Cook entitled "The Importance and Advantages of Prescription Writing in Medical Practice," the author says. "If a physician prefers that the prescription shall not be refilled except on his order, it is the common practice to add to the prescription the abbreviation Non. Rep. and this injunction will be honored by the pharmacist." In Essentials of Prescription Writing by Cary Eggleston, M. D., Associate Professor of Clinical Medicine, Cornell University Medical College, the following language appears: "The custom of having prescriptions refilled once or many times is very common, and it is highly advisable for the physician specifically to order that such 5 Drug Trade News. May 2, 1949, p. 20. • American Druggist. March 1949. p. 78. 7 Journal of the American Medical Association, Vol. 107, pp. 965, 967. shall not be done in the case of dangerous drugs. Some physicians have such an order printed on their prescription blanks, but this is not necessary, as the writing of the words, ne repetatur, or the abbreviation, ne rep. in some conspicuous place on the prescription will prevent its being refilled.” 8 How can the foregoing facts and arguments be brushed aside? When the language of the present act recognizes that prescriptions are customarily refilled and when there is ample proof of an established custom recognizing this practice, how can an administrative agency reach a conclusion in complete variance with these facts? This is a question that the author cannot answer. Perhaps an answer to the problem may be found in a study of the background and of the practical problems encountered in the routine enforcement of the act, with particular reference to enforcement at the retail level. ENFORCEMENT OF THE ACT Soon after the act became effective, retail pharmacists began to complain that drug manufacturers were avoiding their full labeling responsibilities by using the prescription legend on drugs having primarily, if not entirely, an over-the-counter sale. Under the regulations, retailers were forced either to decline to make the sale or to relabel the product with adequate directions for nonsupervised use. This situation led, in 1944, to the revision of the regulations under section 502 (f) of the act so as to restrict the use of the prescription legend to drugs which could not be safely or effectively used without medical supervision. The primary responsibility for selecting such drugs was left with the manufacturers, since the act conferred no authority upon the Food and Drug Administration to create classes of drugs or to specify the manner in which drugs of each class should be labeled and sold. But the implication and result of the regulations, when viewed in the light of the remaining subdivisions of section 502, presented the problem of whether a drug which, in fact, is safe and efficacious only when used under medical supervision, may be labeled for over-the-counter sale without running afoul of sections 502 (a), 502 (f), or 502 (j). It appears that the view of the Food and Drug Administration is that the act itself classifies drugs into counter items or prescription items on the basis of efficacy and safety following a factual determination on a case-by-case product-by-product basis. If this be the proper interpretation of the act, then obviously the law is basically a restrictive-sales law; that is, it controls not only the manner in which a drug is labeled but the exact manner in which it must be sold. Surely, if this be the proper interpretation of the act, no one should be more surprised than Congress. The battle for the enactment of the act is portrayed in volumes of committee hearings, committee reports, and congressional debates, and in countless early drafts of the act. All of this material seems to support the conclusion that Congress assumed and intended that a drug consumer would receive adequate protection if the label told him what he was taking, how to take it, and when to stop. This is borne out by the oft-repeated quotation from the report of the Senate committee on S. 5: "The bill is not intended to restrict in any way the availability of drugs for self-medication. On the contrary, it is intended to make self-medication safer and more effective. For this purpose provisions are included * * * requiring that labels bear adequate directions for use and warnings against probable misuse * * * Accordingly, there is little to support the view that anything in the act or in its legislative history requires drugs to be divided into two classes, the one class for distribution over the counter directly to consumers and the other class for distribution on prescription only. Therefore the present regulation which, by implication if not directly, requires the use of the prescription legend on drugs that may be used safely and effectively only under medical supervision is of questionable validity.9 WISDOM OF ADMINISTRATIVE POLICIES Yet, in the enforcement of the act, the Administration undoubtedly encounters daily instances in which consumers are injured as a result of the use of drugs without medical supervision. These instances probably involve true over-thecounter sales and prescription refills of so-called dangerous drugs. Possibly to combat this evil the Administration has announced its policy on prescription refills and has taken the view that drugs bearing the prescription legend cannot be Essentials of Prescription Writing, pp. 106, 107. For an excellent discussion of the validity of the regulations under Section 502 f (1) see Williams, "Exemption from the Requirement of Adequate Directions for Use in the Labeling of Drugs," 2 Food Drug Cosmetic Law