Dr. LEE. There are no centers, per se, being developed under this program. This is to extend and improve cooperation, but it does not physically create any new centers.

Mr. SPRINGER. Yes, I am familiar with this, but you are going to have a place which is going to be the center of this. I think we are talking in the same language. You are talking in terms of regions with the center in one place, aren't you?

Dr. LEE. The regions involve cooperation between multiple institutions.

In some cases, there may be a single medical school, that is the center, for example, of a continuing education program. But the development of better care for patients will involve hopefully all of the hospitals within that region that cooperate in the program.

Mr. ROGERS. Would the gentleman yield?

Mr. SPRINGER. Yes, I will yield.

Mr. ROGERS. In Florida as we have the University Medical School, University of Florida, this probably would polarize with the hospitals in that area. Then the University of Miami has another medical school and would polarize for the medicals in South Florida.

This is a possibility that there might be two regionals or they might combine to work together. This is what you are thinking of, if the plan is acceptable.

Dr. LEE. That is correct. In North Carolina, for example, four schools are already working closely together. You really have four schools that are participating with the State health department, the medical society, and others involved in the program.

Mr. ROGERS. But you might have only one region.

Dr. LEE. Right.

Mr. SPRINGER. Will you supply for the record and again to the members of this committee, the amount of money that actually has been spent in planning and that which is committed to capital investment out there where you are talking-I don't care whether you are talking about renovating or whatnot, that is a separate item.

Dr. LEE. Yes, sir.

(The information requested follows:)

AMOUNT OF REGIONAL MEDICAL PROGRAM GRANT FUNDS OBLIGATED FOR PLANNING AND RENOVATION THROUGH MARCH 1, 1967

To date, the only grants awarded have been for planning; 34 planning grants, totalling $12,018,265. (See Table II.) These planning grant funds may not be used for renovation or alterations of facilities.

Funds may be requested and approved for this purpose in operational grants, however. While no operational grants have been awarded as yet, four applications (Albany, Kansas, Missouri, and Intermountain Regional Medical Programs) have been received and are in the final stage of the review and approval process. Of the total direct costs ($11,658,775), requested in these first four operational grant applications, less than five percent is budgeted for renovations and repairs.

Mr. SPRINGER. We had the organization plan last
Dr. LEE. Yes, sir.

year

Mr. SPRINGER (continuing). After considerable hearings before the committee of which the distinguished gentleman from Florida, Mr. Rogers, was the chairman. We had extended hearings over a period of several months.

My question is this: How has this new organization resulted in appreciatively better control than the coordination by the Secretary and among the various health agencies would require Public Health Service, NIH, and NTA?

Dr. LEE. The reorganization that was approved last year, was directed specifically to the Public Health Service and I think the Surgeon General can describe in some detail tomorrow the better coordination that is possible.

I can give you one example and that is in the area of health manpower. The creation of a Bureau of Health Manpower in the Public Health Service has provided us with a Government-wide focus and a staff to coordinate the wealth of information that we have on healthmanpower. This will help us plan better for support of medical schools and for the other health occupations schools, and to better coordinate activities of the Public Health Service with the Office of Education and the Department of Labor, not only for health manpower development and training, but to work more closely in the support of higher education, for example, and the relation of programs in support of medical education to those for higher education.

Mr. SPRINGER. This is good, Dr. Lee, but I am trying to get a bigger question. Maybe you are not adverse to answer, maybe the Secretary can answer. When we got Mr. Gardner last year before the subcommittee, what we went into in great detail was the ability of the Secretary to manage this sprawling agency and especially NIH, under the kind of structure which he had in which we got from the Surgeon General, from the Secretary, this goes even back to Mr. Celler, that he could not manage NIH under the way this thing was being operated. What I am trying to find out, if you know, is how has this reorganization with the additional Secretaries that the Assistant Secretaries were given last year be better to bring this into a manageable kind of focus?

That is what I am trying to find out.

