hold a public hearing and on the basis of the evidence thus acquired promulgate a list of the drugs which are not safe and efficacious for self-medication.

The public hearing provided for in the bill would operate as follows: The Administrator would prepare a proposal where he would list a number of drugs that, based on advice from the Food and Drug Administration, are tentatively set up as drugs which should be restricted to prescription sale. That would be published in the Federal Register and anyone who cared to object could do so. If objection were raised, there would be precipitated a formal hearing where a record would be made, the outstanding experts of the country would be called by the Government, and presumably by those in opposition to the Government. The findings of fact would have to be based exclusively upon evidence adduced at that hearing. Finally, after the Administrator had reached his conclusion, he would publish his final order, which would be reviewable in the circuit courts of appeals in precisely the same manner that this committee, after 5 years of deliberation, decided that the other appeal procedures should be handled.

These drugs would be required to bear the legend, "Caution: Federal law prohibits sale or dispensing without prescription." If such drugs were so labeled, the retail pharmacist would have a consistently reliable guide to tell him whether or not a drug must be held solely for prescription sale. This would lend uniformity and certainty to enforcement operations.

As we have said, the Food and Drug Administration is of the opinion that for purposes of labeling the present law provides authority to divide drugs into two classes. One, for sale only on prescription; the other, bearing complete labeling, for sale directly to the lay public. Attorneys for some of the largest drug firms and drug organizations in the United States entertain a forthrightly contrary view. They assert their opinion that the law does not provide authority for the regulations which we have issued which make a distinction between prescription drugs and those for over-the-counter sale.

The present law and regulations placed on the manufactuer the initial responsibility of deciding what labeling a drug will bear. Guidance as to whether a drug should be labeled for prescription or over-the-counter sale is expressed in general terms. Individual drugs are not named. Thus, manufacturer (A) may interpret the law one way and sell his medicine bearing the prescription legend; manufacturer (B) may reach a different interpretation and sell the identical article for over-the-counter distribution.

We have a few additional exhibits to add to the collection the committee has already received, and if you care to look at these, each of them are matched drugs, one bearing some sort of directions for use, and the other, of identical composition, bearing the prescription legend. There are literally thousands of different drug items on the market. The only way that we could bring about uniformity under the present law and regulations would be to initiate separate lawsuits in each case. We have developed a number of such cases, but since our facilities will not permit us to attack the problem on a broad front, we have selected those that we believe are of the greatest importance from the standpoint of public health and safety.

By and large, there are three classes of drugs: one, the extremely dangerous drug where there is no conflict of opinion as to whether or not they should bear the prescription legend, and for the most part they bear the prescription legend. Then there are the drugs at the other end of the column, where everyone is agreed that drugs like aspirin and liniments and cough sirups can be properly labeled for over-the-counter sale and by and large there is no great problem in that area. But in between is a wide band where these many, many drugs occur, some of which are labeled one way and some the other.

In June of 1949, E1-0-Pathic Pharmacy and Martin A. Clemens, manager and director, were prosecuted for the shipment of a male sex hormone under false and misleading labeling. It was alleged also that the article failed to bear adequate warnings against its use under conditions where it might be dangerous to health; in particular, that the labeling failed to warn the purchaser that unsupervised use of the drug may result in sterility and in stimulating the growth of incipient cancer of the prostate gland. The defendants plead "not guilty" but the court returned a verdict of "guilty" and imposed fines totaling $1,400. The court made the following remarks at the conclusion of the trial:

From the evidence and the weight of the evidence I am convinced, beyond a reasonable doubt, that the indiscriminate distribution or dispensation for use of the drugs testosterone, methyl-testosterone * * * carries not only a poten

tial but an actual danger of injury to some persons. I am also convinced from the evidence that these drugs do not, other than within a restricted class of cases, produce many or any of the alleviatory and beneficial effects that the labeling given them by the defendants indicate and encourage readers to believe that they will generally produce.

Soon after this conviction the directions in the labelings of these drugs were modified to read in part as follows:

For use by adult males mildly deficient in male hormones when small dosages of male hormones are prescribed or recommended by a physician for paliative relief of such symptoms.

