procedure, with limited court review, where the findings of fact, supported by substantial evidence, socalled, are binding and conclusive upon the court.

The industry made a determined fight on that. It was not opposed to the principle of adequate warnings against improper use. It subscribed to the public purposes of that. But it wanted to be in position to defend itself where it differed with the Food and Drug Administration which should then assume the burden of proof and exercise the various remedies given it by the law.

And here is one of the most powerful sections in the act, a section under which the Food and Drug Administration has power to proceed against all manner of drugs. A drug is misbranded-and I quote this "if dangerous to health when used in the dosage or frequency or duration indicated in the labeling."

That is a cover-all provision and again the people for whom I speak subscribe to the public purposes of that provision and we think it is a sound provision and when the Food and Drug Administration comes before you it must be cognizant that under that great power, regardless of prescription, or nonprescription, or lists or nonlists, if the thing is dangerous to health as it is labeled, they have got this wideopen power to proceed.

Mr. Chairman, I am grateful for the patience which you and the committee have shown in listening to me and I do not want to take advantage of it. I have discussed those substantive provisions. I must ask your indulgence a few minutes longer with respect to the matter of the so-called court review.

Mr. WOLVERTON. Mr. Chairman, has the witness finished?

Mr. HOGE. No, sir; not yet. I wanted to talk about this so-called review.

Mr. WOLVERTON. Mr. Chairman, the reason I inquire is the fact that we are pressed for time; Judge Stephens is present and it is not possible for him to be here on all occasions. I certainly would not want the morning to slip away without giving the committee the opportunity of hearing Judge Stephens.

The CHAIRMAN. We were told that 30 minutes would be enough for this witness.

Mr. WOLVERTON. I think we have observed here, as we have so frequently observed in the past, that when a witness departs from his prepared statement with the thought in mind of saving time, it usually develops that more time is taken than if the statement itself had been read.

This witness has been of extreme value to this committee, in my opinion. He shows a very intimate knowledge of the subject of which he speaks and certainly is very helpful and I should not want to preclude him from making a full statement, nor the opportunity of members to question him. But I am fearful that if he continues much longer—it has now been nearly an hour, although it has seemed much shorter than that-and then if the questioning is carried on, there will be no opportunity to hear Judge Stephens.

I should like the Chair, if he will, to consider the matter of hearing Judge Stephens before the questioning of this witness begins.

Mr. HOGE. Mr. Chairman, may I say that I certainly would not want to foreclose Judge Stephens and, before you called the committee to order, I spoke to Judge Stephens and told him that I should

be happy to yield my position as the first witness to him, so that he might make his statement and leave, if he wished. He said that he did not care to do so.

The CHAIRMAN. We shall have to observe very closely the 5minute rule in questioning.

Mr. HESELTON. Mr. Chairman, may I suggest this? I have read the formal statement of the witness on this problem of trial de novo, and I have read Judge Stephens' statement. I think if Judge Stephens were permitted to make his statement, that the witness might adopt the judge's statement as his own. I think he will find that Judge Stephens has helped him on that point very much.

Mr. HALE. I was about to make the same observation. Judge Stephens' testimony is entirely on the subject of review and it seems to me that it might be helpful to the committee if we could hear Judge Stephens first on that point.

Judge STEPHENS. Mr. Chairman, I am willing to accommodate myself to the convenience of the committee.

Mr. HOGE. I should be very glad if the judge were to take the stand

now.

The CHAIRMAN. How long would it take you to finish your statement, Mr. Hoge?

Mr. HOGE. Not very long; the rest of what I intended to say would conform to that part of my written statement.

The CHAIRMAN. Why not put it in the record.

Mr. HOGE. I did depart, Congressman Wolverton, from my statement, but I did so because my statement was prepared before I came here on Tuesday and, sitting here during the week, I have heard many things that I wanted to bring out to you. As to the rest, I need not depart from my written statement.

Just let me say this, before I yield the chair to Judge Stephens. My paper attempts to show you that before one ever gets to the court, where this question of de novo comes up, there is such a long trek of administrative detail, which I have tried to set out for you in numbered paragraphs, that if one lived long enough, he might not be rich enough to last out those many administrative steps before he ever got to the court to find out what trial de novo in the circuit

court means.

