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amalgamation, say, in HEW or in a new Department of Health if it were established. How would you feel about that?
Mr. STETLER. It is my personal opinion that the time has come that they should not operate as separate entities. I think the reasons that may have been good and existed in the past, for their being separate, no longer exist.
Senator HARRIS. What about some of the questions raised yesterday about slowness of DBS and particularly, for example, we had testimony regarding the serially cultured vaccines. Have you had a chance to look at that criticism of DBS?
Mr. STETLER. I was here yesterday when the doctor from Stanford testified.
Senator HARRIS. Do you have any feeling about the criticism of the way DBS now operates?
Mr. STETLER. I think that over the last several years industry experience indicates slowness and difficulties on many occasions in getting action. I realize that more recently people have said the Department has moved too fast and moved in areas where they haven't had adequate controls. Nevertheless, over the entire record I think they have been slow and in many cases inordinately slow in terms of taking action.
Senator HARRIS. I am really troubled by the dichotomy there, slowness you have talked about. We heard testimony about that yesterday, then, of course, the safety factor, but I am also worried about your suggestion that there ought to be some kind of risk benefit consideration rather than risk.
How could you make that kind of thing work?
DRUGS ARE DANGEROUS
Mr. STETLER. It is made to work every day now. In other words, I don't say that risk should not be taken into consideration. It must be and it is, but when you are dealing with biological products or with drugs, prescription drugs, it must be remembered that they are all dangerous products.
In other words, if risk was the only test you would never market one of these products because they are dangerous. They are going to hurt somebody, and under some conditions they can hurt quite a few people. What you have to determine is whether the benefit that is going to come from marketing the product is sufficient to take the risk. Hopefully minimal risk, but risk nevertheless.
You can't be occupied completely with risk or you wouldn't market the product. If you get employees or people in responsible positions in these agencies that become preoccupied about risk and are not willing or feel they can't take the chance that exists every time you market a product, then there will be fewer and fewer products marketed. A slowdown in the long run would certainly not be beneficial to the public, the consumer, or society in general.
Mr. BRENNAN. The benefit-to-risk ratio in medical science has long been established and is well understood by industry, the regulators and scientists. This bill would seem to apply a brandnew set of standards for making those kinds of determinations with the emphasis more strongly on risk.
To upset this well understood ratio we feel would be entirely inappropriate.
Senator HARRIS. What about the suggestion that was made yesterday that if this amalgamation does take place between DBS and FDA, which you agree with, or even if it stays the same there might be establishment of peer group review, as we are familiar with in NIH. Do you have any reaction to that?
Mr. STETLER. Yes, I think it is desirable. These are very complex scientific questions that DBS and FDA are contending with every day. It is extremely difficult to attract, in large numbers, the type of personnel you have in these agencies because of the many disincentives associated with government service at that level.
Senator Harris. As full-time employees?
Mr. STETLER. Yes. The only way in the world I know to compensate for that is to consult with the experts that are outside government. They are usually quite willing to do that. That is one of the reasons why we are attracted to a health-type agency. You would, theoretically, at least, in that kind of environment have all of the in-house health expertise that does exist and probably a better mechanism or incentive for attracting outside experts. The use of outside expertise is absolutely essential in the operation of this kind of activity by the Government, in my opinion.
POLIO VACCINE Senator HARRIS. Back to another question we were talking about a while ago and something that came up yesterday, and I am interested in this as an example: Why, did the Dr. Sabin oral polio vaccine have to be tested in the Soviet Union rather than here?
Mr. STETLER. It didn't have to be, and I am sure there were tests in the United States as well. I must admit in that particular instance I am not conversant with all of the facts and the details. At that time I wasn't associated with the industry and it is not a matter of personal knowledge to me. I know there were other tests done in the United States. They were not conducted exclusively in the Soviet Union.
Senator HARRIS. Let me ask you another amalgamation question and that has to do with the Department of Agriculture.
What about consolidating the animal vaccine and drug programs in the Department of Agriculture with similar programs of FDA and DBS. How do you feel about that?
Mr. STETLER. We don't have an official position on that, I must say, personally I think it make good sense and, I think, too, the sponsors of S. 3419, which would look to a health complex, would bring into that new agency some of the activities of these other departments.
Senator HARRIS. You raise, I think, a serious question about the amount of funds authorized for this new agency, if there is to be such an agency. Do you have any suggestion about what additional funds other than those that would be authorized in this bill would be necessary?
Mr. STETLER. I raise that as a question because frankly I am not absolutely sure of one feature. In the bill there is a provision that says the personnel and I think it says budget will be transferred from existing agencies to the new agency.
Then it does say also that the limitation on funds for the first year will be $180 million, second year $200 million. I read that to mean that that is intended as a limitation on the total funds available to this new agency
If it is, to me on its face it is inadequate if you intend to do everything the Food and Drug Administration is doing, who say they need $180 million, DBS, which has a budget of $10 million and then a great number of other new activities. I wouldn't be able to guess what the cost of administering that program would be, but on its face it seems to me that $180 million is inadequate.
Senator HARRIS. I would think so, too.
EFFICACY OF BACTERIAL VACCINE
Finally, in response of the urging of this subcommittee, DBS, as you know, has begun a review of the effectiveness of drugs it previously licensed. I understand you have written to the Director of the National Institutes of Health objecting to DBS review of the efficacy of bacterial vaccine.
I wanted to ask you about the public policy questions that are involved in allowing drugs to remain on the market which even the manufacturers can't show are effective and which can cause or may cause patients to forego or postpone more effective methods of treatment and which we have heard may induce such side effects or effects such as fever, dizziness, muscle pain. How do you react to that?