At the same time the firm engaged in extensive newspaper advertising such as:

*

SENSATIONAL NEW FORMULA! MALE HORMONES

*

*

Mailed to you in plain wrapper.

Sixty tablets, $5.25 postpaid.

Caution: Take only as directed.

Double your money back guaranty.

*

If, after taking these tablets for at least 10 days, you don't feel that you are deriving benefit from their use, return box and the unused tablets and we will cheerfully give you double your money back.

The Government instituted injunction proceedings to prevent the sale of such medicines otherwise than on prescription.

The district court found in favor of the defendant and held that the directions appearing on the label are adequate, stating:

can be read.

* * *

The cartons * * * the word "physician" is used at least four times, "under supervision of a physician," "under direct supervision of a physician," and I don't know what more words would be put upon their cartons that would be a greater warning, except, "to be used only upon a prescription from a physician."

84416-51-7

I think that is what the Food and Drug people are trying to get at. That is, they want these medicines to be sold only upon the prescription of a physician.

In this connection, it may be mentioned that investigation of 19 purchasers of the article showed that only 1 was deterred from making use of the drug without medical advice by reason of the reference in the labeling to physicians, and this was so even though the label stated that the drug might stimulate the growth of incipient cancer. This case was appealed. The appeal has been argued. A decision is expected any day.

This brings us back to the listing proposed in the Durham bill. So long as some firms in the drug industry believe that the act does not provide authority to require drugs that are not safe or effective for self-medication to be limited to prescription sale, there will be many that do not so restrict them. If it develops that authority to make this distinction is not contained in the act, then a most serious public-health problem will arise. Many deaths and drug injuries would occur if such drugs as cortisone, penicillin, thyroid, the sulfonamides, cinchophen, sex hormones, and so forth, were thus made available for sale directly to the public.

Opposition has been expressed to this bill on the ground that the Government is empowered to determine whether or not a drug is efficacious for its intended use. The language of the bill does not justify this conclusion.

The bill does not authorize the Administrator to determine the efficacy of a drug. It authorizes him to hold a hearing where the evidence of the best informed experts in the country would be received. On the basis of this testimony he would then determine not whether the drug is efficacious, but whether or not a layman can use the drug effectively without the diagnosis or supervision of a physician.

We submit that it is just as important that a drug be effective in the hands of the person who acts as his own physician as that it be safe in the sense that it will not poison him. For example, aminophylline is relatively nontoxic. It is not a poison. It is an effective diuretic and will reduce swelling of the ankles other than that caused by insect bits and the like. A layman cannot effectively treat himself with the diuretic because the underlying cause of the swelling is heart or kidney disease and the use of the diuretic to control the symptom does not affect the progress of the underlying cause. Thus, the ill-advised use of the diuretic may indirectly hasten the death of the patient. Methionine and choline are relatively nontoxic drugs. Doctors find them useful in treating such liver diseases as cirrhosis and certain inflammations. Laymen cannot make the liver-function and other tests necessary to adequately treat these diseases.

We have on the market now a new antibiotic similar to penicillin and aureomycin. This drug is not under the certification system which went through this committee. If a person were to treat himself for gonorrhea without medical assistance with this terramycin, which is relatively safe, he might have concurrently an exposure to gonorrhea and syphilis. The treatment of gonorrhea with the penicillinlike drug, terramycin, would conceal all of the early symptoms of the syphilis and the patient would progress through those early symptoms of syphilis without knowing that he had the disease, and the first knowledge that he had contracted syphilis simultaneously

would be when he had some of the very, very serious last-stage manifestations of the disease.

In the brochure that goes to doctors dealing with this relatively safe drug appears the statement:

Because treatment with terramycin may mask the early signs of syphilis, dark field examinations of the exudate from the suspected primary lesions of syphilis should be made prior to treatment of gonorrhea. Monthly serological tests for a minimum of 3 months should be made in all cases in which treatment is given, and concomitant syphilis is suspected.

In our opinion, this is a striking example of an instance where a drug for all practical purposes is safe, but where it cannot be effectively used by a layman without medical supervision, although the drug itself is very efficacious.