Mr. WOLVERTON. Mr. Chairman, I have noticed in the prepared statement of the witness that he makes reference to the review section. Would the members of the committee feel that they would like to hear his views on that particular phase on which he has not yet touched except in the few words that he has just mentioned, before Judge Stephens takes the stand?

The CHAIRMAN. If he will do so briefly.

Judge STEPHENS. I should be glad myself to hear what this gentleman has to say on the review section.

Mr. HOGE. I have great respect for your time, and I do appreciate your hearing me.

On the ninth page of my statement you will see that I have there tried to itemize in numbered paragraphs the number of steps which one complaining of this power which is sought, would have to take before he ever got to the court regardless of the nature of the review:

In the first place, there would be a hearing under the so-called clause (2). That is the clause which would give the Administrator

the power to restrict the sale of those drugs which he considers unsafe or ineffective except on prescription. Mr. Larrick has told you here that that would be a matter on which they would like to bring experts. from all over the country and put them on the stand.

In the second place, there would be a petition to the Administrator proposing the addition or deletion of a drug, or drugs, from any listing of drugs promulgated by the Administrator in accordance with clause (2).

And I call your attention to the fact that all through those steps the phrase is used "any interested person." So that the action might expand far beyond inter parties action; that is, between the man interested in a given drug and the Food and Drug Administration. Presumably the Medical Association could be in it. Presumably other manufacturers who had drugs similar but not entirely alike.

After that, the Administrator sets another hearing, a hearing before the Administrator upon such petition, following which the Administrator "shall make public his action upon such proposal."

Then after that, one files objections to the Administrator's action, within 30 days after he has made such action public, specifying the changes desired and stating reasonable grounds therefor and requesting a public hearing upon such objections.

Then comes what apparently is the third hearing, again for all interested parties, the record getting bigger and bigger as we go. Then he shall make public his action on this third one and then, within 90 days one has an appeal to the circuit court of appeals in accordance with the provisions of section 701 (f) and (g) of the Federal Food and Drug Act.

Those provisions are that you file a summons and petition to get into the court and that if further evidence is to be taken, the court refers it back to the Administrator for the taking of further evidence; and at that time I have lost count; it is the fourth or the fifth hearingthen the certified copy goes to the circuit court.

Now, ordinarily the circuit court is bound by the findings of the Administrator if supported by, as the phrase goes, "substantial evidence." That has been a very vague and indefinite phrase and has been of little practical value. What value it may have in the future under the recent decision of the Supreme Court in one of the Labor Board cases remains to be seen.

The Supreme Court did say that the Administrative Procedure Act had imposed greater obligations upon the courts in these matters than they had been exercising in the past.

As I say in my paper, and let me repeat, that over this wearisome road one may never discover what is meant by a trial de novo in the circuit court. Trial de novo commonly denotes a new trial, but I do not really know what it means in the bill before you. The wording of the bill is not that there shall be a trial de novo, but that the appeal shall be in the "nature of a trial de novo."

Ordinarily the words "trial de novo" denote a trial all over again, a complete trial, examination of witnesses, introduction of exhibits, ruling on objections, and other interlocutory steps.

When you consider that the matter is in the court of appeals whose usual functions are to hear appellate matters on records and briefs, it is unlikely and this is only my opinion-that a trial de novo in that sense is intended.

I have tried to look into the law a little on this and the phrase, "nature of a trial de novo," has been used by appellate courts sometimes in referring to their power and their function in equity cases. Courts have said that their review of equity cases is in the naturethey use those words "in the nature of a trial de novo." have meant apparently-and I gather this from reading the cases What they only is that they will review the whole record, that they will take notice of errors and that they will apply what was the old equity rule, that the findings are against the clear weight of the evidenc

The new rule, under the rules of civil procedure, is that the appellate court will not ordinarily disturb the lower court's findings except when they are clearly erroneous. believe, that the committee on the rules intended by that to bring And the note to the rule says, I forward the equity rule.

That may be what this provision is intended to mean, although the action here, of course, is not an equity one. statute is a criminal statute and any violation of the Commission's The food and drug order under this clause (2) of the bill would be punishable as a crime.

