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Kipling wrote a poem about the Irish Guards in which he said, "We are not so old on the Army lists, but we're not so new at the game.' After 150 years we are fighting for France again.

You might be new on this job but you have been around.
Dr. GODDARD. Yes, sir. That is very appropriate, sir.

GENERAL STATEMENT

Mr. FOGARTY. Go right ahead, Doctor.

Mr. GODDARD. 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 the 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.

The budget before you today was, of course, developed before I came to this office; however, I have had a chance to sit with the staff and perform an intensive review of our fiscal year 1967 request. I wholeheartedly subscribe to the proposals presented in this budget for new programs and for strengthening of our continuing programs. It is a budget that enables us to move forward and meet the vast responsibilities I alluded to earlier.

THE 1967 BUDGET

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

Over 20 percent or 163 of the new positions and an increase of $2.5 million will be assigned to our Bureau of Medicine to aid in the review and evaluation of new drug and investigational drug applications and supplemental data. These resources will also help us in our reevaluation work to determine the safety and effectiveness of all new drugs approved since 1938. As you may remember, this was one of the key provisions of the 1962 Kefauver-Harris Drug Amendments. In addition, these resources will permit us to expand our medical and science information program, including adverse reaction reporting and medical reference services. The request would also allow us to enhance the professional development of our medical staff by part-time assignment of these persons to research and teaching

centers.

For programs in regulatory and voluntary compliance and education, an increase of $2.4 million and 235 positions is proposed. Most of this increase will go to FDA's 18 field offices, including 170 new positions for field drug regulatory work, which will permit more inspections and more drug analyses in our laboratories and will strengthen FDA's surveillance of drug manufacturing and marketing. There will also be a greater number of inspections and sample analyses of hazardous foods and imports. To expand the consumer information program, an increase of $600,000 will improve our consumer education programs through use of films and television. We will also be conducting consumer surveys. Additional funds are requested to promote voluntary compliance in the regulated industries.

The budget contains 130 new positions and an increase of $1.8 million for scientific research and evaluation programs. The largest portion of these resources will be devoted to special studies on the chemical and biological contamination of foods and to the study of ways in which drugs act on experimental animals. The increase in the research and evaluation budget will also permit us to expedite the processing of pharmacological data submitted with new drug and investigational drug applications.

In the drug abuse area, 104 positions, including 102 in the field and about $2.8 million is requested to strengthen control over the illicit traffic of stimulant, depressant, and counterfeit drugs as provided in the Drug Abuse Control Amendments of 1965.

For administration and support of these programs, I have outlined above, 88 positions and $1.1 million is proposed. Funds will be used for a major expansion of our science information program during fiscal year 1967, an in-house training program, expanded data processing services, and other improved administrative services. Of the above total, only 7 positions are requested for executive direction and 29 to improve agency administrative services.

În summary, of the 720 new positions requested, 302 are field positions and 418 will be at headquarters. Viewed in another way, 500 of the increase is for work in the vital drug area and the remainder is for work in foods, pesticides, and general support areas.

BUILDINGS AND FACILITIES

We are requesting an increase of $4 million for our buildings and facilities program. Of this, $2.7 million will be needed to complete buildings already in process of being constructed and provide the equipment they need.

Mr. Chairman, I would like particularly to urge favorable consideration of an item included in the budget for planning a new headquarters research facility. This facility would house the scientific staff that FDA needs to hire between now and 1970, in order to continue to make progress in answering the scientific questions facing the agency. FDA has for too long housed its laboratory research staff in inadequate facilities. Unless we can provide first-quality equipment and facilities for our scientists, we cannot hope to recruit and retain first-quality scientists. Unless space is available, we cannot expand our laboratory research efforts to provide the answers we need to make decisions on matters vital to the Nation's health. An amount of $950,000 in planning funds is requested for this purpose.

With the assistance of my staff, I would be pleased to answer any questions that you may have relating to this request.

May I introduce Mr. Sparer on my immediate left, the financial management officer, and Mr. Winton Rankin, the Acting Deputy Commissioner.

Thank you.

Mr. FOGARTY. Where is Dr. Sadusk today?

Dr. GODDARD. In the Bureau of Medicine Building, I imagine, in Virginia.

Mr. FOGARTY. He generally comes to these hearings. Is this another change you have made?

Dr. GODDARD. I felt I should be as knowledgeable as possible about the budget before you and attempt to answer all of your questions. I have reviewed the budget with the staff and specifically spent a good deal of time with Dr. Sadusk on matters before that Bureau.

Mr. FOGARTY. I think he is one of the best additions Food and Drug has had there in years. I think he should be here.

Also I want to say, Dr. Goddard, having known you over the years, that I think the Secretary made a good appointment when he appointed you to head this agency.

Mr. FLOOD. Do you know Dr. Goddard of Pennsylvania?

Dr. GODDARD. No, I do not.

Mr. FLOOD. One of the best men in the country. He has been there through three or four administrations for both parties.

BUDGET SUMMARY

Mr. FOGARTY. The adjusted appropriation for 1966 is $52,939,000 and the request for 1967 is $63,454,000, an increase of $10,515,000 and 720 positions.

When we see this increase in positions many Members of Congress think of it as an extraordinary increase. However, back in the days of Secretary Hobby she appointed a topnotch committee to look into the needs of the future for Food and Drug. We followed those recommendations.

