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We encouraged the Food and Drug Administration to meet with representatives of these groups as they have been accustomed to doing at times in the past.
I personally met with Food and Drug people and met with representatives of the scientific community, both in and out of Government and in and out of industry, and through a whole series of conferences that went on from perhaps September through December of last year, we were better able to interpret in the final regulations the intent of the regulatory agency to resolve some of the concerns, and most of the concerns I think, that were expressed by the scientific community.
It is in that context of participation in development of regulations that involve policy questions and relationships with the scientific community that the representative of the Secretary does become directly involved, and probably should be, and is welcomed, I might say, by the Commissioner of the Food and Drug Administration.
Mr. Nelsen. Of course, in the interpretation of acts of Congress, I presume that you would want to be on the absolute safe side as to interpretation, and we would want you to be.
Mr. Jones. Yes, sir.
Mr. NELSEN. Sometimes we fail to communicate to the necessary degree so that a Department enforcing an act of Congress does not have all the clarification they need, and I did have this one particular instance in mind.
I think we moved a little perhaps to the cautious side and further than we needed to, but it is not something that cannot be repaired if that is true.
Mr. Chairman, those are all the questions at the moment.
Mr. Jones. Mr. Chairman, may I go back to one of Mr. Nelsen's earlier questions? I will provide the exact numbers for the record, but I think it would be important in terms of the Presidential appointees as contrasted with civil servants or career people
Mr. NELSEN. Yes,
Mr. Jones. The President when he came into office had virtually a handful of appointments to fill the policy positions in the Department. They numbered 9 out of almost 80,000 employees. When policy is a responsibility of the Executive under the statutory authority that the Congress has provided, and which require interpretation of authority and the exercise of the judgments having to do with policy decisions, the Secretary in our Department is handicapped by the relatively few people available to help him with this broad task that you suggest.
Mr. NELSEN. I think we understand that when responsibility is delegated to an individual he must have people to work with him. I do recall down in the Rural Electrification Administration I had one but I selected all of my top people from the ranks and had some good ones, very good ones.
Mr. Jones. Yes. This in no way minimizes the effective role of the career public servant in the Department.
Mr. NELSEN. I understand.
Mr. Jones. Because they provide the continuity which is quite important.
Mr. NELSEN. Thank you, Mr. Chairman.
Mr. ROGERS of Florida. Thank you, Mr. Chairman.
Speaking of the new drug law now, I noticed in the paper this last week that a statement was attributed to Dr. Frances Kelsey which dealt with difficulty evidently in finding space and personnel to handle the data flowing into the FDA under the new law and the new regulations and I think the columnist insinuated that drug companies were purposely inundating the agency with this mountainous paperwork trying to keep Dr. Kelsey from performing her functions.
Of course, under the new law and the regulations, manufacturers must supply additional information on the testing of new drugs that was not required before.
Certainly, in making these statements Dr. Kelsey is not implying that they should not furnish this information, I presume?
I Mr. Jones. You are quite correct, Mr. Rogers.
Mr. ROGERS of Florida. What steps have been taken now to provide the necessary space and personnel to handle this information that is required by the law?
Mr. Jones. Dr. Kelsey was appointed Chief of Investigational Drug Branch, Division of New Drugs, Bureau of Medicine.
The recruiting of physicians for the Bureau of Medicine, I am informed, has been successful beyond that which we had anticipated.
They now have commitments of 60 professional people to fill 57 authorized positions, so that they are, if these people fulfill the commitments they have made, being recruited successfully.
Mr. ROGERS of Florida. What is the time limit on that?
Mr. Jones. They will be coming in. The amount of space available to the Bureau of Medicine is totally inadequate. There has been a 15percent increase in the personnel authorized for the Food and Drug Administration for each of the last few years.
They have gone from 1,000 to something over 3,000 employees in 5 years. I can give you the exact figure. I think it is in the testimony that Mr. Larrick provided for you earlier, which I will not repeat.
Federal office building 8, a building adjacent to the headquarters of Health, Education, and Welfare, is under construction for the Food and Drug Administration.
