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statement, I am certain that there are several members who would be interested in your viewpoint.
Mr. Dunn. If that is requested of the chairman, I will be glad to Mr. WOLVERTON. I take it there would be no objection to that? The CHAIRMAN. No.
Mr. WOLVERTON. There are many more questions I would like to ask, but my colleagues here are anxious to ask you some questions and the time is very short within which it can be done, so I will withhold any further questions in the hope that my colleagues will develop some of the matters that are in my mind.
Basically what I am interested in is protection of the patient consumer, and at the same time not adding unduly to the costs.
Mr. DÚNN. That is exactly my view.
Mr. O'HARA. Mr. Dunn, I fully appreciate that in your statement you have pointed out specifically what you are for and what you are against in this bill.
May I ask you this question: In its present form would you approve this bill as a whole with its good and its bad; would you say that the good outweighs the bad, or that the bad outweighs the good?
Mr. Dunn. I do not think that is a question that I should be required to answer, because I am equally in favor of a sound amendment of this law. Mr. Chairman, may I inject at this moment that I have got to take
I a plane at 11:55 to Atlanta. I am to lecture tonight at Emory University on the Food, Drug, and Cosmetic Act, and following that at other Southern law schools.
The CHAIRMAN. When can you be back?
Mr. Dunn. I will be glad to come back at any time in the future, and at your call after tomorrow.
The CHAIRMAN. Well, we cannot always operate this committee on the basis of taking care of one bill. We will see you when we can call
Mr. O'Hara. Mr. Chairman, I do not want to prevent the gentleman from making his plane. Therefore I will withhold any questions until he is here again.
Mr. Dunn. Thank you.
Gentlemen, the bell has rung for us to be present on the floor of the House; so, we will recess the hearing at this time until 1:30, when we hope to be able to make some progress.
understand that the bills on the floor this afternoon will not be such as to require the presence of all of us over there.
Will you come back at 1:30, Mr. Larrick? (Thereupon, at 11:15 a. m., the committee recessed until 1:30 p. m. of the same day.)
(The hearing was resumed at 2 p. m.)
STATEMENT OF GEORGE P. LARRICK, ASSOCIATE COMMISSIONER
OF FOOD AND DRUGS, FOOD AND DRUG ADMINISTRATION, FEDERAL SECURITY AGENCY
Mr. LARRICK. My name is George P. Larrick, Associate Commissioner of Food and Drugs.
Mr. Chairman and gentlemen of the committee:
In the enforcement of the Federal Food, Drug, and Cosmetic Act our inspectors routinely investigate each report of death or injury from drugs. They visit coroners, police departments, emergency hospitals, health departments, charitable agencies, and other organizations where information may be available concerning injuries or deaths from the improper use of drugs.
Recently, while visiting a large hospital in New England, an inspector learned that in May 1950 a man died there and it appeared that the excessive use of benzedrine was contributory to his illness and later death. The widow advised the inspector that for 13 years her husband had been having a prescription for benzedrine sulfate refilled. She showed the inspector an empty box which bore the prescription number, the name of a local physician, and the name of a drug store. The physician executed an affidavit that he had last seen the deceased in 1937 and at the time had written a prescription for 14 10-milligram tablets of this drug. The same prescription had been refilled for 13 years and the amount delivered had been very substantially increased until just before his death this man was taking as much as 250 milligrams a day. The prescribing physician asserted that it was never his intention that the patient take more than the original 14 tablets which he prescribed.
The inspector next visited the drug store as an ordinary customer and presented a prescription for benzedrine. He returned repeatedly to the same store, and his prescription was repeatedly refilled. Other inspectors presented prescriptions for other drugs such as nembutal, which is a sleeping pill, and sulfadiazine, which is a drug used to treat venereal disease. All of these were refilled repeatedly. The doctors who had written the original prescriptions were not consulted. This case is now in the course of preparation for criminal prosecution. Our files record hundreds of deaths and injuries caused by the misuse of drugs.
In explaining to yov gentlemen what our present law requires in our opinion, and what our enforcement activities are, I will refer to several incidents of this general nature. I do not want you to understand from these references to these incidents that that is characteristic of the drug business generally. I think we must recognize that retail pharmacists generally are very honorable gentlemen, good citizens who wish to abide by the law. The same is true of the manufacturers; but, as in every industry and every profession, there are fringe elements who are capable and do do things which the majority would deplore.
