This is purely in accordance with the legalistic verbiage of the act, but all it actually does is this: If a petitioner or applicant for a license to manufacture, et cetera, is refused, and then through HEW all of the processes there are activated on this question. Then he has the right, if he so sees fit, to present to a court a petition. That does not mean that the court in procedure will grant the petition but at least it gives him an opportunity to place before the court such documentary evidence and testimony as necessary to sustain his position, that they acted arbitrarily, or they did not act at all or some confusion resulted in their refusal to act.

I think all other drugs, except those, are biologically active, this actually takes place. Biological drugs, in accordance with our present programing of scientific presentation of issues before courts, there certainly cannot be any retention on the part of the authorities to say that a court could not pass upon at least equities involved and the question of whether or not a toxic effect is actually prevalent or other matters which may affect the drug on the market which might affect some other organ or membrane of the body.

Anyway, it gives an opportunity to an individual or a group of individuals who feel that they have a remedial method through a drug to curtail or, in a measure, to benefit the man on the street that they ought to have a judicial form to make that determination.

With respect to the determination, of course, it is within descretion of the court to send it back to HEW to determine whether they took such preliminary steps in accordance with the procedures of the Health, Education, and Welfare.

As you know, Mr. Chairman, the question of judicial review has been accepted in many fields of the law, and I recommend this bill to you. for the purposes intended. It will not in any way affect or destroy the competence in the Government operation of HEW.

Sometimes themselves they, with the medical men who are expert in fields disagree but at least it would add to the question of a precaution to not destroy in part or in whole the advancement of medicine and drugs.

Further, Mr. Chairman, if I may add this, it will give an opportunity for a public evaluation of the progress of research and a determination on having the public represented by a neutral court that will weigh the evidence and make a determination in accordance with the scientific facts of experts who will testify before the court.

I think it is a needed step.

It would also relieve the Department of Health, Education, and Welfare from certain responsibilities where there is such a disagreement or where they feel that the procedures have not been met in accordance with the rules of the scientific development or research as to drugs, and relieve them as to confusion in the public issues.

I am sure that this would only be used in a controversial sense in matters where the determinations must be made carefully and with an intent to protect the public if the drug is not the type of drug that should be placed upon the market.

I think this is an absolutely necessary remedial legislation in view of the fact that we passed a strict drug law this last session and this will be a type of remedial legislation which will give rise to a prevention of a shutoff with the Food and Drug Administration as the final judge.

33-262-64

I ask your favorable consideration of this bill.

Mr. ROBERTS. The gentleman, as usual, is very persuasive and the Chair concedes that there may be a great deal of logic in his position.

Does the gentleman know or think of a concrete example where he feels there may be some abuse of discretion, some arbitrary situation or some improper judgment that has been used where this bill would correct it?

Mr. LIBONATI. I understand there are some situations in the past and present of which I could apprise the chairman-and of course they are very rare-of these situations where this would apply.

Mr. ROBERTS. Can the gentleman think of any concrete example? Say, for instance, in the thalomide situation, what would have happened under this bill if this type of legislation could have taken the doctor to the courts?

Mr. LIBONATI. I think if the facts were known after the Department approved the drugs, I don't think the Department would have ever released the drug. I think in that field there was no measurable apprehension that they had notice of until the drug was actually used which affected other organs of the body.

In other words, it had its effect in accordance with the control of what they were endeavoring to perfect with the drug in a curative sense, but it is only after the use of a drug that if there are aftereffects that can be curtailed immediately by order of the HEW. After all, no one, even the good Lord, can determine which ill effects which benefits one part of the body will do in the long run to some other organ in the body. That can only come unfortunately, through studying the effects of this drug and determining whether those effects of this drug have also created this problem in another area of the body.

Mr. ROBERTS. Did not the gentleman state in his formal statement that in the case of other types of drugs, we have this type of review; is that correct?

Mr. LIBONATI. Biological drugs have never been given this opportunity of review.

Mr. ROBERTS. I said the gentleman said in cases of other types of drugs there is this review.

