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NOMINATION

GOVERNMENT

Storage .111VIENTS

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TM a I HEARINGS

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OR AND PUBLIC WELFARE -0

T ITED STATES SENATE ,-R

11

NINETY-THIRD CONGRESS

FIRST SESSION

ON

CHARLES C. EDWARDS, M.D., OF MARYLAND, TO BE AN

ASSISTANT SECRETARY OF HEALTH, EDUCATION AND

WELFARE

MARCH 29, 1973

Printed for the use of the

Committee on Labor and Public Welfare

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COMMITTEE ON LABOR AND PUBLIC WELFARE

HARRISON A. WILLIAMS, JR., New Jersey, Chairman

JENNINGS RANDOLPH, West Virginia

CLAIBORNE PELL, Rhode Island

EDWARD M. KENNEDY, Massachusetts

GAYLORD NELSON, Wisconsin

WALTER F. MONDALE, Minnesota

THOMAS F. EAGLETON, Missouri

ALAN CRANSTON, California

HAROLD E. HUGHES, Iowa

WILLIAM D. HATHAWAY, Maine

STEWART E. MCCLURE, Chief Clerk

ROBERT E. NAGLE, General Counsel

ROY H. MILLENSON, Minority Chief Clerk

EUGENE MITTELMAN, Minority Counsel

JACOB K. JAVITS, New York

PETER H. DOMINICK, Colorado

RICHARD S. SCHWEIKER, Pennsylvania

ROBERT TAFT, JR., Ohio

J. GLENN BEALL, JR., Maryland

ROBERT STAFFORD, Vermont
NOMINATIONS

THURSDAY, MARCH 29, 1973

3

U.S. SENATE,

COMMITTEE ON LABOR AND PUBLIC WELFARE,

Washington,D.C.

The committee met pursuant to notice, at 9 :35 a.m., Senator Harrison A. Williams, chairman, presiding.

Present: Senators Williams, Randolph, Pell, Kennedy, Mondale,

Cranston, Javits, Taft, and Stafford.

Also present: Senator Percy.

Committee staff members present: Robert E. Nagle, general counsel to committee and Roy H. Millenson, minority staff director.

The CHAIRMAN. This hearing is on the nomination of Dr. Charles C.

Edwards who is nominated to be Assistant Secretary of Health, Edu-

,cation, and Welfare for Health.

Senator Percy.

Senator PERCY. Thank you, Mr. Chairman.

Mr. Chairman, I am here to introduce Dr. Charles C. Edwards for

confirmation as an Assistant Secretary of Health.

Dr. Edwards received his bachelor's and medical degrees from the

University of Colorado in 1945 and 1948 and earned his degree in

surgery from the University of Minnesota in 1956.

He served in the U.S. Navy's V-12 program from 1942 to 1946. He

later completed his internship at St. Mary's Hospital, Minneapolis,

in 1949. As a Navy lieutenant, he served with the U.S. Marine Corps in

Korea during the period 1950-52.

Dr. Edwards held a teaching fellowship while fulfilling requirements for the master's degree in physiology at the University of

Minnesota in 1949-50. He held a surgical fellowship from 1950 to

1956 and served as assistant to the staff in surgery of the Mayo Clinic

in Rochester, Minn., in 1955-56.

Dr. Edwards maintained a private practice in surgery from 1956

to 1961, in Des Moines, Iowa. He was on the teaching staff of Iowa

Methodist Hospital and Mercy Hospital, Des Moines, from 1958 to

1961. He also directed the medical education program while at Iowa

Methodist before moving to Georgetown University Medical School in

Washington, -D.C., in 1961 as instructor of surgery. Dr. Edwards was

a consultant to the U.S. Public Health Service while at Georgetown1961-62.

In 1962 Dr. Edwards became associate director, medical education of the American Medical Association, and in 1963 was named director, division of socioeconomics activities for AMA.

In 1967 Dr. Edwards was named vice president of the managing office

(1)

—a
2

of Booz Allen & Hamilton, Inc., a, Chicago management consult- ing firm to handle health affairs. In 1969 he became Commissioner of the Food and Drug Administration, and after a distinguished career in the FDA, President Nixon nominated Dr. Edwards to be Assistant

Secretary for Health in the Department of Health, Education, and Welfare.

Dr. Edwards is a diplomate American Board of Surgery and holds membership in numerous scientific and technical associations includ- ing AMA, the American College of Surgeons, the Association of American Medical Colleges and Board of Trustees of Food and Drug

Law Institute. He is a member of several advisory boards and com- mittees in areas related to public health and hospital practice, namely

the American Society of Internal Medicine and Princeton University

Health Services Advisory Council. Dr. Edwards has authored more

than 25 technical articles.

It is primarily in connection with Dr. Edwards' position as Com- missioner of FDA that I have had an opportunity to work with him. Together with senator Ribicoff and Senator Javits we have authored

the Consumer Protection Act. This is a piece of legislation that deeply involves the consumer, and of course has an effect upon all regulatory agencies, including FDA.

Of all the members of Government with whom I have worked in

recent years to try to implement action, to issue directives and regula- tions that will better protect the safety and health of the American

consumer, Dr. Edwards stands well above anyone in cooperating with the Senate, in considering the findings that we have been able to bring

to his attention, and in expediting necessary action to protect the interests of the consumer.

It is for this reason that I, with great enthusiasm, endorse and support his confirmation as Assistant Secretary for Health.

Dr. Edwards has the potential to be an absolutely outstanding ap- pointee. His professional credentials are impeccable. His record of

Government service and his demonstrated ability to work with a

bureaucracy and get things done have been very impressive to me and

to many of my colleagues in the Senate who have also worked closely

with him.

I thank you very much indeed.

The CHAIRMAN. Thank you for your statement, Senator Percy.

Dr. Edwards, we will include your biographical sketch along with

the public law that created the position and other pertinent material

dealing with the office in the record at this point. Senator Percy did

an admirable job in covering your life's activities.

BIOGRAPHICAL SKETCH OF DR. CHARLES C. EDWARDS, COMMISSIONER, FOOD AND

DRUG ADMINISTRATION

Dr. Edwards received the bachelor's and medical degrees from the University

of Colorado in 1945 and 1948 and earned his degree in Surgery from the Univer- sity of Minnesota in 1956.

He served in the U.S. Navy's V-12 program from 1942 to 1946. He later com- pleted his internship at St. Mary's Hospital, Minneapolis, in 1949. As a Navy Lieutenant, he served with the U.S. Marine Corps in Korea during the period 1950-1952.

Dr. Edwards held a teaching fellowship while fulfilling requirements for the

Master's Degree in Physiology at the University of Minnesota in 1949-1950. He held a Surgical Fellowship from 1950 to 1956 and served as assistant to the staff in surgery of the Mayo Clinic in Rochester, Minnesota in 1955-1956.
3

Dr. Edwards maintained a private practice in surgery from 1956 to 1961, in

Des Moines, Iowa. He was on the teaching staff of Iowa Methodist Hospital and

Mercy Hospital, Des Moines from 1958 to 1961. He also directed the medical

education program while at Iowa Methodist before moving to Georgetown University Medical School in Washington, D.C. in 1961 as Instructor of Surgery.

Dr. Edwards was a consultant to the U.S. Public Health Service while at Georgetown (1961-1962).

In 1962 Dr. Edwards became Associate Director Medical Education of the

American Medical Association, and in 1963 was named Director, Division of

Socio-Economics Activities for AMA.

In 1967 Dr. Edwards was named Vice President Managing Office of Booz Allen

and Hamilton, Inc., a Chicago management consulting firm. In 1969 Commissioner

FDA.

On March 13, 1973, President Nixon nominated Dr. Edwards to be Assistant

Secretary for Health in the Department of Health, Education, and Welfare.

Dr. Edwards is a diplomate American Board of Surgery and holds memberships in numerous scientific and technical associations including AMA, the

American College of Surgeons, the Association of American Medical Colleges

and Board of Trustees of Food and Drug Law Institute. He is a member of

several advisory boards and committees in areas related to public health and

hospital practice, namely the American Society of Internal Medicine and Princeton University Health Services Advisory Council. Dr. Edwards has authored

more than 25 technical articles.

He and his wife reside in Washington, D.C. and have four children.

REORGANIZATION PLAN No. 3 OF 1966

Prepared by the President and transmitted to the Senate and the House of

Representatives in Congress assembled, April 25, 1966, pursuant to the provisions

of the Reorganization Act of 1949, 63 Stat. 203, as amended.'

