Dr. WOLFE. May I make just one comment?

Mr. ROGERS. Certainly.

Dr. WOLFE. Not only have Covington and Burling and probably other lawyers been pushing in Washington for programs to Indemnify the vaccine manufacturers. At the level of the CDC for a comparable period of time there has been action including some studies, I am told by the General Counsel's office, down in Atlanta to push such programs. In other words, one the door is open for this particular kind, swine flu, it is likely that it will rapidly spread to all kinds of immunization. The drug industry has pushed the Government, at least through the forum of the CDC, to become an advocate for indemnifying them against law suits by injured patients.

Dr. Sencer, who is the head of the CDC, has for several years talked about indemnification. He once made the outrageous proposal that Abbott Labortories, as a result of having infected intravenous fluid that led to 100 deaths and thousands of cases of blood poisoning, should be indemnified by the Government because of all the business they lost and lawsuits brought against them because of their infected products.

I suggest that if the head of the CDC is thinking about things like this then we really do have to be very concerned that this is not something that would be limited, even though it would be incorrect even if limited only to swine flu. But it is going to extend to other vaccines and possibly to other drugs.

To me that is a frightening prospect.

Mr. ROGERS. Yes. Thank you very much.

If you would let us have some suggested language, we would be grateful.

Ms. JOHNSON. Do you mean indemnification in general or the swine flu program specifically?

Mr. ROGERS. The swine flu situation basically.

Thank you so much. And thank you for your patience.

The subcommittee stands in adjournment, subject to the call of the Chair.

[Whereupon, at 6:13 p.m., the subcommittee adjourned, to reconvene at the call of the Chair.]

SWINE FLU IMMUNIZATION PROGRAM

TUESDAY, JULY 20, 1976

HOUSE OF REPRESENTATIVES,

SUBCOMMITTEE ON HEALTH AND THE ENVIRONMENT,

COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE,

Washington, D.C.

The subcommittee met at 10 a.m., in room 2118, Rayburn House Office Building, Hon. Paul G. Rogers, chairman, presiding.

Mr. ROGERS. The subcommittee will come to order, please.

We are continuing our hearings today on the proposed swine flu vaccination program for the Nation.

We are pleased to have representatives of the Department of HEW and particularly the Assistant Secretary for Health, Dr. Cooper and his colleagues with us this morning.

We welcome you back to the subcommittee.

I think it would be helpful if you could bring us to date now on what has happened since our last meeting: negotiations and the various proposals you have considered and what other recommendations you may have.

STATEMENT OF THEODORE COOPER, M.D., ASSISTANT SECRETARY FOR HEALTH, DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE, ACCOMPANIED BY WILLIAM H. TAFT IV, GENERAL COUNSEL, HEW; RICHARD M. KRAUSE, M.D., DIRECTOR, NATIONAL INSTITUTE FOR ALLERGY AND INFECTIOUS DISEASES, NATIONAL INSTITUTES OF HEALTH; DELANO MERIWETHER, M.D., SPECIAL ASSISTANT FOR THE SWINE FLU PROGRAM; JAMES F. DICKSON III, M.D., DEPUTY ASSISTANT SECRETARY FOR HEALTH; DAVID J. SENCER, M.D., DIRECTOR, CENTER FOR DISEASE CONTROL; HARRY M. MEYER, JR., M.D., DIRECTOR, BUREAU OF BIOLOGICS, FOOD AND DRUG ADMINISTRATION; AND GENE R. HAISLIP, DEPUTY ASSISTANT SECRETARY FOR LEGISLATION (HEALTH)

Dr. COOPER. Thank you, Mr. Chairman.

I have with me on my right the General Counsel of the Department, Mr. Taft; to my left, Dr. Dickson, Deputy Assistant Secretary for Health; Dr. Sencer from CDC; Dr. Harry Meyer from the Bureau of Biologics, FDA; Gene Haislip, Deputy Assistant Secretary for Legislation; Dr. Richard Krause, Director, National Institute of Allergy and Infectious Diseases; Dr. Delano Meriwether, program manager for the national immunization program.

Mr. ROGERS. We welcome all of you gentlemen to the committee.

Dr. COOPER. Since our last meeting, at which time you asked us to return to try to work out an agreement within the confines of authority that could accomplish the objectives of the program by agreements or contracts between ourselves and the manufacturers, we have in fact continued those negotiations in great detail.

Secretary Mathews has met with the manufacturers and representative of their legal inside and outside departments and some of the insurance companies with which they are related.

We have met with the President during that period of time. We have gotten his advice and instructions as to how to proceed. He reaffirmed his support. As you may recall from his press conference yesterday, he reaffirmed the need to get on with finding a solution to the problem so that the public could have this form of protection.

I have a statement in full. If we could put it in the record that would be fine.

Mr. ROGERS. Without objection it will be made a part of the record at this point.

[The statement referred to follows:]

THE PRESIDENT'S NEWS CONFERENCE OF JULY 19, 1976

SWINE FLU IMMUNIZATION PROGRAM

Q. Mr. President, can we ask you about the swine flu program? We understand it is in jeopardy now. The insurance companies will not insure the pharmaceutical companies which are making up the batch of vaccine. What can you do about it, can the government supply insurance?

THE PRESIDENT. Last week the Secretary of HEW and Dr. Cooper met with the four manufacturers and their legal counsel. I got a report Friday from Secretary Mathews. He was more optimistic than some of the press stories seemed to indicate. I have not talked to him today, but we are going to find a way, either with or without the help of Congress, to carry out this program that is absolutely essential, a program that was recommended to me unanimously by 25 or 30 of the top medical people in this particular field.

So, we are going to find a way, and I think we will eventually do it. And I expect the full cooperation of the industry and all other parties involved.

