Nor are we inclined to accept the view that the present type of labeling is creating confusion among the druggists. Every druggist is, or should be, familiar with the requirement that if a drug carries the exact prescription legend provided for in the regulation it may then be sold only upon the written prescription of the physician. If a drug does not carry this exact prescription legend it may then be sold without a prescription. If the druggist makes a sale of a product that does not carry the exact prescription legend and the drug is sold as packaged and labeled by the manufacturer, any resulting.charges of misbranding rest, under the present act, with the manufacturer rather than the druggist.

As

It is further reasoned by the proponents of this measure that if this provision is enacted "thousands of items" will be added to the list of drugs which may be freely sold without the necessity of a prescription. By what process this is to be accomplished without endangering the public health has not been disclosed. previously indicated, the drugs which now carry the prescription legend do so because the manufacturer deems it necessary in the interest of public health thus to restrict their distribution.

II

Our second basic objection to this provision is that the proposed bill does not meet the problems which have been advanced as necessitating its enactment. As far as we can see, H. R. 3298 contains no provision which would enable the Administrator to bring about the elimination of any of the alleged cases of confusing label statements with greater ease than is already possible under the provisions of the present act. If the Administrator now believes that certain drugs are labeled in a manner which produces confusion to the pharmacist and thereby endangers the public, he has ample authority under the present act either to issue clarifying regulations or to correct the situation through court action.

III

Our third objection is that this provision is basically unsound and appears to constitute a substantial step toward the Government control of medical practice. This provision reverses the philosophy of the present law in that it transfers the primary responsibility of determining which drugs are to be available for selfmedication and which drugs are to be used under medical supervision from the medical profession and the drug manufacturer to the Government. The determination as to the availability of drugs for self-medication should be continued as in the past, for by what reasoning can it be said that the decision of an administrative body as to the availability of self-medication should be substituted for the determination of this factor by the medical profession? Certainly such administrative decisions would border on the control of the practice of medicine and this very fact was recognized by the Food and Drug Administration in its Trade Correspondence No. 356 which stated:

66* * * The * * * act, however, is not intended to regulate the practice of medicine. * * * You must, therefore, reach a decision for yourself as to whether or not you will recommend the sale of these items and preparations of them for prescription use."

It is also provided in this proposed amendment that appeals from determinations and orders of the Federal Security Administrator are to be made to the circuit court of appeals and such appeals shall be in the nature of a trial de novo. This requires the members of an appellate tribunal to make factual determinations on the technical aspects of safety and efficacy of drugs. The Federal Food, Drug, and Cosmetic Act, and regulations issued thereunder should continue to provide objective standards to which the manufacturer and other persons must conform and under which performance is susceptible of judicial appraisement.

IV

Our final objection is directed toward the implications of the phraseology of this provision, as it unduly extends without a corresponding public need the authority of the Federal Security Administrator. As an example, we mention the logical interpretation which must be given to subsections (b) (2) and (b) (3) when considered in connection with section 505 of the present act. Section 505, the new drug provision, now requires the Administrator to review and pass upon the data presented in reference to the safety of a new drug. Considering subsections (b) (2) and (b) (3) of the proposed amendment concomitantly with section 505, efficacy of use must be given equal consideration with safety of use whenever a new drug application under section 505 is presented to the Administration.

We, therefore, reiterate our opposition to this provision in the proposed amendment to the Federal Food, Drug, and Cosmetic Act. If, in the interest of public health, this committee deems it necessary to make revisions in the present law relating to the refilling of prescriptions, and subject to the approval of the interested professions, we have the termity to suggest that section 503 (b) be amended as indicated in the proposal which we have furnished to the clerk of this committee. In conclusion, we wish to indicate that the Food and Drug Administration, less than 3 years ago, recognized the impractical nature of such a provision as is now proposed, for in response to the request "Please send us a list of drugs which may be legally sold on prescription," Mr. A. C. Murray of that agency stated:

"Obviously, no list of drugs falling into the category in question is feasible; and if it were attempted the list would need amendment daily. Fortunately, the retail pharmacist, by reason of his training, is in a position to reach an intelligent conclusion with respect to any particular item; and manufacturers of drugs very generally are guiding him by supplying directions for use in the labelings of the medicines he sells over the counter, or are conspicuously marking the packages with the legend 'Caution: To be dispensed only by or upon the prescription of a physician'" (3 FDC Law Quarterly 194, 203).