It will be inadequate when completed. It is not built to the size asked for at the time it was planned, but it is even less adequate now.
This building will not be available until October 1963 for some of the offices. It will be another 2 years, so we are told, before the laboratories in this building are fully available.
There has been in the last 2 weeks a development in which Dr. Kelsey's branch and the Bureau of Medicine, in toto, have been provided an additional 11,500 square feet of space in the building they now occupy, and which is adjacent to the space they now have.
The Secretary last week made a personal inspection of this space. He has asked specifically that certain things be done to improve it.
The Administrator of the General Services Administration is fully cooperative and trying to provide space. Office space is at a premium in Washington and it is very difficult to get, but Dr. Kelsey's situation has been greatly relieved by the additional space made available within the last 2 weeks. On the point of whether or not the drug industry is
deliberately providing this large volume of data, I do not believe this is a factor at all.
Mr. ROGERS of Florida. They are simply complying with the law?
Mr. Jones. They are complying with the law. There are some 2,500 drugs under investigational use for which plans of investigation must be filed by June 7 to be able to continue the investigational use after that date.
We observed last week some of the paper submitted for new drug applications. This is also a part of the responsibility of the Bureau of Medicine. They range in size from one volume to one stack comprising 53 volumes about 8 feet high.
This is a space problem that is very difficult and it involves a great deal of work in a very brief space of time.
Mr. ROGERS of Florida. The papers that are submitted are those that have been requested to be submitted under the law. Are they not?
Mr. Jones. Yes. The drug industry is not deliberately inundating the Bureau of Medicine or the Food and Drug Administration.
They are responding to requirements of law.
Mr. Rogers of Florida. Is there any way to cut down that paperwork and still get the necessary information?
Mr. Jones. If there is such a way, Mr. Rogers, it will come out in the experience over a period of a year or two. It would be unfair, I think, to assume that there can be a change now when the program is just coming into being and we have not had the experience to know what can be cut down and what cannot.
The sponsors are responding to what our interpretation of the intent of Congress was in the Drug Amendments of 1962 and I think the companies are responding appropriately and properly.
I think the only concern that the companies have which I have heard them express is whether or not the Food and Drug Administration can secure and maintain, in sufficient volume, the qualified people properly needed to process these documents. This is a problem in which we are deeply engaged now.
Mr. ROGERS of Florida. What has disturbed me a little bit about this is the fact that the statements were made saying we didn't have the necessary space and didn't have the necessary personnel.
As I recall, Dr. Kelsey herself, I think, came over and testified on the bills, I guess last year, maybe the year before, and I wondered why provisions were not made as soon as Congress passed the law to provide the necessary personnel and space.
Why must it wait all of this time and become critical? Why couldn't it have been done in the meantime?
Mr. Jones. Mr. Rogers, it takes a great deal of time to create space where it doesn't exist. If it were just a question of going out and renting 50,000 square feet of office space, this would be very simple.
Mr. Rogers of Florida. I notice now they are tearing down temporaries right now a block or so away from Health, Education, and Welfare. I just noticed them coming in today, and the last few days they have been tearing these down and yet we are crying for space. Who makes that decision?
Mr. Jones. The General Services Administration has the responsibility on request from the departments.
Mr. Rogers of Florida. But you have requested the necessary space ?
Mr. Jones. Oh, yes. They are well aware of this.
Mr. Jones. Yes. They have been working very hard to find space that doesn't exist.
Mr. ROGERS of Florida. But they are tearing some down that does exist.
Mr. Jones. Well, on Independence Avenue, they are tearing down one of the temporaries, but I think this had to be to effectively use other buildings.
Mr. Rogers of Florida. But you have received an additional 11,500?
Mr. Jones. And it has relieved the situation temporarily. We are still not out of the woods but we have made some progress.
The long term plan, Mr. Rogers, provides that the Department will have available for the Food and Drug Administration the present Federal Bureau of Investigation Building, which is immediately south of the new Federal Office Building No. 8.