During the past decade medical science has discovered many new and potent drugs which are very useful in the treatment of disease. It has been said that 50 percent of the drugs now prescribed by physicians were unknown 10 years ago. When the medicines are administered by skilled physicians they cure many ailments. Most of these drugs, however, are quite potent and capable of doing harm if they are misused. This is also true of some drugs which were available
earlier. Female sex hormones, called estrogens, are very useful in the hands of skilled physicians, but in a case under the Food and Drug Act in California recently, where the drugs were sold without prescription, eminent medical authorities testified that improper use is capable of stimulating the growth of incipient cancer; it may impair fertility and cause hemorrhage from the uterus. Male sex hormones, called androgens, when misused may lead to injuries in the nature of impaired fertility and they may stimulate growth in incipient cancer of the prostate. This is important, because competent authorities estimate that 50 percent of the men over 50 years of age suffer from incipient cancer of the prostate. In the great majority of these individuals the cancer never becomes active, but vital statistics do show that 5 percent of deaths in men past 50 are due to cancer originating in the prostate.
Penicillin, sulfonamides, benzedrine, and a wide variety of other drugs readily lend themselves to serious abuses. The problem even involves therapeutic devices. In spite of the fact that it has been established that unskilled exposure to X-ray can cause cancer 20 years later, we found a number of beauty salons that used X-ray for the removal of unwanted hair.
The Federal Food, Drug, and Cosmetic Act prohibits
act with respect to a drug
if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated or misbranded.
Basic requirements of this statute, as far as drugs are concerned, are that drugs used for self-medication must be safe for their intended use, and they must bear adequate directions for such use. Many drugs can be used safely and effectively under the supervision of a physician, but cannot be so used in self-medication. We have mentioned a few examples.
To accomplish the purposes of the act as expressed over the years by the reports of this committee, it was necessary to promulgate regulations which would restrict some drugs to physicians' use. These regulations provide that such drugs can legally be shipped in commerce if they bear the legend, "Caution: To be dispensed only by or on the prescription of a physician,” and bears this legend in place of any directions for use.
It is our view that when a pharmacist receives drugs in interstate commerce bearing this legend, he causes them to be misbranded if he sells them otherwise than on a bona fide prescription. We believe that the Supreme Court's decision in the Sullivan case establishes that this is the law. The Court held that the purpose of the act was to safeguard the consumer by applying the act to articles from the moment of their introduction into interstate commerce, all of the way to the moment of their delivery to the ultimate consumer.
In enforcing this construction of the statute, 136 criminal prosecutions against retailers have been terminated in the Federal courts.
We submit for inclusion in the record, if you wish, a list of these cases. (The list referred to appears, beginning on p. 97.)
In addition, there are 50 criminal prosecutions which have either been filed with the Federal courts or are in the course of being prepared in our General Counsel's office or in the Department of Justice. We have at the moment 263 reports of deaths or injuries from drugs
which are uninvestigated. We have 79 cases under active investigation. We have 26 where the investigations have been completed but the paper work has not yet been completed for reference of the cases to the appropriate United States attorneys.
In the Seventy-fifth Congress, third session, this committee submitted report No. 2139, on April 14, 1938, on the bill which later became the Federal Food, Drug, and Cosmetic Act. The report stated in part:
The act herewith reported is the culmination of more than 5 years of study by your committee. This act seeks to set up effective provisions against abuses of consumer welfare growing out of inadequacies in the Food and Drugs Act of June 30, 1906
On page 3 the same report continues:
In order to extend the protection of consumers contemplated by the law to the full extent constitutionally possible, paragraph (k) has been inserted prohibiting the changing of labels so as to misbrand articles held for sale after interstate shipment
Page 8 of the same report says:
Other provisions of section 502 are designed to require the labeling of drugs and devices with information essential to the consumer. The bill is not intended to restrict in any way the availability of drugs for self-medication. On the contrary, it is intended to make self-medication safer and more effective. For this purpose provisions are included in this section requiring the appropriate labeling of habit-forming drugs, requiring that labels bear adequate directions for use and warnings against probable misuse, and setting up appropriate provisions for deteriorating drugs.