Whatever the extent of the trial de novo is to be-and the bill is not clear-it is easy to see from the things that I have tried to say to you hurriedly in these closing moments, that instead of being relieved of bureaucratic control, those many intermediate steps will mean that the manufacturers and the distributors of drugs would be the more completely enmeshed in administrative procedure.

One closing word, Mr. Chairman. Mr. Larrick said here that the legislative standard which the manufacturers had proposed, which is the standard taken from the regulations, was just as good in their opinion as the standard in the bill before you. They liked it. The only difference between Mr. Larrick and me, to close by repeating what I said at the beginning, is that Mr. Larrick wants the power to apply the standard judicially with very limited reviews, whereas we want him to have the standard, but we want him to assert the standard in the forums and under the procedures where he bears the burden of proof.

I thank you gentlemen very much.

Mr. WOLVERTON. I take it, Mr. Chairman, that the witness has finished his statement and is ready for questioning?

Mr. HOGE. Yes.

Mr. WOLVERTON. Have you covered all that you wish to say? Mr. HOGE. Well, I did, by trying to conserve your time at the end and by realining my written statement.

Mr. WOLVERTON. Have you had the opportunity to cover the situation that you had intended to bring to the attention of the committee?

Mr. HOGE. Yes, sir; I have.

Mr. WOLVERTON. Then the questioning of this witness, Mr. Chairman, it seems to me, could await the testimony of Judge Stephens. The witness has been so positive in his statements and has shown such a wide knowledge of his subject and certainly has made evident his sincerity of purpose, that necessarily it will provoke, I assume, a great many questions on the part of the committee who desire to avail themselves of all the information this gentleman has to give us. Mr. HOGE. I shall welcome the questions, Mr. Chairman; I only hope that I can answer them.

The CHAIRMAN. Without objection, we shall proceed to hear Judge Stephens now.

STATEMENT OF HON. HAROLD M. STEPHENS, CHIEF JUDGE, UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCUIT

Judge STEPHENS. Mr. Chairman and gentlemen of the committee, my name is Harold M. Stephens. I am chief judge of the United States Court of Appeals for the District of Columbia Circuit and, as such, a member of the Judicial Conference of the United States.

I appear here in respect of this bill as I did a few days ago in respect of S. 658 to present the views of the Judicial Conference with respect to certain procedural aspects of this bill.

As I said the other day in respect of S. 658, the Congress has very properly and we think wisely imposed upon the Judicial Conferencethe duty of advising Congress with reference to legislation affecting the business of the courts.

And so I am here to reflect the views of the chief justice and my colleagues on the Judicial Conference. You are so familiar with the terms of this bill that I will not assume to repeat its introductory provisions, but to say only for the purpose of introducing my comments that, as the previous speaker has indicated, they require that after the Administrator has made a final ruling upon the question of deletion from or addition to the list of drugs which he is to promulgate under the act, there is to be an appeal to the circuit court of appeals and the bill provides that that appeal shall take place in the following

manner.

An order so issued by the Administrator may, within 90 days after its issuance, be appealed by any interested person in accordance with the provisions prescribed in subsections 701 (f) and (g) of this act, except that an appeal from the Administrator's order issued hereunder shall be in the nature of a trial de novo without presumptions in favor of either party to such appeal.

Subsections 701 (f) and (g) of the act, which must be read in connection with another subsection (e), contemplate that the Administrator shall receive evidence and make a record and make findings of fact; and that there shall then be an appeal to the appropriate circuit court of appeals of the principal place of business or residence of the appellant.

The first comment that we wish to make from the point of view of the Judicial Conference is that this de novo provision in the court of appeals is quite unsuited to the function of a circuit court of appeals, if it means a de novo hearing in the usual sense of that term; that is to say, a new trial, with the calling of witnesses and the cross-examination of witnesses, and the like. Because the United States circuit courts of appeals are courts which review errors of law, including the failure to support a finding with substantial evidence. And this is done upon a record and on written briefs and oral arguments which we hear.

We have a very large number of such cases to deal with coming from both the commissions and the courts, and if we are to have to interrupt our proceedings to hold trials, we will have to give away, I