Mr. LIBONATI. Yes, I would say ordinarily no one can measure the total effect of a drug except for the purpose intended unless in their study and in its application on humans which comes after they have tested the drug on animals or plants as the case may be, then they can make a determination when these effects show up.

There are today some drugs that are used where it is understood that a certain organ of the body will be affected but the fact that the devastation of the disease will destroy the human if he does not get help, they try to alleviate the effects of this drug on the organs, and in those cases it is a diagnostic fact which the medical profession has tried to control.

Mr. ROBERTS. I thank the gentleman.

Mr. Brotzman.

Mr. BROTZMAN. I would like to welcome our distinguished colleague to the subcommittee and I would like to ask two or three questions.

If I understand correctly, the refusal by the Secretary to issue a license or if he suspends or revokes a license to prepare products is what gives rise to this bill's operation; is that not correct?

Mr. LIBONATI. I would say yes; in terms.

Mr. BROTZMAN. My first question is this: A quick reading indicates that this appeal shall first go to the court of appeals. An appeal is taken from a suspension and then that appeal goes to the U.S. court of appeals rather than to the Federal district court.

Mr. LIBONATI. U.S. court of appeals, but they can refer it for factfinding.

Mr. BROTZMAN. What is it that the U.S. court of appeals has before it to consider? What kind of record do they have to review?

Mr. LIBONATI. They take the record from HEW that is prepared and then whatever other supplemental evidence there is from the petitioner or the licenses.

Mr. BROTZMAN. I am not acquainted with all of the administrative procedure.

Is there a record that is prepared before the Secretary that he would certify to the U.S. court of appeals so that they could in fact review that record?

Mr. LIBONATI. Yes, they prepare a record and they incorporate in the record the entire proceedings relative to what they ask in the way of affirmances and interrogatories and forms and they make a determination then and they will also put in their conclusion why they refused the issuance of a license.

It may be even on a question involving the procedures in the research of the drug that were not in conformity with the norms or laws that have been set up by the AMA on questions of the proper preparation for research in drugs, first on animals or plants and so forth in order that the toxic quality of the drug can be measured very minutely and what effect it will have on humans.

Mr. BROTZMAN. Correct me if I am wrong, but if a court is reviewing a decision made by an administrative agency, is it not correct that short of arbitrary or capricious action, they will uphold the finding of the administrative agency.

Mr. LIBONATI. I do not think that is correct if the ruling is based on where they are limited to making a ruling by their rules and the court, on the other hand, will look at the rules derived to the individual.

I do not think you are correct, if the drug has a curative effect and the end result would delay the progress of the disease or diminish the effect of the disease.

Mr. ROBERTS. I think the question of the gentleman from Colorado is answered in the bill on page 2, line 19, where you say, "The finding of the bill states the findings of the Secretary with respect to questions of fact shall be sustained if supported by substantial evidence and considered on the record as a whole.

Mr. BROTZMAN. This is what I was getting at. I had read this specific sentence.

The determination, therefore, to be made by the court of appeals is whether or not there was substantial evidence presented to the Secretary to substantiate his particular finding?

Mr. LIBONATI. To issue a license or to withhold a revocation.

Mr. BROTZMAN. Issue, revoke, or suspend. In other words, Mr. Libonati, if there is substantial evidence on the record certified to the court of appeals, to support the position of the Secretary, then the case is all over; is that right?

Mr. LIBONATI. No he may call them in to sustain their position. I am sure you realize in instances like this where so much is dependent upon the welfare of human beings that they would be very thorough in their investigation and determination.

Mr. BROTZMAN. I want to know your concept on this. If the court determines there is substantial evidence, then the case is all over; isn't that correct?

In other words, the Secretary would be right.

Mr. LIBONATI. They could serve notice on the Secretary to issue the license by order of the court. Primarily, in most instances where the Secretary has some reason to deny the license, they may ask the applicant for the license to correct those procedures and continue on and then make a reapplication. It is purely a question of procedure as to what in the court's determination would be proper relative to this drug which must have some remedy in its application.

Mr. ROBERTS. Let the Chair state there can be some disagreement as to what the procedure will be but I am sure counsel can straighten us out on this in executive session.