Dr. LEE. With the creation of the substantive Assistant Secretary such as my office, better coordination is possible. I described in some detail in my testimony the areas where we coordinate activities of the operating agencies.

Coordinating programs and developing legislation are major functions of my office.

As as develop legislative proposals we have to examine the array of health activities in the Department. We advise the Secretary. As I mentioned in my testimony, there are health activities in the Office of Education, Administration on Aging, Social Security, and Welfare Administration. We are working to coordinate these programs; this can't be achieved all in a year.

I do not believe Secretary Gardner, to my knowledge, has ever stated that he could not manage NIH. The National Institutes of Health is one of our best managed institutions. I think that the Secretary feels that there are very close working relationships between the National Institutes of Health and the other elements of the Public Health Service, and also with the other elements in the Department and with other departments concerned with biomedical research and research manpower.

Mr. SPRINGER. Well, admittedly, I can see you are not the person to answer this question. Thank you. It is perfectly all right. Thank you, Mr. Chairman.

The CHAIRMAN. Dr. Lee, I believe that if you would have Dr. Goddard present his statement then we can ask questions of both of you and save time.

Dr. LEE. All right, sir.

The CHAIRMAN. We will have the testimony of Dr. Goddard.

Dr. Goddard, if you would make your presentation, I think it will help us to move along.

STATEMENT OF HON. JAMES L. GODDARD, M.D., COMMISSIONER OF FOOD AND DRUGS, DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE

Dr. GODDARD. Thank you.

Mr. Chairman, members of the committee, I am happy to appear before the committee today to discuss the programs and some of the current problems of the Food and Drug Administration.

FDA's essential mission is consumer protection-and, in many instances, this means life protection. All of our citizens, therefore, are vitally involved in the manner in which FDA carries out this mission. This committee, certainly, has been intimately concerned with consumer protection problems in defining FDA's responsibilities for dealing with most of them. I am grateful that the committee has provided this opportunity for a review of the agency's work.

FDA's responsibilities have grown through the years as an inevitable byproduct of the swift technological and scientific advance that has transformed our Nation and its industries. The agency is currently responsible for the enforcement of the Federal Food, Drug, and Cosmetic Act; the Hazardous Substances Act; the Filled Milk Act; the Import Milk Act; the Tea Importation Act; and the Federal Caustic Poisons Act.

These laws were enacted by the Congress in recognition of, and in response to, specific national needs. It was 60 years ago in January that the first of these basic consumer protection measures-the original Food and Drug Act-became effective.

Dr. Harvey W. Wiley and his associates-including the brave young men who made up what was so aptly called the Poison Squaddramatized the need for this legislation, vividly demonstrating the health hazards posed by certain chemical preservatives which had been introduced into foods and by highly toxic substances used as ingredients in so-called medical preparations.

This original act was not perfect, but it represented a great forward stride in meeting basic consumer protection needs.

Deficiencies in the original Food and Drug Act were exposed over the years, and were made obvious in 1937 by what became known as elixir of sulfanilamide tragedy.

More than 100 Americans, many of them children, died because a new sulfanilamide drug preparation contained diethylene glycol, a highly toxic solvent which had never been tested to assure its safety.

The Congress responded by enacting the Federal Food, Drug, and Cosmetic Act of 1938-which today is still the foundation of American consumer protection.

This foundation has been strengthened through the years by the passage of many significant amendments. The Kefauver-Harris Drug Amendments of 1962, for example, marked a giant step forward in assuring that our citizens receive drugs that are both safe and effective.

The enactment of the 1962 amendments was spurred by the thalidomide tragedy in Europe, where thousands of babies were born with serious deformities as the result of the use of this drug by the mothers during pregnancy.

As you gentlemen know as well as I, there is a constant need to appraise the protection afforded the consumer under our existing statutes. The 89th Congress enacted three measures which significantly expanded the responsibilities of the Food and Drug Administration.