PUBLIC HEALTH SERVICE

SEcrioN 1. Transfer of functions.— (a) Except as otherwise provided in subsection (b) of this section, there are hereby transferred to the Secretary of

Health, Education, and Welfare, (hereinafter referred to as the Secretary) all

functions of the Public Health Service, of the Surgeon General of the Public

Health Service, and of all other officers and employees of the Public Health

Service, and all functions of all agencies of or in the Public Health Service.

(b) This section shall not apply to the functions vested by law in any advisory

council, board, or committee of or in the Public Health Service which is

established by law or is required by law to be established.

SEC. 2. Performances of transferred functions.—The Secretary may from time

to time make such provisions as he shall deem appropriate authorizing the performance of any of the functions transferred to him by the provisions of this

reorganization plan by any officer, employee, or agency of the Public Health Service or of the Department of Health, Education, and Welfare.

SEC. 3. Abolitions.—(a) The following agencies of the Public Health Service

are hereby abolished:

(1) The Bureau of Medical Services, including the office of Chief of the Bureau

of Medical Services.

(2) The Bureau of State Services, including the office of Chief of the Bureau

of State Services.

(3) The agency designated as the National Institutes of Health (42 U.S.C.

203), including the Office of Director of the National Institutes of Health (42

U.S.C. 206 (b) ) hut excluding the several research Institutes in the agency designated as the National Institutes of Health.

(4) The agency designated as the Office of the Surgeon General (42 U.S.C.

203 (1) ), together with the office held by the Deputy Surgeon General (42 U.S.C.

206(a)).

(b) The Secretary shall make such provisions as he shall deem necessary respecting the winding up of any outstanding affairs of the agencies abolished by

the provisions of this section.

',Effective June 25, 1966, under the provisions of section 6 of the Act; published pursuant to section 11 of the Act (63 Stat. 203; 5 U.S.C. 1332).
4

SEC. 4. Incidental transfers.—As he may deem necessary in order to carry out

the provisions of this reorganization plan, the Secretary may from time to time

effect transfers within the Department of Health, Education, and Welfare of

any of the records, property, personnel and unexpended balances (available or

to be made available) of appropriations, allocations, and other funds of the Department which relate to functions affected by this reorganization plan.

[From the Federal Register, Mar. 22, 1968]

REORGANIZATION ORDER—OFFICE OF THE SECRETARY, ASSISTANT SECRETARY FORHEALTH AND SCIENTIFIC AFFAIRS ET AL.

Under the authority of section 6 of Reorganization Plan No. 1 of 1953 and

section 2 of Reorganization Plan No. 3 of 1966, I hereby order the reorganization

of certain health functions of the Department as follows:

The Assistant Secretary for Health and Scientific Affairs shall be responsible

for the direction of the functions of the Public Health Service and the Food

and Drug Administration.

Delegations of authority. All delegations of authority to the Surgeon General

and to the Commissioner of Food and Drugs effective date of this Reorganization

Order are hereby revoked. All such authority is hereby delegated to the Assistant

Secretary of Health and Scientific Affairs, subject to all the reservations of authority in effect immediately prices to the effective date of this Reorganization

Order.

Pending further orders by the Assistant Secretary for Health and Scientific

Affairs and delegations, including all redelegations by the Surgeon General of thePublic Health Service or the Commissioner of Food and Drugs to any other officer

or employee of any office, institute, bureau, division, center, or other organizational unit in effect immediately prior to the effective date of this Reorganization

Order shall continue in effect in them or their successors.

Redelegation of authority. The authority delegated to the Assistant Secretary

for Health and Scientific Affairs may be redelegated as he may deem appropriate.

It may be successively redelegated, except as any delegation may be explicitly

limited.

Continuation of regulations. All regulations, rules, orders, statements of policy,

or interpretations with respect to the Public Health Service or the Food and

Drug Administration heretofore issued and in effect prior to the date of that

Reorganization Order or to become effective subsequent to said date are continued in full force and effect.

Prior statements of organization, functions, and delegations of authority. Tothe extent inconsistent with this Reorganization Order, all previous statements

of organization, functions, and delegations of authority, and chapters of the

Department's Organization Manual are superseded by this Reorganization Order..

Effective date. This reorganization Order shall be effective March 13, 1966.

Dated: March 13, 1968.

WrLBUR J. COHEN,

Acting Secretary.

[FR. Doc. 68-3482; Filed Mar. 21, 1968, 8 :47 a.m.]

[From the Federal Register, April 5, 19681

REDELEGATION OF AUTHORITY—OFFICE OF THE SECRETARY, DIRECTOR, NATIONAL

INSTITUTES OF HEALTH ET AL.

I hereby revoke the delegation to the Surgeon General made by me on March 18,

1968.

I hereby delegate to the Director, National Institutes of Health, the authority

heretofore delegated to the Surgeon General, Public Health Service, pertaining

to the functions presently assigned to the National Institutes of Health, the

Bureau of Health Manpower, and the National Library of Medicine.

I hereby delegate to the Administrator, Health Services and Mental Health

Administration, the authority heretofore delegated to the Surgeon General, Public Health Service, pertaining to all of the functions presently assigned to thePublic Health Service except the functions assigned to the National Institutes of

Health, the Bureau of Health Manpower, and the National Library of Medicine.

The Surgeon General will hereafter serve as the principal deputy to the As-
5

sistant Secretary for Health and Scientific Affairs and as such will exercise all

of the authority of the Assistant Secretary in his absence.

These authorities may be redelegated.

This redelegation becomes effective April 1, 1968.

Dated: April 1, 1968. PHILIP R. LEE,

Assistant Secretary for Health and Scientific Affairs.

[F.R. Doc. 68-4115; Filed, Apr. 4, 1968; 8 :48 a.m.]

REORGANIZATION—CERTAIN HEALTH FUNCTIONS

Under the authority of section 6 of Reorganization Plan No. 1 of 1953 and

section 2 of Reorganization Plan No. 3 of 1966, and further to DHEW Reorganization Order dated March 13, 1968, I hereby order the further reorganization of

certain health functions of the Department as follows:

Organization. Three new operating agencies are hereby established to carry

out the functions and responsibilities of the Public Health Service and the Food

and Drug Administration. These operating agencies make up a newly constituted

Public Health Service:

(1) The National Institutes of Health.

(2) The Health Services and Mental Health Administration.

(3) The Food and Drug Administration.

Functions and responsibilities—Office of the Assistant Secretary for Health and

Scientific Affairs: The Office of the Assistant Secretary for Health and Scientific

Affairs shall continue to be responsible for all functions presently assigned to it.

National Institutes of Health. The National Institutes of Health shall be responsible for all of the functions presently assigned to the National Institutes

of Health, the Bureau of Health Manpower, and the National Library of

Medicine.

The National Institute of Health shall be headed by a Director who reports

to the Assistant Secretary for Health and Scientific Affairs.

Health Services and Mental Health Administration. The Health Services and

Mental Health Administration shall be responsible for all of the functions presently assigned to the Public Health Service except the functions assigned to the

National Institutes of Health, the Bureau of Health Manpower, and the National

Library of Aledicine.

The Health Services and Mental Health Administration shall be headed by

an Administrator who reports to the Assistant Secretary for Health and Scientific Affairs.

Food and Drug Administration. The Food and Drug Administration shall be

responsible for all of the functions presently assigned to the Food and Drug

Administration.

The Surgeon General of the Public Health Service shall provide professional

leadership and guidance concerning all Department health functions and shall

serve as the principal deputy to the Assistant Secretary for Health and Scientific

Affairs.

The Food and Drug Administration shall continue to be headed by a Commissioner who reports to the Assistant Secretary for Health and Scientific

Affairs.

Continuation of Regulations. All regulations, rules, orders, statement of policy, or interpretations with respect to the Public Health Service or the Food and

Drug Administration heretofore issued and in effect prior to the date of this

Reorganization Order or to become effective subsequent to said date are continued in full force and effect.

Prior Statements of Organization, Functions, and Delegations of Authority.

To the extent inconsistent with this Reorganization Order, all previous statements of organization, functions, and delegations of authority, and chapters of

the Department's Organization Manual are superseded by this Reorganization

Order, except that, pending further orders by the Assistant Secretary for Health

and Scientific Affairs, all redelegations by the Surgeon General of the Public

Health Service or the Commissioner of Food and Drugs, to any other officer or

employee of any office, institute, bureau, division, center or other organizational

unit in effect immediately prior to the effective date of this Reorganization Order

shall continue in effect in them or their successors.

Effective date. This Reorganization Order shall be effective April 1, 1968.

Dated: April 1, 1968.