quarterly 155 (1947). relabeled with adequate directions for unsupervised use. Unquestionably these policies of the Administration have been adopted to further the interests of the public health and to that extent they are laudable in purpose and design. But whether they are justified by the act and whether they are wise from a long-range point of view are entirely different questions. Their justification under the act is, to say the least, flimsy. Their wisdom from a long-range point of view will now be explored. Basically the question is what type of drug control is best calculated to protect the public health and, at the same time, preserve the freedom which is so essential to progress. In its policies under the act the Administration has drifted further and further down the road toward administrative, as distinguished from legislative, control. Its regulations divide drugs into classes and specify their manner of sale in a way not contemplated by Congress. Its announcements have established new rules for prescription refills and new policies in respect to truthfully labeled drugs having, in the opinion of the Administration, no scientific merit. This drift toward administrative control has been implemented by amendments providing for certification of insulin and certain antibiotics and for the establishment of standards and tests for those preparations. And now comes the Durham bill. It would place the stamp of congressional approval upon the division of drugs into two classes and would empower the Administration to make the classification by regulation, after a public hearing. When we have reached the point where the way in which a drug must be sold is determined by an administrative agency, we have arrived at the summit of administrative control. We can go no further. THREAT IN ADMINISTRATIVE DRUG CONTROL Far from being necessary, the continued drift toward administrative drug control is a threat to the protection of the public health. The real threat lies in the substitution of the judgment of the administrative agency for the judgment of free and independent physicians. Physicians should be free to prescribe the remedies of their choice without governmental interference. Congress should not attempt, directly or indirectly, to regulate the practice of medicine or to impair the freedom of the individual physician to practice according to the dictates of his own knowledge and experience. Nor should Congress, by regulating the filling and refilling of prescriptions, interfere with the relationship between pharmacists and physicians. These two professional groups, who have contributed so handsomely to the health of the Nation, have worked side by side for centuries. They understand each other and members of both groups understand the nature of drugs and the dangers associated with their use. The right of the pharmacist to exercise his professional judgment should not be revoked by Congress. The proper exercise of professional judgment by the pharmacist is a safeguard to the public health which must be preserved. The importance of its preservation far outweighs the risk of exposure to the public health caused by the improper exercise of professional judgment in a few isolated cases. EDUCATIONAL APPROACH It is believed that an educational approach, rather than a legislative approach, is more calculated to correct the abuses cited by the Administration. The professional groups should disseminate information to their members upon the importance of inquiring into requests for the refill of prescriptions for dangerous drugs. Pharmacists should be worthy of the high ideals of their profession. They should be reminded to scrutinize requests for the refill of prescriptions where such scrutiny is indicated for the protection of the patient. Medical groups should again remind their members to mark a prescription "nonrefillable" if it is not to be refilled. Articles in appropriate publications should advise consumers against following the practice of using certain well-known dangerous drugs without medical supervision. CONCLUSIONS The following conclusions may be briefly stated: It is 1. The Administration's conception of the word "prescription" is wrong. justified neither by the language of the act nor by the customs and teachings of the medical and pharmaceutical professions. 2. The Durham bill is not necessary. 3. If there are abuses in the refilling of prescriptions with resulting injury to the public health, the problem should be dealt with on an educational, not a legislative, basis. 4. If the educational approach is not adequate, and it is therefore concluded that additional legislation is required, such legislation should be drafted with a view of having Congress, itself, establish the rules, thereby reversing the trend toward administrative control. The CHAIRMAN. Mr. Sibley requires only 5 minutes for his statement and that will let us finish with him and we can adjourn until tomorrow morning. STATEMENT OF GEORGE H. SIBLEY, VICE PRESIDENT AND GENERAL COUNSEL, E. R. SQUIBB & SONS Mr. SIBLEY. My name is George H. Sibley, and I am here on behalf of E. R. Squibb & Sons, drug manufacturers, as a vice president and general attorney of that company. The manufacture by E. R. Squibb & Sons of drugs and medicines of a prescription character dates back to 1858 when Dr. E. R. Squibb, a member of the Medical Corps of the United States Navy, was persuaded by a group acquainted with his unusual capacities to set up a small manufacturing laboratory dedicated to producing and improving, through research and development of scientific skills, drugs and medicines of standard quality, tested