ought to have final authority to establish standards, to promulgate regulations, to decide when and who to prosecute, and to enforce agency rules and orders. Would you care to clarify how you disagree with that feeling on my part? Secretary RICHARDSON. I essentially agree with it. Again, I would like to have the opportunity to look at the proposed statutory language, but I have no difficulty with the general thrust of what you have just outlined. Senator PERCY. A very delicate area, sensitive to business certainly, and affecting the Consumer Protection Agency legislation that we have under discussion in another bill, is the power of subpena. In discussing section 103 of S. 3419, you note that subsection 103 (a) (7) empowers the Administrator of the Agency to obtain by subpena where necessary such information as he is authorized to acquire. And you go on to observe, subsection 103 (a) (13) would authorize the Administrator to issue subpenas to compel the attendance of witnesses at hearings. You then correctly note there is no provision authorizing the court to enforce the subpenas or establish penalties for noncompliance. Am I correct in inferring that you believe the Agency should be empowered to issue subpenas for this purpose, and appropriate authority to enforce the subpenas should be contained in the bill itself? Secretary RICHARDSON. Yes, you do infer correctly that we believe there should be that power and it should be backed up by the capacity of the courts to enforce it. SUBPENA AUTHORITY Senator PERCY. It is my understanding that presently FDA does not have subpena authority to obtain information from business firms in connection with its food and drug regulatory activities. In view of the fact that this legislation would grant such authority to the Commissioner for Product Safety, do you think it would be logical to vest similar authority in the Commissioner for Food and the Commissioner for Drugs? Secretary RICHARDSON. Yes, I think it would. Senator PERCY. Apart from the issue of where the consumer safety function is located, do you agree with me that to avoid the possible. intrusion of political or other considerations and prosecutions for health and safety violations, the Agency head should be permitted to take cases to court without depending on Justice Department attorneys and without prior approval from the Justice Department? Secretary RICHARDSON. I think it would be useful for the Commissioner to have that authority. I am not sure he would want to exercise it in every case. It could necessitate the very substantial enlargement of the in-house legal staff, when for many purposes reliance on the U.S. attorney's office around the country would serve very well. Senator PERCY. I have a few more questions but I would like to yield to the chairman. Senator RIBICOFF. Senator Javits was required to be at another. meeting and will submit questions in writing, Mr. Secretary. We would appreciate your answer for the record. (See exhibit 12, p. 303.) AN INTERRELATED ENTITY WITHIN HEW There are a few questions I would like to ask of you now. You stress on pages 11 and 12 that you have drawn together what would otherwise be separate agencies into an interrelated entity within HEW. Don't you believe in light of the argument you have made, that have been made by scientists in the academic community, industry representatives and consumer advocates alike, the regulatory function of DBS should be consolidated with those of FDA? Secretary RICHARDSON. We have given quite a lot of thought to that, Mr. Chairman. I have had the opportunity in recent days to review the matter and I think the answer is affirmative, that they should be so consolidated. Senator RIBICOFF. If that is the case, these are your intentions, there are a few questions I would like to follow up. REGULATORY FUNCTIONS Are all regulatory functions of DBS to be transferred to FDA? Senator RIBICOFF. What percentage of the DBS budget is being transferred? Secretary RICHARDSON. We do not have any clear answer to that yet, Mr. Chairman. I would like to furnish that later. We have identified the regulatory function under these headings: protocol review, product release, label review, processing of licensing action, investigations of violations of the biological products control provisions of the Public Health Service Act, scheduling of inspections, review of investigational applications, and, eighth and last, legal activities involving promulgation of regulations. But, we do not have a clear budgetary allocation of functions. Senator RIBICOFF. When you arrive at that, will you please submit it for the record? Secretary RICHARDSON. I will be glad to. (See exhibit 13, p. 308.) VACCINE REGULATIONS Senator RIBICOFF. Will vaccine regulations be placed in the Bureau of Drugs, and what will be the position of the person chosen to be in charge of the vaccine department? Secretary RICHARDSON. The answer to the first question is it would be placed in the Bureau of Drugs. I do not have the answer to the second question. Dr. Edwards? Commissioner EDWARDS. This would be placed, Mr. Chairman, under an overall Office of Drugs, under which would be the Bureau of Drugs, Veterinary Drugs, and what will be a Bureau of Biological Standards. As far as the person to head it, we have not arrived at that. Senator RIBICOFF. Will the NIH research committee continue to have the responsibility for finding a new head of vaccine regulations? Secretary RICHARDSON. No. Of course, with the transfer of function, Mr. Chairman, it would become the responsibility of the Commissioner of Food and Drug to fill this position. Senator RIBICOFF. What provision is being made to replace Dr. Murray? Secretary RICHARDSON. At the present moment, there would probably be a function still underway in NIH. We had proposed the transfer as part of the consolidation which would occur under the Department of Human Resources and the question of whether to do it sooner has been focused by the consideration devoted to the legislation now before you. Dr. BERLINER. I think, I could tell you exactly how the matter stands. At the moment there is a search committee considering the names of people who have been suggested as possible candidates to assume the directorship of the Division. But I think that they are probably going to have to recess their activities until the nature of the position becomes clear, that is, until a decision is made as to how much of the activities of the Division will be transferred to FDA. Senator RIBICOFF. When you know that, you will make the decision, and when you find the man you will put him in the job immediately? Dr. BERLINER. That is correct. RESEARCH ACTIVITIES Senator RIBICOFF. What will be done with the research functions now performed by DBS? Will they stay in a separate division or come over to FDA? Dr. BERLINER. The research activities presumably will stay at NIH. But whether they will remain in a separate division or not will depend on what they add up to when the split is made. Senator RIBICOFF. Will the