Mr. HALE. Then really your answer to the whole thing is that pharmacists are a pretty good lot. I hope you are right. As far as my experience goes, I have always found them so. It still does

worry me a little, I will say.

Mr. HESELTON. I have one final question. In line with what Mr. Hale asked you earlier, do you have any knowledge of whether there is any amount of double membership-that is, cases where members of your association are also members of the Retail Druggists Association? Mr. FISCHELIS. Oh, yes; there are many.

Mr. HESELTON. So that we have a confused situation as to which recommendations really constitute the recommendations of the pharmacists?

Mr. FISCHELIS. I don't think you will find us very far apart on this. We all have the same objective. We want to have the opportunity to fill prescriptions that are given orally. We may differ as to what extent labeling ought to indicate to a pharmacist what he ought to do. Some of us feel that our professional judgment, based on our education, is sufficient so that we can determine that.

Mr. WOLVERTON. Up to the time that the witness said they were not very apart, I confess that I thought I was on some sort of a merrygo-round. I have heard opinions on this bill by pharmacists, and I have heard the pharmacists differ with drugstore owners or at least their national organization, patients, and consumers. We have heard from the Food and Drug Administration, the manufacturers of drugs for over-the-counter use, and the manufacturers of drugs for prescription purposes. The only horse on the merry-go-round that seems to be vacant at the present time is that which would ordinarily be occupied by the doctors.

As the different witnesses have come before this committee, each giving their views, it seems to me the merry-go-round has gone faster all the time. It may be a good place to stop and recess when this witness says that we are not very far apart.

The CHAIRMAN. The hearing will be recessed until tomorrow morning at 10 o'clock.

(Whereupon, at 4:40 p. m., the hearing was recessed until Friday, May 4, 1951, at 10 a. m.)

FEDERAL FOOD, DRUG, AND COSMETIC ACT

FRIDAY, MAY 4, 1951

HOUSE OF REPRESENTATIVES,

COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE,

Washington, D. C.

The committee met, pursuant to recess, at 10 a. m., in room 1334, New House Office Building, Hon. Robert Crosser (chairman) presiding. The CHAIRMAN. The committee will come to order. The first witness this morning will be Mr. Harrop.

STATEMENT OF LESLIE D. HARROP, GENERAL COUNSEL, AMERICAN DRUG MANUFACTURERS ASSOCIATION

Mr. HARROP. Mr. Chairman and members of the committee, my name is Leslie D. Harrop. I am the general counsel for the American Drug Manufacturers Association and the Upjohn Co.

The American Drug Manufacturers Association is composed of 66 manufacturers of pharmaceuticals, chemicals, biologicals, and allied products. The membership includes such well-known firms as ParkeDavis, Lilly, Squibb, Lederle, Sharp & Dohme, Winthrop-Stearns, Abbott, Upjohn, Penick, Merck, Pfizer, and Johnson & Johnson. A complete list of the membership is attached to this statement.

H. R. 3298 was introduced to try to clear up the confusion that has resulted from a statement made 2 years ago by the Commissioner of Food and Drugs. Commissioner Dunbar then stated that in the opinion of the Food and Drug Administration no prescription could be refilled. Since traditionally then, and at the time the Food, Drug, and Cosmetic Act was enacted in 1938, some 30 or 40 percent of all prescriptions in a drug store were refills of old prescriptions, it is understandable that Commissioner Dunbar's statement caused consternation in retail drug groups.

The purpose of H. R. 3298 is to define what prescriptions a druggist may refill at will and those for which the further authority of the physician must be secured. With that avowed purpose, we have no objection. We heartily endorse the principle of clearly outlining the situations in which a pharmacist may refill prescriptions without further authorization from the physician.

At the same time we are entirely in accord with the statement that dangerous drugs should only be dispensed originally on prescription and that such prescriptions should only be refilled if and when and as the physician may direct.

We wish to propose three changes in this bill. With these changes we give such an amended bill our full support. (The proposed amended bill follows:)

143

[H. R. 3298, 82d Cong., 1st sess.]

A BILL To amend section 503 (b) of the Federal Food, Drug, and Cosmetic Act

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, is amended to read as follows:

"(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―

“(1) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, it is not generally recognized among experts qualified by scientific training and experience to evaluate its safety, as safe and efficacious for use except by or under the supervision of a practitioner licensed by law;

"(2) if an effective application under section 505 limits it to use under the professional supervision of a practitioner licensed by law, 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 Administrator may by regulation remove drugs subject to section 505 from the provision of this subsection when such requirements are not necessary for the protection of the public health.

"A drug which is subject to clause (1) or (2) of this subsection shall be deemed to be misbranded if at any time prior to dispensing its label fails to bear the statement 'Caution: Federal law prohibits sale or dispensing without prescription'. "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.

"The provisions of this section of the Act shall not be applicable to drugs now included or which may hereafter be included within the classifications stated in section 3220 of the Internal Revenue Code (26 U. S. C. 3220), or to marijuana as defined in section 3238 (b) of the Internal Revenue Code (26 U. S. C. 328 (b))." Mr. HARROP. I believe the clerk has copies of the modified bill amended as we suggest, for the members of the committee.

No. 1 is to delete section (b) (1), lines 10 and 11, on page 2. The necessity for deletion of this section is to be certain that the exempt narcotics are not inadvertently placed under a prescription limitation. As the Federal Security Administrator has pointed out, exempt narcotics preparations are those containing such a small quantity of these drugs that they are harmless and thus freely available over the counter.

