the adoption of nonproprietary names. The objectives of this program are to facilitate the selection of suitable nonproprietary names for drugs and to encourage the use of such names wherever indicated in labeling, in advertising, as titles in the official compendia, and in the sicentific literature. The new program represents a dovetailing of the nomenclature interest of the AMA and the U.S. Pharamacopoeia. Briefly, it consists of the modification of the nonmenclature committee of the council on drugs. The joint AMA-USP Nomenclature Committee consists of two members appointed by the AMA and two members by the USP and is staffed by the AMA. It is the responsibility of the committee, after consultation with FDA and after working and negotiating with the pharmaceutical manufacturer, to designate the nonproprietary drug name which will then be adopted by both organizations; that is to say, the AMA and the U.S. Pharmacopoeia. In the event that a decision cannot be reached between this joint committee and the manufacturer as to the nonproprietary name to be assigned, either the commitee or the manufacturer may take the matter to a nomenclature review board, appointed by the USP, which will determine the merits of the controversy and make the final decision as to the name.

In addition to facilitating the adoption of nonproprietary names, the new program should result in a faster and much wider dissemination of the newly adopted nonproprietary names of drugs. As in the past, all interested cooperating agencies throughout the world will be consulted for their comments.

The USP will adopt the name so selected as the USP title, when and if the drug concerned is admitted to the USP, and will also undertake to publish lists of the names at frequent intervals. The AMA and the USP will organize a concerted campaign to acquaint the editors of all medical and pharmaceutical journals of the availability of nonproprietary names for all drugs that are likely to be the subject of published articles.

The American Medical Association believes that the system of adopting nonproprietary or generic names for drugs has been reasonably effective in the past, and that the new joint nomenclature committee will make it even more effective and expeditious in the future. Further, the close cooperation of the AMA and USP in this program will greatly increase the use of such names and eliminate any confusion or possibility of confusion that may exist at present.

In summary on this point, we believe that the problems which remain in the field of drug nomenclature can and should be solved by the profession itself. Physicians will adopt and use nonproprietary names for drugs only when they are convinced that the use of such names will facilitate and improve their practice of medicine. We believe that the programs I have described will be most convincing to them. We do not believe that the suggested legislative alternatives will.

I would now like to direct my comments to other provisions of S. 1552 which cause us serious concern. They are those parts of section 4 of the bill which would grant to the Food and Drug Administration the authority to determine, evaluate, and pass on the efficacy of new drugs. In the same vein, we are concerned with part (b) of section 3 of the bill, dealing with patent law

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amendments, which would give the Secretary of Health, Education, and Welfare the authority to determine whether the therapeutic effect of a drug modification or combination is "significantly greater" than that of the drug so modified. Under this latter authority, a patent could not be issued for the drug until the Secretary had determined that the therapeutic effect was significantly greater.

Our concern with these sections of the bill stems from many sources. As we understand them, they are intended to reduce the number of drug products on the market and to prevent a nonefficacious drug from ever reaching the market. Although physicians do not want useless drugs cluttering up the practice of medicine and although it is difficult for physicians to become familiar with all of the drugs which have become available during the past two or three decades, we are convinced that the Food and Drug Administration cannot solve these problems for us. I would like, now, to discuss the basis for this conviction.

The first item to consider is the possibility of useless drugs appearing on the market because the Food and Drug Administration does not now have the authority to stop their production and distribution. In discussing this matter, it is well to remember that we are talking about products which will be consumed only if they are prescribed by a physician. Hence, his training and experience, his continually expanding knowledge of drug therapy, and his professional responsiblility to his patient, act as powerful barriers to the sale of useless drugs. Secondary barriers exist in the adverse economic results which would generally follow for a pharmaceutical manufacturer who attempted to market a useless prescription drug.

A second and more important reason for our concern over these parts of section 4 of the bill arises out of an understandable but nevertheless extremely important misconception on the part of many of the term "efficacy" as this term is used in medicine. Physicians seek to treat effectively the medical problems of individual patients. A physician does not treat 10 cases of hypertension, he treats 10 individual patients, each of whom has a medical problem he has diagnosed as hypertension. This difference becomes especially important when he elects to use drug therapy in the treatment of these 10 individual patients. He may find that the same dosage of the same form of the same drug will be efficacious in each and all of his 10 patients. Or he may find that one or more of them need different dosages, or different forms of this same drug. He may, indeed, find that one, two or three of them are allergic to the nonactive ingredients used in a brand of the drug and that a different brand, with other nonactive ingredients, is the efficacious answer. Thus, in one patient, a specific dosage of a specific drug might be said to be efficacious. While in another, it would be described as totally ineffective.