[ SEAL] WILBUR J. COHEN,

Acting Secretary.
6

[From the Federal Register, Mar. 16, 1972]

STATEMENT OF ORGANIZATION, FUNCTIONS, AND DELEGATIONS OF AUTHORITY—

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH

In the statement of organization, functions, and delegations of authority of the

Department, Chapter 2-110, entitled Office of Assistant Secretary for Health and Scientific Affairs (35 F.R. 1123 and 35 F.R. 3948) should be deleted and the following statement added:

SECTION 1N.00 MISSION.—The Assistant Secretary for Health is the principal advisor and assistant ot the Secretary on health policy and all health-related activities in the Department. He is responsible for the direction of the health agencies of the Department, for providing leadership and policy guidance for health-related activities throughout the Department and for maintaining rela- tionships with other governmental and private agencies concerned with health.

SEC. 1N.10 Organization. A. Under the supervision of the Assistant Secretary,

the Office of the Assistant Secretary for Health consists of the following prin- cipal operating components:

Deputy Assistant Secretary for Policy Implementation.

Deputy Assistant Secretary for Policy Development.

Deputy Assistant Secretary for Population Affairs.

The Surgeon General.

Special Assistant for Nursing Home Affairs.

Special Assistant for Science.

Special Assistant to the Secretary for Drug Abuse Activities.

Office of International Health.

[FR. Doc. 68-4121; Filed Apr. 4, 1968; 6 :49 a.m.]

B. In the absence of the Assistant Secretary, the Deputy Assistant Secretary

for Policy Implementation functions as Acting Assistant Secretary.

SEC. 1N.20 Functions.—A. The Assistant Secretary for Health: (1) Directs

the activities of the Public Health Service, which is composed of the Health Services and Mental Health Administration, the National Institutes of Health and

the Food and Drug Administration; and (2) as the Secretary's principal ad- visor on health, provides leadership and guidance on all other health and healthrelated activities, including research and development, education and training,

the organization, financing and delivery of health care services, and problems

of public and environmental health. In addition, he is responsible for the direc- tion of nursing home affairs throughout the Department directing coordination

of drug abuse activities throughout the Department and providing principal

point of contact within the Department with the Special Action Office for Drug Abuse Prevention, and exercises specialized responsibilities in the areas of pop- ulation affairs, international health and in the transportation and disposition of certain hazardous materials. He coordinates the health and health-related func- tions of the Department with those of other Federal agencies and provides advice and assistance on health matters to such agencies as requested.

B. The principal components of the Office of the Assistant Secretary for Health, operating under the general direction and supervision of the Assistant

Secretary, have the following functions and responsibilities:

Deputy Assistant Secretary for Policy Implementation. Resolves, and advises

on day-to-day operating problems and is responsible for insuring that established

health policy and objectives are effectively carried out through the budget, planning, and legislative processes and through program operations. Makes recommendations to the Assistant Secretary on budget, organizational, and management policies and problems.

Deputy Assistant Secretary for Policy Development. Advises on and conducts policy analysis and development and health policy planning; provides guidance for such activities within the health agencies and with respect to health and health-related issues throughout the Department. Coordinates health data ac- tivities, and assists in the evaluation of health and health-related programs. Maintains liaison with other public and nongovernment health policy analysis

and planning activities.

Deputy Assistant Secretary for Population Affairs. Advises on programs of national importance in the fields of population dynamic, fertility, sterility,

and family planning. Directs population and family planning activities within

the three health agencies of the Department.
7

Surgeon General. Advises and assists on professional medical matters, especially as they relate to personal, public and environmental health (including the

transportation and disposition of certain hazardous materials), bath nationally

and internationally. As the ranking officer of the Public Health Service Commissioned Corps, the Surgeon General functions as principal advisor on top

Corps appointments and policies.

Special Assistant for Nursing Home Affairs. Serves as the departmental focal

point for managing nursing home affairs. Directs and coordinates nursing home

activities in both the health and non-health agencies.

Special Assistant for Science. Advises on matters pertaining to biomedical research and research training, drug research and development, environmental

science, and related scientific problems. Serves as a focal point for liaison on

matters of science with other Federal departments and agencies and with nongovernmental organizations.

Special Assistant to the Secretary for Drug Abuse. Serves as the principal departmental contact with the Special Action Office for Drug Abuse Prevention,

receiving, referring and following-up on all major SAODAP requests, coordinates

all intra-DHEW staff work on major drug abuse issues, leads and coordinates

negotiation of all major policy issues with SAODAP, monitors the implementation of drug abuse legislation and progress toward achievement of defined objectives of drug abuse programs. With the Assistant Secretary for Health,

brings directly to the attention of the Secretary major issues requiring Secretarial decision

Office of _international Health. Provides assistance and guidance on, and coordinates, the international health activities of the Department. Prepares analyses of selected international health policies and programs for the Department

of State, maintains liaison with international institutions and organizations and

other departments and agencies on international health matters and arranges

international technical assistance in the health field at the request or other

departments and agecies.

Date: November 9, 1972.

ELLIOT L. RICHARDSON,

Secretary.

[F.R. Doc. 72-19719 Filed 11-15-72; 8 :50 a.m.]

[From the Federal Register, March 19, 1973]

STATEMENT OF ORGANIZATION, FUNCTIONS, AND DELEGATIONS OF AUTHORITY—

OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH

In the statement of organization, functions, and delegations of authority of

the Department, chapter 2-110, entitled Office of Assistant Secretary for Health

(37 FR 24377) should be deleted and the following statement added:

SECTION IN.00 Mission.—The Assistant Secretary for Health is the principal

advisor and assistant to the Secretary on health policy and all health-related

activities in the Department. He is responsible for the direction of the health

agencies of the Department, for providing leadership and policy guidance for

health-related activities throughout the Department and for maintaining relationships with other governmental and private agencies concerned with health.

SEC. IN.00 Organization.—Under the supervision of the Assistant Secretary,

the Office of the Assistant Secretary for Health consists of the following principal operating components:

1. General functions:

Deputy Assistant Secretary for Program Operations.

Deputy Assistant Secretary for Policy Development.

Deputy Assistant Secretary for Medical and Scientific Affairs.

Deputy Assistant Secretary for Administration and Management.

Executive Assistant.

Special Assistant for Public Affairs.

2. Special functions:

Deputy Assistant Secretary for Population Affairs.

Director, Office of Nursing Home Affairs.

Director, Office of International Health.

Director, Office of Professional Standards Review Organizations.

Special Assistant for Drug Abuse Prevention.

SEC. IN.20 Functions.

A. The Assistant Secretary for Health: (1) directs the activities of the Public

96-920-73--2
8

Health Service, which is composed of the Health Services and Mental Health

Administration, the National Institutes of Health and the Food and Drug administration; and (2) as the Secretary's principal advisor on health, provides

leadership and guidance on all other health and health-related activities, including research and development, education and training, the organization, financing and delivery of health care services, and problems of public and environmental health. In addition, he is responsible for the direction of nursing home

affairs throughout the Department, directing coordination of drug abuse activities throughout the Department, and providing the principal point of contact

within the Department with the Special Action Office for Drug Abuse Prevention, and exercises specialized responsibilities in the areas of population affairs,

international health and in the transportation and disposition of certain hazardous materials. He coordinates the health and health-related functions of the

Department with those of other Federal agencies and provides advice and assistance on health matters to such agencies as requested.

B. The principal components of the Office of the Assistant Secretary for

Health, operating under the general direction and supervision of the Assistant

Secretary, have the following functions and responsibilities:

1. General functions. Deputy Assistant Secretary for Program Operations.

Resolves, and advises on, day-to-day operating problems, reviews and coordinates program activities and the presentation thereof to Congress, insures that

established health policy and objectives are effectively carried out through

program operations and through the budget and legislative processes, and makes

recommendations for organizational changes designed to improve program

coordination.

Deputy Assistant Secretary for Policy Development. Advises on and conducts

policy analysis and development and health policy planning and provides guidance for such activities within the health agencies and with respect to health

and health-related issues throughout the Department.

Deputy Assistant Secretary for Medical and Scientific .A_ffairs. Advises, assists, and provides leadership and guidance on professional medical and substantive scientific and technical matters and represents the Assistant Secretary

for Health at meetings of medical and scientific organizations.

Deputy Assistant Secretary for Administration and Management. Advises and

assists on budget and other management problems and policies, provides leadership and guidance to the health agencies on management policy, and directs

supporting and staff services in budget management, personnel management

analysis and administrative services.

Executive Assistant. Provides personal assistance to the Assistant Secretary

in managing his immediate office and his appointments and speaking engagements,

advises, and represents him, on relationships with outside organizations, is

responsible for the activities of the Executive Secretariat and for committee

management, and performs a variety of ad hoc assignments.