SECOND CITIZENS ADVISORY COMMITTEE

How long ago was the other committee appointed?

Dr. GODDARD. The second Citizens Advisory Committee? It was in 1962.

Mr. FOGARTY. Does this keep up with their recommendations? Dr. GODDARD. I have read that report and I believe it is consonant with their recommendations, Mr. Fogarty.

Mr. FOGARTY. There really were no specific recommendations regarding the funding level in the second committee's report.

Mr. CARDWELL. The original report recommended a threefold or fourfold increase over a period of 5 to 10 years. That would have taken the agency to about 3,200 employees.

Meanwhile, a number of new programs and new laws were enacted, the latest of which was the drug abuse control amendments and prior to that the Kefauver-Harris amendments. The old recommendation is really quite outdated. The Hobby committee, as I recall it, did not specify any numerical goal for staffing the resources

but did, consistent with the original report, propose further strengthening of the agency.

DEPARTMENT AND BUDGET BUREAU REDUCTIONS

Mr. FOGARTY. You have a budget request for $63,454,000. What was the request originally? I refer now to your predecessors really. Dr. GODDARD. The Department's request?

Mr. FOGARTY. The original request to the Department.

Dr. GODDARD. $80,410,000 was the amount in the 5-year budget which was considered.

Mr. FOGARTY. What did the Department do about that?

Dr. GODDARD. The departmental allowance was $73,902,000.

Mr. FOGARTY. And then the Bureau of the Budget cut you back to $63 million?

Dr. GODDARD. Yes, sir.

Mr. FOGARTY. So we should be considering about $80 million here rather than a budget of $63 million.

How many positions went along with the $80 million figure?
Dr. GODDARD. 7,009 positions.

Mr. FOGARTY. What increase, compared to the 720?

Dr. GODDARD. 2,299 increase in positions.

Mr. FOGARTY. They cut you two-thirds?

Dr. GODDARD. Yes, sir.

UNOBLIGATED BALANCE IN 1966

Mr. FOGARTY. What is the $60,000 of unobligated balance, "reserve," which shows up in the budget tables in the 1966 column? Mr. SPARER. Residual on the review made in about the first quarter of the year in response to the President's cost reduction program. This is what remains of that money.

REORGANIZATION PLANS

Mr. FOGARTY. Recently there has been a rather major reorganization of Food and Drug. Do you have additional organizational changes in mind?

Dr. GODDARD. At the present time, I have asked the staff to provide me with recommendations based on their knowledge of the mission of the agency which would enable us to further husband our scientific manpower and accomplish better administration of the agency. We are in the process at this time then, sir, of reviewing several proposals for additional reorganizational activities.

VACANCIES IN TOP POSITIONS

Mr. FOGARTY. What was the situation at the first of the year and what is it now with regard to vacancies in the top positions? The agency has had problems in filling these top positions.

Dr. GODDARD. Of the top positions, since I have come with the agency, the Director of the Bureau of Veterinary Medicine post has been filled. A person has been selected to be Director of the new Bureau of Drug Abuse Control. A Deputy for that Bureau is to be. selected this week. Several candidates are being interviewed by the

proposed new Director, by myself, and Mr. Rankin, and have been interviewed by others.

There is, as yet, no person in sight for the Associate Commissioner for Science.

As to the Director of the Bureau of Regulatory Compliance, I have asked for suggestions of persons within the agency as to potential candidates. I have asked for the assistance of the Office of Personnel and the Secretary for other candidates in other parts of Government to be submitted.

We are making some progress in filling some of the top positions.

WORK BACKLOG IN BUREAU OF MEDICINE

Mr. FOGARTY. Where are your serious backlogs of work and how serious are they?

Dr. GODDARD. The most serious backlogs of work in my opinion are in the Bureau of Medicine. The last monthly report

Mr. FOGARTY. Is that headed up by Dr. Sadusk?

Dr. GODDARD. Yes. At the time of the last monthly report there were 1,434 investigational new drugs pending review; 250, approximately, new drug applications were pending review. There were some 5,000 drugs which have been marketed since 1938 for which action has not been taken to determine safety and efficacy.

Not all of those require detailed reviews, but this does amount to a very substantial backlog.

COMPLEXITY OF DRUG REVIEWS

I understand how complex these reviews are because I have undertaken to do some of them personally on the new drug applications. These are often accompanied by documentation which, in some instances, may reach from the floor to the ceiling, and each page of these submissions is reviewed by a medical officer and the pertinent points are incorporated into the medical summary.

The month before last, four new drug applications were completed. Last month I believe there were 12 completed. I mention this to give you some perspective as to the imbalance between the backlog and the numbers being completed.

STRENGTHENING DRUG REVIEW STAFF

We are taking steps to try to help Dr. Sadusk strengthen his program through assigning Public Health Service commissioned officers beginning July I who are eligible for the number of specialties he now has vacancies in. This would be 50 medical officers, approximately, who then will be trained in the procedural matters related to drug review, and we think by the end of the year we will have a substantial record to show improvement in the backlogs and in the hope of getting on a more current basis.

Mr. FOGARTY. You think this budget will allow you to do that? Dr. GODDARD. Yes, sir. These are positions, I might say, that were incorporated in the budget. In fact, at the present time there are 65 vacancies for medical personnel in the Bureau of Medicine and we can easily accommodate these 50 individuals and still not impede his selection of career civil service personnel for the Bureau.

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