The point I am making is this. A drug's efficacy varies from patient to patient, sometimes for known reasons such as allergy, and at other times for unknown reasons. Hence, any judgment concerning this factor can only be made by the individual physician who is using the drug to treat an individual patient. A physician can be told many things about a drug, including its chemistry, its mode of action and, to some extent, its toxic properties. But he must judge

its efficacy. If this precise usage of the word "efficacy" is kept in mind, the consideration of legislation which would request that an administrative agency of Government determine the efficacy of drugs can proceed more fruitfully.

Unfortunately, even we physicians use the word "efficacy" in a different context when we compare drugs and when we compare drug therapy to other forms of treatment. It is not unusual for clinical investigators to say that drug X is more effective than drug Y in the treatment of a disease or that drug Z is ineffective. And in most instances they leave out the intended qualifying phrase "on the average" or "in general." Within the medical profession this omission is not critical since every physician understands its implication. But in discussing the legislation under consideration, these qualifying phrases are extremely important. A drug which is, on the average, less efficacious than another, must still be available to every physician since it may be completely efficacious in treating the medical problems of one of his patients. We do not practice medicine on the averagewe seek to solve or alleviate the problems of each and every patient.

These considerations, then, are the basis for our concern with those parts of section 4 of the proposed bill which would grant to the Food and Drug Administration the authority to determine, evaluate, and pass on the efficacy of drugs.

We realize that the literal effect of the proposed amendments to the Food and Drug Act would be to give the FDA the power to evaluate the efficacy of a new drug only in light of its efficaciousness in use under conditions prescribed, recommended, or suggested in the labeling. We are concerned with this apparently limited grant of authority and with the very distinct possibility that, by granting a governmental agency the statutory authority to pass on the efficacy of a new drug, Congress will be enabling that agency through administrative interpretation of the law to decide the relative or comparative efficacy of a new drug in terms of drugs already on the market. We are apprehensive that the Food and Drug Administration would, under these amendments to the act, decide that it had the authority to refuse to allow a drug to be marketed merely because it was, in their opinion, not the most efficacious drug for the purpose intended or was not as efficacious as one might ideally wish.

A physician is trained during his many years in medical school, internship, and residency, and continuously learns after he enters into the practice of medicine, to use his professional judgment in determining what particular drug is best for a particular patient suffering from a particular disease or condition. We believe that only the physician has the knowledge, ability, and the responsibility to make that decision in regard to that particular patient and that he should not be deprived of the use of drugs that he believes are medically indicated for his patient by a governmental ruling or decision. This would be the resulting situation, in our opinion, if these proposed amendments were enacted into law. Medical history and experience clearly demonstrate that the only possible final determination as to the efficacy and ultimate use of a drug is the extensive clinical use of that drug by large numbers of the medical profession over a long period of time.

It is frequently impossible for any person or groups of experts or a governmental agency to determine beforehand that a drug is going to be efficacious or nonefficacious for a particular condition, or that a drug will be of no benefit in the treatment of other diseases and conditions. The history of medicine and pharmacology clearly indicates that only by extensive clinical experience in depth and wide usage can the true efficacy of a drug for the treatment of a particular condition be established. Moreover, and equally important, we know that many of the drugs we use today in treating particular conditions. were never originally intended for such use and it was only through trial that the value of these drugs was discovered.

Even with the vast information resources at the disposal of the AMA we realize that the patient's physician must still be free to decide which drug will be most effective in the treatment of his medical problem. It is for these reasons that the House of Delegates of the American Medical Association at its meeting in New York City just a week ago voiced its strong and unanimous opposition to the provisions of this legislation which would amend the Food, Drug, and Cosmetic Act to authorize the Food and Drug Administration to determine the efficacy, as well as safety, of a prescription drug prior to the approval of the new drug application.

The report of the Board of trustees, which was approved by the house of delegates stated, in part:

This position is based on the conviction that a decision with respect to the effectiveness of drugs is dependent upon extended research, experimentation, and usage. The medical knowledge which is necessary for a continuing opinion on the effectiveness of drugs would not be available to the Food and Drug Administration in arriving at a decision as to the effectiveness of a new drug if such decision had to be made at the time of the introduction and only on the basis of limited clinical testing. An important inherent danger in the unilaterial determination of efficacy by Government is the prevention of the manufacture and marketing of a drug, the efficacy of which might later be determined to be significant.