One of these was the Drug Abuse Control Amendments of 1965, which provide more stringent regulation of the manufacture and distribution of amphetamines, barbiturates, and other non-narcotic drugs found to have a potential for abuse.

The Bureau of Drug Abuse Control, which was established by our agency to implement this legislation, is moving vigorously against the illicit and health-threatening traffic in these stimulant, depressant, and hallucinogenic drugs.

Since its organization a year ago, the Bureau has recruited and trained more than 200 agents and has established nine field offices in major cities across the country.

At the same time, we have recognized that a new "police force" will not in itself eliminate the drug-abuse problem. Our agency also is giving major attention to education and to the research which is essential to increase our understanding of the underlying causes of drug abuse.

The 89th Congress also enacted the Fair Packaging and Labeling Act, which was considered by this committee during extensive hearings last summer. This legislation will help the consumer in making informed choices by requiring labeling that plainly shows the identity, quantity, and other information about consumer commodities and by prohibiting nonfunctional slack filled packages.

We are now meeting with industry groups and developing the regulations to implement those provisions of the act which will be enforced by FDA. We hope to put these regulations into force as promptly as possible after the law becomes effective on July 1, 1967.

Proposed regulations also are being issued to implement the Child Protection Act of 1966, which amended the Hazardous Substances Labeling Act.

This, too, is a measure with which this committee is familiar.

The amendment closed major gaps in the protection provided under the original act. The act now applies to unpackaged as well as to packaged hazardous substances. And commodities that are too dangerous for household use even with label warnings-as well as products for children that are found to be hazardous-now can be banned from interstate commerce.

The existence of this new act enabled us to deal swiftly with highly inflammable toy dolls that appeared on the market last Christmas. The enactment of a law-no matter how strong-cannot become meaningful, of course, unless there are adequate means for its enforce

ment.

The FDA, unfortunately, was handicapped for many years by a serious lack of resouces to do its enforcement job.

During the midyear of this century, while the food, drug, and cosmetic industries were experiencing explosive growth in the midst of a technological revolution, FDA grew hardly at all.

For example, in 1955, the total staff numbered 829-just six positions more than there were 10 years earlier. Between 1938 and 1955, when the total U.S. population grew by 31 million persons, FDA manpower and appropriations remained almost constant.

In 1957, however, FDA began to move forward as additional resources were provided for the agency to carry out its expanded responsibilities.

This change was stimulated by the report of a citizens advisory committee in 1955, which kindled a broader awareness of the agency's needs.

Today, as the result of appropriation increases in recent years, FDA has a budgeted staff of about 5,000. We are doing our utmost to fully utilize these increased resources for the benefit of the American

consumer.

The FDA staff is now operating under an entirely new organizational structure approved by the Secretary last year. We have sought to strengthen the overall administrative direction of the agency while at the same time decentralizing to permit greater decisionmaking discretion in the field within well-definied policy guidelines. A chart showing the present organization is attached to this statement. (See p. 213.)

More efficient utilization of scientific and medical personnel-always in short supply-was a major consideration in the reorganization. The agency's two scientific bureaus were consolidated into a single Bureau of Science to facilitate the flow of scientific data within the agency and to permit greater use of the interdisciplinary approach so often required in dealing with contemporary environmental problems.

The restructuring of the Bureau of Medicine was particularly significant in improving the agency's capability to review and evaluate new drug applications and investigational plans for new drugs.

Since January 1 of this calendar year we are beginning to bring down the backlog of applications which developed following the imposition of the more stringent requirements of the Drug Amendments of 1962, and we expect to eliminate the backlog of overage applications by June 30, 1967.

The appraisal and review of drugs is now being handled along "team" lines. A single group of medical officers follows the development of drugs that are similar in structure or use. Pharmacologists also have been brought into close association with these "teams." Six Divisions have been established within the Bureau's Office of New Drugs to deal with separate classes of drugs. The same group of