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RENTAL SPACE COSTS

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.

BALANCED STRENGHTENING OF ALL ACTIVITIES

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.

REPORTING OF ADVERSE DRUG REACTIONS

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.

KAISER-PERMANENTE PILOT STUDY

We are

Recently an additional element was added to the program. 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.

LACK OF DENTAL CARE IN KAISER-PERMANENTE PROGRAM

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.

Mr. FOGARTY. I took time to go through it and I was quite impressed with their multiphasic program in Oakland. I did not think of it until afterward, but there was no dental program of any kind. I thought dentistry would be important.

Dr. GODDARD. As the father of three children I would agree.

Mr. FOGARTY. I didn't think to ask them because it did not come to me until 2 or 3 weeks later. They had almost everything else but nothing on dentistry.

INTERNATIONAL SYSTEM ON ADVERSE DRUG REACTIONS

What has been done to set up an international system on adverse drug reactions?

Dr. GODDARD. We are working with the World Health Organization, and I am advised that at its current session of meetings there was a favorable response to cooperative agreements which would facilitate the exchange of information on adverse reactions among the countries, and at an early date we can expect a visitor from the World Health Organization, I believe within the next month to 6 weeks, to discuss final details with respect to our methodology involved and how we might share information with other nations, and vice versa.

MEDICAL REFERENCE SERVICE

Mr. FOGARTY. Just what services does the Medical Reference Service give? This is mentioned briefly on page 20.

Mr. SPARER. Primarily they do the abstracting for the medical officers. These people are skilled at reviewing the articles in the many medical journals which must come under our monthly

surveillance.

Dr. GODDARD. We are interested in obtaining from those journals information on drugs that are being investigated in the sense of an investigational new drug.

ACCESS TO FOREIGN JOURNALS

Mr. FLOOD. Do you have translators?

Mr. SPARER. We have none.

Dr. GODDARD. The National Library of Medicine does, however, have translators and on special request it is my understanding articles have been translated for the Food and Drug Administration by the National Library of Medicine.

Mr. FLOOD. Do you examine foreign journals?

Dr. GODDARD. We do receive abstracts from the National Library of Medicine from their foreign journal service.

Mr. SPARER. We have contracted with foreign countries to get translations, in cooperation with the National Library of Medicine.

SCIENCE INFORMATION PROGRAM

Mr. FOGARTY. What about the science information program? What is that all about?

Dr. GODDARD. We have had a study carried out by the Arthur D. Little Co. in two phases-to assist us in developing the plans for an information system which would be an integrated agencywide science

information system. In the many matters that come under the cognizance of the Food and Drug Administration some of these are related to primarily food additives, some primarily to insecticides and pesticides, and others to drugs. However, there are often interrelations and the scientists in different parts of the agency would benefit by having information available to them.

We are also anxious in this program to make information more quickly available to the scientists through its storage and dissemination from a computer system, so the science information system is an attempt to devise a computer-based storage and retrieval of scientific information for the major categories of scientists within the Food and Drug Administration.

RESEARCH BREAKTHROUGH FUNDS

Mr. FOGARTY. In connection with your research you say in 1967 the budget includes "research breakthrough funds."

Dr. GODDARD. Yes, sir.

Mr. FOGARTY. What is that?

Dr. GODDARD. This is a relatively small amount of money to make available to the Director, Bureau of Scientific Research, funds which when some promising item or development occurs as a result of studies currently underway they can be exploited. This, in other words, would be construed as being unprogramed money available for rapidly shunting it into promising new areas.

COOPERATION BETWEEN NIH AND FDA ON AREAS OF RESEARCH

Mr. FOGARTY. The description of some of your research, and I notice it especially in connection with some of the basic food research, sounds a great deal like research NIH is doing. What procedure do you have to avoid duplication?

Many people think Food and Drug and NIH do not work as closely together as they should.

Dr. GODDARD. I am meeting tomorrow with Dr. Shannon to further strengthen our existing ties with the National Institutes of Health and to make certain that any duplication of effort that occurs is knowing and desirable duplication of effort.

Mr. FOGARTY. Give me one example.

Dr. GODDARD. Pesticides and

Mr. FOGARTY. I am referring to NIH.

Dr. GODDARD. We are doing some work on aflotoxins in food. I would be surprised if they are not doing work on aflotoxins in foods, but our work is more related to the ability to measure these compounds, detect their presence, and then to undertake some of the studies related to the possible significance of small amounts. This is a newly discovered area of food contamination, as you may be aware. Oral contraceptives are brought to my attention, and the estrogens in general. Both are the subject of study carried out by FDA and NIH.

In the oral contraceptives the kinds of studies I am aware of are related to safety and efficacy in monitoring the population of females to try to get at the problem of thromboembolic phenomena.

As to the estrogens, our research is related to the methodology inherent in detecting their presence, and the availability of them in

the medications being prescribed. The National Institutes of Health research, on the other hand, would be a more basic kind of research activity concerned with the basic physiological and pharmacologic effect on the body.

Mr. FOGARTY. I thought you did real basic research.

Dr. GODDARD. I have asked Dr. Summerson, the Director of the Bureau of Scientific Research, to characterize their research program to me so I might have a better understanding. He does not feel there is a basic research program. As you know, it is difficult sometimes. You get carried down a path which is related to methodology. He feels it is largely 80 to 85 percent applied research or methodology research.

INTERDEPARTMENTAL PESTICIDE COORDINATION AGREEMENT

Mr. FOGARTY. What is the interdepartmental pesticide coordination agreement and how is it working out?

Dr. GODDARD. This is a committee which exists with the Department of Agriculture, Public Health Service, Food and Drug Administration, and the Fish and Wildlife Service, Department of the Interior. My knowledge of its activities through my previous position and what I have learned since I have been here at FDA is that it is working well. I cannot comment for others but we have worked in close concert with the Department of Agriculture through this committee.

AGRICULTURE OBJECTIONS TO FDA POSITION

Mr. FOGARTY. In the past there were quite a few objections from agriculture about the requirements being too tight. Have you changed your position in the past year?

Mr. RANKIN. We have not changed our position, Mr. Fogarty. There is a proposal under consideration right now recommended by some State agencies that in the milk area particularly we allow a small residue of DDT and related products which form when DDT goes through the cow to be present in fluid milk.

A proposal has been published in the Federal Register. There is opportunity for all interested persons to state their views, and when the comments are in, the Food and Drug Administration will evaluate them and arrive at a decision.

I would say in general that we were not aware that the Department of Agriculture as a department has taken a position of opposition to our position on pesticides. There have been some units of the Department which raised question

Mr. FOGARTY. I didn't mention the Department particularly. was talking about agriculture interests in general.

Mr. RANKIN. Agriculture and industry?

I

Mr. CARDWELL. One purpose for establishing the interdepartmental committee was to be certain that the environmental health implications of pesticides, that that responsibility fell to DHEW clearly. The one purpose of the committee is to see that DHEW represented through the Food and Drug Administration and Public Health Service does take an almost arm's-length position, vis-a-vis a pesticide.

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