tion in the future, to depart from the relatively close supervision and regulation that was required by the law at the time they issued this report.

Mr. LARRICK. I believe that close supervision is desirable.

Dr. GOLDBERG. Can you foresee any time or any set of circumstances under which it would be practical and realistic for FDA to relax its close supervision of industry activities relating to the safety and the efficacy of drugs!

Mr. LARRICK. No.

Dr. GOLDBERG. Just one further question. How does FDA distinguish between new drugs and drugs that are not classified as "new"! We have been talking about new drugs. I think that for many of us there is an area of uncertainty in this respect.

Mr. GOODRICH. We have to operate under the statutory definition of a "new drug" as any substance not generally recognized among qualified experts as being safe and effective for its intended uses. This was the only practical guideline that we could agree on when we went to House Interstate and Foreign Commerce about this new law. They were desirous to have a better definition of a "new drug," and we would like to have a better definition. But the only alternative seems to be to either let us arbitrarily say this is new or not new, or to adopt an objective standard of this kind and enforce it.

We have been very successful in applying this definition. It doesn't mean something brand new. It means an article that is not generally agreed upon by all experts as being safe and effective. If there is a difference of opinion about it, then it is a new drug.

So we have been able to work with this definition without any real problem. And the same thing carries for food additives and other

areas.

Dr. GOLDBERG. Do you have a process of continuous review by which new drugs become old at various points!

Mr. GOODRICH. Yes. This is a new drug status branch that Mr. Larrick mentioned. This was an operation in the past that was handled both in the Bureau of Enforcement and in the Bureau of Medicine. We have now tried to organize the status branch so we will have a uniform policy.

Mr. FOUNTAIN. I have some other questions, but I think most of them can wait, Mr. Larrick, until we have you back at some later date. However, I have one with which I shall close.

You mentioned a number of ways in which FDA has been upgraded scientifically. I would like to ask if you have other plans along these lines.

Mr. LARRICK. Yes. By "upgrading" I don't mean that we don't have fine, perfectly competent scientists now. But we have the support of the Secretary and his staff in appointing these people that I have discussed. Hopefully, that will bring some new scientific outlook to FDA. The new medical director has spoken at length of his hope to get our scientific personnel who are within his bailiwick appointed to positions on the faculties of the universities in the area and to participate in some of the activities that will keep them right up to date in the areas of the judgments that they have to make.

We have the prospect of moving into what I believe will be the finest food and drug laboratory building in the world about next Febru

ary. The building is essentially completed. I think that is going to do a very great deal to stimulate the morale of our people.

As I said, Congress has been kind to us. We have now the most up-to-date, modern laboratory apparatus, whereas 10 years ago we did not.

We have 18 field laboratories throughout the United States, and Congress has given us the money so that we have rebuilt 13 of them completely from stem to stern. We have assurances that the remaining dilapidated buildings will be completely replaced.

We think those things are going to operate to open up some new vistas for the scientists in the Food and Drug Administration and permit us to do our job better than we have in the past.

Mr. FOUNTAIN. Thank you very much, Mr. Larrick.

We appreciate your coming and bringing your colleagues with you. You have been most helpful. Your statement today was a very fine and full statement. I know you would like to elaborate more, and we would like to have more time to ask questions which would give you that opportunity. But I think maybe we have touched upon those things which are of greatest importance at this time in laying the background for the record.

I would like to say that if there are other comments you may care to make, or some supplementary answers you want to give to any of the questions which we have posed today, we would be delighted to include them in the record.

Mr. LARRICK. May I thank you, Mr. Chairman. May I say that your unfailing courtesy is most appreciated, and the penetrating questions that you and your staff have asked are very promotive of self-interest.

Mr. FOUNTAIN. Thank you very much. The hearings on drug safety will continue in the morning at 9:30 here in this same room. At that time testimony will be taken from Dr. Hugh H. Hussey and associates representing the American Medical Association; Dr. William S. Apple, representing the American Pharmaceutical Associa tion. Dr. Austin Smith, president of the Pharmaceutical Manufac turers Association, who was scheduled to appear tomorrow will testify at a later date.

The committee stands in recess until tomorrow at 9:30 a.m.

(Whereupon, at 3:55 p.m., the subcommittee was recessed, to reconvene at 9:30 a.m., Wednesday, March 25, 1964.)

37-272-64-pt. 1—15

DRUG SAFETY

(Part 1)

WEDNESDAY, MARCH 25, 1964

HOUSE OF REPRESENTATIVES,

INTERGOVERNMENTAL RELATIONS SUBCOMMITTER

OF THE COMMITTEE ON GOVERNMENT OPERATIONS,

Washington, D.C. The subcommittee met at 9:30 a.m., pursuant to recess, in room 1310, Longworth Office Building, Hon. LH. Fountain (chairman of the subcommittee) presiding.

Present: Representatives L. H. Fountain, Florence P. Dwyer, and Bill Stinson.

Professional staff present: Dr. D. C. Goldberg and W. Donald Gray. Mr. FOUNTAIN. The subcommittee will come to order.

Let the record show that a quorum is present.

I will not repeat my opening statement of yesterday, but I will quote a portion of it dealing with the purpose of these hearings for the benefit of any members of the press or others who were not here.

We all know that while the Food and Drug Administration has the legal responsibility for approving or disapproving applications for the marketing of new drugs, others, including the medical profession and the manufacturers of drugs, are also intimately involved in assuring the safety of drugs.

Accordingly, we have invited representatives of the American Medical Association and others to participate in these hearings.

It is my hope that the subcommittee's hearings will provide an opportunity for open and frank discussion of the problems and the prospects of assuring the safety of drugs and thereby contribute to a better public understanding of this important subject.

