-

There is reason to believe that the officials and employees of the food, drug, and cosmetic industries are, as a class, as well or better informed concerning the operation of the food and drug laws than any other group in the country. The public, on the other hand, has only a vague impression of the role of Government in protecting the food and drug supply its misconceptions vary from being unaware that such function is performed to the belief that each tablet in a bottle of aspirins has been tested by a Government scientist. It is understood that an increase in the dissemination of information to the public will require the cooperation of the Congress. It is thought that this cooperation will in fact increase with the success of the program. Certainly the ultimate assurance of financial support of a regulatory agency should be not the goodwill of the industry it regulates but public understanding of the job it does.

Greater emphasis should also be put upon the continuing training of FDA employees, including the attendance of scientific personnel at meetings, seminars, and symposia, under both public and private sponsorship, which are calculated to enhance their scientific interest and understanding, and upon the training of State and local health officers in the methods and procedures of food and drug law enforcement.

It is recommended:

6. That funds be sought to make possible the wider distribution of FDA reports and bulletins, that programs be developed for the training of FDA and other food and drug personnel, and that the participation of FDA scientists in scientific meetings and the preparation of scientific papers be encouraged. CONCLUSION

We conclude that the essential functions of the Food and Drug Administra. tion have been and are being performed. We conclude that FDA personnel are more than ordinarily dedicated to the purposes of the agency. We conclude that decisions have not been made in defiance of the public interest or to conform with considerations of personal gain or aggrandizement. We conclude that the relationship of FDA personnel to the regulated industries can be stabilized at the level of helpful cooperation. We conclude that the growth of the food, drug, and cosmetic industries and the increased responsibilities of the Food and Drug Administration with respect to those industries, call for the consideration of sɔre reorganization, the promotion of increased efficiency, increased staff, improved facilities, and encouragement by these means and others to even greater devotion to the job.

U. S. DEPARTMENT OF
HEALTH, EDUCATION, AND WELFARE
Office of the Secretary
Washington 25, D. C.

December 29, 1960

MEMORANDUM FOR THE PRESS

Charles H. Kendall, who directed the special investigation of charges involving certain operations of the Food and Drug Administration, is General Counsel of the Office of Civil and Defense Mobilization.

He was assisted by Charles Austin Doan, M.D., Dean of the School of Medicine at Ohio State University; and William A. Costello, Regional Inspector for the Internal Revenue Inspection Service covering the States of New Jersey, Pennsylvania, Delaware, and Maryland.

Mr. Kendall's services were made available by Governor Leo Hoegh, Director of the Office of Civil and Defense Mobilization. Mr. Kendall has been General Counsel of that agency and its predecessor, the Office of Defense Mobilization, since 1953. A native of Buffalo, N. Y., Mr. Kendall earned his law degree at the University of Buffalo in 1933. After practicing law in Buffalo for eight years, he came to Washington in 1941 and served as assistant to John Lord O'Brien in the Office of Production Management and the War Production Board until 1944, when he joined the United States Navy. After two years of active duty aboard an aircraft carrier, Mr. Kendall served for two years as General Counsel of the Office of the Foreign Liquidation Commissioner and then for 2 years as General Counsel of the National Security Resources Board. In 1951 he was appointed General Counsel of the Defense Production Administration, from which he was appointed General Counsel of the Office of Defense Mobilization.

Mr. Kendall served as Legal Advisor to the Presidential Mission to China and the Philippines in 1946. He is a member of the National Council of the Federal Bar

Association.

Dr. Doan has been Dean of Medicine as well as Director of Hospitals and Director of Medical Research at Ohio State University since 1944.

A native of Nelsonville, Ohio, he did his undergraduate work at Hiram College,

Ohio, and his graduate work at the University of Cincinnati, Johns Hopkins University, where he earned his M.D. degree in 1923, and Harvard Medical School.