Special Assistant for Public Affairs. Advisers and assists on communications

with the various publics served by the Health Service and coordinates

the public affairs activities of the three hea'th agencies with policy directives of

the Assistant Secretary for Health.

2. Special functions. Deputy Assistant Secretary for Population Affairs. Advises on programs of national importance in the fields of population dynamics,

fertility, sterility, and family planning and directs population and family planning activities within the three health agencies of the Department.

Director, Office of Nursing Home Affairs. Serves as the department focal

point for managing nursing home affairs and directs and coordinates nursing

home activities in both the health and nonhealth agencies. _

Director. Office of International Health. Provides assistance and guidance on,

and coordinates, the international health activities of the Department; prepares

analyses of selected international health policies and programs for the Department of State, maintains liaison with international institutions and organizations and other departments and agencies on international health matters

and arranges international technical assistance in the health field at the request

of other departments and agencies.

Directdr, Office of Professional Standards Review Organizations. Serves as the

Department's focal point for managing professional standards review organization (PSRO) activities and directs and coordinates PSRO activities in both the

health and nonhealth agencies.
Special Assistant for Drug Abuse Prevention. Serves as the principal departmental contact with the Special Action Office for Drug Abuse Prevention, re-

•ceiving, referring and following up on all major SAODAP requests, coordinates

all intra-DHEW staff work on major drug abuse issues and, with the Assistant

Secretary for Health, brings directly to the attention of the Secretary major

issues requiring Secretarial decision.

Dated:.March 2, 1973.

FRANK C. CARLUCCI,

Acting secretary.

[F.R. Doc. 73-5157 Filed 3-16-72;8 :45 a.m.]

The CHAIRMAN. Do you have a statement you would like to make

.at this time?

Dr. EDWARDS. No, Senator, I do not.

The CHAIRMAN. First of all is our question of your willingness to

appear before this or other committees of Congress in response to

their reasonable calls. Will you respond willingly?

Dr. EDWARDS. Absolutely.

The CHAIRMAN. We appreciate that.

Let us turn right to the questioning. I am sure Senator Kennedy,

chairman of the Subcommittee on Health, has many questions.

I have some questions from Senator Pell who could not be present.

Senator Pell was interested in answers to these questions.

First, when will the Department of Health, Education, and Welfare furnish the Congress with the third phase of the systems analysis

on health as required by law?

Dr. EDWARDS. Senator, I had an opportunity to chat with Senator

Pell I believe it was yesterday or the day before, and he brought this

particular issue to my attention.

I have checked into it after our conversation, and it was in December that we submitted the second edition of this particular systems

analysis report that he was interested in.

Senator Pell, and I believe rightly so thought this was a rather

inadequate and poorly done document. We are trying to upgrade the

quality of the document, and we do have an appendix to the document that is now at the Government Printing Office and will be coming up to the Senate in what I would suspect is just a matter of printing time. I imagine that to be approximately 2 weeks.

Again, the quality of the document is considerably better than the

document which you received and which the Senator criticized in

December.

The CHAIRMAN. I appreciate that.

Another question: What is the present status of the international

data bank for cancer research?

Dr. EDWARDS. The international data bank, shortly after the passage by the Congress of the Cancer Act in 1972, the National Cancer

Institute convened a conference here in Washington which included

the World Health Organization agencies to discuss this whole subject.

It was from these recommendations that the National Cancer Institute hired a staff which is currently on board. They are now in the

process of developing a model which they think can be used for a

total data information system on cancer research throughout the

world.

This particular model they are using for registration throughout

the world. I think it is underway, and I think it is underway in a
10

very meaningful way, and we will have a report to the Senator and

to the Congress.

It is part of our cancer plan which we now have under review and

which I hope will be up here shortly.

The CHAIRMAN. Senator Randolph.

Senator RANDOLPH. Mr. Chairman, I had the privilege of talking

with Dr. Edwards, and he did mention very briefly the problem of

cures for cancer in this country.

I asked him if what we hear is true, that if we had some type of

prompt medical treatment, early diagnosis and then treatment, we

could save an estimated quarter of a million lives annually.

Is that just out of the sky somewhere, that figure, or is there some

reason to believe that the figure * is somewhat correct, and also that

we may have well over a quarter of a million of our American, citizenry who do have cancer because we do not have enough medical

research?

Is it true that through research, we will have drugs or treatment

programs that can solve to a greater degree the dread disease which

afflicts so many Americans? Would you make your comment?

Dr. EDWARDS. Yes, Senator. Again, I think that as a ball park

figure that is reasonably accurate.

Probably the key ingredient in terms of our conquest of cancer

is early diagnosis. Even if we are fortunate enough to find a cure

for cancer or cures for cancer, the essential first ingredient is early

diagnosis in bringing whatever type cancer it may be to the attention

of the physician. S I think the points that you have made are

-accurate.

We have a tremendous amount that needs to be done in continuing

to push for early diagnosis, annual checkups, and so forth. I think

this is very important. There is no question that numerous lives can

be saved throughout the world.

Senator RANDOLPH. One further question or perhaps two or three.

Dr. Edwards, we are seeing or 

hearincr. 

there is going to be an expiration of the Hill-Burton program and the regional medical program.

Senator Kennedy especially knows of my concern in both of these

areas, and I have discussed the regional medical program as it has

affected West Virginia during the past few years.

What is your feeling about the need to continue these, or are you

in accord with the phasing out or the stoppage of these efforts?

Dr. EDWARDS. Let me address myself, Senator, first to the regional

medical program. As you know, the President has proposed in his

new budget to phase out the regional medical programs. I am obviously in support of that position.

I feel that although the regional medical programs were certainly

well conceived in terms of intent, I think without any question the

reg',-)nal medical programs have had an identity problem. They have

really had a problem trying to decide what their real mission in life is.

Since moving over from Food and Drug Administration, as I have

studied this and looked at the figures as to how the regional medical

programs have spent their money—and they have had considerable

resources—it seems to me quite obvious that there has been tremendous overlap and duplication with already ongoing programs in the

Federal Government.
11

I am thinking of programs in the field of health research and

development, the cancer authority, and the heart authority. There is

tremendous overlap and duplication.

Of course with this phaseout, we have to continually be alert because there are some good regional medical programs throughout the

United States. There is no question about it. I think we have to assist

these programs in helping assure that the activities that they have

under their jurisdiction, the good programs, are not lost, and that

they are picked up by some other authority.

With regard to the Hill-Burton program, it also is true that the

President has proposed to phase this out. It is our opinion, and certainly his opinion, that we do have sufficient hospital beds in the

United States. Their utilization and the number obviously vary from

region to region, but overall we do have an adequate number of beds.

We also feel that there are sufficient authorities and sufficient

groups from which funding can be obtained so that we no longer need

this particular program.

In addition, we feel that many of the financing programs have now

taken into consideration depreciation, and the allowances for depreciation which can be utilized for modernization, renovation and new

construction.

We feel there are other Government authorities able to provide

funding for hospitals and we believe that this will adequately take

care of the hospital construction and renovation, the continuation of

this.

Senator RANDOLPH. Dr. Edwards, I am not interested in a confrontation with the administration. Certainly members of this committee, regardless of their party label, I hope are not interested in

that, but I am asking you because I have a very real concern.

Where is the Presidential authority to do what is now proposed to

be done with respect to the regional medical programs?

Dr. EDWARDS. Senator, I am not certain that I can give you the

exact Presidential authority. As you know

'

I did not personally have

any involvement in the establishment of the current budget. Obviously I do not disagree with it or I would not be here, but nevertheless I was not involved in the establishment or figuring out where the

authority came from and so forth.

I prefer not to answer that question or attempt to answer it, because

I am not certain.

Senator RANDOLPH. You might check that out and give us a further

reply.

Mr. EDWARDS. From my point of view, I can assure you that my

record at the Food and Drug Administration has certainly been one

of very meaningful working relationships with the Congress, both

the Senate and the House.

I am equally convinced that in the broad health care field this

working relationship has to exist, or it cannot really come to grips

with what you want to do and what we want to do and so I am hopeful that any confrontations at least in the health area can be

minimized.

Senator RANDOLPH. In a moment I am going to yield to someone

else on the committee, to Senator Kennedy, chairman of our Subcommittee on Health, who I know has many questions to ask you.
12

I have been concerned about the expiring of the program in June

of the Developmental Disabilities Act, and I wonder if you feel that

program has failed.

Dr. EDWARDS. No, I do not think it has failed. Like all programs,

there are successes and failures, but as a general rule I do not think

it has failed; no.

Senator RANDOLPH. Do you think HEW perhaps can administer

that act better if there is a renewal of it, and do you have recommendations as to how you would like to improve that program if it is

carried forward?