Mr. ROGERS. You might want to refresh the committee's memory on the most pertinent points.

Dr. COOPER. The President was asked, "Mr. President, can we ask you about the swine flu program? We understand it is in jeopardy now. The insurance companies will not insure the pharmaceutical companies which are making up the batch of vaccine. What can you do about it? Can the Government supply insurance?"

The President answered, "Last week the Secretary of HEW and Dr. Cooper met with the four manufacturers' legal counsel. I got a report Friday from Secretary Mathews. He was more optimistic than some of the press stories seemed to indicate." He had not talked with him today-that was yesterday-but he then said, "We are going to find a way with or without the help of Congress, as you are aware, to carry out their program that is absolutely essential," a program that was recommended to him unanimously by 25 or 30 of the top medical people in this particular field.

He said, "So we are going to find a way. I think we will eventually do it." He expects the full cooperation of industry and all of the parties involved.

In the meetings that went on since we last met with you, there have been further refinements of contract language, which was the subject

of press conferences and full public information, about the contents of the proposed contracts as well as a delineation of the remaining issues last week.

After the meeting between Secretary Mathews and the representatives that I mentioned, we asked that they review the proposals and contracts with their legal staffs and with their insurers at the end of the week and the beginning of this week, to let us know if they could proceed with the negotiation of contracts.

We were informed yesterday essentially that no one was specifically prepared to negotiate a contract on the basis of language that had been proposed at the meeting earlier.

In addition, the issue was raised about the imminence of the termination of production in at least two of the manufacturers.

On reviewing this information-as Secretary Mathews released in his comments yesterday-the General Counsel and in consultation with the Secretary, we analyzed the situation and looked into what other options were available within our current authorities as well as what needs might be anticipated for further legislation.

Secretary Mathews is in a Cabinet meeting at this moment at which the subject is likely to arise. Prior to that Cabinet meeting, the Secretary, Mr. Taft and I, discussed the background analyses with the staff of the President. Through that medium we were asked to proceed with a way to try to continue within our authority that production that might be in jeopardy and to discuss with you and members of the subcommittee what would be the best course, including legislation, for the resolution of the issue.

We are here for that purpose and stand ready for whatever time is necessary to try to insure the availability of this kind of preventive protection for the public.

In addition, you no doubt have been made aware of the rumors of outbreaks of influenza, particularly in the Southern Hemisphere, that has been reported but not confirmed by our monitoring stations and by the World Health Organization, by our contacts between our agency, CDC and the Bureau of Biologics and their counterparts, particularly in Australia.

I would propose, Mr. Chairman, that in order for you to have the most up-to-date and scientific information about the status of those monitorings, I will ask Dr. Sencer to comment and then perhaps Dr. Meyer and Dr. Krause could comment on the continuing clinical study, particularly in young people, which is a remaining area of clinical trial and investigation in order to determine dosage and possible exclusion.

As a summary statement of the latter, I would remark that, reviewing our management schedule, the basic scientific work is on schedule. The studies are going along.

The problems are, because of the liability question, insuring production and obtaining the vaccine.

There is also one other issue that was raised during our hiatus between meetings. This was the report from the Armed Forces Epidemiological Board. They had selected vaccines made by two of the four manufacturers and were recommending it for people down to 18 years of age in a different dosage than people heard about from our own recommendations.

I think when Dr. Meyer makes his comments, in particular, and perhaps Dr. Sencer and Dr. Krause, that this can be clarified. This is not an indication as some people thought that the Armed Forces advisors who had been sitting in on all the meetings, and we on theirs, had found the vaccines of the other two companies inappropriate for any use or anything of that order or that they were bad or of poor quality. I think we are in a position to clarify that particular issue.

I would say in summary that the problems we are facing are not scientific at the moment. They seem to be fiscal, related to the question of liability. In order to be complete, I see that once we resolve this particular issue, which I hope we will be able to do, on the liability of the manufacturers of the vaccine, that there are about a dozen States that potentially have problems of malpractice insurance for the administration of the program.

But short of that aspect, the public design, the voluntary effort, the participation of communities and professions, have been going along quite well and on schedule. Dr. Sencer could also comment on this.

So in all segments we have an update which would, in essence, indicate that the program is basically on schedule, and that we could get our objective met by the end of the calendar year if we could, in fact, insure both production and availability for administration within the system that we have proposed.

I think that underscores in a very real way that all the parties here have a responsibility to try to resolve this in the interest of the public and not in the interest of any particular industry or profession but in the public interest.

I would propose, Mr. Chairman, that we ask Dr. Sencer to bring you up to date on the epidemiological rumors and then have the other experts comment on the status of the activities in the program before we get into specific proposals.

Mr. ROGERS. That would be fine.

Dr. Sencer?

Mr. WAXMAN. Mr. Chairman, before he begins, it seems from Dr. Cooper's testimony that the problem as he sees it, is not a biological problem, but a fiscal question dealing with the questions of liability. While I am sure we would like to hear an update on the production of the vaccine, the possibility of the flu epidemic elsewhere in the world which may confirm the fact that we will have an epidemic. in this country, shouldn't we address ourselves to that question before we

Dr. COOPER. I am not trying to avoid any questions, Mr. Waxman. But the point is a very important one as far as I am concerned. We talk about what is a risk and what is not a risk, whereas the insurers may be talking about a risk that they define in their terms as uninsurable. I am concerned that the American people not interpret this as something wrong with the vaccine. It is a very safe vaccine. As compared with other ones that are given for a wide variety of circumstances to children and adults, this has very fine data. I want to make sure that everybody understands that when we are talking about "risk", we are not talking about medical risk. We are talking about financial risk because of the scope of the program, their capacity, as I understand their case, and the legal climate of increased liability suits.