a prescription, when he could buy all the type that he wants that does not require it?

Mr. WALLER. We do not know which is which and when.

Mr. BECKWORTH. You do not?

Mr. WALLER. We do not know which is which. As I said, I may want calcium carbonate.

Mr. BECKWORTH. Could you not find out by asking?

Mr. WALLER. I buy from the wholesale house. He would have to go and check the label, when I gave him the order in the morning. Mr. BECKWORTH. Surely the salesman who waits on you could tell you.

Mr. WALLER. He could not, because he has 40,000 items on the shelf. The label may change tomorrow.

Mr. BECKWORTH. Do they change them from day to day?

Mr. WALLER. They may. Since 1944 they have changed some labels.

Mr. BECKWORTH. What is the big advantage of a given manufacturing company labeling a drug in such a manner that it requires a prescription, when he perhaps would not have to do that?

Mr. WALLER. Well, sir, I could give you some of my own opinions. Mr. BECKWORTH. Give me one.

Mr. WALLER. One of them is that they want to shirk responsibility of complying with label requirements of the act. One other that has been told to me is that certain manufacturers limit their sales to so-called ethical avenues, and in that manner they can create a general opinion that these drugs are sold only by ethical methods. Or they may even sell them to doctors, by doctors dispensing them. Mr. BECKWORTH. May I ask you this question: In the case of the first exhibit, the sulfur ointment compound

Mr. WALLER. Yes.

Mr. BECKWORTH. Would you say that half of that which is sold annually is sold on the basis that requires a prescription, or what kind of a division would you make?

Mr. WALLER. I would say that the one that requires no prescription is sold more often, because it is manufactured by a very reliable company, and a company which caters to the druggists probably more. Mr. BECKWORTH. Then this company that does that is not afraid to assume the responsibility?

Mr. WALLER. That is right.

Mr. BECKWORTH. What kind of company generally is it that is afraid to assume the responsibility? Is it what might be termed the new manufacturer or the small manufacturer?

Mr. WALLER. It may be just the opposite. It may be a big one. Mr. BECKWORTH. The thing I have not been able to understand is that there is bound to be some reason, economic or otherwise, why there is this great diversity you have enumerated by the exhibits. I hope somebody will try to make that clear.

Mr. WALLER. I can make it clear only in this manner: The only reason that my experience has been able to bring an answer to this question is primarily that there is a certain definite liability both civilly as well as criminally in an improper labeling, and they just do not want to take a chance. That is the greatest reason for the whole story.

Mr. O'HARA. Mr. Chairman, I just have a couple of short state

ments.

Mr. Waller, of course, I think all this group has a very warm affectionate feeling for the retail druggists of America, because they are the people whom we think of as we deal with them back home, when we are ill and when our families are ill. I do not know of anyone who is in any way opposed to the thing which you request on the refill of prescriptions. I think it is only sensible, sane, and should always have been in existence, in my opinion, except as to those exceptions which are very reasonable and appropriate.

But the trouble is that in some of the provisions of the bill there is some difficulty, just as Mr. Beckworth has expressed, of understanding some of the differences which we have not heard as yet, probably, and some of the different viewpoints. I do say to you frankly that naturally we are all concerned over the safety of the public.

Mr. WALLER. Surely.

Mr. O'HARA. We want proper food and drug laws and vigorous enforcement of the Food, Drug and Cosmetic Act, for anything within the realm of reason.

I just wanted you to know that, so that there would be no misconception of my viewpoint on this matter.

Thank you, Mr. Chairman.

The CHAIRMAN. We will have to adjourn to answer the roll call of the House.

We shall meet tomorrow morning at 10 o'clock.

(Thereupon, at 3:06 p. m., Wednesday, May 2, 1951, an adjournment was taken until 10 a. m., Thursday, May 3, 1951.)

FEDERAL FOOD, DRUG, AND COSMETIC ACT

THURSDAY, MAY 3, 1951

HOUSE OF REPRESENTATIVES,
INTERSTATE AND FOREIGN COMMERCE,

Washington, D. C.

The committee met, pursuant to adjournment, at 10 a. m., in room 1334, New House Office Building, Hon. Robert Crosser (chairman) presiding.

The CHAIRMAN. The committee will be in order. Mr. Dunn will be the first witness.

