them is the Antibiotic Drug Branch. That I believe is self-explanatory. They had a big new job handed to them because 21 new antibiotics which had not previously been subject to certification were put under certification by the Kefauver-Harris bill, and they had to pass on the question of efficacy which they did not have to pass on previously.

The New Drug Status Branch has a number of responsibilities, the principal function of which is to produce uniformity in the Food and Drug Administration about what is and what is not a new drug. We are dealing there with a statutory definition using words of craft. And the industry writes in with great frequency and says: I have a drug to be composed of this, this, and this, and it will have this claim on it, and so on; is it a new drug? We set up this branch to pass on that question and try to bring about consistency in our answers.

The Investigational Drug Branch is a new group with which you are very familiar. They deal with drugs at the time that they reach the clinical testing stage.

Controls Evaluation Branch: Each new drug application has a section in it that deals with the controls. If it is a spinal anesthetic, you have to have a control there that will run bacteriological tests to make sure that you are not shooting living bacteria into the spinal column. You have to have a very specialized control that will deal with pyrogens. Those are substances that cause an elevation in temperature. You have to have very, very meticulous chemical controls. The right methods of analysis must be used. The right size sample must be taken. Drug Control Evaluation is a highly skilled, specialized branch of pharmaceutical chemistry. We have a special group of people who are not only trained in this branch of pharmaceutical chemistry but who have had vast experience inspecting pharmaceutical houses and know that aspect of the operation as well. They pass on that phase of the application.

We have a Surveillance Branch which is responsible for keeping track of the new drug after it is on the market. That task is blowing up like a balloon with surveillance dealing not only with the drugs that we are currently passing under the new regulation we told you about, but going back and picking up this whole problem from 1938 to date, taking on all the brochures that are put out from all the pharmaceutical houses in the country and moving on into the advertising and whatnot.

I would anticipate that because of these new jobs we will have some further reorganization to do and some further breaking down as the workload, size, and character begins to emerge.

The Medical Evaluation Branch, which is the final unit in the New Drug Division, I think is self-explanatory. It has to do with the evaluation of the therapeutic capabilities of the drug in relation to the claims that are made.

Would you wish to have a very simple chart that says this for the record!

Mr. FOUNTAIN. If there is no objection, that will be included in the record.

(The chart referred to follows:)

1 Dr. Joseph F. Sadusk, Jr., became Medical Director on Apr. 1, 1964, and Dr. Smith returned to his position as Director of the New Drug Division.

209

Mr. GRAY. This Surveillance Branch you mentioned appears to have a pretty big job cut out for it. How many people do you have in that Surveillance Branch!

Mr. RANKIN. We have approximately 10 people in that Branch, as I recall. Is that correct?

Dr. SMITH. Approximately.

Mr. LARRICK. I do want to make clear that we are currently restudying the relationship between this Branch and the Division of Medical Review. As the old drugs disappear and more and more of the drugs are in the new drug area, there probably will be some adjustments to make.

Mr. GRAY. I don't want to dwell too long on this, Mr. Larrick.

A couple of more points: You mentioned that you take these pharmacologists, physicians, chemists, and so on, and you give them special training which equips them to make recommendations concerning the safety of drugs for the good of society and so on.

What kind of special training do you give these people?

Mr. LARRICK. I think Dr. Ralph Smith can comment on the special training.

Dr. SMITH. I can, Mr. Gray. When a new man comes in, he is given close supervision by his supervisors or the men who have been carrying on the work over the past few years. He is gradually given more and more responsibility and receives his training more or less by the preceptor system.

Of course there are certain courses to which he is exposed that are given to large numbers of new Food and Drug employees which make them familiar with the Food and Drug procedures, Food and Drug laws, and so forth.

But the important part of his training is on a preceptor basis. Mr. GRAY. I am sure that all of your medical officers are M.D.'8. Dr. SMITH. That is right.

Mr. GRAY. What portion of them are specialists as opposed to general practitioners!

Dr. SMITH. I am sorry I don't have the absolute numbers. A considerable number are certified by a specialty board or do have a specialty.

Mr. LARRICK. We would be happy to supply that for the record and complete the record.

Dr. SMITH. There are some in internal medicine, some in obstetrics, and gynocology, and so forth.

Mr. FOUNTAIN. It would be interesting to have that for the record. (The information referred to follows:)

You asked that we supply the percentage of our medical officers who are specialists. We now have a total of 85 medical officers in the Bureau of Medicine but this question appears to relate specifically to the Division of New Drugs so we have developed statistics reflecting the percentage of specialists in that unit:

Division of New Drugs (May 4, 1964)

Total medical officers--.

51

Medical officers who are board certified or board eligible specialists------Medical officers whose specialty is pharmacology (for which there is no board certification)___

Total specialists---.