Some of the representatives of the manufacturers have questioned me as to our conception of the application of this act to narcotics that are controlled under the Harrison Antinarcotic Act, and they wished me to state for the record that this bill is so drafted as to prevent any overlapping of authority between these two agencies of Government. The purpose of the language, as we construe it, is to let the Narcotics Bureau regulate exempt narcotics and other narcotics, and the Food and Drug Administration would deal with the strength, quality, and purity of the narcotics that are sold for medicinal purposes.

To summarize: This bill is needed not only to give relief to the great majority of pharmacists who earnestly wish to protect public health and comply with the law; it will make the legal requirements to protect public health simple, certain, and clear. The present requirements are not as clear as they should be. A pharmacist cannot readily understand his obligations from reading the law and regulations. They are very difficult to explain to lay juries.

Mr. HELLER. I was very much interested in the case that you cited, the New England Benzedrine case, and I would like to ask this question: Is benzedrine sulfate, referred to in that case, a dangerous drug within the definition of your regulations under section 502 (f) of the act?

Mr. LARRICK. Yes, sir.

Mr. HELLER. Well, then, do you believe that the druggist in question had any doubt as to the dangerous character of this drug? Mr. LARRICK. He should not have had, sir.

Mr. HELLER. No doubt at all?

Mr. LARRICK. There shouldn't have been any doubt, in my opinion. Mr. HELLER. Well, then, if he could not have had or should not have had any doubt, and let us call it a reasonable doubt, why would he be any more likely to abide by the proposed amendment than by the present law?

Mr. LARRICK. I don't think that he had any question in his mind as to the dangers of the drug, but he may have had question in his mind as to our authority to regulate. I don't maintain for a minute, Mr. Heller, that any law will stop all violations; no law will be selfregulating. But the clearer and the more explicit the prohibitions are, and the easier it is for the ordinary layman to understand precisely what he is held to, the more people will abide by the law, in our opinion.

Mr. HELLER. But in any event, the present law is sufficient to protect the consumer, is that correct?

Mr. LARRICK. The present law, so far as it has been interpreted, is sufficient to protect the consumer.

Mr. HELLER. Then would you please explain what additional protection the consumer would have, under the new law, against the irresponsible sale of dangerous drugs without prescriptions?

Mr. LARRICK. Well, the first thing that it would do would be to simplify enforcement. In this case that we used as an example, it is now necessary to first locate the few drug stores that are following these illegal practices; and then, to get the evidence in a form that is presentable in Federal court, the food and drug inspectors in the guise of customers enter the store and make the "buys. Then they take the next step and they prove that the drug that is involved has moved in interstate commerce. Then if the case were to come on for trial, we would have the involved business of proving all of this chain of evidence, that the drug was dangerous, what it did, and what it didn't do that phase of it would be much simplified if the prohibited act were stated clearly in a regulation which listed the drugs which he could not sell over the counter.

Mr. HELLER. Since the purpose is to simplify the enforcement of the law, would not the better approach-and I do not know, I am just trying to find out-would not the better approach be to change the procedure rather than to change the substance of the law?

Mr. LARRICK. I don't quite know what you mean by changing the procedure. How could you do that, sir?

Mr. HELLER. I do not know.

Mr. LARRICK. I don't know.

Mr. HELLER. I would like to know if there is not a way of doing it. Mr. LARRICK. Mr. Goodrich reminds me that in that particular area, one lawyer who was highly respected by the pharmacists of the vicinity gave them advice which was directly contrary to the advice that we would have given them if they had come to us. He said it was permissible to refill prescriptions under certain circumstances.

We think that the list is the best way to simplify our procedure, so long as we are acting under the commerce clause and in interstate

commerce.

Mr. HELLER. You have cited certain cases which your agency is now enforcing. Do you have a complete list, or could you make that available to the committee, of all cases in which you have tried to enforce the present law?

Mr. LARRICK. You mean in this particular type of case-there are about 3,000 total cases each year. I have anticipated that question, Mr. Heller, and I have that.

Mr. Heller. Will you make that a part of the record?

Mr. LARRICK. Yes, sir.

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