Mr. EDWARDS. Senator, I cannot speak specifically as to what I

think we ought to do in that particular program.

I think there are very few programs in HEW administered that can

not be administered better however.

Senator RANDOLPH. Thank you, Mr. Chairman.

The CHAIRMAN. Thank you, Senator.

Senator Javits.

Senator JAVITS. Dr. Edwards, I have seen your financial statement,

and I do not see anything in it that would particularly worry me.

However, I want you to answer whether there is any holding that

you have, which has any relation of some tangible character to the

responsibilities you will undertake, so that you could perceive some

possibility of a conflict of interest between these securities that you

and your wife or your children own and your duties?

Dr. EDWARDS. No, Senator Javits. I have gone over that in some

detail, and the stocks that I own I cannot see any basic conflict.

I obviously had to be very careful about that at the Food and

Drug Administration, so I think it is applicable now to the health

field generally.

Senator JAM'S. If you saw anything like that, would you either

sell or divorce yourself from the responsibility?

Dr. EDWARDS. Absolutely.

Senator JAvrrs. The other question I have for you is this. There

will be a great effort to develop and pass into law a national health

scheme. I use the word "scheme" rather than insurance or anything

else in order not to prejudice the issue.

Do you feel in your heart a conviction that you can deal justly and

equitably, in an objective fashion, in the interests of the broad range

of the people with such a legislative proposal and that you are not

locked into any doctrinaire position as a doctor, who wants to hurl the

epithet "socialized medicine" at such a scheme, just to destroy it and

beg the question?

Give us some of your thinking on that.

Dr. EDWARDS. I would like to, Senator.

First of all, I believe very strongly that there has to be a national

health insurance plan. I think that this plan obviously has to have

certain general overall characteristics.

I think it has to be available and that everyone should have an

opportunity to be covered by health insurance.

I think that it has to build upon the strengths of the current system,

and certainly not the weaknesses, and you have alluded to several.

At the same time we have to build into the system certain efficiencies

and economies that will allow us to operate this system within cer-
13

tam n financial economic bounds. We have to build in certain utilization control factors which are in my judgment important.

We in the Administration are currently taking a new look at the

national health insurance scheme. We are looking at last year's administration of the proposal. We are looking at other proposals that

have been considered. We are looking at new approaches.

As Secretary Weinberger indicated just the other day, he feels

very strongly about having a plan of this type before the Congress

within the fairly near future. I do not like to put an exact date on it,

but certainly sometime in the next month or two.

Senator JAVITS. And you will lend yourself creatively toward that

objective?

Dr. EDWARDS. Absolutely.

Senator JAvirrs. Without being locked in, as I say, to any bias of

the profession?

Dr. EDWARDS. No. I do not believe I have any biases except that

I have the bias that we have to have a national health insurance

scheme of some kind.

We, have to build into that scheme certain quality control factors

that we currently do not have in the health care system in the country.

There are a number of specific issues like this that we really have to

think long and hard about, and the PSRO program will be one of

the key ingredients to any kind of a national health insurance scheme.

Senator J.:WITS. You will vote yourself in support of this question

of peer review and other similar issues?

Dr. EDWARDS. We are right now. I think probably at least in my

udgment it is the single most important thing that we have facing

us today.

Senator JAVITS. The other question I would like to ask you: Do you

subscribe to the principle that in our society we cannot accept the

proposition of who shall live and who shall die, or who shall be well

and who shall be killed, should be based on economic grounds?

Dr. EDWARDS. I absolutely subscribe to that philosophy. I believe

everyone should have access to quality health care.

Senator JAvrrs. I feel very strongly that is in a fashion our Hippocratic oath, as Senators and Representatives of the people, and I

want to be sure you feel that way.

Dr. EDWARDS. I wholeheartedly support that philosophy.

Senator JAVITS. My last question Doctor, is that we have raised

some issues with the Secretary which fall in your department about

the closing of the Public Health Services hospitals.

There are some plans afoot with which we disagree. I happen to

have a particular example of that in Staten Island in my State. I am

sure other Senators have the same situation in regard to other PHS

hospitals.

Will you assure us that you will review that situation with a view

toward coming to another independent conclusion?

Maybe you feel, as HEW apparently does, but maybe you do not.

I would like you to assure us you will review it.

Dr. EDWARDS. I certainly will, Senator. We sent just last evening to

the Congress our proposed plan for phasing out the Public Health

Service inpatient capabilities. In that plan we did not address ourselves to Staten Island and also to Norfolk, because we were unable
14

to provide what we considered an adequate alternative option for the

inpatient services.

It has been submitted to the Congress.

Senator JAVITS. That is the issue of course, whether you will or

will not shut down on inpatient services. Have you made a review of

it already?

Dr. EDWARDS. I have looked over the plan that was submitted as of

yesterday, and again I am convinced that it is a sound plan, that

we are providing adequate health care in those areas where we are

proposing to close down the inpatient capabilities of the hospitals.

We are in that position. That is our recommendation. Unless the

Congress sees otherwise, obviously we will carry out that mandate.

Senator JAVITS. Have you seen the testimony of the General Accounting Office in respect of the legality of closing down the inpatient

services for these hospitals?

Dr. EDWARDS. NO.

Senator JAVITS. Would you be kind enough to review that. We will

furnish it to you. You have it, I am sure.

Dr. EDWARDS. I am sure we do.

Senator JAvrrs. Will you be good enough to assure us that you will

review that legal opinion, but the GAO is the arm of the Congress

in that matter? I would greatly appreciate.

Dr. EDWARDS. Absolutely.

The CHAIRMAN. Senator Kennedy.

Senator KENNEDY. Thank you very much, Mr. Chairman. I want

to extend a warm welcome to Dr. Edwards, and congratulate him on

his nomination.

As you were mentioning, Dr. Edwards, one of the real challenges

in the health area is pulling together the various line responsibilties

that exist within HEW that affect the whole health care system.

As an Assistant Secretary of Health you have the line authority

for HSMHA and NIH, but you do not, as I understand it, in the

area of medicare and medicaid.

Do you have any plans or ideas about how to bring about a more

coordinated and administratively sensible organization? Are you

considering ways to exercise line authority over the financing

programs?

Dr. EDWARDS. Yes, Senator. Let me address myself to several issues

that bear on that point.

First of all, let me say that we certainly cannot have the kind of

input to have a meaningful national health insurance program without being involved more than we are today in a Bureau of Health

Insurance of SSA and the MSA group of SRS.

We have to be more involved in the decisionmaking that goes into

the development of standards, and things of that nature that require

a medical input.

We are currently in the process of doing a reorganization of Health

Services and Mental Health Administration. As you know, this is an

organization that has grown over the years, to the extent that it has

a budget of nearly $2 billion and some 27,000 or so employees.

Unfortunately the way this has grown has not lent itself to either efficiency or to meaningful direction in terms of an overall mission for the operation.
15

We are reorganizing this in a way which will take into account the

Bureau of Health Insurance of SSA and MSA., and give us a far

greater role in the development of the policies that come out of those

two organizations. I think this is absolutely essential.

Further addressing myself to the subject of coordinating, one of

the things that has not been true over the years in terms of the role of

the Assistant Secretary for Health, no one has ever really coordinated

and tried to develop within the Department of Health, Education, and

Welfare an overall national health strategy.

The National Institutes of Health have tended to develop their

strategies, the FDA has developed its strategy, and HSMHA developed its . strategy with little or no regard to what the others were

doing.

We find ourselves in the time when money is a little hard to come

by, and the trough is not quite as full as it used to be, with the rising

costs of our operation, we must first develop a meaningful national

strategy and develop a priority system in which we would fund those

issues that are most important to the welfare of the Nation.

This is what we are trying to do right now, and reorganization of

HSMHA will certainly take this into consideration.

Senator KENNEDY. You see this as one of your prime responsibilities, a more coordinated effectively administered health system in

the country?

Dr. EDWARDS. If we do nothing else but pull together these other

autonomous units into a single working meaningful one, we will have

made one of the really great contributions to the central health effort

that have been made over the last 50 years.

It is a tough job. There will be a number of obstacles to accomplishing this over the years, but in my judgment it can be done.

Senator KENNEDY. Let me go, if I may, into a matter which we

talked about in your last appearance before the health subcommittee.

This was on the use of the drug Depo-Provera. You indicated in response to some questions that if the use of Depo-Provera were widespread, this would be a matter of considerable concern to you.

During the course of those hearings you learned that Depo-Provera

was used widely in the practice of medicine in Tennessee, and also

that its manufacturer Upjohn was sending it to a number of different

people who were using it inappropriately.

