Abbott Laboratories v. Gardner

PETITIONER:Abbott Laboratories
RESPONDENT:Gardner
LOCATION:United States Food and Drug Administration

DOCKET NO.: 39
DECIDED BY: Warren Court (1965-1967)
LOWER COURT: United States Court of Appeals for the Third Circuit

CITATION: 387 US 136 (1967)
ARGUED: Jan 16, 1967
DECIDED: May 22, 1967

Facts of the case

In 1962, Congress amended the Federal Food, Drug, and Cosmetic Act (“FFDCA”) to require manufacturers of prescription drugs to print the “established name” of the drug “prominently and in type at least half as large as that used thereon for any proprietary name or designation for such drug,” on labels and other printed material. The purpose of this amendment was to alert doctors and patients about identical drugs that sold under separate names at different prices.

The act delegated authority to the Commissioner of Food and Drugs to publish proposed regulations designed to implement the statute. The Commissioner, George P. Larrick, published regulations mandating that drug manufacturers print the established drug name every time its corresponding proprietary name is used.

Abbott Laboratories brought suit against Anthony J. Celebrezze, the Secretary of Health, Education and Welfare and Larrick under the Declaratory Judgment Act (“DJA”) and the Administrative Procedure Act (“APA”). Abbott Laboratories argued that the “every time” rule was outside of the scope of the authority given to the commissioner by Congress.

Chief Judge Caleb M. Wright of the district court granted the declaratory and injunctive relief sought by Abbott Labs, finding that the FFDCA did not permit the Commissioner’s “every time” interpretation. The U.S. Court of Appeals, Third Circuit, reversed without touching upon the interpretation question. District court Judge Weber, writing for a unanimous court, held that Abbott Labs could not challenge the commissioner’s rule under the DJA or APA. Abbott Laboratories and 37 other drug manufacturers appealed the decision.

Question

Did Congress authorize judicial review of the commissioner of the FDA’s authority to require Abbott Laboratories to print the established name of a drug every time its proprietary name is used?

Earl Warren:

Number 39, Abbott Laboratories et al., Petitioners versus John W. Gardner, Secretary of Health Education Welfare et al.

Mr. Gessell.

Gerhard A. Gessell:

Mr. Chief Justice, May it please the Court.

This case is before the Court on a writ of certiorari from the Third Circuit.

It involves a question of the interpretation of the Federal Food, Drug and Cosmetic Act, the petitioners here plaintiffs below are group of drug companies who were confronted with a mandatory enforcement regulation which they believe was issued beyond the statute and beyond the authority of the Secretary of Health Education and Welfare and the Commissioner of Food and Drugs.

Accordingly, they filed a suit in the District Court at Wilmington under the declaratory judgment of the statute and the Administrative Procedure Act asking for relief from the mandatory enforced with requirements of this particular regulation alleging that they were seriously injured in their business in any way which I will refer to later in some more detail.

Potter Stewart:

They asked for a declaratory judgment, didn’t they?

Gerhard A. Gessell:

Declaratory judgment and an injunction Mr. Justice Stewart under the Administrative Procedure Act.

The case was heard on cross motions for summary judgment.

There are no facts in dispute.

It’s a pure issue of law as to what this particular section of the statute means.

All administrative proceedings are over.

These petitioners or plaintiffs stand in the posture where they must conform with this regulation which they consider invalid or they must get to redress through this action in the Court or await being sued. If they simply await being sued and undertake to exist that they are paroled, they will be subject to criminal proceedings.

They will be subject to civil proceedings in the way of injunction.

They will be subject to seizure, indeed multiple seizure, of their products.

And they are also subject to what perhaps is the most reprehensible situation of all which undoubtedly some members of the Court would be familiar.

The indirect enforcement power of this agency to deny company’s opportunity to put drugs on the market or denied on certifications and in other petty administrative ways prevent companies that wish to challenge this legislation from going about their otherwise lawful and normal business.

Abe Fortas:

Reprehensible, Mr. Gessell?

Gerhard A. Gessell:

I think it’s seriously reprehensible Mr. Justice Fortas.

The indirect type of enforcement of that kind puts a company in a position where it is unable to get the type of hearing which our type of society contemplates should be appropriate.

Now, the issue here is I believe quite narrow.

