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 (chairinan) 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:)

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[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 pre-cription, 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 dispersed upon a written prescription of s practitioner Ecensed by law to administer sich drag or upon an oral preseription 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 filled by the pharmacist.

“The Administrator may by regulation remove drugs subject to section 305 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 statoment '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 hold 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 Cole (26) U. S. C. 3229), or to marijuans as defined in section $238 (b) of the Internal Revenue Code (25 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 narcoties are not inadvertently placed under a prescription Fritation. As the Federal Security Administrator has pointed out, exerint narcoties preparations are these 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 narcoties at all, and all of the other substances of section 302 (d) of the Food, Drug, and Cosmetic Act are a'really controlled under the provisions of the following section (b) (2).

The last paragraph on page 4 is believed to have been included for the mo rosa of e, minating these preparations from the operation of this b ́t but it weald be clearer if section (51) was stricken.

2. Pelete section (b) (2). Ines 12 through 16, on page 2, and substitute in eu thereof the following:

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(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 symptoms. I 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

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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.ssociation, 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.

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If the drug has a caution legend on it, the druggist knows he may not lawfully sell it without a prescription. So far, 112 druggists have been convicted because they willfully violated the law and sold prescription drugs across the counter.

Now, that really is a tribute to the druggists rather than a condemnation of them; when you consider there are 50,000 druggists in the country, and only 112 of them have been violating the law or been convicted of it, that is a pretty small number. You are not going to have perfect compliance with the law at any time, and of that we are all very much aware.

Far from being confusing, the situation is crystal clear. What is confused is not what drugs can be sold without prescription, but what prescription can be refilled without first getting the physician's approval. The examples shown this committee do not bear upon this problem at all. If H. R. 3298 is adopted, with the revisions we propose, it will clarify the doubt as to refillability of prescriptions.

Some witnesses, in particular Mr. Warnack and Mr. Waller, stated flatly that caution-legend items are on some relatively harmless drugs. because the manufacturer is trying to escape his responsibility by making such statements. They are talking about the law and the regulations as they were prior to the change in the regulations in 1946. From 1939 to 1946, the regulations of the Food, Drug, and Cosmetic Act allowed a manufacturer to choose, without any rules other than his own choice, whether he wished to sell his drugs across the counter or whether he wished to put a prescription legend on them and confine them to a physician's use. In 1946 the regulations were changed. From that time to date there are only two classes of drugs. Under the law, if adequate regulations can be written for a drug for lay use, the law says that they must be written, and it it misbranded if you don't write them. If, on the other hand, its toxic potentialities are such that it can only safely and efficaciously be administered under a physician's supervision, then it must bear the caution legend and it must be sold only on prescription; and under the standard we propose here, that type of prescription would require the physician's authorization before it could be refilled.

The exhibits that were brought in had a number of drugs that are slightly confusing unless you understand how the chemical manufacturer operates. These are preparations, two of them put out by Merck & Co. and two put out by Mallinckrodt. Both are large chemical manufacturers. They make raw materials. They sell them mostly to manufacturers of pharmaceuticals and to druggists; and in the case of the sales to the druggist they are for the purpose of use in compounding prescriptions. It is much like going out and buying the material for a suit. You buy the goods, but you don't expect to have the buttons sewn onto it and the buttonholes worked into it. If you want a suit, you buy a suit, but if you buy the materials you buy the materials.

These are raw materials. However, any druggist that wants to sell those across the counter, like calcium carbonate, can buy, and they do buy, from so-called label houses, prepared labels. These come in a roll, and they have a rack of these prepared labels, in the prescription pharmacy. The pharmacist just tears off a label and puts it on the 2-ounce package and sells it. It has the directions on it.