Do you know whether the Food and Drug Administration has followed up on that aspect of the problem?

Dr. EDWARDS. I cannot give you the exact details. I know we are

following up on those groups that were using it without an IND.

We had our advisory committee give us certain recommendations

on the use of this which we have not implemented as yet. It is still

under study, but we are trying to certainly look into it in considerable

detail as to how this is being used against our regulations.

As you know, we have no control over the practice of medicine. We

do require, but it is not always followed, that any one using an experimental drug like this, or a drug for an experimental purpose, work

with us, and unfortunately this is not always done.

Senator KENNEDY. You see, it raises an issue which I know you are

all too familiar with by virtue of your time as Commissioner of the

Food and Drug Administration: the difficulty of preventing the mis-
16

use of experimental drugs, especially when those drugs are approved

for only a few indications.

We have reviewed that on other occasions. You remind us now about

the importance of establishing quality controls in the practice of

medicine, Obviously the use of drugs is of very considerable importance, and I am just wondering from our point of view how we

are going to be able to get a handle on this particular problem.

I am just wondering how, having come from the Food and Drug

Administration, now moving into an area of prime responsibility for

health in general, you are going to have any better handle on this

problem. Are you going to suggest to us legislative action to try to get

a handle on it.

Dr. EDWARDS. Senator, I have not had the opportunity yet to really

think in terms of new legislation. It is an extremely complex problem.

I think there is probably no single answer as to how we are going to

come to grips with it.

I think Congress in its wisdom in passing the PSRO legislation

definitely made a step in the right direction.

If we can develop some kind of quality control mechanism, it will

help, but in addition to that the pharmaceutical industry has to take

a much more active part in terms of monitoring the use of experimental

drugs.

The medical profession has to become more directly involved, or

perhaps if that does not do the trick, then I think obviously legislation will have to be the answer. I would be hopeful that we perhaps

have enough legislation currently.

There are always going to be unfortunately, as in any system, as

you know better than I those who do not quite operate by the

rules. But nevertheless I think that probably there are enough in the

current societies that if we can get the groups relatively involved in the

PSRO activity which is probably one of the major programs that can

do more to minimize this problem than anything.

Senator KENNEDY. Are you going to have recommendations other

than the PSRO's ?

Dr. EDWARDS. We definitely will. I am not able to say right now,

but we will have additional recommendations on the subject.

Senator KENNEDY. As you are developing those, would you draw

attention to these particular problems? I think we have identified,

with your help in the Food and Drug Administration, the experimental use of drugs and also unregulated experimental surgery. What can

be done in these areas? We already have had, as you probably know,

the introduction of legislation to ban psychosurgery.

Dr. EDWARDS. Right.

Senator KENNEDY. You can see we are perplexed and troubled by it,

and I would agree with you if you can handle this particular problem

without the need of legislation, fine. If not, I think in the areas of

drugs and also experimental surgery, we are going to have to take

some kind of action to protect the consumer.

Dr. Edwards. I think, as you have indicated, Senator, this is not just

an HEW problem or not just a congressional problem.

It is a problem in which we have to cooperate with you and vice

versa, and I hope that we can share our thoughts with you on the subject.
17

Senator KENNEDY. If we could go back as a followup at least to your

line of questioning, Senator Randolph, about the phasing out of some

of these authorities, the regional medical programs, the Hill-Burton

program, and the elect upon continued support of community mental

health centers. I am not interested in wrestling around with the distinction between a permanent or a demonstration program. The Senate

has acted to extend those programs. None the less, what I am interested

in is your view. The House is considering a similar piece of legislation

which would extend the programs for a 1-year period. I am sure you

are aware we have tried, over the period since May of last year, to

have an input from the administration in the consideration of a number of these programs, to try to make them more efficient, and eliminate

some of the inefficiency and duplication.

Through a series of circumstances we were unable to have that,

particular input, and I am not interested in reviewing that background.

We have extended these programs for 1 year with the commitment

to use the time for a thorough review of the entire Public Health

Service Act, hopefully with the recommendations of the administration, as to how they can be made more efficient and more equitable,

and eliminate the waste. That is our intention.

I am interested in a number of things. First, can you give us any

indication now, if the House acts in a way in which the Senate acted

for the continuation or extension of these programs, what the attitude

of the administration would be?

Dr. EDWARDS. Senator, I have not had any specific discussions on

what would happen in terms of the Administration's attitude and

their actions if in fact the public health authorities are extended.

My own personal feeling, however, is if the Congress extends them,

they are extended. We will carry out our responsibilities in administering the laws; and hopefully continue in discussion on how we can

make the system more efficient.

After all, you and the Congress are the ones that will call the ultimate shot on this, and we will abide by your decision.

Senator KENNEDY. Sometimes that has been a somewhat more open

question. [Laughter.]

Dr. EDWARDS. I recognize that, and I recognize some of the real differences of opinion, but again I can only say from our point of view in

the health field that we have the responsibility of administering and

managing the laws that are passed by the Congress. We certainly will

do that if that is the way it ends up.

Senator KENNEDY. Could you at this time give us any idea as to

when the views of the administration would be known on these several

authorities which have been extended by the Congress?

We received the other day the proposal on the extension of the medical libraries legislation, some general comments from the Secretary

about the extension of some of the other programs. I know it is difficult in setting dates, but is there anything you can tell us about that?

Dr. EDWARDS. I think the Secretary intends to send up today—I

think he sent up this morning as a matter of fact; I cannot tell you

exactly which proposals—but a number of specific legislative proposals.

Senator KENNEDY. In these areas?

Dr. EDWARDS. In these 'areas; right.
18

• Senator KENNEDY. Could you augment this testimony and include

those as well?

Dr. EDWARDS. Absolutely.

[The information subsequently supplied follows:]

[ S. 1515, 93d Cong., 1st sess.]

A BILL To make permanent the authority to conduct national health surveys and studies

Be it enacted by the Senate and House of Representatives of the United States

of America in, Congress assembled, That section 305(d) of the Public Health

Service Act is amended by striking out "and" before "$25,000,000", and by

inserting ", and such sums as may be necessary for each succeeding fiscal year"

after "June 30, 1975".

[ S. 1450, 93d Cong., 1st sess.]

A BILL To consolidate and extend the authorizations for appropriations for assistance

to medical libraries, to repeal provisions for assistance for construction of facilities and

for grants for training in medical library sciences, and for other purposes

Be it enacted by the Senate and House of Representatievs of the United

States of America in Congress assembled, That this Act may be cited as the

"Medical Library Assistance Amendments of 1973".

CONSOLIDATION AND EXTENSION OF APPROPRIATIONS AUTHORIZATION; REPEAL OF

CONSTRUCTION AND TRAINING AUTHORITIES

SEC. 2. (a) Section 390 of the Public Health Service Act is amended by inserting after subsection (b) the following new subsection:

"(c) In order to enable the Secretary to carry out the purposes of this part

there are authorized to be appropriated such sums as may be necessary for the

fiscal year ending June 30, 1974, and each of the next two fiscal years."

(b) Subsection (b) of such section is amended by striking out clauses (1)

and (2) thereof, and redesignating clauses (3) through (7) as clauses (1)

through (5), respectively.

(c) Section 391 of such Act is amended by striking out clause (3) and redesignating clause (4) as clause (3).

(d) Section 392(b) of such Act is amended to read as follows:

"(b) The Board shall advise and assist the Secretary in the preparation of

general regulations and with respect to policy matters arising in the administration of this part."

(e) (1) The first sentence of section 395(a) of such Act is repealed, and the

second sentence of such section is amended by striking out "Sums made available under this subsection shall be utilized by the Secretary to" and inserting

in lieu thereof "In order to carry out the purposes of section 390(b) (1), the

Secretary may".

(2) The first sentence of section 395(b) of such Act is repealed, and the

second sentence of such section is amended (A) by striking out "Sums made

available under this subsection shall be utilized by the Secretary in making"

and inserting in lieu thereof "In order to enable the Secretary to carry out the

purposes of section 390(b) (2), the Secretary may make", and (B) by striking

out "entering" and inserting "enter" in lieu thereof.

(f) (1) The first sentence of section 396(b) of such Act is amended by striking

out "Sums made available under this section shall be utilized by the Secretary

for making" and inserting in lieu thereof "In order to enable the Secretary to

carry out the purposes of section 390(b) (3), the Secretary may make".

(2) Section 396(a) of such Act is repealed, and sections 396(b) and 396(c)

are redesignated as section 396(a) and 396(b), respectively.

