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

foods.

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:)

Sample collection and inspection for pesticide residues

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

coast.

We will during this phase build up a cadre of trained personnel. This will continue through the second year. That would be through

60-627-66-pt. 2- 2

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:)

Violations in abuse of dangerous drugs

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.

EMERGENCY PREPAREDNESS

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.

Mr. FOGARTY. Now, I have not asked much about enforcement of the old food and drug program because it is pretty well known to us, and the justifications are pretty complete, but if you have any special problems to discuss, we would be glad to have you tell us about them.

FOOD AND DRUG ENFORCEMENT POLICY

Dr. GODDARD. There has been the question raised as to whether the Food and Drug Administration has become "soft" on enforceI have looked into this matter with the responsible staff. I think there is indeed a basic misunderstanding because of the change of the nature of our actions.

There are fewer enforcement actions taken today, a somewhat smaller number than in previous years, but I find nothing in the actions taken to suggest the agency has become "soft" in the area of enforcement. The only major problems relate to workload. This we are attempting to get at earlier. We are studying our field services: what is being done in the districts, looking at the workload carried out by each district, and formulating a national program.

Mr. FLOOD. Periodically, and currently, the ugly rumor raises its head that the combination of these four, five, or six great big drug people really patronize your shop and that when it comes down to putting the cards on the table, if it is really important to them, they are powerful enough in all kinds of ways to discourage you.

Are there any of your endeavors directed against any one, or all of them?

How do you plead to this indictment?

Dr. GODDARD. I was not aware I was being indicted.

Mr. FLOOD. You are.

Dr. GODDARD. I have seen no evidence that the agency has, since I have been there, or, in fact, with respect to cases known to me that occurred before my appointment as Commissioner, that would suggest this kind of pressure has been substantially brought to bear on the agency. There are accusations, and I am aware of these

accusations.

Mr. FLOOD. Currently?

Dr. GODDARD. Yes.

I have not found any evidence to substantiate the accusations. I am, however, reviewing all of the procedures involved in our new drug applications and our IND's (investigational new drug applications).

WORKSHOPS SUPPORTED BY INDUSTRY

Mr. DUNCAN. On page 22 of your justification, under "Cooperative research," you discuss the workshops that you are setting up on teratology, and you indicate that two of these workshops have been. held to date, and the words that I think are significant are, "Both are supported by industry grants.'

Is this sort of thing desirable, to use funds from the industry to carry on functions of the Food and Drug Administration? Does that not result in a perhaps more subtle, but nonetheless active, form of influence on your activities?

Dr. GODDARD. This certainly could be examined from that point of view.

Mr. DUNCAN. Perhaps rather than saying result in influence on your activity, at least it can very well create the impression of such a result.

Dr. GODDARD. Yes, and oftentimes the impression must be avoided assiduously as the result.

We are requesting funds as the budget indicates to sponsor these. However, I must point out this is quite frequently done in the scientific field. Industry does support workshops attended by all agencies. Let me say in the matters relating to our responsibilities, I would intend in the future to see if it is in the public interest that we support these kinds of workshops.

Mr. FLOOD. Suppose American Airlines subsidized a laboratory for research for the Federal Aviation Administration. That would raise the eybrows.

Dr. GODDARD. There have been instances to my knowledge in the past where industries, such as the aviation industry, through the Flight Safety Foundation, will hold a scientific symposium on a specific subject. The agency which regulates that industry quite appropriately does send people to participate in those kinds of meetings.

Mr. FLOOD. No quarrel with that.

Dr. GODDARD. You are getting at the question of actual sponsorship which is implied in the justifications.

Mr. DUNCAN. Yes. This is the only instance where I can use words out of your own mouth to raise the point I want to make.

Mr. RANKIN. I believe the workshops that are referred to on page 22 have a special purpose which needs to be kept in mind. They are not laboratories of the Food and Drug Administration, nor are they laboratories to administer the Food, Drug, and Cosmetic Act. These are scientific symposiums attended by scientists from research institutions, universities, industry, and Government to enhance the exchange of information on teratology, an area in which there is a tremendous need today for a full flow of information, and in no sense of the word could the sponsorship of one of these workshops in my view be regarded as influencing the Government in a decision made later with regard to a specific application.

Mr. CARDWELL. I think one point you want to bear in mind-I am not sure of the details of the workshop, but it has to do with birth defects. Very often these workshops are sponsored by a university with the Government putting up some share of the cost and industry making a grant, arm's-length grant to a university. But the university serves as the sponsor. The conference usually is held under the aegis of the university, so there is no opportunity, it seems to me, for conspiracy between industry and an agency that regulates the industry.

Mr. DUNCAN. I am not suggesting there was. I suggest this is an area where a subtle influence can be exerted and where people can think it could be exerted. I am perfectly willing to accept this as a perfectly innocent one. I want you to take full advantage of the information available from the industry and the cooperation of the universities.

Mr. FLOOD. You should act out of an abundance of caution.

Dr. GODDARD. May we submit for the record a statement of sponsorship of these two conferences?

(The information referred to follows:)

INFORMATION ON TERATOLOGY WORKSHOPS

The workshops in teratology were held at the University of Florida, February 2-8, 1964, and at the University of California, January 25-30, 1965. They were sponsored by the Drug Research Board of the National Academy of Sciences and the Teratology Society. These workshops were supported by a grant directly to the university concerned by the Pharmaceutical Manufacturers Association. The workshops were suggested by the Commission on Drug Safety in their report published December 1963.

The objectives of the workshops were:

1. Teratologists would exchange information and techniques with each other and with scientists of related disciplines during these workshops.

2. Neophyte investigators in this field would receive instructions and demonstrations in techniques of teratologic research from established investigators in the field.

These objectives were achieved by means of lectures, discussions, and demonstrations by leading investigators from this country and Canada with participation by the workshop group in the actual procedures demonstrated.

The third workshop is to be held at the University of Colorado in April 1966 under a grant by the American Medical Association.

The grant for the workshop is made directly to the university to cover the costs of the faculty, supplies, materials, travel, and other necessary expenses in conducting the workshops.

In 1967, FDA plans to contract with a university to sponsor these workshops at an estimated cost of $30,000 each. Each participant would pay their own traveling expenses.

Mr. FLOOD. Your position is like Caesar's wife.
Dr. GODDARD. I fully understand.

DISTRICT OFFICE REQUESTS FOR ADVICE ON ANTIBIOTIC PRODUCTS

Mr. FLOOD. Why would each of your district offices, as you say on page 16, with reference to antibiotic drugs, send in about 25 requests per year for medical advice about antibiotic products?

Mr. SPARER. This could be an inspector picking up a sample from a drug firm. These are the ones being marketed or processed, and the inspector might come across a batch or sample and something might look bad to him, and he would send it in to the Bureau of Medicine for a medical judgment.

Mr. FLOOD. The same antibiotic?

Mr. SPARER. No. These would be different.

Mr. RANKIN. We have a program, Mr. Flood, of first certifying each batch of antibiotics for human consumption on the basis of our laboratory tests.

Dr. GODDARD. The pharmaceutical firm must obtain the new drug approval and then after that each batch must be sampled and checked by our laboratories before it is approved for release, so it is a batch-bybatch certification program.

Mr. RANKIN. In order to maintain the integrity

Mr. FLOOD. Do you have laboratories in the regions?

Dr. GODDARD. Each of the districts does have a laboratory.

Mr. FLOOD. And they on their own motion can so act.

Dr. GODDARD. Not on a de novo application. The bioassay in the antibiotic and insulin program is down here at headquarters.

Mr. FLOOD. These can, on their own, conduct these batch surveys or tests?