Mr. STETLER. We wrote two letters to Dr. Marston based on the HEW proposal for efficacy review, which appeared in the Federal Register. In one letter we requested an extension of 30 days to give our companies an opportunity to express whether or not they were going to try to make the attempt to get the evidence required.
The other letter did not say you can't do it or you shouldn't check efficacy. What we said was if you try to apply the May 1970 regulations of FDA dealing with proof of efficacy, to biologic products, you are going to raise a great number of difficulties and probably impossibilities in terms of the evidence that is available or the evidence that can be acquired.
What we are trying to say in that letter is that it may not be as simple as it looks on its face. Give us a chance or whomever you want to consult with, to sit down and discuss the possibility of complying with the May 1970 FDA efficacy requirements.
Now, also with respect to biological products, I understand, and I am certainly no scientist, that the tests that are available are quite imprecise. That is the reason why there are products that are marketed, that are used quite broadly by physicians, for which it is very difficult to establish potency. The types of tests available also account for the variations in terms of potency that are found by the Government, by industry or at different times by both.
That is why some of these products have been on the market. Not that they are ineffective or impotent or that somebody is trying to foist a bad product on the public, because in actual operation they have done a job.
We know that the vaccines and others of these products have done a tremendous job.
If we would have had to comply with the May 1970 FDA efficacy requirements, or if we would have had to have them meet a certain predetermined test, these products would not be marketed. That is why we say before you move full steam ahead on new requirements of proof, that at least let us have an opportunity to sit down and discuss the difficulties it will create.
Now, DBS has required, with respect to 30-some products, that within a 30-day period, which has passed as of April 15, the companies that marketed the products had to declare their intention to submit "adequate" data within 180 days. If they didn't so state, the license, and these are licensed products, would be revoked.
The firms that said yes, that will try to comply with the efficacy requirements, have 180 days in which to produce that proof. On many products that is an absolute impossibility. Hopefully in the 180 days we will be able to sit down and hav a reasonable discussion as to whether these proposed standards are too tough, in the hope that some of these products which are quite effective can be retained on the market.
That is really what we were trying to do—to enter into a reasonable discussion with DBS in the correspondence, not to say you can't do it.
We didn't raise the legal issue. There is a legal point that DBS has contended for 20 years; that there is no legal authority for th to check efficacy. We didn't really go into that point extensively because the General Counsel of HEW has ruled that the authority that FDA has carries over under the food and drug law to DBS. We are not in a contest on that point. We really want to make sure that the tests they require can be met and that some of the products which are extremely good just don't go off the market.
Senator HARRIS. Thank you, Mr. Stetler and Mr. Brennan.
Our final witness for this morning is Miss Judy Jackson with the Public Interest Group here in Washington.
We are glad you are here. We will be pleased to hear from you. TESTIMONY OF JUDY JACKSON, PUBLIC INTEREST RESEARCH
GROUP, WASHINGTON, D.C. Miss JACKSON. Thank you very much, Mr. Chairman and distinguished members of the subcommittee.
Incidentally, I would like my full statement to be included in the record.
Senator HARRIS. Without objection, that will be done. (See exhibit 6, p. 160.) Miss JACKSON. Thank you for providing me with the opportunity to express my views on S. 3419, the Consumer Safety Act of 1972.
I am Judy Jackson, a law professor currently on leave from the University of Toledo College of Law and associated with the Public Interest Research Group in Washington, D.C. That is one of Ralph Nader's groups. I have been specializing largely in monitoring the Certainly section 111(a) of the bill providing for civil penalties against the new agency if it approves the marketing of a product which is found to constitute a safety hazard would make "no" the only safe statement for any employee of the new agency to make.
MARKETING OF NEW MEDICINES What the FDA, or any agency charged with the premarketing clearance of drugs, does not need are incentives for inaction.
We are seeing more and more concern recently over delays in obtaining approval for the marketing of new and improved medicines. Without attempting to identify a single or the most important cause, it is a fact that the number of new drugs, particularly new single chemical entities, marketed each year, has decreased since the passage of the 1962 amendments. In addition, many drugs discovered by U.S. firms have been introduced and used successfully in foreign markets for varying periods before being approved for marketing in the United States.
We are convinced that S. 3419, if enacted, including drugs, would further delay if not jeopardize the future development of new medicines for yet unconquered diseases, and could result in the loss of U.S. world leadership in drug research.
That, in essence, is why we are not in favor of S. 3419 as written. Quite possibly the new agency will be important, and independent, and successful, but that is certainly not assured. Major problems are certain to arise in the period between the time FDA and DBS were dismantled and the new agency took over.
It seems likely that many key FDA and DBS personnel would be considered unsuitable for employment in the new agency, and that many others would seek employment elsewhere. In the interim, consumer protection, with respect to drugs, at the Federal level would be, at least, in chaos. At a time when consumers are stressing their concern about health matters, the agency most skilled in the field would be torn down, its work reassigned and diluted with other new bureaucracies, in a new kind of governmental conglomerate.
There is a sound alternative to S. 3419, insofar as the regulation of drugs and medical devices is concerned. Very recently a bill to establish a single, separate, Cabinet-level Federal department of health was introduced, as S. 3432 by Senator Ribicoff, and H.R. 14199 by Representative Paul Rogers. It has bipartisan support with 23 cosponsors in the Senate, with yourself as one of the sponsors, I believe, and 60 in the House. This legislation gives health matters the priority in the Federal Establishment which they deserve. In bringing all related functions together, it would provide a blueprint for order and direction in health care at a critical time. Under these bills the FDA and the DBS would move from the present HEW structure and into a position of new stature and prominence.
We therefore urge that drugs and related medical products be removed from S. 3119, in the interest of effective consumer protection