A BILL To amend section 503 (b) of the Food, Drug, and Cosmetic Act of June 25, 1938, as amended Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That subsection (b) of section 503 of the Federal Food, Drug, and Cosmetic Act, as amended, be amended to read as follows:

"SEC. 503. (b) A drug dispensed by filling or refilling a written or oral prescription of a practitioner licensed by law to administer such drug shall be exempt from the requirements of section 502, except paragraphs (a), (i) (2) and (3), (k), and (1), and the packaging requirements of paragraphs (g) and (h), if the drug bears a label containing the name and address of the dispenser, the serial number and date of the prescription, or of its filling, the name of the prescriber, and, if stated in the prescription, the name of the patient, and the directions for use and cautionary statements, if any, contained in such prescription. This exemption shall not apply to any drug dispensed in the course of the conduct of a business of dispensing drugs pursuant to diagnosis by mail or otherwise without examination of the patient. If the drug is intended for use by man and, for the purposes of this Act, bears on its label, a statement that it is to be dispensed only by or on the prescription of a physician or dentist; such exemption shall apply only if such drug is dispensed upon a written prescription of a practitioner licensed by law to administer such drug or upon an oral prescription of such practitioner which is reduced to writing and filed by the pharmacist, or is dispensed by refilling a prescription if such refilling is authorized by the prescriber in the original prescription or by oral order and such order is reduced to writing and filed by the pharmacist.

"The act of dispensing a drug contrary to the provisions of this subsection shall be deemed to be an act which results in the drug's being misbranded while held for sale."

(Thereupon an adjournment was taken until 10 a. m., Saturday, May 5, 1951.)

FEDERAL FOOD, DRUG, AND COSMETIC ACT

SATURDAY, MAY 5, 1951

HOUSE OF REPRESENTATIVES,

COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE,

Washington, D. C.

The committee met at 10 a. m., Hon. Robert Crosser (chairman) presiding.

The CHAIRMAN. The committee will come to order.

First, I would like to put into the record a statement by Mr. James G. Flanagan, counsel and legislative chairman of the drug, chemical, and allied trades section of the New York Board of Trade.

(The statement referred to is as follows:)

STATEMENT OF JAMES G. FLANAGAN, COUNSEL AND LEGISLATIVE CHAIRMAN OF THE DRUG, CHEMICAL, AND ALLIED TRADES SECTION OF THE NEW YORK BOARD OF TRADE

My name is James G. Flanagan. I am counsel for and chairman of the legislative committee of the drug, chemical, and allied trades section of the New York Board of Trade. I am also vice president and general counsel of S. B. Penick & Co. of New York, manufacturers of bulk drug and chemical products.

The drug, chemical, and allied trades section is composed of over 700 drug and chemical manufacturers throughout the country representing a cross section of these industries. I might add that I am not paid for my work as counsel for the section or for representing it.

It is appreciated that the complex Federal Food, Drug, and Cosmetic Act and regulations promulgated thereunder have created problems for all concerned with the supplying of drugs and medicines and that all regulation required in the public interest is to be and is wholeheartedly supported by the drug and chemical section and the manufacturers and distributors of these products which comprise its membership.

The objective of the bill under consideration is primarily to relieve the confusion which the retail pharmacists claim to have encountered as the result of the official interpretation of the act in respect to the refilling of prescriptions and the lack of uniformity on the part of drug manufacturers in distributing the same or similar drug products either on a prescription basis or over the counter with directions

for use.

Our section does not believe that H. R. 3298 would accomplish the objective and hence does not support the bill for the following reasons:

As the result of the Sullivan case (332 U. S. 689) it is unlawful for a pharmacist to dispense drugs received by him after interstate shipment, labeled by the manufacturer to be sold on prescription only, except on the written prescription of a doctor, dentist, or veterinarian.

At present, under the law and regulations, the manufacturer has the responsibility of determining whether the individual drugs which he manufactures are to be prescription drugs or not but, generally speaking, the toxic and potent drugs are required by the regulations promulgated by the Food and Drug Administration to be sold on prescription only.

The Food and Drug Administration has taken the position that once a prescription for a drug has been filled, it is illegal under the present law for the druggist to refill such a prescription even though the prescribed drug may be one which may be freely sold over the counter under the directions for use with which it was labeled by the manufacturer.

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It is recognized that there are abuses in the refilling of prescriptions for drugs which need remedial action, but the bill goes far beyond the bounds for the correction of that problem and would not completely solve the problem.

In the first place, it proposes that the Food and Drug Administration be given I wide power to classify into two groups those drugs which may be sold on a prescription basis only and those which may be sold only with full directions for use on an over-the-counter basis.

Secondly, it is proposed in the bill that once a prescription for a drug, shipped in interstate commerce under a prescription label, has been filled, it cannot be refilled. But if the doctor prescribed a drug which the manufacturer labeled with full directions for use, the prescription could be refilled as often as the patient desired.

