Page images
PDF
EPUB

legislative activities with a close and continuing relationship with the Food and Drug Administration. Our Council on Drugs, over the years, has had a number of members from the FDA, and numerous other Government physicians and pharmacologists have served as consultants to the council in its drug evaluation program. Our department of investigation has enjoyed a longstanding close relationship with FDA in developing information on quackery and medicines and devices of questionable value.

At the present time, the AMA and the FDA are formulating final plans to act as cosponsors of a National Congress on Medical Quackery, to be held in Washington, D.C., on October 6–7 of this year.

Our committee on cosmetics and the former committee on toxicology have also worked closely with FDA over the years, most recently concerning the above-mentioned Hazardous Substances Labeling Act. The Council on Foods and Nutrition is most active in exchanging information with FDA and in cooperating with it, the Federal Trade Commission, and the U.S. Post Office in sponsoring an aggressive campaign against food fadism and food and vitamin quackery.

With this record of AMA support and cooperation in food and drug matters as background information, I would like to comment on those sections of S. 1552 which concern us directly as physicians and which will directly affect the practice of medicine and the public health.

Section 4, part (7) of the bill provides that a drug manufacturer must include with any drug information transmitted to physicians (a) a copy of all printed matter, which the Secretary of HĚW has required to be included in any package in which the drug is distributed, and (6) in the case of a new drug, a complete statement of all findings of fact made by the Secretary with respect to that drug.

The manufacturer must include in all advertisements and other printed matter issued, including those in medical journals, (a) the official name in addition to the brand name, (b) warnings, prefaced with the approval of the Secretary, as to any dangerous or harmful property of the drug, (c) a full and correct statement of the drug's efficacy.

Section 4, part (13), proposes among other things that a new section 510 be added to the Federal Food, Drug, and Cosmetic Act, which section would direct the Secretary of HÈW to compile, publish, and distribute to physicians, annually and at such other times as he deems necessary or desirable, a list of drugs which have the potentiality of serious, dangerous, or harmful effects, and would also require the Secretary to publish and distribute to physicians and others copies of all printed matter which he has required to be included in any package in which any drug is distributed or sold.

Before commenting on these proposals, let me cite the aims we, as physicians, are desirous of achieving.

We want all physicians to be well trained and fully informed on all aspects of the practice of medicine.

We want this body of knowledge and reservoir of skills to include a high degree of competency in the selection and proper use of drugs.

We want a continuing and expanding flow of usful drug products placed at the disposal of these physicians.

[ocr errors]

a

These are some of the aims we seek and which we have diligently pursued for more than a century. And since the American people now enjoy the finest medical care in the world, we believe the aims have been effectively pursued.

There is still room for improvement. Physicians can be better trained and even better informed.

The improvement of existing drugs and the search for new ones can be accelerated and the quest must continue for the means by which even better medical care can be made available to more and more people.

As I have pointed out in the first part of this statement, the American Medical Association has never hesitated to sponsor or endorse Federal legislation in the health field when our experience as physicians indicated that such legislation is necessary. On the other hand, we recognize that there are problems in the health field which are not by their very nature susceptible of solution by means of legislation. We believe that in these instances the profession can and should utilize other techniques and resources not at the disposal of the Federal Government. În this vein, let me review the activities of the AMA in supplying information to physicians on drugs, their uses, dosage forms, side effects, and hazards.

Our council on drugs was founded in 1905 as the council on pharmacy and chemistry, and has since that time borne well its responsibility of informing physicians concerning drugs. The general purposes of the council are stated in the current edition of one of its publications, “New and Non-Official Drugs," formerly known as “New and NonOfficial Remedies," as follows:

The function of the council on drugs is to examine and evaluate available evidence relating to the actions, uses and dosage, hazards and other pertinent properties of drugs and to encourage rational therapeutics by timely, informative reports to the medical profession.

The council, through the years, has informed the medical profession of its evaluations of drugs by publishing complete monographs on individual drugs in the Journal of the American Medical Association, which goes to every member of the association and thus to virtually every practicing physician. It has also published annually, since 1906, the previously mentioned “New and Non-Official Drugs," a graphs and other pertinent drug information. Recently, the association's board of trustees approved a greatly expanded drug information program, the purpose of which is to bring to physicians even more complete information and sound, considered opinions on drugs as currently, expeditiously, and scentifically as possible.

The American Medical Association's expanded drug information program will include

(1) Submission by pharmaceutical manufacturers, to the AMA, of copies of their pharmacologic, toxicologic, and clinical data submitted at the time of a new drug application to the FDA and as they become available thereafter.