43

Percentage of medical officers who are specialists--

Mr. RANKIN. May I add on the training question to what Dr. Smith has said: We have had going for quite some time now weekly and sometimes biweekly seminars at which there are detailed discussions of new medical developments, sometimes by members of the Food and Drug Administration, and quite frequently by people from outside Government who have done extensive work in this field. And that is an important part of this training operation also.

Mr. GRAY. Among the medical officers who are specialists, is any effort made to see that they work primarily on new drug applications that are relevant to their field of specialty? Or do you perhaps give a geriatric drug to a pediatrician!

Dr. SMITH. Shall I answer that!

Mr. LARRICK. If you

will.

Dr. SMITH. We give the appropriate drug to the appropriate man. Mr. GRAY. There is a conscious policy to do that.

Dr. SMITH. Yes, sir.

Mr. LARRICK. If we are heavily loaded and we don't have any geriatric problems, we are not going to sit and wait until one comes in. Mr. GRAY. You are saying that this would be your general policy, but you are not always able to follow that completely.

Mr. LARRICK. That is right.

Mr. GRAY. Just one final question, if I may, Mr. Chairman.

You mentioned the matter of outside consultants. Would you comment on the degree to which you employ outside consultants and under what circumstances you go to outside consultants in making your decisions.

Mr. LARRICK. I will start that if I may.

The secretary and Mr. Jones, who represents him, have been working with us on forming a topflight, overall medical consultant panel of truly leading American medical people. The formulation of that committee is almost completed. I suspect that will be one of the first things that Dr. Joseph Sadusk, Jr., will do when he is appointed. In addition to that, I think Dr. Smith would be the best informed person to tell you about the extent to which we call on the National Research Council and other outside groups on a formal and informal, and an individual and collective basis in connection with some of our problems.

Dr. SMITH. Mr. Gray, this practice has been growing over the past few years, although even up to the present time it is not very extensive. We may have applications which we consider difficult and feel the need of outside help. That may be obtained by formally bringing about the appointment of a group or panel or committee. We may ask some medical society to name a committee or name a list from which we can pick a panel, or in certain instances we have picked certain people ourselves.

This panel would then meet and consider the application and offer us an opinion.

In certain instances our outside help would consist of informal requests for opinions, either written or possibly even by telephone. Occasionally the outside consultation would consist of requesting further information from the investigators who had investigated the drug.

1 Boisfeuillet Jones, special assistant to the Secretary of HEW for Health and Medical Affairs, until his resignation in June 1964.

All of those various methods of obtaining consultation have been used.

And, of course, we have the standing committee, which I believe was mentioned earlier, the Advisory Committee on Investigational Drugs, which has been meeting regularly once a month for several months now and has been of great help to us in administering the investigational drug regulations, and actually helping us in certain detailed problems. Mr. GRAY. To what extent are you guided by the decision reached by your outside consultants? Are you obligated to accept their decisions!

Mr. LARRICK. The responsibility for administering the law is ours. We do not delegate that to anyone.

Mr. GRAY. Then they are asked for guidance which you may or may not see fit to follow!

Mr. LARRICK. That is right. We have to stand or fall on our own decisions.

Mr. FOUNTAIN. That is the general policy with all consultants. I should say that ought to be the general policy. I was reminded that it isn't always true in certain places.

I have a number of additional questions, but since Mr. Gray has gone into some detail I will yield to Mrs. Dwyer at this time. Mrs. DWYER. Thank you, Mr. Chairman.

Commissioner Larrick, because the health of our Nation is our most precious asset, I would like to ask you this question: In terms of your own understanding of FDA's responsibilities, do you believe you have the manpower and the material resources available to you to do thoroughly adequate job?

Mr. LARRICK. We do not. Our appropriation amounts to 19 cents per capita, and we don't believe that is enough. You understand I am not trying to usurp the President's budget.

Mrs. DWYER. In these days of poverty, then, you could make effective use of additional funds, could you not!

Mr. LARRICK. The Congress has been very generous with us in the last 6 or 7 years. We have progressively grown in strength. But I think we will very much need to continue that growth to discharge the obligations that we have.

Mrs. DwYER. Just one more question: Can you tell us a little more about the composition of your Advisory Committee on Investigational Drugs, and how many members there are, how they are chosen, who they represent, how often do they meet, and what are their principal functions. Or have you put this in the record any place!

Mr. LARRICK. No, we have not. With your permission, I would ask permission to put it in the record. I can give you a very brief statement. I think I could make a better statement in the record.

Mr. FOUNTAIN. Are you referring to the National Advisory Council!

Mr. LARRICK. No.

Mrs. DWYER. No; that hasn't been formed as yet, I don't believe. Mr. FOUNTAIN. Go right ahead.

I want to inquire about the Council. That is why I asked. Mrs. DWYER. Will he have permission to insert this in the record. Mr. FOUNTAIN. Yes; if there is no objection, that will be inserted in the record.