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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.

Vr. 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 apprinted 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.


Vr. 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.


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.


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.


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.


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.


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.


Vr. 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.


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


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.


We are taking steps to try to help Dr. Sadusk strengthen his program through assigning Public Health Service commissioned officers beginning July 1 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 drig 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 Fere 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.


Mr. FOGARTY. Of the $10,515,000 increase, $4,086,000 is for mandatory cost increases, and of this $497,000 is for full-year costs of rental space to be occupied in 1966.

I thought these costs were picked up by GSA the second year.
Mr. SPARER. After we have carried them for 1 full year.

Mr. FOGARTY. Is that not a change in policy?

Mr. SPARER. It may be. I am not sure.

Mr. CARDWELL. As I recall the general policy, GSA would pick up in the budget the annual rent in the first budget opportunity. I gather in this case it missed the budget cycle and it probably had to fall over to the next budget cycle.


Mr. FOGARTY. The program increase, represented mainly by an increase of 720 positions, is an across-the-board strengthening of all activities. Is that right?

Dr. GODDARD. Yes, sir.

Mr. FOGARTY. Would you like to add to what was in your opening statement with regard to any or all of the seven activities for which increases are listed on page 5?

Dr. GODDARD. In general, sir, we are attempting to develop a balanced program which will enable us to make progress in all the areas of our responsibility.

Mr. FOGARTY. How can it be balanced when you ask for 2,000 additional employees and get only 700?

Dr. GODDARD. Balanced only in respect to the numbers available. We are attempting to strengthen our medical evaluation to take care of the backlog which occurs.

Mr. FOGARTY. Did you spread the cuts right across the board, too?

Dr. GODDARD. No. These were selectively made. The major cut was in the Bureau of Regulatory Compliance, which requested 1,123 additional positions. In their submission 500 were allowed by the Department and 200 by the Bureau of the Budget.

I have not reviewed the original submission. I concentrated on the request before this committee.

Mr. FOGARTY. I understand that. We will be a little lenient with you today but next year will be a different story. We will see what you learned in a year.

Dr. GODDARD. Fair enough.


Mr. FOGARTY. Are you satisfied with the reporting of adverse drug reactions.

Dr. GODDARD. I am not satisfied at the present time, and this should not be inferred to be a criticism of the program which is being developed and being operated by the Bureau of Medicine, but rather an indication of my feeling that we need a very comprehensive system of adverse reaction reporting which will give us a good baseline from which we can make more intelligent appraisals of the risks involved in administering drugs.

You are well aware of the fact that this must, of necessity, involve very large numbers of patients. The adverse reporting system, the number of reports, has increased and we are getting good cooperation from the participating hospitals.


Recently an additional element was added to the program. We are funding a pilot study this year with Kaiser-Permanente, a group health plan on the west coast, which in the 1967 appropriation year would be expanded to include not only inpatients and their hospital facilities but also outpatients, so we will begin to get a larger data base just from that one source alone.

We are working toward an aggressive program of adverse reaction reporting.

Mr. FOGARTY. What is the arrangement you have with Kaiser now? Dr. GODDARD. The arrangement is that the Kaiser-Permanente physicians would provide reports on adverse experience with drugs initially in the in-patient population under their supervision, and the next year, if the work shows promise, it would be expanded and carried into the out-patient work.

Mr. FLOOD. What is adverse here?

Dr. GODDARD. The drug may cause a side effect which is not desirable. It is this side effect, such as the occurrence of hives in a patient receiving penicillin, that we term an adverse reaction.

Mr. FLOOD. Where is this different from an allergy to a drug? Dr. GODDARD. In some instances it is not an allergic phenomenon but, let us say, if a diuretic is given to a patient and he happens to have some undiagnosed disease of the liver, there may result serious symptoms. I am oversimplifying it. I should not infer that all diuretics have this effect, but we are trying to get at the problem of side effects of drugs or potentially threatening effects of drugs which are not originally planned for.

Mr. FLOOD. I have in mind something else. Do you get reports on good effects you were not looking for? You were down the street looking for one thing and stumbled on something twice as good that you didn't expect. Do you have a report on that? Is there such a thing?

Dr. GODDARD. Yes, such things do occur. Generally I would say the good effects tend to get more quickly reported in the medical literature than the bad effects because the physician recognizes that here is something potentially valuable which heretofore had not been recognized, so it often becomes

Mr. FLOOD. Such a thing can and has happened?

Dr. GODDARD. Yes, indeed. It is less of a problem for us than the adverse effect, however.


Mr. FOGARTY. Have you been through this Kaiser-Permanente program?

Dr. GODDARD. Not since my appointment as Commissioner. I have reviewed the proposal and I am familiar with the organization and the work they do.

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