STATEMENT OF CHARLES WESLEY DUNN, NEW YORK 20, N. Y., REPRESENTING AMERICAN PHARMACEUTICAL MANUFACTURERS' ASSOCIATION

Mr. DUNN. Mr. Chairman and gentlemen of the committee: I am a member of the New York bar, with offices at 608 Fifth Avenue in New York City. I testify as general counsel of the American Pharmaceutical Manufacturers' Association at 500 Fifth Avenue in that city. It is one of the two national associations of manufacturers of drugs used by the medical profession, and it has over 200 members, throughout the country and in Canada.

This hearing deals with a proposed amendment of the Federal Food, Drug, and Cosmetic Act (hereinafter called the FDC Act), known as the national food and drug law, which is administered by the Federal Security Administrator (hereinafter called the Administrator) through the Food and Drug Administration (hereinafter called the FDA). My qualifications to discuss the law of this act may be summarized, as follows: I have specialized in the food and drug law for nearly 40 years I think more than anyone else in the profession-I have published numerous books on it; and I testified at all the legislative hearings on the FDC Act and the major amendments of it.

During that period I have been general counsel for the national associations of both food and pharmaceutical manufacturers and also general or special counsel for many of them individually.

I now hold the following offices: Chairman of the food, drug, and cosmetic law divisions of both the American and New York State Bar Associations; chairman of the editorial advisory board of the Food, Drug, and Cosmetic Law Journal; president of the Food Law Institute, a public organization to develop food and drug law instruction at university law schools and to publish research studies of this law; and professor of law at New York University in charge of its national center of post-graduate instruction in the food and drug law.

H. R. 3298, by Mr. Durham (S. 1186 (by Mr. Humphrey) is an identical bill) is sponsored by the National Association of Retail

75

Druggists. It amends the special prescription drug law in section 503 (b) of the FDC Act, in a way that significantly affects both retail druggists and drug manufacturers. We approve the purpose of this bill, because that law should be amended to strengthen its protection of public health; and we also approve the amendment thus proposed, subject to the technical correction and substantial revision hereinafter stated.

But that special prescription-drug law of section 503 (b) supplements the basic prescription-drug law of the FDC Act, established by the regulations under section 502 (f) (1); and it is also indirectly supplemented by the new drug law of section 505. We must first review this basic prescription-drug law, because it has a decisive relation to the proposed amendment of section 503 (b); and this review can be quickly made.

Section 502 (f) (1) requires the labeling of a drug to bear adequate directions for its use, except where this requirement is not necessary for the protection of public health as to particular drugs and the Administrator exempts them by regulations. They exempt a prescription drug, as thus defined and subject to certain marketing conditions. Such a drug is here defined to be one which

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 generally recognized among experts qualified by scientific training and expericence to evaluate its safety or efficacy, as safe and efficacious for use except by or under the supervision of a physician, dentist, or veterinarian.

This is the existing definition of a prescription drug which has long been in the act. This is an objective and fundamental definition; and to a layman it may appear involved and complex. But it is actually an appropriate and sound definition; and its practical meaning is clear. For such a drug is thereby defined in effect to mean one which should be used only under medical control, where this is. scientifically indicated from the standpoint of both its safety and efficacy-and "efficacy" of course means the therapeutic value of a drug.

Likewise the conditions then named for the marketing of a prescripdrug are appropriate and sound, per se. They are in major part and substance:

(1) The manufacturer must plainly label such drug with this notice, "Caution: To be dispensed only by or on the prescription of a physician" (alternatively dentist or veterinarian);

(2) He must sell it to be dispensed only by or on the prescription of a physician, and so forth, in his professional practice;

(3) It must be so dispensed; and

(4) Where it is dispensed on a prescription, its labeling must bear the directions for use so specified.

This basic prescription-drug law is manifestly designed to provide that a dangerous drug shall be dispensed only on a prescription basis, for the protection of public health; and the importance of this provision cannot be overemphasized.

The term "dispensed" is not defined, but it practically refers to a retail sale by a druggist under the supervision of a registered pharmacist, as provided by the State pharmacy law. The FDC Act reaches. the retail sale of any drug originating in interstate commerce, notwithstanding the sale itself is in intrastate commerce.