some initial regulatory step, and I think that is true in a number of areas Mr. Elkind cited when he talked about the Space Agency model, where you do analysis of the product because you suspect there may be a problem. When you begin to get evidence there is a potential problem or a long-range problem, then you begin to set warning standards saying "This may be a problem now," "It is more likely to be a problem," or "We think it is a problem," before there are injuries.

That can be done much more effectively in an agency outside HEW than inside.

Senator PERCY. I have a few procedural questions I think we can get precise answers to; so, we offer all of them, and if there is anything you want to supplement for the record, you can.

TERM OF OFFICE

In establishing a new agency, how important is it that the head of the agency have a set term of office?

Mr. TURNER. I believe it is important to make a way to have that person responsible so that he is not set for life in a job. To the extent that a set term accomplishes that, I would be for it. I would also be for some kind of method to remove a person who does not perform the job properly.

Senator PERCY. Is that important also, that each Commissioner has a set term of office?

Mr. TURNER. Yes.

Senator PERCY. Should the Commissioner be appointed by the Administrator rather than the President?

Mr. TURNER. I think that the Administrator should have an input into the appointment, perhaps a nominating procedure, but I believe the Commissioner should be appointed by a higher level.

Senator PERCY. The FDA has undergone a number of reorganizations and certainly has had one under the present Commissioner. With each reorganization there is inevitably a period of transition and confusion while the agency readjusts. How long do you think it would take before the new agency would be operating smoothly?

Mr. TURNER. I think if the agency would be moved out intact as it is now with the product safety office added as designed to be added in the bill, it would take a short time, I think, for that agency to operate smoothly.

Senator PERCY. What do you mean by a short time?

Mr. TURNER. I do not think it would take longer than a year at the outside, and I think the food and drug activities can continue without any interruption.

READJUSTMENT PERIOD

Senator PERCY. Is there benefit to be derived from the reorganization adequate to warrant this period of readjustment of a year?

Mr. TURNER. Yes; because I think the readjustment would apply only to the product safety area which would be comparable if it were put in HEW. You have to do the same thing in the office in HEW that you would in the independent agency.

Senator PERCY. I will ask you the same question Senator Javits put to Mr. Elkind.

S. 3419 VERSUS S. 1177

Do you see any conflict between this bill and S. 1177 which would establish an independent agency to represent consumer interests before Federal agencies and courts?

Mr. TURNER. I not only do not see them as contradictory or in conflict, I see them as supplemental to each other, and, essentially so. I believe there has got to be some kind of independent input of consumer - points of view rather than have it referenced back to the director of the agency.

Senator PERCY. You have spoken of the need for accountability of a person ultimately responsible for the regulatory decision. What difference does it make whether the person is a Cabinet Secretary or the head of an independent agency?

Mr. TURNER. In the case of the Cabinet Secretary at this point, we have a situation where a man who is ultimately accountable is not actually the man who makes the decisions on the line, on the routine basis. Therefore, the decisions are made when they become crisis decisions. The man who is involved intimately with those decisions ends up not being the person who makes the final decision.

The perfect example is DBS. In DBS it is delegated by HEW to the head of NIH, that he shall be authorized responsibility for vaccine regulation and yet to date the activities are run by the Director of the Division of Biologics Standards. Very unfortunate, I think, is the division of daily on-line activity and ultimate final responsibility or accountability

COORDINATION WITHIN HEW

Senator PERCY. The Secretary of HEW has admitted that in the past there has been inadequate coordination among the constituent agencies right within HEW, even when he has the ability to knock heads together and have them roll if they do not coordinate and work together. He had difficulties and has been very candid and frank in admitting it. He apparently believes the only way, however, to achieve a higher degree of coordination is to keep these interrelated agencies within the Department under a common superior and force them to work together.

If an independent agency is created, what arrangements can be made to require interaction with related agencies in HEW and elsewhere in the Government?

Mr. TURNER. Well, to take the first part of the question: It seems to me that it is inherent in the function of HEW that it will be impossible for any of these great departments to knock heads together on the lower echelon, the reason being that the individuals who are doing the actual day-to-day work do not get the attention of the persons who are making the decisions until there is a crisis.

INTERAGENCY AGREEMENTS

My suggestion for handling the problem of taking DBS and FDA and relating it to HEW, which will give functions of merit to it, will

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be a much stronger reliance on interagency agreements. FDA and DBS have an interagency agreement on efficacy. I believe we should have interagency agreements between institutes generating scientific information on foods and drugs, and products for that matter, which will cause that information to move directly from the institute when it is generated into the decisionmaking process of the regulatory agency. This, I think, will be more likely to happen if the agency is outside HEW than inside. As it has been inside, the only way we can accomplish these kinds of relationship is by creating a high priority by putting a spotlight on a crisis area. Then, the Secretary will begin to try to bring together some of the functions.

Senator PERCY. Thank you very much, indeed. I turn the chair back to the chairman.

Senator HARRIS. You heard my question a while ago to Mr. Elkind about the standing with the Congress insofar as appropriations are concerned for an independent agency as compared to, say, being within HEW.

Would you care to comment on that?

Mr. TURNER. I think that is clearly a record that the independent agencies have not gotten large budgets from Congress, but I think that that is a result rather than a cause of their problems. I think it is a result of their inherent weakness as agencies. I believe the money will follow the function, and when you are establishing a safety function, and you do have the strong base of the 60-and-some years of the food and drug law development in the courts and in Congress and by the agency, it will be not only possible but highly likely that the funds needed will come forward.

