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 enforcement. I 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 condueling 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. 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? 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. 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? |