Mr. BROTZMAN. I know our colleague is a distinguished attorney himself and I am not trying to be argumentative about the provisions. I just want to understand what the bill is supposed to do so I can understand the rest of the testimony.

Mr. LIBONATI. A judicial appeal is to do equity where equity is found. If there are no equities and in the practical acceptance of the report of the HEW, you will find they will be sustained in most cases.

It is the one case where they, by their own limitations and rules and procedures must frown against or deny that the court can alleviate this situation if the drug is worth saving. I think we will all agree to that, that no man advancing a drug that he formulated through research and so forth would persist if there were no value to the drug at all to follow this procedure.

It certainly would expose him to the fraudulent position that he had taken to the drug and the misrepresentations made.

I think that in itself is a guard against this law being used promiscuously by persons who have no honesty of purpose in pursuing their rights.

Mr. ROBERTS. Even under this procedure, if the gentleman from Colorado will yield, the proponent or applicant would be at a tremendous disadvantage.

The burden of proof is going to be upon him to reverse the agency under this bill. So he would be in a very bad position to start even with this legislative authority.

Mr. LIBONATI. He would have to show that he followed and served every requirement of the law in order to get into the court. His petition can be dismissed without giving him any judicial appeal at all if they feel there is no basis upon which to issue.

Mr. BROTZMAN. Thank you.

Mr. ROBERTS. Mr. Rogers.

Mr. ROGERS of Florida. The purpose, I understand, of your legislation, is simply to allow an aggrieved party to have some remedy beyond the departmental level, to go to the courts, if necessary, to set aside an order which would not be sustained by substantial evidence. Mr. LIBONATI. And also the public interest involved, of course, if the drug has remedial application.

Mr. ROGERS of Florida. Thank you very much.

Mr. ROBERTS. I thank the gentleman.

The next witness will be Dr. Roderick Murray, Director, Division of Biological Standards, National Institute of Health; accompanied by Mr. Theodore Ellenbogen, Office of General Counsel.

We are glad to have you before our committee and you, Mr. Ellenbogen. We have not seen you since the Drug Act.

STATEMENT OF DR. RODERICK MURRAY, DIRECTOR, DIVISION OF BIOLOGICAL STANDARDS, NATIONAL INSTITUTES OF HEALTH, PUBLIC HEALTH SERVICE, BETHESDA, MD.; ACCOMPANIED BY THEODORE ELLENBOGEN, DEPUTY CHIEF, DIVISION OF LEGISLATION, OFFICE OF THE GENERAL COUNSEL, DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE

Dr. MURRAY. I am Dr. Roderick Murray, Director of the Division of Biological Standards of the National Institutes of Health, U.S. Public Health Service.

This Division has the responsibility for carrying out those provisions of the Public Health Service Act which deal with biological products.

We have no prepared statement. The Department has presented formal comments on this bill and included in this document are some recommendations for perfecting amendments and if there are any questions on that, Mr. Ellenbogen would be happy to speak to it. Mr. ROBERTS. Do you favor the bill with the amendments? Dr. MURRAY. We have no objection to the bill.

Mr. ROBERTS. The Department has not taken a formal position as yet.

Mr. ELLENBOGEN. We have taken the formal position that we have no objection.

Dr. MURRAY. I would like to say in the history of this type of activity; that is, the licensing of biological products, which does go back to 1902, we have had no occasion where such a grievance has come up, and there does exist within the regulations relating to biological products a procedure under which the Surgeon General can appoint a board in order to look into a grievance and give whatever redress is necessary.

I would like to point out, parenthetically, that the substance of all of these actions is actually scientific and technical in nature. Action on licensing of biological products will depend upon such matters as the safety, the purity, and the potency of these products, and that in licensing a product or in denying the license for a product, all of the available information will be taken into consideration, and that the expertise in this regard does not completely reside within our Division or within the Public Health Service, inasmuch as when particularly difficult problems of a scientific nature come up, it is possible to confer with the very best scientific talent in the country on this matter.

Mr. ROBERTS. Dr. Murray, give us a good example of what you would consider a product covered by this bill.

Dr. MURRAY. I would think that the recently licensed live measles vaccine is a good example. If I might take a few moments and de