In the District Court, the District Court found that the companies had standing to sue that there was a right to bring an action under the declaratory judgment statute, the Administrative Procedure Act, and the District Judge then proceeded to the merits and held that the plaintiffs were correct with respect to the interpretations of the statute.

When the Government took the matter to the Third Circuit, the Third Circuit did not come to the issue on the merits.

The Third Circuit took the position that the Food and Drug Act did not provide a basis for a suit such as has been brought here and held that the controversy was not right that there was no threatened, haste or controversy and that therefore the action was premature.

And petitioners lost in the Court of Appeals on that ground without the Court of Appeals coming to the merits.

We accordingly are here on a – cert was granted on a procedural question as to the whether or not a case or controversy exists in the face of this allegedly illegal regulation and whether the statute permits if there is a right of controversy as we feel there is, whether the statute permits this particular type of action.

Now, the regulation in issue is designated by the defendants as an enforcement statute.

It is immediately operative and it applies to all prescription drugs and to all companies selling prescription drugs throughout the United States.

It is mandatory in its terms, it is stated in the words of command and it directs compliance.

And the statute is so worded and the regulation is so worded that if a company chooses not to comply, its drugs will be deemed misbranded and accordingly all of the consequences that flow upon a misbranded article under the statute criminal, civil and other types of sanctions apply.

Gerhard A. Gessell:

The particular regulation in issue is a regulation that directs that in the case of a prescription drug whether a label be used or an advertisement be used any type of printed literature of any kind every time the brand name or trade name of the drug is used, that must appear opposite the generic name that is to say the technical name of the particular drug.

The agency takes the position that the provisions of 502 (e) (1) of the statute which are printed at page 4 (a) of my main brief if the Court please requires this interpretation of the statute.

We take the position that the statute requires only that there be prominent display of the generic name and that there is no requirement that that name appear every time, all the time whenever the brand name appears.

It is Mr. Chief Justice, as all were — we had briefs before Your Honor here with some 40 plaintiffs and every time we said “petitioners” we put a parenthesis in and spelled out the names of the 40 different companies that are before you today.

Now, the — the injury that is facing this industry is of several types.

They are not only facing these sanctions but they would be required under these regulations to change their materials, to undergo addition expense, to publish a type of literature that would be certainly at the least confusing and far less effective.

We think the controversy is clearly right for adjudication.

The statute’s directions are explicit and the question presented is a mere and simple question as to whether or not the statute reads the way the Food and Drug Administration says it reads.

There’s an impact that is clearly adverse on the business of these petitioners, the regulation controls the manner in which they have to conduct their business.

It sets a standard of conduct and there are no further administrative proceedings or any other thing of that kind to which they can advert.

The government says there’s an exemption provision but that is not the case, the exemption provision does not read with respect to the advertising aspects of the regulation.

So this problem, this horns of the dilemma officer’s choice or which you want to call it, that confronts these companies is a realistic, actual and immediate type of controversy from which the only relief that they can seek is by asking for declaratory judgment and protection under the Administrative Procedure Act unless they simply want to sit back and face the penalty uncertain as to time, uncertain as to his business consequences, certain to contain highly adverse publicity, certain to bring discredit upon the company if they’re sued in one form or another in some manner or another.

Now, we have a very interesting situation here after the Court of Appeals in our case held that the controversy was not right, the companion case to be argued next came before the Second Circuit and there Judge Friendly dealt with the very problem that I’m dealing with here, discussed in specific detail, the decision in our Third Circuit case and held quite contrary to the Third Circuit that — and in the manner in which we say is the appropriate type of holding here that the controversy was right, that there was a judiciable controversy, and that it should be determined now and not at some later time.

Potter Stewart:

And Judge Friendly saw no real distinction between your case and his case, did he?

Gerhard A. Gessell:

On the question of the rightness Mr. Justice Stewart, of the controversy, there are substantial differences between the two proceedings (Voice Overlap) but on the questions of whether this type of threat from a regulation creates a right controversy, there was agreement — there is agreement, and the two cases are all the same.

Potter Stewart:

Well, you agree and Judge Friendly agrees, I think counsel in the next case don’t entirely agree.

Gerhard A. Gessell:

Counsel in the next case have a very trouble some problem because they have numerous factual issues and they seek to distinguish the two cases I suppose because of that.