As it is now, the levels of budgetary request you have to go through are very many, and each of those levels believes it must have a policy input into that budget. That is what we are trying to cut through. Senator HARRIS. I agree with that. I think you are absolutely right. That is, I think, the question this committee ought to consider. Let me ask you a separate question, not related to that.

REGULATORY BODIES

The things that worries me about regulatory bodies generally, as it probably does you, at the national level as well as around the States, you look at these regulatory bodies, and almost as fast as we can create them they become controlled by those who are supposed to be regulated. That is true at the Federal level, I know. This bill has a division in it about mandamus suits, and so forth. Will that give us some insurance against the control of the agency by those it is supposed to regulate, and are there other safeguards that you can point to or suggest?

Mr. TURNER. Well, I think that definitely it will give some assurance but that the basic problem you are alluding to, the problem of regulatory agencies being captured by those they regulate, has a couple of clauses which will help avoid capture by industry and are used in the argument for this bill.

First of all, when the ICC, for example, was created, or the FDA was created originally, they were created with the support and the development of the industries involved; that is, the development did not take place until after they had received the endorsement of the industries that were going to be regulated by them. This is a crucial step in the history of the regulatory agencies. It also seems to me it is a crucial reason why they have been weak agencies and have not been trying to get the funding they were needing. They were captured before they came into existence.

PEOPLE MUST BE INVOLVED

In addition, I think it is very important for the American public to act on something it already knows and that is that Government is not a substitute for themselves acting for their own rights. Much too often, we think that creating a Government agency will then solve all of our problems and we can go away and everything is taken care of. By historical examination and current observation, this is clearly untrue. People must be involved. If they learn they must be involved, then, Government will not be looked upon as failing when it does not score touchdowns for the public.

Government is supposed to be the referee. It is not supposed to be the guys playing on one side. Government is not consumers; Government is not industry. The consumer movement's major and most effective argument against Government up until now has been its tendency to play on the industry team. What we are now arguing is not that Government should play on the consumer team, we are arguing the consumer team ought to get in there and do its lawsuits, have its advocacy agencies, develop organizing principles to bring itself to bear in the economy, and the Government ought to be strictly a referee agency which basically makes sure the minimum rules established are enforced, make sure there is no tripping, no unnecessary roughness, and so forth.

But above and beyond that, the quality of the society must depend upon the interaction between the people acting as consumers in the marketplace and the people acting as sellers in the marketplace and that interaction referred by the Government will be the greatest insurance against having the agency captured by industry.

Without that concern by the public, I think we are going to have a hard time.

Senator HARRIS. You have been very helpful, and also very patient. Thank you very much.

Mr. TURNER. Thank you very much. I always appreciate listening to Mr. Elkind. He has fantastic information on the subject.

Senator HARRIS. Thank you, Mr. Turner. I want to call now on Dr. Leonard Hayflick.

Dr. Hayflick is a professor at the Stanford University School of Medicine.

Dr. Hayflick, we are pleased you are here and pleased to hear from you at this time.

TESTIMONY OF DR. LEONARD HAYFLICK, PROFESSOR, STANFORD UNIVERSITY SCHOOL OF MEDICINE, STANFORD, CALIF.

Dr. HAYFLICK. Thank you, Senator Harris.

I am pleased your committee thought to invite me here. The thrust of my remarks, which have been submitted as a formal document, will be abstracted at this point.

Senator HARRIS. As we have done earlier, without objection, we will print the entire statement in the record.

(See exhibit 4, p. 119.)

Dr. HAYFLICK. Thank you.

My remarks are really based on 10 years of experience in dealing with the policies and some of the people at the Division of Biologics Standards, which we refer to here as DBS.

It will be my purpose to make three salient points from which I intend to draw five conclusions.

The points to be made are the following:

1. That DBS has been inordinately slow to respond to new research developments which lead to the improvement in the safety, purity, and efficacy of virus vaccine products for which it is responsible.

2. That DES's activities in the area of biomedical research raise serious questions of conflicts of interest arising between DBS and non-DBS scientists which can work to the disadvantage of the public. 3. That DBS's policies or lack of policies have worked to the detriment of their constituencies.

SLOW RESPONSES

Although there are several examples of slow responses by DBS to new research developments, I will confine my substantiation of this charge to the arena of human virus vaccine substrates where my firsthand experiences extend over the last decade.

The production of human virus vaccines has historically depended upon advancements in the field of tissue or cell culture. Virus vaccines consist of viruses in either a killed or weakened state. Thus, in order to produce vaccines, it is necessary to produce large amounts of virus particles. These can only be produced in living cells, either from animals or from man. It is extremely important that the cells in which the virus grows are free from contamination. If the cells contain disease-producing microbial contaminants, vaccine viruses could spread an unwanted disease. The cells of some animals in which vaccine viruses are produced have been shown to contain contaminants which have caused cancer in laboratory animals and human tissue cultures and have caused human fatalities.

HUMAN CELL CULTURES

In 1961, my associates and I isolated human cell cultures in which vaccine viruses could be produced. We believe that these cells were safer than animal cells in which vaccines were then being produced. Yet, for more than 10 years, DBS failed to encourage manufacturers to work on licensing a single vaccine produced in these cells, and con