potency, and efficacy. His principles have since dominated the policies of the company. This is mentioned in order that your committee may appreciate that E. R. Squibb & Sons, in criticizing certain features of proposed H. R. 3298, does so with a sense of responsibility toward the professions of medicine, dentistry, and pharmacy and with conscientious regard for the best interests of patients served by them and by manufacturers. Our objections and a short summary of our reasons therefor are as follows, and with due respect for the important duties and responsibilities which in the public welfare are lodged with the Food and Drug Administration. You have heard the suggestions by Leslie Harrop on behalf of the American Drug Manufacturers Association. That section 503 (b) (2) be in effect compromised by deleting in its proposed language in the Durham bill, and substituting the language which appears on page 2 of his statement and which I won't bother to read to you. As a member of the American Drug Manufacturers Association, E. R. Squibb & Sons subscribes to that proposed compromise language. I do wish to point out, however, that should such compromise language not be amendment to the bill, we do have indeed a very serious problem to consider with respect to the proposed language of the Durham bill. This as you fully know by now authorizes the Federal Administrator to determine what drugs are "unsafe or effective for use without the professional diagnoses or supervision of a physician or dentist." Section 503 (b) (3) then properly implements this provision, by requiring, in effect, that a drug so found to be unsafe or ineffective must be sold upon written prescription and its label must bear the statement: "Caution: Federal law prohibits sale or dispensing without prescription." It has heretofore been generally recognized that a patient's physician has the primary responsibility for his patient's health and that his judgment should prevail with respect to prescribing medication and the conditions under which such medication should be used and continued or discontinued. The filling of the physicians' prescription is then backed by the skill, knowledge, and professional responsibilities of the pharmacist. Manufacturers of drugs and medicines endeavor to provide the physician with those remedies designed to meet the needs of his patients. Those needs vary widely and the drug which may be effective with respect to one patient may prove relatively ineffective or wholly ineffective with respect to another patient. This is quite apart from any considerations of safety of use of a drug or medicine of a toxic character. Manufacturers of drugs and medicines undertake as a legitimate charge upon their responsibility the expenditure of vast sums of money to determine through laboratory testing and clinical trials the safety and efficacy of their products. The ultimate success of their enterprise depends upon the conscientious discharge of that responsibility. It is submitted that to shift that responsibility to the Federal Government is not in the interests of the public health. Any such step, as was brought out by Mr. Dunn yesterday, is a clear step toward socialized medicine. If this responsibility is shifted it cannot be discharged without the expenditures of vast sums by the Federal Government for the purpose of determining for itself whether a drug or medicine is unsafe or ineffective for use without the professional diagnosis or supervision of a physician or dentist and accordingly whether it should be sold or dispensed only upon prescription. Thus the Federal Government will come to be regarded, inevitably we think, as relieving the manufacturer of the product of responsibility which we believe is vital to the public welfare. I would merely like to add that literally millions of dollars are spent by the drug manufacturers every year in fellowships and grants to universities, to clinics for study, testing, clinical trials of these drugs, that the medical departments of the responsible drug houses are in constant contact and discussion with medical associations and societies from the city to the county to the National and State levels, that the same staffs are in frequent consultation with the Federal Drug Administration in an attitude of cooperation, that this is not a case where there is any unfriendly position being taken, but purely one in which we think that the manufacturer, along with the medical profession and the pharmacist, should have the primary responsibility for classifying drugs as prescription or nonprescription and over-thecounter items. Section 503 (b) (3): This provision, in part, undertakes to set forth the conditions under which a prescription may be refilled by a pharmacist by requiring that such refilling be authorized specifically by the prescriber in the original prescription or by oral order and agreement of the prescriber to confirm such order in writing within 72 hours. It is submitted that the provision invades unnecessarily in many instances the prerogatives of the pharmacist and the discharge of his professional responsibilities. This is so because in many instances a physician or dentist may prescribe quite properly a drug or medicine which is not essentially regarded as a prescription product and with respect to which there is no divergence of reliable opinion as to its safety of use or effectiveness. It is submitted that the confusion thus unnecessarily created and which, as to refillable prescriptions, may involve the patient and physician or dentist in unnecessary expenditure of time or expense could be settled in a simple way. This could |