(g) (1) The first sentence of section 397(a) of such Act is repealed, and the

second sentence of such section is amended by striking out "Sums made available

under this section shall be utilized by the Secretary, with the advice of the Board,

to" and inserting in lieu thereof "In Order to enable the Secretary to carry out

the purposes of section 390(b) (4), the Secretary may, with the advice of the

Board,".

(2) Clause (6) of section 397(b) of such Act is repealed, and clause (5) of

such section is amended by striking out "; and" inserting a period in lieu

thereof.
19

(3) The first sentence of subsection (d) of section 397 of such Act is repealed.

(h) The first sentence of section 398(a) of such Act is repealed, and the

second sentence of such section is amended (A) by striking out "Sums made

available under this section shall be utilized by the Secretary, with the advice

of the Board, in making" and inserting in lieu thereof "In order to enable the

Secretary to carry out the purposes of section 390(b) (5), the Secretary may, with

the advice of the Board, make" and (B) by striking out "entering" and inserting "enter" in lieu thereof.

(i) Sections 393, 394, 399, and 399b of such Act are repealed. Sections 395,

396, 397, 398, and 399a are redesignated as section 393, 394, 395, 396, and 397,

respectively.

EFFECTIVE DATE

SEC. 3. This Act shall be effective with respect to appropriations for fiscal years

beginning after June 30, 1973, except that in the case of any individual who, for

the fiscfil year in which this Act is enacted, has been awarded, directly or through

an institution, a grant or other assistance under section 394 of the Public Health

Service Act (as in effect prior to such enactment) for a fellowship, traineeship,

or other course of education or training, such section shall remain effective to

continue such grant or other assistance from appropriations under section 390(c)

of the Public Health Service Act (as amended by this Act) for fiscal years

ending prior to July 1, 1976.

[ S. 1632, 93d Cong., 1st sess.]

A BILL To extend for three years the programs for comprehensive State and areawide

health planning, and for comprehensive public health service and health services

development, and to repeal a requirement that at least 15 per centum of a State's

formula allotment for public health services be available only for mental health services.

Be it enacted by the Senate and House of Representatives of the United States

of America in Congress assembled, That (a) sections 314(a) (1), 314(b) (1) (A),

314(d) (1), and 314(e) of the Public Health Service Act are each amended by

inserting ", and such sums as may be necessary for each of the next three fiscal

years" after "for the fiscal year ending June 30, 1973".

(b) The first sentence of section 314(b) (1) (A) of such Act is amended by

striking out "and ending June 30, 1973" and inserting in lieu thereof "and ending

June 30, 1976".

SEC. 2. Effective with respect to appropriations for fiscal years beginning after

June 30, 1973, section 314(d) (7) of such Act is repealed.

[ S. 1633, 93d Cong., 1st sess.]

A BILL To make permanent the program of research and demonstrations relating to

health facilities and services

Be it enacted by the Senate and House of Representatives of the United States

of America in Congress assembled, That section 304(c) (1) of the Public Health

Service Act is amended by striking out "and" before "$94,000,000", and by inserting ", and such sums as may be necessary for each succeeding fiscal year" after

"June 30, 1973".

[ S. 1634, 93d Cong., 1st sess.]

A BILL To amend the Drug Abuse Office and Treatment Act of 1972 to modify the

authorization of appropriations for the program of special project grants and contracts,

and for other purposes

Be it enacted by the Senate and House of Representatives of the United States

of America in Congress assembled, That subsection (b) of section 410 of the Drug

Abuse Office and Treatment Act of 1972 is amended by—

(1) striking out "$100,000,000" and inserting "such sums as may be necessary"

In lieu thereof; and

(2) striking out "$160,000,000" and inserting "such sums as may be necessary"

in lieu thereof.

Senator KENNEDY. You have talked with Senator Javits about a

health insurance program, and I think it is particularly important

that we have a chance to consider the extension of the Public Health
20

Act over the period of the next year along with the idea of the administration's program on health insurance. We need to develop a strategy

for the reform of the overall health system including organization

and delivery of health care, not just financing mechanisms.

I would hope that as the administration develops its particular proposals it would take that into consideration as well, so that they complement each other.

Dr. EDWARDS. Your point is extremely well taken.

Senator KENNEDY. I think the significance of this point is dramatized quite clearly by the dilemma that we are facing with the extension of the mental health centers legislation, as to whether the community mental health centers are really going to be able to find financinob

from third party payments.

As you probably know in the administration proposal on health

insurance last year there was no real provision for reimbursing the

community mental health centers. Yet the administration's budget

proposal with regard to community mental health centers, fulfills the

commitment for the 8 years for the ones that have been started, but

after that they would be on their own.

I -reviewed with the Secretary on other occasions, and I have really

no intention of doing so today, the fact that it is an extremely small

part of the payment for compensation in the community mental

health hospitals that has heretofore come from third party payments.

It is very, very small.

So I would hope that in the administration's proposals on mental

health centers, or when you have your health insurance proposal, that

you are going to be able to outline to us how that is going to be done,

because I think it is one of the very important questions which I think

today remains unresolved. -

I know the Secretary has explained his view, that he thinks resources

can be raised in local communities, in the State and other kinds of

mechanisms, but I am sure you are aware that the various studies that

have been done within the administration have dramatized the difficulty in gaining compensation in these areas, and I think that would

certainly be my conclusion as well.

I am very hopeful, that regardless of the outcome of the extension

legislation and whether the administration will veto it or not, that you

will consider these particular problems, because I think they are terribly important and really basic to the continuance success.

I do not know if you have any reaction.

Dr. EDWARDS. The point you have just made regarding the phasing

out of the community mental health centers program is a good example, and we are basing our case partly on the availability of funds

elsewhere.

This is one of the things we are going to have to provide in orm

national health insurance scheme, some increased funding for this

kind of activity.

Senator KENNEDY. .1-11St fin ally on this Point, Dr. Edwards, under the

range of services that are being provided, for example in these neighborhood health centers and other community oriented facilities, which

I think have been extremely successful, your own evaluation study has

indicated difficulty in getting third party payments.

think there is a wide range of different services provided today,
21

and one of our concerns would be that a health insurance program not

bring about a dimunition of these essential programs.

Maybe there are certain ones again that can be improved. I am not so

sure it is very difficult to indicate which ones they would be, and I

think in most instances they probably could be improved.

I do not know whether it is fair to ask you about your impressions

of these various evaluations that have taken place at HEW; 1 percent

of the funding in many of these health programs is reserved for evaluation of programs.

I think generally, during any period of time, perhaps the Congress

has not been as farsighted as we should have been in evaluating the

various health programs. That is why we provided the set aside of

the 1 percent for evaluation to take place. I think we all realize the

importance of it.

As a former associate in the Booz Allen & Hamilton consulting firm,

I do not know whether I want to put you in a position of saying what

you think of outside evaluations.

Dr. EDWARDS. Senator, with or without the Booz Allen, I think it

has got to be a mix. I think unfortunately too many of the programs

that are ongoing in the Department of Health, Education, and Welfare have never had built into them any evaluating process, in-house

evaluating. I think good management has to have constant mechanism,

or a mechanism which will constantly evaluate the operation of their

program. This has not been done in most instances.

We have worked hard. I think we have pretty well got it under control. On occasion, it is important to bring in outside expertise, but

perhaps it has been highly overdone. Frequently we think because we

bring someone in from the outside, we are suddenly going to have

simple answers to some complex problems. It does not happen that

way.

The need for good balance between in-house evaluation and extra--

mural evaluation is very important.

Senator KENNEDY. Finally, Dr. Edwards, let me raise just one or

two other issues with you. In May of 1971 HEW put out a white paper

on health policy for the 1970's. On page 37 of that document it says:

"Finally the administration would use the supremacy laws of the

Constitution to preempt in connection with Federal insurance programs those legal barriers that limit the use of allied health personnel

or organizational form of HMO. The goals of the administration are

to develop 450 by the end of 1973, 100 of which would serve areas.

with scarcity of health care resources. By the end of fiscal 1976 the

plan calls for 1,700 HMO's, with a potential of enrolling 40 million

people"; and on February 21, 1973, Secretary Weinberger sent his

HMO statement to Congress and stated this proposed legislation is

designed to carry out the President's recommendations for Federal

program to assist in demonstrating the feasibility of health maintenance organizations as a part of a pluralistic health care delivery

system.

"We view the effort to assist and develop health maintenance organizations as a demonstration effort that will emphasize different forms

of HMO's and will emphasize geographic distribution of the concept

that has already been proved workable," and so on.

What do you think accounts for the rather dramatic change in the.

