MEDICAL OFFICER (APPROPRIATE SPECIALTY) GS 602-14, BUREAU OF DRUGS, OFFICE OF SCIENTIFIC EVALUATION

INTRODUCTION

The incumbents of these positions work in one of the Divisions of the Office of Scientific Evaluation (exception Division of Clinical and Medical Devices). The functions of the Office of Scientific Evaluation and the Divisions are described in the Supervisory Staff Manual Guide, FDA 1332. The incumbents perform the medical evaluatory review of drugs required by the Food, Drug, and Cosmetic Act, which must precede the approval of a drug for shipment in interstate commerce for investigational use, for commercial marketing, and follows and evaluates reports and literature of marketing experience. In essence, they thoroughly evaluate the great body of clinical experience data submitted by the nation's drug industry to support NDA, IND, and associated applications and

develop a medical judgment which is generally accepted as authoritative by their supervisors as to the safety and efficacy of subject drug application. As a result of the 1962 Kefauver-Harris Amendments to the Food, Drug, and Cosmetic Act, industry conducts and medical officers review an increasingly large volume of research data. As a consequence of the growing sophistication of drugs under development, the medical evaluation for which the incumbents bear initial and substantial responsibility have become increasingly complex and significant. The duties of this position are essentially those of a senior medical specialist and constitute the journeyman level for medical officers in these Divisions.

DUTIES

In performing this evaluatory work, the medical officer determines whether clinical trials of new drugs on man are soundly conceived and supported by prior animal testing and other controls adequate to justify tests on man; whether applications by manufacturers for permission to market new drugs for general use should be approved based on an evaluation of the evidence of their safety and effectiveness; whether proposed labeling contains truthful claims for safety and effectiveness, and adequate directions for use and warnings against misuse. The medical officer reviews supplements and amendments to previously approved NDA's, most of which were approved on the basis of safety only and must be thoroughly reviewed for efficacy in acting on a supplement; periodic reports submitted by sponsors on drugs approved for marketing; adverse reaction inspection, and other surveillance reports. Makes medical decision in each case as to whether the drug should be withdrawn from the market by the sponsor, whether the previously approved NDA should be revoked, whether changes in the labeling are required, and, in the case of supplements, whether the information available supports approval of the supplement.

Reviews the summaries of pharmacologists and chemists, and makes his medical summary and recommendation that an NDA or a supplement submission be approved, is incomplete on specific points, or be disapproved; that an IND be continued or modified, or terminated, or an effective NDA be withdrawn or revoked.

The Medical Officer is assigned work in the area of his medical specialty, inasmuch as this is practicable based on the applications received. Normally, drug submissions assigned for review will include drugs whose evaluation will be difficult and require mature professional judgment: however, when it is possible to make a determination in advance, drug applications involving the most difficult, advanced, or controversial elements will be assigned to other Medical Officers considered to be the Agency's foremost specialists in the area.

In order to arrive at a conclusive medical opinion, the Medical Officer considers a variety of types of information, (such as research findings, clinical studies, etc.) on the drug and related drugs. After consultations with superiors, provides authoritative comment on research set-ups and new techniques, by phone or personal contact with drug company representatives. Prepares correspondence requesting information on facts of the case inadequately presented.

Consults with other medical specialists and scientists within FDA and in other government agencies, universities, hospitals, and clinics. May recommend that additional studies be made under an FDA contract, or that consideration of a drug or group of drugs be given by a specially constituted committee of physicians and scientists.

Keeps abreast of the progress in medical and related sciences by reviewing the scientific literature, attending conferences, and participating in staff seminars at which cases and special topics are discussed.

SUPERVISION AND GUIDANCE RECEIVED

The incumbent works under the general supervision of the Division Director or a senior Medical Officer. The incumbent makes his study of each case with relative independence. During the course of review, however, he and his supervisor will discuss periodically the progression of the review, and emerging problems and information gaps. The supervisor will advise the Medical Officer regarding the unusual or controversial aspects of the case. Following the Medical Officer's completion of the case, if the supervisor disagrees with the conclusions reached, he discusses his disagreements with the Medical Officer and with any other interested Medical Officers and scientists in an attempt to reach an agreement.

LEVEL OF PROFESSIONAL DEVELOPMENT

Completion of residency training of 3 or 4 years required by the specialty board and 1 or 2 years of experience equivalent to the former in breadth and intensity; completion of 3 or 4 years residency training as a quality resident; or Board certified, but not considered eminently outstanding within his specialty field as evidenced by significant accomplishments and/or experience.

MEDICAL OFFICER (APPROPRIATE SPECIALTY) GS 602-15, BUREAU OF DRUGS, OFFICE OF SCIENTIFIC EVALUATION

INTRODUCTION

The incumbents of these positions work in one of the Divisions of the Office of Scientific Evaluation (excepting the Division of Clinical and Medical Devices and Scientific Investigations Staff). The functions of the Office of Scientific Evaluation 34-974-74—33

and its Divisions are described in the Supervisory Staff Manual Guide, FDA 1332. The incumbents perform the medical evaluatory review, required by the Food, Drug, and Cosmetic Act, which must precede the approval of a drug for shipment in interstate commerce for investigational use, for commercial marketing, and follows and evaluates reports and literature on marketing experience. In essence, they thoroughly evaluate the great body of clinical experience data submitted by the nation's drug industry to support IND, NDA, NDA Supplements and periodic and special reports to develop a medical judgment which is generally accepted as authoritative by their supervisors. As a result of the 1962 Kefauver-Harris Amendments to the Food, Drug, and Cosmetic Act, industry conducts and medical officers review an increasingly large amount of research data. As a consequence of the growing sophistication of drugs under development, the medical evaluation for which the incumbents bear initial and substantial responsibility have become increasingly complex and significant. The duties of this position are essentially those of a senior medical expert.

