and in anticipation of their more appropriate and efficient regulation under S. 3432.

We are appreciative of the opportunity to present our views to the subcommittee, and will be pleased to answer any questions you may have.

Senator HARRIS. Thank you, Mr. Stetler.

On page 4 of your statement you say, "Indeed, the new agency may simply invite stronger pressures and greater impediments to progress. I wonder if you could elaborate on the pressures from whom and why they would be stronger than they are now and what sort of impediments you are talking about that would hinder progress.

MARKETING OF NEW DRUGS

Mr. STETLER. The major impediment, the one I specified in the statement, was the difficulty in getting FDA to move expeditiously in connection with the marketing of new drug products.

Senator HARRIS. Are the pressures you are talking about from the industry?

Mr. ŠTETLER. There are pressures now from various sources. What I say is that under the new bill not only would those pressures exist but quite possibly additional pressures. I can't conceive of there being any lessening of pressures on the Food and Drug Administration.

Senator HARRIS. You mean pressures from the industry or from whom?

Mr. STETLER. Industry, Congress, consumers, the press, the same pressure sources that exist now. The one additional thing that was mentioned earlier that is in the bill, is the invitation for litigation in the form of mandamus-type actions.

Normally that is considered as an extraordinary legal remedy. I think under the bill it would probably become an ordinary legal remedy. There are provisions, incidentally in the present Food and Drug Act that permit any interested party, whether he is an individual or the industry, to litigate, to question the actions of the Food and Drug Administration.

We think they are sufficient and appropriate and many cases have been brought. The invitation in this bill would certainly be louder and probably more accepted. There is a question, in connection with the discretionary powers of an agency like the FDA, as to whether or not it should always be subject to that kind of questioning.

The result, I am sure, is that they would become more conservative and they are very conservative now, and in some instances too conservative. It would be difficult to get the average employee in the FDA to take an action when he knew that not only would he be subject to all of the questioning that comes his way now but possibly a good deal

more.

AMALGAMATION

Senator HARRIS. Let me ask you about some amalgamation of the questions.

What about the possible amalgamation of FDA and DBS, aside from the separate agency, which you oppose, what about that kind of

Ce agai

is fo

stat

T!

anc T!

ing

out a fa

enti.

1962

have

vary Stat

TI furt cines

worl

TI Quit and certa disma

It= consic:

many sumer

at leas:

about

torn de racies, i

There drugs and lish a sing introduced. sentative I' in the Senat in the House Federal Esta functions toge

"4

୧୮

'S

"

new Department of Health if it

about that?

pinion that the time has come that ence entities. I think the reasons that usein the past, for their being separate,

some of the questions raised yesterday early, for example, we had testired vaccines. Have you had a chance sterday when the doctor from Stanford

are any feeling about the criticism of wer the last several years industry experificulties on many occasions in getting ently people have said the Department ved in areas where they haven't had adeessorer the entire record I think they have ses inordinately slow in terms of taking

troubled by the dichotomy there, slowWe heard testimony about that yesterday, Factor, but I am also worried about your to be some kind of risk benefit considerabat kind of thing work?

RUGS ARE DANGEROUS

ade to work every day now. In other words, I ould not be taken into consideration. It must

you are dealing with biological products or on drugs, it must be remembered that they are

risk was the only test you would never market because they are dangerous. They are going to under some conditions they can hurt quite a few ave to determine is whether the benefit that is marketing the product is sufficient to take the risk. -isk, but risk nevertheless.

pied completely with risk or you wouldn't market get employees or people in responsible positions - that become preoccupied about risk and are not I can't take the chance that exists every time you Ict, then there will be fewer and fewer products the DBS would down in the long run would certainly not be beneposition of newblic, the consumer, or society in general. We therefore. The benefit-to-risk ratio in medical science has long moved from S. sed and is well understood by industry, the regulators This bill would seem to apply a brandnew set of making those kinds of

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.

FUNDING

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 improvise. That is the reason why there are products that are marketed, that are wed 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 fost a bad product on the public, because in actual operation they Turvo 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 have 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.

LEGAL AUTHORITY

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 them 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 distinquished 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