regulatory functions for the Communicable Disease Center over Clinical Laboratories also be transferred to FDA? Dr. BERLINER. That is something I will have to refer to Dr. DuVal. Dr. DUVAL. Mr. Chairman, we have not yet made a determination concerning whether any activities of the Center for Disease Control should be considered for movement to FDA. Senator RIBICOFF. When that decision is made, you will inform the Committee what your decision is? Dr. DUVAL. Yes, sir. Senator RIBICOFF. Senator Percy? AUTOMOBILE RECALL Senator PERCY. Mr. Chairman, I would like to take this occasion to publicly clear the record of a criticism which I made of an automobile manufacturer the other day. It was reported that a particular car's axle could drop down 9 inches to a foot at any time, whether the car was going at 10 miles an hour or 70 miles an hour. I was highly critical of the solution that the automobile manufacturer had foundto have a warning bell go off when it dropped down. I felt that any reassurance which might save the person from a crash, but might cause a heart attack instead, was hardly a solution. I was very pleased to read in the paper that same night that a policy decision had been made by the company-and I know those policy decisions take days or weeks to make to call back the cars at a cost of some $25 million. It is going to repair them. I therefore wish to withdraw my condemnation of the policy decision and replace it with commendation. But this is the only right thing that could have been done under the circumstances. Therefore, if the cost of $25 million can be absorbed by one company when it feels obligated to do so, I feel that other companies will have to recognize their responsibility to likewise correct defects as quickly as possible. They must also start building quality control into their products. And, certainly, Senator Ribicoff and I were deeply concerned about the vaccine case. I abhor government regulation and I hate to write such legislation, just as we all hate to see price and wage controls today. It is not a way to run a free society. If something is wrong or amiss in a free society, which permitted us to get into a position where you had to have a stop-gap measure that would prevent the abuses of the system that were being carried on, so here the same principle applies. We are going to have regulation upon regulation for industry unless industry will take upon itself its own self-policing job and establish standards that will be acceptable to a far more discerning and consumer-conscious public than we now have. When in business I constantly had to remind my fellow executives that this is not a producer's economy but rather a consumer's economy, and it must be such if it is ever to be the strong economy we want it to be. MANPOWER With your permission, I have a few questions that I should direct, I think, to Commissioner Edwards, because they are somewhat technical. I would like to know-possibly you cannot answer all of them, but could put the answers in the record the extent of FDA use of the Bureau of Standards facilities and its manpower. Commissioner EDWARDS. I will have to submit that for the record. I would say, though, that we are increasingly using the Bureau of Standards and this coming year we will be using it quite extensively. Senator PERCY. I would like to have the total number of man-years the Bureau has supplied to FDA over the past 3 years, broken down in the areas of food, drugs and consumer products. Are FDA requests for use of Bureau or test facilities or personnel ever turned down? Commissioner EDWARDS. Not to my knowledge. But, again, I would have to check. (See exhibit 14, p. 309.) Senator PERCY. If they have been turned down, I would like to know that. And, if so, what reasons were given for doing so. Do you feel it would be advisable in this legislation to provide for greater access, by whatever new consumer safety function we create, to the facilities of the Bureau of Standards? Commissioner EDWARDS. I think it would be perhaps a very wise step. The Bureau of Standards presents a tremendous resource for this whole area of product safety and standard setting and other activities in this field. Senator PERCY. I have a very high regard for the Bureau and its capability. I have also a high regard for the terrific task that faces us in the area of health and safety, as posed by the consumer product safety regulations. Could you take a look and see whether you feel it would be reasonable and logical to earmark possibly as much as a third or maybe at least a third of the Bureau's efforts to be directed for health and safety? Commissioner EDWARDS. We will. (See exhibit 15, p. 310.) Senator PERCY. It is a great Bureau. We have one of the most elaborate and best equipped laboratories in the world out there. Yet, I get the feeling the facility is not being adequately used by the regulatory agencies who have a priority role in protecting public health and safety. If the choice were simply between uniform screw threads and safer lawnmowers that were unable to chop childrens' arms and legs off, I would a lot sooner see the Bureau's activities turned toward the latter than to the former. Any help we can give you in seeing that you get your fair share of the Bureau's vast resources and do not have to duplicate them, we are prepared to give. FIELD STRUCTURE OF FDA Lastly, reference has been made to the field structure of FDA, which would include its instruction and surveillance teams. I am particularly concerned with the report that because consumer product safety regulation is a relative newcomer, it may not have sufficient surveillance and inspector man-years assigned to its needs, as compared to the areas of food and drugs. Do you have any information on that? Commissioner EDWARDS. I think that is an accurate statement. But the proposed 1973 budget and the new manpower ceilings we have received from the Secretary and administration take this into account. In 1973, we will bring the field force, the product safety aspect of our field force up to a level approximately equal to the Food and Drug activities. Senator PERCY. Could you supply us with a breakdown of the number of man-years involved in these functions, specifically in the separate areas of food, drugs, and consumer products? Commissioner EDWARDS. Yes. (See exhibit 16, p. 311.) Senator PERCY. Mr. Chairman, I have no further questions. I want to express my deep appreciation to you as one of the few members of the Government Operations Committee not running for President, but instead judiciously moving ahead with these hearings so we have a full chance to study the testimony very thoroughly. I think the testimony and responses we have had today have been extremely helpful. Senator RIBICOFF. The committee will stand adjourned until tomorrow morning at 9:30, at which time Mr. Carlucci and Mr. Ahart will testify. Secretary RICHARDSON. Thank you very much. (Whereupon, at 12 o'clock noon, the committee adjourned to reconvene on Wednesday, May 3, 1972, at 9:30 a.m.) |