Dr. Doan is a member or officer of scientific societies and has held several positions with the United States Government. These have included service as Expert Consultant to the Surgeon General of the United States Army; Chairman of the Hemotology Study Section of the National Institutes of Health, U. S. Public Health Service; and member of the Commission on Blood and Blood-Forming Organs of Panel on Clinical Physiology, National Research Council. Dr. Doan also served in the Medical Corps of the U. S. Army during World War I, advancing to Sergeant in Charge of the Bacteriological Laboratory.

Mr. Costello was born in Lawrence, Massachusetts, and attended the Massachusetts Institute of Technology and Suffolk University Law School, receiving an LL. B. degree, cum laude, from the latter school.

He first entered Government service in 1938 as an agent with the Internal Revenue Service, and subsequently served as a Special Agent with the Federal Bureau of Investigation from 1942 to 1946. After leaving Government service, he accepted employment with a Boston corporation as Counsel and Protection Manager, and, beginning in 1948, engaged in the private practice of law for several years in Boston. He re-entered the Internal Revenue Service in 1955, and has served in his present position since that time.

He is a member of the Bar in the States of Massachusetts and New Hampshire

and is admitted to practice before the United States Supreme Court.

Mr. Costello is married and is currently residing in Bryn Mawr, Pennsylvania.

1

"3. That a reasonable control be put upon the access of industry representatives to FDA personnel considering actions affecting the industry."

"4.

I believe that this recommendation is a sound one provided that emphasis is given to the word "reasonable." The right type of relationships between FDA personnel and industry can be very beneficial to the consumer. On the other hand, relationships that result in undue pressures being exerted by industry cannot be condoned.

I have requested the Commissioner of Food and Drugs to develop a memorandum for me setting forth what is now being done in order to achieve this "reasonable control" together with recommendations for additional steps that he believes should be taken. It is my intention to act on these recommendations and to make my decision public not later than January 16, 1961.

That a closer relationship between the FDA and its personnel on the one hand and State and local health authorities and staffs on the other hand be encouraged."

I agree with this objective. I have asked the Commissioner of Food and Drugs to provide me with a memorandum setting forth what is now being done in order to achieve the objective and containing recommendations designed to achieve further progress in this area. It is my intention to act on these recommendations and to make my decision public not later than January 16, 1961.

"5. That reorganizational steps be taken to assure FDA scientists that their views will be presented and considered in the making of decisions at the Commissioner's level."

I agree with the objective of this recommendation. I have requested the Commissioner of Food and Drugs to work with the Office of Administration in the Office of the Secretary with the end in view of presenting to me not later than January 16, 1961, a reorganization plan designed to achieve this objective.

"We conclude that FDA personnel are more than ordinarily
dedicated to the purposes of the agency."

"We conclude that decisions have not been made in defiance
of the public interest or to conform with considerations of
personal gain or aggrandizement."

The

The Special Investigative Unit has made six recommendations: recommendations and the actions I have taken or propose to take on the recommendations follow:

"1. That existing regulations concerning the conduct of FDA
employees be reexamined for clarity and specificity, and
that the receipt of gratuities from and the payment of
expenses by industries subject to regulation on both
food and drug laws be expressly forbidden."

"2.

The Department has had regulations, including regulations
relative to the receipt of gratuities and the payment of
expenses, concerning the conduct of all employees of the
Department of Health, Education, and Welfare who are
engaged in regulatory activities. All of these regulations
have been reexamined and changes have been issued from time
to time during the past few months. I am releasing today a
codified version of all of these regulations. I feel that
they are consistent with not only the letter but the spirit
of the recommendation made by the Special Investigative Unit.

That an office of internal inspection be established in
FDA reporting directly to the Commissioner with a small
professional staff to conduct field and headquarters
office inspection, to make investigations of alleged mis-
conduct by employees, and to serve as a direct channel of
communication to the Commissioner for complaints by or
against any employee of the agency."

I have accepted this recommendation and have requested the
Commissioner of Food and Drugs to designate an Assistant to
the Commissioner and charge him with these duties. I have
asked to have the position filled by January 16, 1961.