In our situation, unlike theirs, there is no confusion as to the meaning of the statute in its – or the regulation in its operations.

There is no further proceedings before any court, there is nothing to determine except what this statutes means.

Abe Fortas:

What do you — how do you draw the line Mr. Gessell between administrative actions that are reviewable on injunction and administrative actions where you have to wait until summing — the actions taken by the agency, what’s the — how would you define it as theoretical or general manner?

Gerhard A. Gessell:

Well, as I read the Administrative Procedure Act to start there, if the process of rule making is complete, this Court has said that is a final agency action.

Abe Fortas:

Would you apply it only in the cases where there has been rule making?

Gerhard A. Gessell:

I think that is all we have before us here —

Potter Stewart:

Well, how —

Gerhard A. Gessell:

— I am sure there are types of — there are types of agency action short of rule making which perhaps because of their emergency character or something else would fall in a different basis.

Abe Fortas:

Well, let’s go to another field.

Let’s suppose the Securities and Exchange Commission adopts a rule that affects the securities industry or rule let’s say regulating brokers in some way or other, is it your theory that when that rule making process is completed, the brokers may bring an injunctive action and that the Court have jurisdiction to entertain that and that the brokerage companies have standing to maintain it and that the controversy is right without waiting for the SEC to take action against a particular company?

Gerhard A. Gessell:

Oh, yes and it is —

Abe Fortas:

— that is now — that is a novel position —

Gerhard A. Gessell:

No.

Abe Fortas:

Isn’t that an administrative law?

Gerhard A. Gessell:

No, it is.

It is a position —

Abe Fortas:

Well, tell me —

Gerhard A. Gessell:

— of this —

Abe Fortas:

Well, tell me what supports it?

I mean to say, isn’t that contrary to the assumptions on which lawyers in courts and legislatures have here before proceeded in the field of administrative law?

Gerhard A. Gessell:

No.

No Mr. Justice Fortas, that issue specifically has been decided by this Court in three cases, Columbia Broadcasting, Frozen Foods and Storer have all dealt with that question and have all decided that the controversy was right.

There, there were rules by the Federal Communications Commission for example in both Storer and Columbia Broadcasting that specified that a station could only — broadcasting company could only own so many stations or that a certain types of contracts would be considered improper and a license would be canceled if the matter came up.

And the Court in both of those instances said that the matter was right and it could be —

William O. Douglas:

No —

Gerhard A. Gessell:

— decided without enforcement of the regulations.

Abe Fortas:

Yes.

But now, let’s — let me take this with you again looking forward and you’re thinking of all many of those cases.

But I suppose that when you come to test, let’s suppose that to get in the proceeding on the merits here, you get beyond the purely semantic question of whether on its face the statute supported what the Commission had did here, and you get to a question of reasonableness, and that is raised by your complaint here, isn’t it?

Gerhard A. Gessell:

No, we just say —

Abe Fortas:

Or do you mean —

Gerhard A. Gessell:

— that the statute doesn’t permit this, that in terms of the merit in broadcasting, this goes beyond and that there is no power on the part of the Secretary —

Abe Fortas:

Would you want —

Gerhard A. Gessell:

— to change the meaning of the statute.

Abe Fortas:

You raise the question of the reasonableness of the regulation?

I thought you did.

Gerhard A. Gessell:

Well, we — we consider it unreasonable but the way the case has come up there isn’t any —

Abe Fortas:

I am not asking what you consider, do you so allege?

Gerhard A. Gessell:

Yes we do.

Abe Fortas:

Alright.

Now, in order to evaluate that allegation, wouldn’t it be necessary to consider the specific impact of the regulation upon specific products and specific industry problems and may — may not that be the difference between this case and the cases to which you referred?

Gerhard A. Gessell:

Well, I think not for two reasons.

In the first place, in this case our allegations on which we rest our charges of unreasonableness all conceded.

Gerhard A. Gessell:

It’s conceded this is confusing, it’s conceded that this —

Abe Fortas:

You mean the Commissioner concedes —

Gerhard A. Gessell:

Yes —

Abe Fortas:

— that this is —

Gerhard A. Gessell:

— the cross motions for summary judgment here and all of our allegations of our complaint are accepted as fact.

