drugs and antibiotics, and it recognizes the importance of and need for comprehensive competent scientific data and information on the safety and efficacy of new drugs. I shall continue to insist upon the fullest submission of safety and efficacy data necessary for intelligent study and evaluation of new drug applications. 9 10 I concur in this recommendation that FDA should have a sound research progrem on methodology and drug testing. Such a research program is an essential part of the Food and Drug Administration's effort to improve its enforcement operations. We recently increased our work in this area end plan to broaden it still further. I concur in this recommendation that the Commissioner Recommendation 11 Comments I concur in this recommendation that FDA needs expanded resources support. Without adequate resources of both funds and personnel the great responsibilities imposed upon the Food and Drug Administration cannot be met. I anticipate increased recognition of this fact. ### We realize that you have many demands on your time, but feel that you may wish to assist us in the evaluation of this agent in particular since the manufacturer hasused à general comment of yours as a reference in what may or may not be a misleading fashion in the product brochure. There is enclosed a collection of data, reprints, and summaries of published papers supplied by the manufacturer. You will render invaluable assistance to the Council by reviewing this material and providing us with your assessment and evaluation of the drug... Your comments are especially invited concerning the adequacy of the laboratory and clinical data, usefulness, indications and contraindications and toxicity of the drug; comparisons with other similar drugs would also be helpful... Each drug description is designed to provide fair comment and criticism based on available evidence, whether or not this is considered adequate to establish usefulness. Thus, the monographs may be either favorable or unfavorable. EXHIBIT 3 Washington, D.C. Honorable Arthur S. Flemming Secretary of Health, Education, and Welfare Washington 25, D.C. Dear Mr. Secretary: I am happy to submit herewith the report of the Special Investigative Unit appointed by you last June to look into certain charges involving employees and operations of the Food and Drug Administration. The opinions expressed are the joint and several opinions of the members of the Unit, without dissent. I trust that you will find them helpful. The other members of the Unit have authorized me to express our appreciation for the very fine cooperation of the many persons upon whom we had to call for help, from your own office, Mr. Miles' office, the General Counsel's office and the entire Food and Drug Administration. We also wish to thank you for the expression of confidence in us which is implicit in the assignment. Sincerely yours, Enclosure 73753 0-61-pt. 2-2 /s/ Charles H. Kendall REPORT TO THE SECRETARY OF HEALTH, INTRODUCTION This is a report based upon an investigation into the personnel and operations of the Food and Drug Administration. The investigation was made, at the request of the Secretary of Health, Education, and Welfare, by a special investigative unit, made up of an investigator, a doctor, and a lawyer, none of whom was earlier connected with the Food and Drug Administration or the Department of Health, Education, and Welfare. The report is advisory only, involving opinions and recommendations based upon searching inquiry over a period of six months. The Food and Drug Administration is that agency of Government charged with the administration and enforcement of the Federal food, drug, and cosmetic laws. It and its predecessor agencies have for 54 years been responsible for providing the people of the United States with such assurance of safety and wholesomeness in food and drugs as the Congress has from time to time seen fit to require. As of this time the pertinent statutes call for the maintenance of a great many safeguards in terms of purity, potency, cleanliness, labeling, specifications, toxicity and control in the fields of food, drugs, and cosmetics. The faithful and effective performance of these functions is, of course, directly related to the health and well-being of every individual and therefore stands high among the responsibilities of Government itself. In the Spring of this year a witness before a committee of the United States Senate said: "I believe also that hundreds of people, not merely in this country, suffer daily, and many die because the Food and Drug Administration has failed utterly in its solemn task of enforcing those sections of the law dealing with the safety and misbranding of drugs, particularly prescription drugs." This statement was made by a physician of substantial training and experience, including experience as an official of the Food and Drug Administration. It was made shortly after evidence had been produced before the same committee to the effect that a former FDA official Dr. Henry Welch, Director of the Antibiotics Division had, over a period of seven years, received about two hundred thousand dollars in payment for services to a publishing firm which payments had been measured by the amount of sales to the drug industry of advertising space and reprints of articles in the publishing firm's journals. The accusation and the disclosure, in juxtaposition, colored and accented each other. It was under these circumstances that the Secretary of Health, Education, and Welfare made the assignment to this unit, and to a committee of scientists appointed by the President of the National Academy of Sciences, of responsibility for a thorough and impartial examination into the facts. The scientific committee reported, under date of Sept. 27, 1960, that the scientific decisions of the Food and Drug Administration were acceptable and showed no evidence of disregard of the public health. This report deals with issues of employee integrity and relationship to the regulated industries. |