This will be available only after the new Department of Justice Building is authorized and built. This is 5 or 6 years off probably but there is a tunnel already constructed between the new Food and Drug Building and the FBİ Building in anticipation of this.
Furthermore, we have made a policy decision that to the extent that space will not be or isn't provided permanently in the Health, Education, and Welfare complex in Washington, then we will concentrate at the Beltsville, Md., site where we already have animal laboratories and we are now building a pharmacological laboratory. We also have authorization for plans for an additional building at Beltsville. Between these two sites then, we would hope to get authorization from the Congress to provide adequately for our needs, but the timelag is the problem.
It just takes time to get space. It takes time to identify and recruit personnel.
Mr. ROGERS of Florida. Of course, all of this additional data that is required is to facilitate the prompt evaluation and so the manufacturer and the investor can know and take action to prevent unnecessary hazards?
Mr. Jones. Yes. I think it is important to remember, too, Mr. Rogers, what the Congress did as a matter of policy in the HarrisKefauver drug amendments and the regulations that came out of the Department in relationship to these amendments.
The failure of the Food and Drug Administration promptly to review the investigational drug reports will in no way stop the investigations.
It gives the Food and Drug Administration the data to determine whether or not the investigation is being carried on by the sponsor in a manner that assures reasonable consumer protection.
The Food and Drug Administration then has the obligation on review of this data to move in and stop it or to require its modification in those instances where it is evident to the Food and Drug Administration that consumer protection is not adequate. The burden is on the Food and Drug Administration to review promptly those that are most suspect, and then to move right ahead with all the review. They can move in at any time their reviews indicate a need, but the investigation can go on and will not be stopped by these reports.
Mr. Rogers of Florida. Do you foresee any difficulty in communicating with the sponsor with all of this information coming in? For instance, if you get a report of an adverse effect, would that be immediately communicated to the sponsors?
Mr. Jones. Immediately.
Mr. Rogers of Florida. So they can take whatever action is necessary?
Mr. Jones. They give priority to the obviously difficult situations. Adverse reports would be factored right into the communications system. Most of the sponsors would voluntarily take action immediately once they had the information. We are also working very hard on the communications aspect of adverse drug reactions.
Mr. ROGERS of Florida. The internal organization of Food and Drug and Public Health Service also comes within your jurisdiction?
Mr. Jones. Yes: I oversee this for the Secretary.
Mr. Jones. They are the responsibility of the respective constituent agency heads. The Commissioner has this responsibility, the Surgeon General has this, and the Secretary has the approval.
Mr. Rogers of Florida. For the Secretary you are the one who would handle the internal organization perhaps if they came up?
Mr. JONES. In collaboration with the administrative assistant secretary of the Department who has the general administrative function of the Secretary's office, but you are correct in your assumption.
Mr. Rogers of Florida. Are there any specific reorganization proposals pending with respect to either of those agencies, Food and Drug Administration and the Public Health Service?
Mr. Jones. Yes, sir. The Public Health Service has asked in the bill before your committee for specific authority which would be immediately used to provide a Bureau of Environmental Health, and a sister Bureau of Community Health Services. This would discontinue the Bureau of State Services because these two new Bureaus would be created out of it.
The Food and Drug Administration is studying along with us the recommendations of the Citizen's Advisory Committee which did make recommendations for major organizational shifts.
This report was a very constructive report. It was very direct. It pulled no punches. We consider it highly constructive.
The major recommendations of this report will be adopted by the Food and Drug Administration. A major portion of the report is devoted to organizational recommendations.
I think the Food and Drug Administration is getting geared and moving rapidly toward an organizational pattern that pretty well reflects the recommendations of this report.
Mr. ROGERS of Florida. Could you let us have the specifics of what you are planning later on? And what about the discussion of aspects of the Mental Health Institute perhaps to be made into a bureau !
Mr. Jones. This is a matter that is much more complex than would appear on the surface. The Surgeon General has appointed a task force in the Public Health Service which is reviewing this particular issue at this particular time.
The ramifications of creating a Bureau of Mental Health are pretty widespread in the Service. I can give you some of the details.