2-year period on that policy?
Dr. EDWARDS. I am not sure I can answer your question. I had

nothing to do with the development of the 1971 policy. I think it was

totally unrealistic. What we are attempting to do now—in the demonstration route—is to provide startup funds and initial operating funds

to various kinds of HMO's. This is a very realistic policy. I happen to

believe HMO's are very important in terms of the total health care

system. I think there is a great deal of spade work that needs to be

done before we can develop a national policy that says we are going

to have x number by x date. I just do not think it can be done.

We are moving in the right direction now, and the 1971 position was

• a wrong position.

Senator KENNEDY. Do you have some studies which would show it

was unrealistic ?

Dr. EDWARDS. There are some studies that have been done. I do not

have them at my fingertips. I am not even sure what the studies are,

but I am speaking personally, probably, more than with the benefit

of any particular study.

Senator KENNEDY. Well, I want to thank you for your appearance

here, Dr. Edwards. I think we have got a lot of work to do, both those

of us on this committee, and you within the administration in getting

a handle on these various health proposals and programs. I hope that

we would be able to work together. The kind of problem that we are

confronted with and the number of proposed programs to be phased

out I think presents us with some very significant difficulties and

problems.

I think, for example, in the Hill-Burton hospital program, Mr.

Weinberger is entirely correct about the overbuilding of various hospital beds, but you cannot ignore the importance, which has been recognized in 1972 and 1973 budgets, about the importance of building

ambulatory care facilities and modernization of various hospitals, particularly those in many of the great urban centers of this country. I do,

not think there is any member of the committee who wants to waste

the money in overbuilding hospital beds. Yet, I think all of us on the committee recognize the need for the continued support for ambulatory

care and support for modernization of some of the hospitals in areas

of tremendous need.

I would hope that we are not going to be constantly put in a posi- tion where we are trying to force things on each other, without co- opergtions of the kind that is in the Nation's interest.

I think obviously in the regional medical programs there are a

number of parts that ought to be altered and changed and streamlined.

But there are some parts of it that are valuable. I am hopeful that

we can try and achieve what I think has been the President's goal of efficiency and elimination of waste.

I think we are going to have still some problems obviously in other

areas in which we are going to have to just wrestle them out. But I

think there is a wide variety of matters which hopefully we could

work together on and not be put into positions of complete hostility

and confrontation, and I hope that, as with Dr. Duval, that we can

work together to try and achieve what is in the best interest of the public.

I want to thank you for your appearance and for your comments

and look forward to voting for your nomination.
23

Dr. EDWARDS. Thank you, Senator. I can only say I completely shareyour thoughts on the need to work together in a cooperative way.

The CHAIRMAN. Senator Taft.

Senator TAFT. Thank you very much, Mr. Chairman.

Dr. Edwards, I would like to join in welcoming you here. We have

had an acquaintanceship and a friendship over a number of years. I

have no particular questions for you. I wish you well in your undertaking. There are many extremely important developments in the

health field and I think you are very well qualified for this position.

I am delighted you are going to be in the position of working with

us to try to come up with meaningful answers to those problems.

Dr. EDWARDS. Thank you, Senator Taft.

The CHAIRMAN. Senator Cranston.

Senator CRANSTON. I want to join in expressing my pleasure at your

nowination that is presently before us. I am confident your experience

in public service, both in the community and in government, will enable

you to provide effective leadership in coordinating and directing;

the programs of the National Institutes of Health, the Health Services and Mental Health Administration, and Food and Drug

Administration.

The programs administered through these agencies affect the lives of

every individual in the country, and obviously there importance cannot be simply overstated. I am proud the State of California has contributed so much to the Nation's resources in terms of trained health

manpower, advances in biomedical research and development of innovative programs and ways of providing health services. I look forward

like the other members of this committee to working with you, Dr.

Edwards, in building upon these resources for the benefit of the Nation

and in insuring the contribution they have made and are capable of

making in the future, not lost by virtue of sacrifices, scientific advances

to unwise budget consideration.

I have just two very brief questions to ask you.

First, can you tell me what you plan in developing outlines or developing guidelines for PSRO's to develop their recommendation and

input from consumers as well as in all health disciplines and with all

health disciplines in these organizations?

Dr. EDWARDS. Senator, thank you very kindly for your comments.

As far as PSRO's are concerned, as you know the law is rather specific, in regard to the constitution of the advisory council. We are in

the process right now of evaluating some 250 names that have been

submitted to us by organizations that both consumer, professional and

those designated by the law—we will very shortly have our recommendations to the Secretary. It is still in draft form. But we have got

good cross sectional representation.

We have good professionals on the council, and we also have some

very knowledgeable consumer groups.

Senator CRANSTON. Thank you. On the question of transferring the

in-patient care responsibilities to community facilities, have you consulted representatives of the beneficiaries 

Dr. EDWARDS. I am certain they have been specifically consulted,

Senator. A lot of this was done before I got here, and I am not sure

exactly what organizations were consulted. I know some were, but I

would not want to be specific. I will look into it.
24

Senator CRANSTON. Do you not think groups like this should be

consulted?

Dr. EDWARDS. Absolutely.

Senator CRANSTON. Thank you very much. I am to delighted to

have the opportunity to vote for you and work with you.

The CHAIRMAN. Senator Mondale.

Senator MONDALE. Thank you very much. I note by your biography

that you have spent a lot of time in my State of Minnesota.

Mr. EDWARDS. I certainly did.

Senator MONDALE. I have many questions, but I think I will just, in

the light of the time, ask questions in one area, namely the proposed

termination of training grants for medical schools.

Last week Senator Humphrey and I and others had hearings in

Minnesota on the proposed budget, and some witnesses came over

from the University Medical School which from your own experience

you know to be one of the outstandino•

b

teaching and research institutions in the world. One of them said that a demolition committee could

not have hurt the medical school more than this budget. They emphasized, among other things, the termination of training grants.

As I understand their argument, training grants are the essential

way that they encourage the brightest in the medical class to pursue

the somewhat underpaid, monkish life of medical service. They work

in teams, then with some of the senior research people in the field of

health, and it is a vital element in the medical research system of our

country. Could you respond to this?

Dr. EDWARDS. Yes, Senator. First, let me say there is no question certainly in my mind that we have to continue to have in the pipeline,

people who are adequately trained to do good research in the biomedical delcl. There is no question about that. I think that anyone who is

really honest with you would have to say, however, that the research

training grants have over the years—although they have done a lot

of good—they have also been abused and misused.

I think one of the things the medical schools in this country have

got to do is take a good hard look at the way they have used medical

funds.

Senator MONDALE. Would you say this budget looks toward reform

as you have mentioned it, or does it just terminate the program?

Dr. EDWARDS. It obviously terminates the program. We in health

field though have got a tremendous responsibility—in other words, the

administration's position is that there are sufficient trainees in the pipeline to keep an adequate supply of good research people in the medical

institutions throughout the country.

Senator MONDALE. Do you see any value in the training grant

program?

DI EDWARDS. I think it served a very, very meaningful role.

Senator MONDALE. I do not mean in the past tense. I mean in the current situation, the future?

Dr. EDWARDS. We have to have some kind of resources available to

those who want to pursue careers in research. One of the administration's positions is that we feel that there are funds available under the

Office of Education to pursue these careers, not just for those interested in the biomedical field, but physics and other fields. In other

words, we feel that there is sufficient in the pipeline to keep it going

and that they are sufficient in the way of resources in the Office of
25

Education to provide the funding for those that are truly interested

in careers 

Senator MONDALE. Would you agree though that most medical

schools in this country do not concur with what you just said?

Dr. EDWARDS. I certainly agree.

Senator MONDALE. Thank you.

Senator KENNEDY. Nor does NIH or the NIH report?

Dr. EDWARDS. No. I recognize, Senator Mondale and Senator Kennedy, that this is not a popular position and as I said, one of the real

),;ripping responsibilities that we have involved in the Federal effort

is to monitor this to be sure that it is coming off—if this is the route it

goes.

Senator MONDALE. If the President's budget approaches this in the

way I understood your first answer to be—reform—let's take a look

at the waste. I think you would find a tremendous amount of sympathy

and cooperation, if you focused on cutting down on waste because

none of these programs are perfect.

We all agree there is waste. But what worries us is this arbitrary

immediate termination of programs which are both good and bad. It

would be far better to approach it in the way that your first answer

suggested.

The CHAIRMAN. Senator Pell.

Senator PELL. I have no questions except to say I had a good talk

with Dr. Edwards, and he is aware of the frustration of many of us in

Congress. We pass laws which we find are not being followed. I think

he will do the best job he can, and I look forward to supporting his

nomination.

Dr. EDWARDS. Thank you, Senator.

The CHAIRMAN. Anything further, gentlemen?

Thank you very much, Dr. Edwards.

[ Whereupon the committee proceeded to further business.]

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