(2) Analysis by the AMA of these and other data submitted. The council will, after the FDA allows a new drug application to become effective, publish a preliminary statement containing informative material for the physician. The statement will be published in the weekly Journal of the American Medical Association in the section specifically devoted to that purpose. The AMA will continue to keep posted on all developments concerning drugs previously reported and will report this information in the Journal in a column, “New Drugs and Developments in Therapeutics.”

(3) The preliminary statements on drugs, the subsequent statements of information published in the Journal, and other information becoming available during the first several months of general use of the drug, will be combined into an extensive monograph to be included in “New and Non-Official Drugs." The drug monographs in “New and Non-Official Drugs,” which is a hard-cover textbook, provides the following information to the physician: chemical or biological identity, including pertinent properties; actions and uses, associated side effects, toxicity, and precautions; and dosage and routes of administration.

(4) The publication annually of a new handbook on drugs entitled "AMA Handbook on Drugs." The handbook will include evaluated information taken from the Journal and elsewhere and will cover single-entity drugs and drug mixtures identified under class headings. The handbook will contain a digest of essential information designed to inform the physician on: (1) the nonproprietary and the trade name or trade names of the drug; (2) the name of the manufacturer or manufacturers; (3) a quantitative statement of composition by generic name or names; (4) the claimed indications for the drug; (5) the stated contraindications, side effects, and precautions; (6) the manufacturer's recommended dosage; (7) the available dosage forms; and (8) an overall appraisal of the drug. This handbook will be kept current by the publication and distribution of quarterly supplements and the weekly reports published in the Journal. A more detailed description of the AMA drug information program is attached to this statement (exhibit A).

Senator KEFAUVER. That will be printed following your statement. Dr. Hussey. Thank you, sir.

The program is being implemented at present and will be completely operational by 1963. In addition to the publications now furnished to physicians, the new drug handbook and quarterly supplements will be distributed to all members and will also be available to nonmembers.

In addition to this program, the AMA has recently undertaken participation in a drug standards laboratory located in Washington, D.C., at the headquarters of the American Pharmaceutical Association. The laboratory will expand the development and checking of specifications for new drugs and will assist in publishing reports on them. It will assist in checking stability and purity, and will launch new studies of general drug characterization and identification. Problems of standardization will be explored and new methods of analysis will be developed.

This program, formally approved in May, is supported financially by the American Pharmaceutical Association, the U.S. Pharmacopoeia, and the AMA, and is directed by a joint committee of the participating groups.

We believe that the continuing education of physicians is the primary, responsibility and prerogative of the profession itself and associated groups. We are now participating with the Association of American Medical Colleges, the American College of Physicians, the American College of Surgeons, the American Academy of General Practice, and others in a project designed to expand and improve postgraduate educational facilities and programs. This important activity, together with the expanded drug information program, should insure the dissemination to the practicing physician of complete, objective, and authoritative information on new drugs when they are first introduced, and up-to-date information on all significant developments in drug therapeutics.

In summary on this point, we believe the information programs designed and administered by the medical profession itself will continue to be effective to that end and that the passage of a law for this purpose will be less effective.

I would next like to comment on that section of part (13), section 4, of the bill entitled “Review of Official Names of Drugs.” This section, among other things, would add a new section 509 to the Federal Food, Drug, and Cosmetic Act. It would give the Secretary of HEW the authority to determine the official name of any drug, which would be the only official name of a drug that could be used in an official compendium. The Secretary would also be given the authority to review periodically all official names of drugs to determine whether any revision of those names is necessary.

For many years the AMA has played a leading role in the adoption of a drug's nonproprietary (official) name.

Senator KEFAUVER. Excuse the interruption, but when you are talking about "nonproprietary " or "official," you mean generic?

Dr. Hussey. I am, sir. I had the "official” in parenthesis only to indicate that in the use of the term "nonproprietary” I intended the same meaning. Actually a name of a drug, when nonproprietary, may not be official in the sense of having a stamp of approval from a Government agency.

Senator KEFAUVER. To avoid confusion, you are referring there to so-called generic names?

Dr. Hussey. Yes, sir. The procedure was explained in some detail—the procedure of adopting nonproprietary names was explained in some detail in our recent correspondence with the committee and is repeated in exhibit B attached to this statement. I will not repeat the lengthy explanation included in the exhibit, but for the benefit of the committee members I will summarize briefly the present procedure.

Simultaneously with the early development of a new drug, consideration of a nonproprietary name is begun. It is the policy of the AMA that the early adoption of a nonproprietary name should be encouraged to facilitate understanding of the properties and proper usage of the drug. It is also our policy that the nonproprietary or generic name should be as simple as possible and that chemically related drugs, used within a given therapeutic area, should preserve some relationship in their nonproprietary names.

In order to improve and streamline the naming process, the AMA and the U.S. Pharmacopoeia recently formulated a joint program for 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

73753-61-pt. 1

« PreviousContinue »