Section 503 * provides an exemption for drugs dispensed on bona fide prescriptions. Such drugs are relieved from the requirement that the label bear the name and address of the manufacturer, the quantity of the contents, the common name of the drug, and the name of each of its active ingredients, and if the prescription is nonrefillable a warning against habit-formation.
Speaking of the prohibition against changing labeling on articles received from interstate sources the conference committee, in House of Representatives report No. 2716, Seventy-fifth Congress, third session, June 11, 1938, stated that the safeguards over drugs had been strengthened by prohibiting tampering with the labeling of, or doing any other act with respect to, a food, drug, device, or cosmetic, if such act is done while the article is held for sale after shipment in interstate commerce and results in such article being misbranded.
On July 8, 1947, Mr. Hale, speaking for this committee, submitted report No. 807, Eightieth Congress, first session, in a proposed amendment to this prohibition which subsequently was enacted. The report states in part:
The insertion of the parenthetical wording "whether or not the first sale" in section 301 (k) is not designed to change the original intended meaning of the section but would simply make it entirely clear that “held for sale” includes the first sale and any subsequent sale.
The report then discussed a decision by the Circuit Court of Appeals for the Fifth Circuit, in the case of Jordan J. Sullivan v. United States. The pharmacists had sold sulfathiazole to soldiers for the self-treatment of gonorrhea and, subsequently, to inspectors of the Food and Drug Administration who visited the store as customers. The circuit court had held that the act did not authorize the
prosecution. Mr. Hale's report continues:
Misbranding which results in effectual treatment with a potent drug, such as those of the sulfonamide group, may render the diseased organisms immune to
the drug. When the resistant strain is spread in the community the sulfonamides are ineffective, even when used by skilled physicians, with the consequence that the interstate market for those useful drugs is substantially depressed.
In order to prevent the frustration and defeat of its purpose, Congress must exercise its power to continue that protection against articles that become filthy, decomposed, deteriorated, or otherwise adulterated or misbranded while awaiting sale to the ultimate consumer. Otherwise the safeguards which were designed to maintain the integrity of the products to the end of their interstate journey become futile and the purpose of the regulation becomes sterile and fails of fruition.
The conviction of Sullivan was later affirmed in the Supreme Court, but at this stage of the proceedings of this committee you had specific knowledge of the type and kind of supervision that we had exercised under the law and which resulted in the Sullivan case to which you refer in this report.
H. R. 3298, which is the bill before you for consideration, would recognize oral prescriptions. The present Food, Drug, and Cosmetic Act in section 503 (b) recognizes only“a written prescription signed by a physician, dentist, or veterinarian." In many circumstances the physician can provide better medical care for his patients by telephoning the pharmacist to fill or refill prescriptions.
In the bill, H. R, 8904, which Mr. Durham introduced in the Eightyfirst Congress, oral prescriptions were recognized but only if the physician agreed to confirm them in writing within 72 hours.
The present bill would not include this requirement but the transaction would be legal if the pharmacist reduced the prescription to writing. We prefer the physician's signed confirmation.
We are in general agreement with this provision but we believe that this committee should give consideration to the fact that this exemption may complicate enforcement with respect to the barbiturates, commonly known as sleeping pills.
The Committee on Ways and Means is presently considering special legislation to deal with the very serious problem which arises because of the extensive use of barbiturates without medical supervision. If adequate legislation covering this special problem is enacted, our reservations concerning oral prescriptions would be satisfied.
Just one very recent brief example to illustrate the sleeping-pill problem:
A 45-year-old married man, the father of two children, died last year from an overdose of barbiturates. Investigation revealed that he had been buying the drug from one druggist over a 2-year period on a copy of a prescription issued in 1945 or 1946. Toward the last he was consuming large quantities of the sleeping pills and the coroner reported barbiturates in the brain tissue. The druggist used a prescription as justification for the sales, but did not contact the doctor about refilling it. The judge who tried the case said it was an aggravated one since a death had resulted from the careless handling of drugs. The penalty was $1,000 and 1 year probation.
The bill before you would require either written or oral authorization from physicians for the original filling or the refilling of prescriptions for habit-forming drugs, drugs which cannot be used safely and effectively by the layman without medical supervision, and new drugs where, for these reasons, the effective application filed under section 505 of the act limits the sale of the drug to prescription use.
Perhaps the most controversial feature of the bill involves the provision that the Administrator of the Federal Security Agency shall