and consumers groups should be invited to attend. One could object that many of the individuals to be invited would be those very same persons who have already appeared at the current Hearings (and their precursors), or have already aired their views in print. But my point is that they have not been in a conference all together and confronted with the same well-structured agenda and directives.

Pre-conference working papers would be prepared, and other relevant published and unpublished information provided in advance. Working groups in various areas would allow for an intimate exchange of views, and plenary sessions would provide an opportunity for general discussion and reports from the working groups. The operational mechanics of such conferences are well known, and models have long been established in the medical-scientific area. It is too much to hope that perfect agreement will be reached, but the published record and summary of such a conference, with statements of areas of agreement and of majority and minority (or pro and cun) positions in areas of controversy, would put into the hands of the public and of the Congress the necessary expert information required for the decision as to the best possible Food and Drug laws.

Summary

1.

2.

The FDA should be given authority by law to determine whether the claims made

for the therapeutic efficacy of a new drug are adequately supported by the

evidence submitted by the manufacturer.

The FDA must be given increased funds to permit it to employ an adequate

number of high-level scientists and physicians, to insure that it can properly perform its expanded duties.

3. Panels of expert extramural consultants should be appointed by some nongovernmental organization to assist the FDA in determining whether a new

drug is safe under conditions of recommended use and whether the therapeutic claims made for it are valid. The panel membership and certain of its de

cisions should be a matter of public record.

4. In our current state of knowledge, the problems in the determination of superior therapeutic efficacy of congeneric drugs are so difficult and so complex that it may prove almost impossible to carry out this section of the proposed legislation.

5.

6.

The difficulties in assignment of generic names of drugs will not be solved by requiring the Secretary of HEW to perform the task.

The suggestion has been made that, in addition to these Hearings at which interested parties express their views separately, a conference be called to permit a free exchange of opinions with regard to drug laws which will be in the very best interest of the health and welfare of the public.

I thank you for your patience in listening to this over-long recital, and trust that some of my comments may be of help to you in your deliberations.

I am Dr. David P. Barr, President and Medical Director of the Health urance Plan of Greater New York, formerly Professor of Medicine at nell University Medical College and Physician-in-Chief at the New k Hospital.

Drugs in great variety are now necessary for the preservation and toration of health. It is imperative that they be available to all n required. We may confidently expect discovery and introduction of ever-increasing number of other drugs that will be useful or essential

occasion.

Proposed legislation should be aimed to prevent unnecesily high costs of drugs and the introduction of useless or dangerous

gs.

At the same time it should be so devised as to avoid any obstruc

n to the acceptance of useful new remedies.

Senator Kefauver in his opening remarks at this hearing presented arly some of the present inadequacies of drug manufacture and distriion. The situation leaves much to be desired.

Prices of ethical drugs are generally unreasonable and excessive. ravagance in advertising and promotion is the custom of all manufac

turers that can afford it.

Manufacturers may introduce drugs before their efficacy is established and may even withhold full information of possible toxic reactions. Preparations representing mixtures or slight modifications of existing remedies are being offered before their utility is demonstrated.

Generic names proposed by the American Medical Association and the U.S. Pharmacopeia are not official and are often not accepted by drug Nomenclature of drugs has become too confusing for the

manufacturers.

practitioner to assimilate.

There is a carefully nurtured suspicion

that drugs presented under generic names may be inferior in quality. The use of brand names instead of generic names for drugs greatly increases the cost to the consumer.

The hard-worked and conscientious practitioner is bombarded by litersture and besieged by detail men distributing free samples and extolling the virtues of incompletely described drugs. Package inserts now required by law are not being sent to the physician and the advertising of most drugs does not include this information. Usually the busy doctor has neither the time nor the experience to explore the true nature of the drug or the validity of the claims advanced by the manufacturer. In his confusion and because of doubts of drugs prepared to sell under official or generic names, he often orders the drugs described by detail men and enthusiastic advertisements.

The possible harm that drugs may cause receives too little considerstion. It is not always realized that no drug possessing activity in the modification of the internal environment of the body can be used without hazard; that the harmful effects may not be immediately apparent; cr that a drug which is ineffective therapeutically may possess toxic properties

which may add to the already appalling risks encountered in the use of drugs now available.

This unsatisfactory state of affairs is continuing in spite of the intent of the present laws, the efforts of the Federal Food and Drug Administration, and the admirable program of education conducted by the American Medical Association. In spite of all existing measures and

efforts, bad practices and abuses continue and increase.

It is obvious to all that reform is necessary to safeguard the availability of essential remedies at prices which people can afford, to prevent the introduction of useless remedies as well as those that possess toxic reactions, and at the same time assure the prompt introduction of new remedies that are useful or necessary.

Personally I am eagerly interested in the proposed legislation for a variety of reasons.

As a physician I am keenly aware of the economic problems of patients of moderate income in purchasing necessary drugs. As an officer in a nonprofit health insurance plan I am interested in the economic protection as well as the health of more than 600,000 persons in the New York area. The Health Insurance Plan of Greater New York, which has been in operation nearly fifteen years, was set up to offer comprehensive, continuing medical care in home, office, and hospital on payment of a single premium. It offers medical, surgical, and specialist care as well as x-ray and laboratory services but has never included the cost of drugs.

When the Plan was founded, this omission seemed not too important, for the expense of drugs constituted a relatively small part of the total cost of medical care. With the constantly increasing number and cost of necessary drugs, this item can no longer be ignored and it is apparent

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