DUTIES

In performing this evaluatory work, the medical officer determines whether proposed clinical trials of new drugs on man are soundly conceived and supported by prior animal testing and other controls adequate to justify tests on man; whether applications by manufacturers for permission to market new drugs for general use should be approved based on an evaluation of the evidence of their safety and effectiveness; whether proposed labeling contains truthful claims for safety and effectiveness, and adequate directions for use and warnings against misuse.

The Medical Officer also reviews supplements to previously approved NDA's, most of which were approved on the basis of safety only and must be thoroughly reviewed for efficacy in acting on a supplement; periodic reports submitted by sponsors on drugs approved for marketing; adverse reaction, inspection, and other surveillance reports. Makes a medical decision in each case as to whether the drug should be withdrawn from the market by the sponsor, whether the previously approved NDA should be revoked, whether changes in the labeling are required, and, in the case of supplements, whether the information available supports approval of the supplement.

Reviews the summaries of pharmacologists and chemists, and makes his medical summary and recommendation to the supervisor that the submission be approved, is incomplete, or specific points be disapproved or be revoked; that an IND be continued, modified, or terminated.

The Medical Officer is assigned work in the area of his medical specialty. Because of his recognized expertise, however, he may be called upon from time to time to work in other areas of medicine where his supervisors feel he can render needed and sound judgment. Is normally assigned cases of the most difficult, advanced or controversial nature when the level of inherent complexity can be predicted in advance. May act as a team leader over other medical officers, pharmacologists, chemists, etc., while reviewing specific applications. In order to arrive at a conclusive medical opinion, the Medical Officer considers a variety of types of information on the drug and related drugs. Identifies additional research necessary to support industry's claims regarding the efficacy and safety of drugs, and provides authoritative comment on research set-ups and new techniques, by phone or personal contact with drug company representatives. Prepares correspondence requesting information on facts of the case inadequately presented.

Consults with other medical specialists and scientists within FDA and in other government agencies, universities, hospitals, and clinics. May recommend that additional studies be made under an FDA contract, or that consideration of a drug or group of drugs be given by a specially constituted committee of physicians or scientists.

Keeps abreast of the progress in medical and related sciences by reviewing the scientific literature, attending conferences, and participating in staff seminars at which cases and special topics are discussed.

SUPERVISION AND GUIDANCE RECEIVED

The incumbent works under the very general supervision of the Division Director. Incumbent, as a recognized expert in his specialty, is responsible for the independent review of cases assigned him. While the supervisor reviews

the medical summary and the outgoing correspondence which affects action on the case, the supervisor as well as medical officers at all higher levels of the Bureau will place great reliance on the judgment of the incumbent, because of his demonstrated, unusually high level of professional competence and analytical ability.

LEVEL OF PROFESSIONAL DEVELOPMENT

Incumbents at this level will be expected to be Board Certified in their respective fields of specialization and have achieved an eminent standing in such fields (considered equivalent to an Assistant or Associate Professorship in a recognized medical school) as manifested by receipt of significant honors and awards, publishing of important research papers, a continuing interest in attending seminars and participating in more formal educational programs, meaningful medical society memberships, and the superior quality of overall medical experience; the level of professional development expected at this grade will also be met by that combination of medical training, experience and professional accomplishment that is equivalent of Board certification expertise in a medical specialty, the above indicated qualifications. Also expected of incumbents are demonstrated integrity, emotional stability, ability to plan and organize work, effectiveness in expressing ideas, productivity, knowledge of and adherence to FDA and Bureau of Drugs policies, and the abilities of a good mentor who can instill confidence in less experienced or qualified physicians. Incumbent's possession of the level of attainment in the areas previously described will be judged by the Bureau Medical/Dental Promotion Review Board. A medical evaluation summary of the above named persons will be recorded in chart-summary form, becoming an addenda to this position description, and will be retained in the official records of the Division of Personnel Management as prima facie evidence of the level of professional development of persons assigned to these positions.

Mr. FOUNTAIN. I think it is apparent from the position description for the GS-15 medical officer that he is expected to be a board certified specialist, or its equivalent, and a recognized expert in his field. He is presumed to be well-qualified to review and evaluate scientific and medical data submitted to FDA with NDA's and to make valid and reasonable scientific and medical judgments and conclusions concerning the safety and effectiveness of new drugs.

Would you agree with that?

Dr. SCHMIDT. Yes.

Mr. FOUNTAIN. The GS-14 medical officer is also generally qualified to make such reviews, evaluations, judgments, and conclusions. Is that correct?

Dr. CROUT. Yes.

Mr. FOUNTAIN. Dr. Crout, the March 8, 1974, Medical World News, at page 64, in an article entitled "The FDA moves to alter its image with physicians" states, and I quote: "According to Dr. Crout, the FDA's medical officers will also be overshadowed to a great degree by the advisory committees." He then goes on to quote you directly. Dr. Crout, as follows: "The individual medical officer has less authority, as does the bureau director or the commissioner."

Now I realize that a quotation sometimes doesn't present the whole picture and that is why I want to ask you whether this article reflects accurately what you said and your views on the matter?

Dr. CROUT. If I could expand on it? I was discussing with the author of that article the difference between a one-man decision and an institutional decision. And I had said that in the past the Food and Drug Administration had been accused of having too much in the way of one-man decisions that a medical officer could in essence on his own merely turn down a new drug application.