Our first witness this morning is Dr. Hugh H. Hussey, director of the Division of Scientific Activities of the American Medical Association.

Dr. Hussey, we are delighted to have you with us. I understand you are accompanied by Mr. Paul Donelan, a member of your legal staff.

Would both of you come to the table!

I understand you have a prepared statement.

STATEMENT OF HUGH H. HUSSEY, M.D., DIRECTOR, DIVISION OF SCIENTIFIC ACTIVITIES, AMERICAN MEDICAL ASSOCIATION; ACCOMPANIED BY PAUL R. M. DONELAN, ATTORNEY, LEGISLATIVE DEPARTMENT

Dr. HUSSEY. Yes. Thank you, Mr. Chairman.

Mr. FOUNTAIN. Will you give a brief biographical sketch of yourself and your colleague?

221

Dr. HUSSEY. My background is one in medical practice originally, with part-time teaching at Georgetown University. Later I became a full-time teacher and professor of medicine at that school and finally dean at Georgetown just before coming to the present position that I hold with the AMA. I came to this full-time work with the AMA about 1 year ago.

Mr. Donelan had better give you his own biographical sketch.

Mr. DONELAN. I am a graduate of Georgetown University Law School. I worked as secretary to a Congressman from 1949 to 1955. I have been with the American Medical Association in a legislative capacity since 1955.

Mr. FOUNTAIN. Thank you very much.

You may proceed, Dr. Hussey.

Dr. HUSSEY. Mr. Chairman and members of the subcommittee, you will recall, Mr. Chairman, that in your letter you asked for the association's comments on the appropriate roles of the FDA, the AMA the individual researcher, and the clinician in insuring the safety of drugs. We hope the information we bring to you today will be helpful to you and the subcommittee in your deliberations.

DRUG SAFETY IN THE PUBLIC INTEREST

The American Medical Association strongly believes that the investigation of new drugs and the surveillance of marketed drugs are most important to the ultimate health of the people of this country. We further believe that the medical profession and the pharmaceutical industry have established an outstanding record in the discovery, exploitation, and use of life-saving, health-saving, and pain-relieving drugs. The benefit to our people from these developments has been so great, particularly over the last two decades, in terms of reduced mortality and the increased control of numerous diseases that it is difficult to speculate what the state of our Nation's health would be without them. For example, 70 percent of the prescriptions written by physicians in 1960 could not have been written in 1950 simply because these medicines had not been discovered or were not available at that time.

We recognize the appropriate goal of Government in protecting the public welfare; at the same time, freedom of scientific research is necessary for the advancement of the Nation's health. The Food and Drug Administration has been charged by the Congress with the serious responsibility of seeing that only "safe" drugs are allowed to be marketed. (The word "safe" as applied to drugs is, of course, relative, since there is no such thing as an absolutely safe drug.) This is a most desirable goal and one which has been supported by the American Medical Association.

However, we are equally aware of the nature of and responsibilities involved in the research, development, and marketing of drugs. If advancements are to be made, these important activities, particularly research, cannot be stereotyped.

It is, therefore, important to insure that creativity is not harmed by the standardization of procedures, through unnecessary and overly burdensome governmental regulation and supervision. Thus, in the best interests of the health care of the American people, consideration

must be given to the work, the practic. 1 problems, and the accomplishments of drug investigators and the pharmaceutical industry, as well as to the responsibilities of the Food and Drug Administration.

The AMA does not want, and we are sure that no one in the Government, in the pharmaceutical industry, or in the scientific professions involved, wants to see a single individual injured by an unsafe drug. We are equally sure these same groups would oppose anything which would delay or prevent the development of life-saving and healthsaving drugs.

AMA'S ATTITUDE TO FDA

The purpose of the American Medical Association is to promote the art and science of medicine and the betterment of the public health. Our concern and responsibility for the betterment of the public health places us in a common role, in many instances, with FDA, since that agency has been charged by Congress to protect the consumer and to guarantee the purity and quality of drugs and devices.

As early as 1891, the American Medical Association supported the enactment of a Federal food and drug law. In 1905, we engaged in intensive legislative efforts to have such a law enacted and, as you know, the first Federal pure food and drug law was enacted in 1906. In 1933, the American Medical Association, realizing that the existing act had certain deficiencies, urged the enactment of an effective national food and drug law for the protection of the consumer.

The AMA was instrumental in the passage of the present Federal Food, Drug, and Cosmetic Act in 1938. In 1951, we supported the Durham-Humphrey amendment. During the 86th Congress, the AMA was one of the chief sponsors and supporters of the Hazardous Substances Labeling Act, which is administered by the Food and Drug Administration.

Over the years, the American Medical Association has enjoyed a relationship with the FDA which has provided for an exchange of information. In some areas of our mutual work, the cooperation extended by both parties has led to fruitful results. Our Department of Investigation has, with FDA, developed important information on quackery as well as on medicines and devices of questionable value. In October 1961, the AMA and FDA jointly sponsored the first National Congress on Medical Quackery, which was the beginning of a concerted, cooperative drive against practitioners of pseudo-medicine who milk the public of millions annually. A second National Congress on Medical Quackery, again jointly sponsored by AMA and FDA, was held in October 1963. And the AMA Council on Foods and Nutrition is also most active in working with FDA in sponsoring an aggressive program against food faddism and food and vitamin quackery.

The AMA has always been well aware of the extensive and serious responsibilities placed on the FDA by the Congress. FDA's duty of protecting the consumer against adulterated and misbranded foods, drugs, devices, and cosmetics, and its responsibilities involving pesticides, food additives, and new drugs are, indeed, a very difficult assignment in view of the tens of thousands of producers of these arti cles in this country and the millions of dollars involved. The American Medical Association applauds the FDA for many of the things which it has done.