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

be done by adding at the end of the language dealing with refilling of prescriptions the following clause:

or if the drug is commonly sold or dispensed without the necessity of a prescription.

The problems in the refilling of prescriptions affecting the physician or dentist and pharmacist and patient could be further simplified by the use by the physician or dentist at the time of writing the prescription of a prescription blank which would bear upon it the following:

Section 503 (b): Insofar as it establishes a procedure for enabling an interested person to file with the Administrator a petition proposing the addition to, or deletion from, the list of drugs promulgated by the Administrator in accordance with clause 2, obtain a hearing and appeal from the decision of the Administrator, the proposed legislation presents a cumbersome and expensive means of relief, desirable only in the event that clause 2 is enacted.

The CHAIRMAN. If there are no questions we will recess at this time. We thank you very much for your statement and the committee will stand adjourned until 10 o'clock tomorrow morning.

Before adjourning, however, we will insert in the record at this point the statement of Mr. Horace Walker, the executive secretary of the District of Columbia Pharmaceutical Association, and also the statement of Abbott Laboratories.

(The statements referred to follow:)

STATEMENT OF HORACE WALKER, EXECUTIVE SECRETARY, DISTRICT OF COLUMBIA PHARMACEUTICAL ASSOCIATION

My name is Horace Walker and I am the executive secretary of the District of Columbia Pharmaceutical Association in whose behalf I appear here today.

The District of Columbia Pharmaceutical Association represents pharmacy and the drug industry throughout metropolitan Washington, both the independent retailer and chain stores, similar in scope to State associations throughout the country.

I should like to point out that we enjoy an enviable record throughout the United States in the field of pharmacy as revealed in the latest United States Census Bureau figures. These figures indicate that druggists in the District of Columbia topped the entire Nation with a per store average of $171,769-this in contrast to the second largest State-per-store average of $130,000 per store in Nevada.

Furthermore, the District of Columbia jumped ahead of 31 States in total drugstore-dollar volume. It is interesting to note, at this point, that figures just released indicate that the average family income in the District of Columbia also topped the Nation for 1950 with an all-time high of $4,130 per family-25 percent higher than the national average.

It is the consensus of opinion among pharmacists in this area that relief from the present state of confusion regarding the handling of prescriptions can best be accomplished through the enactment of H. R. 3298 or S. 1186-the DurhamHumphrey bill.

Our legislative committee, the executive committee and officers of the District of Columbia Pharmaceutical Association, have given this bill considerable study

and hereby wish to go on record as thoroughly endorsing this bill; furthermore, we recommend passage of the bill at the earliest possible date.

It is believed that the provisions of the new bill relative to:

(1) The sanctioning of telephone prescriptions without subsequent confirmation in writing by the prescriber;

(2) Proposed new regulations clarifying the procedure in refilling prescriptions, and;

(3) The provision whereby the Food and Drug Administration will make the decisions as to whether a given drug or preparation is to be sold only on prescription or over-the-counter without prescription. At present, this determination is made capriciously often by the manufacturer.

are in the interest of better pharmaceutical practice and service to the public, we therefore, heartily endorse H. R. 3298, and once more, wish to go on record as favoring its early passage.

STATEMENT OF PAUL GERDEN, GENERAL ATTORNEY AND ASSISTANT SECRETARY, ABBOTT LABORATORIES, CHICAGO, ILL.

Abbott Laboratories has always been desirous of cooperating in any revision of the Federal Food, Drug, and Cosmetic Act which enables the Food and Drug Administration to protect the public health more adequately. The revision under consideration, H. R. 3298, merits scrutiny in order to determine whether its objective and subsequent operation will so benefit the public. This amendment to section 503 (b) of the Federal Food, Drug, and Cosmetic Act in general modifies the existing law by, first, making specific provisions relative to refilling of prescriptions, and second, by vesting in the Federal Security Administrator authority to determine which drugs may be sold without a prescription and which drugs may be sold only on a prescription basis.

The problem relating to refilling of prescriptions is of primary interest to physicians and pharmacists, and comments on these provisions should come from members of these professions. However, the provision which empowers the Federal Security Administrator to determine the items which may be sold solely on a prescription basis is of direct interest to drug manufacturers as well as the public and the medical profession. To this provision we, as drug manufacturers, are unalterably opposed. The following sets forth the reasons for our opposition to this provision of H. R. 3298.

I

First, it has not been demonstrated to our satisfaction that there is any need for such a revision of the procedure for determining which drugs are to carry the prescription legend. We have heard it alleged by the proponents of this amendment that (1) the drug manufacturers are presently using the prescription legend indiscriminately, (2) that this present type of labeling is creating confusion among the druggists, and (3) that "thousands of items" will, as a result of this amendment, be available for sale "over the counter" which are now sold only on a prescription basis.

Under the present law the drug manufacturer is charged with the primary responsibility for adequate labeling of its products. The Federal Security Administrator has provided by regulation that drugs which may not be used safely and efficaciously without medical supervision must carry the following prescription legend: "Caution: To be dispensed only by or on the prescription of a physician.' The manufacturer, in discharging its responsibility for proper labeling, consults with competent pharmacologists, qualified medical advisers, and, in many cases, the American Medical Association Council on Pharmacy and Chemistry, and the Food and Drug Administration in order to determine whether the product should carry the prescription legend or whether it may be sold without restriction. If, under the present law, the Food and Drug Administration comes to the conclusion that the label of a given drug does not indicate the appropriate mode of dispensing, the act provides the Administrator with ample authority to correct such a situation.

We are not surprised that exhibits can be presented showing instances of variations in labeling between different manufacturers of the same drug. However, the variation is no greater or more frequent than the difference in honest medical and pharmacological opinion, or legal opinion as to the meaning of the regulations. When it is considered that the problem of proper labeling involves the concentrated effort of many experts, minor variations may occur.