Mr. Larrick testified yesterday that it was not the intention of the Food and Drug Administration to affect exempt narcotics at all, and all of the other substances of section 502 (d) of the Food, Drug, and Cosmetic Act are already controlled under the provisions of the following section (b) (2).

The last paragraph on page 4 is believed to have been included for the purpose of eliminating these preparations from the operation of this bill but it would be clearer if section (b) (1) was stricken.

2. Delete section (b) (2), lines 12 through 16, on page 2, and substitute in lieu thereof the following:

(2) Because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, it is not generally recognized among experts qualified by scientific training and experience to evaluate its safety, as safe and efficacious for use except by or under the supervision of a practitioner licensed by law.

The language we propose in the stead of that of the bill is taken from the present regulations under section 502 (f) of the Food, Drug, and Cosmetic Act. It would create a positive legislative standard for determining which drugs must be sold only upon prescription and which drugs when prescribed can only be refilled with additional authority from the prescriber.

The standard is similar to that proposed by H. R. 3298, but instead of granting authority to the Food and Drug Administration to determine the facts and create a list of drugs, this change would leave the question properly open to ultimate determination by courts. Some of the examples brought before this committee of similar products of different manufacturers, one bearing a "Caution" legend and the other adequate directions, result from honest differences of opinion among real experts in the field. We are not opposed to a resolution of these differences, but we feel an impartial court should make the decision and make it without the prejudice of prior administrative hearings and determinations of fact. Administrator Ewing with delightful candor told this committee that as now drafted it is conceivable that some future Administrator might decide to put aspirin on the list of drugs for limited refill.

I would like to interpolate here and use one illustration from an administrative ruling in 1945 by the Food and Drug Administration, to the effect that no eardrop preparations, no matter how harmless and innocuous they might be, could be sold except on prescription, because it was possible that they would mask the symptoms of a serious condition; that an earache might be a symptom of a mastoid condition.

Now, you can see how that philosophy can be extended on down. very quickly to aspirin. Aspirin is a pain killer, and as such it may well mask the symptoms of some serious disease. And yet, unless we are going to live in front of an X-ray machine and in a hospital, we have got to be a little bit more courageous about some of these sympI am not suggesting that any serious symptoms should be overlooked, but there certainly is a large field for proper self-medication.

As we visualize it, the committee thus has two routes by which it can separate those drugs that are dangerous and should be limited in distribution, from the harmless ones which can be sold across the counter or refilled at will by the druggist.

The one approach-that of the bill as now drafted-would give vast powers to the Food and Drug Administration, involve lengthy hearings and appeals. The other the one we propose as an alternate would set the same standard. The responsibility for meeting this standard, however, would be placed where it belongs, on the manufacturer. The druggist would need only follow the simple guide of the labels. And you will remember that those exhibits that you have had placed before you consist of two classes of drugs: those that say "Caution-To be dispensed only by or on the prescription of a physician," and the others, which have directions. Each witness, as he went through them, was clear in his mind. He understands

exactly what he can do with those. Where it says "Caution-To be dispensed only by or on the prescription of a physician," that can be sold only upon a prescription, and the other can be sold freely across the counter. The druggist will have a complete guide. He will have his list upon the shelves of his drug store. That list will be constantly up to date because drugs are constantly changing, and you can only depend upon the label. A list would be very stale a week after it has been issued.

If this provision is adopted, henceforth any druggist can tell instantly by a glance at his drug shelves whether the product bears the restrictive clause. If it does, he may not refill a prescription for this drug without authority from the doctor. If the product does not bear such restrictive legend, the druggist is at liberty to refill prescriptions for it at will. Such a guidepost is simple, positive, and constantly up to date.

We submit that when an aggravating problem such as this prescription-refill problem can be solved in a fashion acceptable to most. elements of pharmacy, that this course should be followed over a method that has the vigorous opposition of the majority of pharmacists.

The third change that we propose is to delete lines 15 through 25 on page 3, and lines 1 through 20 on page 4. There is a typographical error in our prepared statement. It reads "1 through 20," and it should read "1 through 14 on page 4."

The material stricken here is that covering the requirements for hearings and court review. If Congress enacts a standard for separation of dangerous from harmless drugs, there will be no necessity for costly hearings, determinations of facts, and appeals. It will also dispose of the question of the propriety of a review, de novo, in the circuit court of appeals.

After this brief and, we hope, clear statement of the views of the American Drug Manufacturers Association, we would like to discuss one or two phases of the hearings about which there appears to be some uncertainty.

Mr. Warnack, Mr. Waller, and again Commissioner Larrick, brought in numerous exhibits where different manufacturers had labeled the same drug, one with a “caution" legend and the other with directions for over-the-counter sale. Each witness said this showed the high state of confusion in retail drug circles. Not one of the witnesses, however, was at all in doubt as to how a druggist is required to sell such products.

May I use the illustration of looking down a street at traffic lights. You see a red one, and you see two green ones, and you see another red one, and you see another red one, and another green one. You might say that is confusing, and yet we know exactly what we must do at each corner. Where it is green we can go, and where it is red we have to stop; and the same thing is true with these labels. They are not confusing at all as to what the druggist may do in selling them. He is horribly confused, and the purpose of this bill is to get rid of that confusion, on what he can refill. There is the confusion, and it is real confusion. He certainly needs the relief that this committee should give him, because he doesn't know whether he can refill anything. The public shouldn't be deprived of proper medicines because of that confusion in the law.