The vesting of the authority suggested by this legislation in the Food and Drug Administration would operate to limit research, the marketing of drugs, and the exercise of discretion by the medical profession.

The marketing of a relatively useless drug is infinitely less serious than would be arbitrary exclusion from the market of a drug that might have been life saving for many persons.

Medicine is both a science and an art. Many of medicine's greatest discoveries have been made only after extensive clinical experience with a great number of physicians treating a great number of patients. As applied to drugs, we do not believe that a governmental authority, or any other authority, can act as an arbiter in deciding beforehand which drugs are going to be effective in a particular situation. Nor can it decide which drugs, with apparently little efficacy for a prescribed condition, will be found from experience to be highly valuable in the treatment of another, possibly totally unrelated, disease.

It is this aspect of medicine, that leads the American Medical Association to oppose, those sections of S. 1552 which would grant to the Food and Drug Administration the authority to determine, evaluate, and pass on a drug's efficacy and thus determine beforehand that a drug should not be marketed.

We will now be pleased to attempt to answer any questions that the committee may have.

(The exhibits referred to follow:)

EXHIBIT A

PROPOSED AMA DRUG INFORMATION PROGRAM

The board of trustees at its meeting on May 27-28, 1961, voted to adopt and implement the following program, which has been proposed to provide an effective plan for the AMA to bring to the physician complete and current information and sound considered opinion about drugs:

I. DRUGS EVALUATED BY THE COUNCIL ON DRUGS

A. Detailed, descriptive statements about new single-entity drugs, and other drugs evaluated by the council according to existing policies, similar in content to the current full council monographs, will be pubished in J.A.M.A. as soon as practicable after a drug first becomes available commercially. These will be called preliminary statements.

B. Additional information, as it becomes available following the preliminary statements on new drugs, will be published in J.A.M.A. in the Council on Drugs' column, "New Drugs and Developments in Therapeutics.”

C. Based on the preliminary statements, subsequent statements in the council column, and other information becoming available during the first several months of commercial sales of the product, a monograph will be prepared for N.N.D.

D. All new material in N.N.D., whether complete monographs or changes in older monographs in light of accumulated knowledge, will be clearly identified as such.

E. No specific time limit would be placed on drugs to be included in N.N.D. but rather decisions would be made by the council based on such factors as the drug's importance to medicine, frequency of use (sales volume), commercial promotion on the drug, and the availability and other compendia of adequate descriptions of the drug's therapeutic value.

F. Each monograph appearing in J.A.M.A. or N.N.D. will be prefaced by a summary of the council opinion, whenever possible, incorporating comparisons with older similar drugs.

G. To expedite publication of essential information on new drugs and new developments in therapy, the Department of Drugs will be responsible for providing copy, monographs, or council comment, acceptable to the editor of J.A.M.A. advising the editor 5 weeks in advance of the space needed (averaging 3 to 4 pages) and providing final, clean copy 2 weeks prior to publication date. H. Wherever possible, statements on any drug will provide references to previous statements in J.A.M.A. and N.N.D. Quarterly indexes to all council statements will be published in the council column in J.A.M.A. Ways will be explored to provide easy identification of the council space in J.A.M.A., such as the use of heavier stock, with prepunched holes for insertion in ring binders.

I. Reprints of council statements will be available on request on an individual or standing order basis.

J. Publication of special reports to the council, timely review articles in areas of therapeutics of current interest, and the annual therapeutic number of J.A.M.A. will be continued.

K. With the introduction of means to clearly indicate new monographs and changes in monographs which have appeared in earlier editions, as well as modifications in type style to make the volume easier to read, better promotion techniques would be introduced to increase the sales and use of N.N.D. It is not anticipated that this could be accomplished before the 1963 edition.

II. NEW PUBLICATION

A. The AMA will publish and distribute to all physicians an annual hard-cover volume, patterned after "Useful Drugs."

B. Basic material for this volume will be authoritative summary statements on drugs evaluated by the Council on Drugs, or appearing in USP or NF, indicating the chemical and physical properties, as well as the actions, the uses, and dosages of the drugs. While this material is being developed, the council should take action to include other sections to make this a volume more useful