However, it fails completely to answer the question as to whether the druggist can refill a prescription compounded from two or more ingredients shipped in interstate commerce under a prescription legend. Under the doctrine of the Sullivan case the Food and Drug Administration has equal control of such prescriptions and the problem in respect to them legally would still remain unsolved. The druggists have a real problem according to the Food and Drug Administration because some manufacturers of a particular drug label it with the prescription legend and others do not. As a result, under the present interpretation of the law by the Food and Drug Administration, prescriptions for some brands of the same drug may be refilled and others may not, depending upon the original labeling by the manufacturer.

This problem would be resolved by requiring uniform labeling of a particular drug and its sale exclusively on either a prescription or an over-the-counter basis depending upon the classification of the Food and Drug Administration.

Under the present regulation, based upon the requirement of the law, that drugs must bear adequate directions for use, a toxic drug which cannot be safely and efficaciously used, except under the direction of a physician, may not be shipped in interstate commerce unless labeled by the manufacturer with the prescription legend. The responsibility presently is on the manufacturer not to make available for over-the-counter sale those drugs which are not generally recognized as safe and efficacious for use except under the direction of a physician. The bill under consideration would by statute deprive a person from refilling a prescription originally prescribed by his physician and which he considered effective for certain conditions, if the Food and Drug Administration had determined that the manufacturer could distribute the drug only on a prescription basis. And yet this would seem to represent self-medication in an enlightened sense and the congressional record of the Food and Drug Act is replete with references to the fact that it was not intended to prevent self-medication.

The fact that the bill as proposed would permit a prescription for a drug to be refilled if authorized by the original prescriber would not be of much practical use if the original prescriber was not available, and the problem of the pharmacist under such circumstances would be difficult to solve under the impersonal wording of the proposed statute.

The Congress is dealing here with a highly personal and intimate problem affecting not only the highly concentrated and industrial areas of our country but also those sparsely settled communities where all the facilities of our modern economy are not equally available.

We should not ask the druggist not to refill a prescription when the need is urgent and not anticipated when originally prescribed, nor should we brand him as a criminal under Federal law if he follows the dictates of his conscience and his professional training.

Our section most earnestly and respectfully urges that the matter be clarified, if necessary, by legislation directed entirely to the abuses of prescription refilling but without, at the same time, requiring drug manufacturers as a collateral measure to discard their time-honored distributing methods.

The CHAIRMAN. The first witness this morning will be Mr. James F. Hoge.

STATEMENT OF JAMES F. HOGE, REPRESENTING THE
PROPRIETARY ASSOCIATION

Mr. HOGE. Mr. Chairman and gentlemen of the committee, my name is James F. Hoge. I am a member of the bar of the State of North Carolina and the State of New York. I am a native North Carolinian, a graduate of Wake Forest College, and there in the city of Greensboro I practiced law for a number of years before going to New York.

My address is 41 East Forty-second Street, New York City, and I am a member of the firm of Rogers, Hoge & Hills.

I appear here today as the general counsel on behalf of the Proprietary Association, whose address is 810 Eighteenth Street NW., Washington, D. C. I say

The Proprietary Association consists of about 150 members. "about" because it varies from time to time. The members are manufacturers of proprietary drugs and cosmetics-what are called in these hearings over-the-counter articles. They are not the exclusive manufacturers of over-the-counter articles. The manufacturers in all three of the associations-the other two having already appeared before you-have large businesses in over-the-counter articles.

The distinction between us is that the members of the other two associations, and perhaps I should name them-the American Drug Manufacturers Association represented here yesterday by Mr. Harrop, and the American Pharmaceutical Manufacturers Association, which was represented by Mr. Dunn 2 or 3 days ago-the members of those associations do not advertise direct to the public. Their advertising is limited to the so-called professional channels, the physicians, the druggists, hospitals, and perhaps other such outlets, whereas the members of the association that I represent advertise direct to the public.

We appear in opposition to this bill, and yet, to make my position clear and I should like to do it at the outset so that you will know to what end I am directing my testimony-the only issue that exists between us and the proponents of the bill is one of ultimate power. That is to say, in the preparation of the so-called list of drugs which shall be limited to prescriptions, the issue we meet is-shall an administrative agency have the power administratively to determine that list with no relief to the industry except that of the limited. so-called administrative court review? Our position is that any power granted should be only the power to institute action looking toward a restriction of drugs to prescription sale; should be limited, as are other similar powers in the law, to instigation by the administrator of actions in the courts where he bears the burden of proof as is common practice in regulatory actions under the Food and Drug Act. That is the only issue between us.

Now, this bill is ostensibly addressed to the exemption of prescriptions and the refills thereof from the labeling requirements, and my statement should be altered to say, "certain labeling requirements of the Federal Food, Drug, and Cosmetic Act."

The Proprietary Association has no opposition to legislation which does that and, were this bill confined to that purpose, the association would support it.

Perhaps I can skip a little here in the interest of time.