Senator HILL. The committee will kindly come to order. Dr. Goddard, I believe this is your first appearance before us as Commissioner of the Food and Drug Administration. I want to tell you that we are very happy to have you here.

I believe we have some idea of some of your problems. We are glad to have you here, and we will be glad to have you proceed in your

own way.

Dr. GODDARD. Thank you, Mr. Chairman.

I am pleased to appear before this committee today, in my capacity as the newly appointed Commissioner of the Food and Drug Administration.

This agency is in a period of transition, occasioned by retirement of Commissioner Larrick and Deputy Commissioner Harvey, and other top management staff. I intend to build on the solid foundation of service to the public that has been a tradition with the Food and Drug Administration. I know the task ahead is a big one and, as Secretary Gardner has recently stated

The work of the agency, though largely taken for granted, is vital to every American, because the Food and Drug Administration serves as the public's protector against contamination, fraud, impurity, and hazards in the products on which our lives depend.

As you know, Mr. Chairman, through much of its history, the agency has existed with a limited amount of resources although the responsibilities placed upon us by Congress have been great. In recent years, with the support of this committee, we have started to make major

headway toward providing the resources commensurate to the agency's responsibilities.

Since 1957 our appropriations have increased from $6.7 million to $53 million in fiscal year 1966. The request before you would bring total appropriated funds to over $63 million.

1967 BUDGET REQUEST

Senator HILL. How much did you ask for from the Budget Bureau ? Dr. GODDARD. $73 million was the Department's request.

Senator HILL. What was your estimate to the Department?

Dr. GODDARD. $80,410,000.

Senator HILL. In other words, out of the $80,410,000 which you thought you needed the budget finally allowed you $63,454,000. Dr. GODDARD. That is correct.

Senator HILL. A reduction of almost $17 million?
Dr. GODDARD. Yes.

As a new Commissioner, I must say I have examined this very carefully and there is a little feeling of gratitude that this change was made. It would be very difficult for me, as a new Commissioner, to absorb as large an increase as was initially requested, at this time.

In the same period, staff has increased from 1,000 positions to 4,700 positions, and, if our request is approved, to 5,400 in fiscal year 1967.

While these increases took place before I came to this office, they highlight the additional responsibilities that FDA has undertaken in recent years and show the support that this committee has given to FDA in fulfilling these responsibilities. I would hope, Mr. Chairman, that during my tenure in this office FDA will continue to merit this support.

Although the budget before you today was developed before I came to this office, I have had a chance to review it in considerable detail. It is a responsible budget which emphasizes strengthening of our continuing programs. I endorse the proposals presented in the budget and feel sure that they will enable us to move forward and meet the vast responsibilities I alluded to earlier.

Now, Mr. Chairman, I would like to more specifically describe our 1967 request. We are proposing a total increase of 720 positions and almost $10.5 million.

MEDICAL EVALUATION

Over 20 percent of the increase, or 163 positions and $2.5 million, will be assigned to our Bureau of Medicine.

Since the Kefauver-Harris amendments of 1962, a large backlog of investigational new drug applications (IND's) have accumulated. There were over 1.440 on hand at the end of fiscal year 1965, and they continue to come in at a rate of approximately 70 per month. Currently it may take up to a year to complete some of these reviews. With an increase of 32 positions in this area, we would expect to reach a decision on these on an average of 50 days after receipt. No applications should take more than a few months to process.

A similar problem exists in new drug applications (NDA's). These are reviewed and evaluated to determine that they establish the safety and efficacy of drugs proposed for general use. The pharmaceutical

industry indicates that there will be a substantial increase in NDA's during the next few years. Currently it takes on an average of 180 days to process these applications, but these are becoming more complex, with some submissions running as high as 10 to 20 volumes. Senator HILL. Do you mean 10 to 20 bound volumes?

Dr. GODDARD. Yes, sir. In some instances they stretch from the floor to the ceiling in our building.

Senator HILL. Your ceiling is not too low.

Dr. GODDARD. No, sir. We have 10-foot ceilings. It is not only a substantial amount of volumes, but every page has to be reviewed by one of the medical officers, so it is a tremendous undertaking.

By the end of this fiscal year, we will be able to reduce the average review time to 130 days, and with the resources requested in fiscal year 1967, we expect to reach a decision on all but the most complicated NDA's within 90 days after receipt, thereby virtually eliminating the backlog. An increase of 13 positions is requested for this program.

Senator HILL. Let me suggest as a matter of interest, you speak of an average of 90 days today. What would that have been 10 years ago today?

Dr. GODDARD. I would think it would be far less because the same criteria were not being applied as are being applied today.

Can you answer that, Mr. Rankin?

Mr. RANKIN. I cannot answer that specifically, but it was somewhat less.

Dr. GODDARD. I think an indication might be made of the number of medical officers assigned to that function at that time. If I remember correctly, it was approximately four.

Mr. RANKIN. It started out in the very early 1950's, as I recall, with two medical officers reviewing new drug applications. Then the number was increased to four in a couple of years and it has grown since that time.

The two medical officers of course could not do the type of review that we now realize is required in this area.

Senator HILL. How old is the Food and Drug Administration? We had a celebration a few years ago. What anniversary was that? Dr. GODDARD. It may well have been the 50th anniversary. This year's is the 60th anniversary of the Food and Drug Administration. The original legislation was passed in 1906 under President Theodore Roosevelt and Dr. Wiley was the head of it.

Senator HILL. I am sure the 50th anniversary is the one I recall. You may proceed.

Dr. GODDARD. Four additional positions are requested to evaluate for effectiveness as well as safety approximately one-third of the 500 antibiotic preparations marketed between 1938 and 1962. This is a requirement of the Kefauver-Harris Amendments on which FDA has not been able to make significant progress. It is an important area and FDA should not defer this evaluation.

MEDICAL REVIEW

An increase of 31 positions and $312,000 is requested for our medical review programs.