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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?
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
Vír. 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 Fou 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 VH.
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. I was talking about agriculture interests in general.
Mr. RANKIN. Agriculture and industry?
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.
BACKLOGS IN OTHER AREAS OF THE AGENCY
Dr. GODDARD. I would say that is certainly true.
If I may go back to one of your earlier questions in order that the record may show some balance in my comment.
Mr. FOGARTY. Surely.
Dr. GODDARD. I didn't mean that the Bureau of Medicine was the only area where there were significant problems to be solved by the agency. We obviously are not carrying out sufficient numbers of inspections on imported foods, and we are attempting to strengthen this area in this fiscal year and the next fiscal year.
Mr. FOGARTY. And you are examining only about 1 percent of interstate shipments of raw agricultural products. Is the importation getting bigger all the time?
Dr.GODDARD. There is a growing volume of importation of specialty
Mr. FOGARTY. Like what?
Dr. GODDARD. Some of the fish products come from many of the Scandinavian countries. There are certain kinds of cheeses imported. There are delicacies from other parts of the world. that come into this country.
PERCENT VIOLATIONS IN INTERSTATE SHIPMENTS
Mr. FOGARTY. Of the interestate shipments of raw agricultural products, what percent are found to be in violation?
Dr. GODDARD. I would have to get that for you. (The information requested follows:)
Incidence of violation (percent).
1 FDA samples 1 percent of the raw agricultural shipments.
FOUR-PHASE BUILDUP FOR DRUG ABUSE CONTROL
Mr. FOGARTY. With regard to the drug abuse control activity, would you describe the four-phase buildup mentioned in the justifications?
Why could it not be two or one? Why four?
Dr. GODDARD. As you know, the agency is conducting activities related to control of drug abuses at the present time. About 100 persons are now working, and have been working in recent years.
The first phase, however, is to establish the new bureau and employ the field staff and put them through a training program, 8 weeks in duration, the first session of which started this morning on the west
We will during this phase build up a cadre of trained personnel. This will continue through the second year. That would be through
fiscal year 1967. The additional persons brought on board will be trained in the methods.
In the first year, we will have five field offices open and in the second year four additional offices will be opened, so, by the end of fiscal year 1967, we will have a nationwide program.
Are there other factors related to the buildup in four phases you wish to comment on, Mr. Rankin?
Mr. RANKIN. Another factor is in the area of the criminal undercover investigations. As we audit traffic in the regulated drugs, the drugs subject to abuse, and control traffic which has been occurring through institutions ordinarily regarded as legitimate, we are going to drive the traffic underground. It will be taken over by the criminal element and will become increasingly more difficult to detect. That, I believe, would be the fourth phase.
DEGREE OF DRUG ABUSE VIOLATIONS
Mr. FOGARTY. Now, I know this is a new program, but can you report any findings to indicate the degree of violation?
Dr. GODDARD. May I submit to you a brief statement at a later date on that? We have a number of actions that have been taken during the past year with respect to violations in sales of drugs in these three categories, but I would prefer to get a summary for you to indicate how much has been done.
(The information requested follows:)
1 All special investigations follow information or a lead to a specific violation.
NOTE.-In fiscal year 1965 there were 63 man-years in undercover and close-out investigations devoted to drug abuse control. Violations were uncovered in 98.6 percent of the investigations. There is no data available on which to base an estimate of total violations. Such data will become known as investigational activity increases and statistical samples are developed.
Mr. FOGARTY. Under "Special programs” on page 70 you mention "emergency preparedness. How much are you spending on this, and what is the difference between this and civil defense?
Dr. GODDARD. My recollection is we have been spending 5 manyears on this activity.
The difference between this and civil defense I would ask Mr. Rankin to answer.
Mr. Rankin. The civil defense program of the Food and Drug Administration is a program that has been carried out with funds assigned by the Department of Defense from moneys appropriated to it. We have had a program for the previous year and this fiscal year through this month amounting to about $50,000 per year for training State and local officials to handle civil defense emergencies, so that is entirely different from the program referred to in this budget.