Abe Fortas:

Well, that’s kind of extraordinary isn’t it that Commissioner would concede that his own regulation is confusing?

Gerhard A. Gessell:

Well, Your Honor I think the reason for it, I think it isn’t extraordinary because it is confusing.

But I think the reason — the reason for it is that the Secretary has taken the position from the beginning that this is the only interpretation which the statute permits.

This is not an economic regulation, this is not a regulation dealing with questions of safety, this is not a regulation that says, we really think we have to do this in our expertise.

This is a regulation that issues because he says, this is what the statute means, it’s the only thing it means, and this is the way it has to run.

Now, I would also say this in response to Your Honor’s question that where you have issues of fact and I would think perhaps that would be the case in many of the type of situation you postulated, this statute provides that there has to be, in the rule making process, an evidentiary type hearing and then that is reviewed by a Court of Appeals.

We have now an evidence — any underlying evidentiary hearing for this regulation whatsoever.

This is just a mandatory direction from the Secretary as to how he proposes to enforce this particular provision of the statute.

And since there is nothing on which to take testimony, nothing on which to concern ourselves except what the statute means, it seems to me that this is the way an industry should be proceed to get a standard rule of conduct determined when the Secretary attempts to impose that illegally.

And it’s — it’s rather amusing here that when the defendants here are turned in an — because they’re rather troubled by this decision of the Third Circuit, they don’t support it in many particulars, when they turn to the question of the merits which was not before the Court in the cert petition but they say, “Well, why don’t — why don’t you decide the merits while you’re here”, they say this is a simple case.

There’s no controversy, the public interest requires it to be promptly determined, and let’s go at it and decide it.

And I almost wondered whether the same person wrote the first part of the brief that wrote the second part because you can’t — in the context of this case, there is nothing in our — to argue about as to the meaning of the regulation, as to the reasons for the regulation, and it’s a pure question of statutory interpretation.

The other aspect of our case concerns whether or not Congress precluded this type of review.

And I would like in few brief moments to deal with that question.

We have in this statute a saving’s clause which states the remedies provided for at this subsection, this is on page 6 (a) of my appendix shall be in addition to and not in substitution for any other remedies provided by law.

The entire legislative history is full of discussion about the right to bring injunctive actions, declaratory judgment actions, no report of Congress, no words in the statute are designed in any way to say that the Administrative Procedure Act and the Declaratory Judgment Act do not apply here.

And we are unable to see how particularly in the face of the saving clause which we believe has general application and the debates that one can say that Congress must have intended, the Government says or we must assume they say.

Well, there’s no basis for such assumptions, no basis for that intention, and that the literature of this Court is full of declarations that say we want a favor the right of citizens to review actions of regulatory bodies.

And I would like just for a moment before you adjourn for lunch to leave this thought with you, I’ve been mitigating around this country a good deal in the last few years and it’s a surprising thing to see the number of times, the Government is seeking to prevent a fair test of their power or their right to do something.

They raise sovereign immunity, they raise standing to sue, they raise venue questions, they raise questions of who should be the party.

And the atmosphere was not unlike that with I heard in this Court last Thursday with respect to the question of this Court’s mandate in El Paso.

The fact of the matter is this Government attitude is that we want to have it our way, we want to make businessmen knuckle under and comply to illegal regulations because we have all these indirect and subversive opportunities to force compliance, and we hope that everybody relied on, we hope that everybody will not challenge the statute that enough people will be frightened to adhere to the regulation even when it’s invalid and thus we’ll have a long period of administrative compliance which will support the regulation.

Thank you.

Earl Warren:

Mr. Gessell, you may continue your argument.

Gerhard A. Gessell:

My colleagues over lunch hour, indicated I may have missed the import of one of your questions Mr. Justice Fortas or at least I have not made clear one point that’s essential to our position.

Gerhard A. Gessell:

This regulation operates from the day it issues.

It doesn’t operates as to some pieces of literature just some pieces of advertising, just to some labels, just to some books, and not other books, or some bulletins and other bulletins.

It operates as to everything in the prescription drug industry that comes under the rubric of labeling or under the rubric of advertising and by the time you put advertising and labeling in their broad definitions together, it’s safe to say in every piece of literature that these drug companies ever get put out, outside of their own internal affairs and probably —

William O. Douglas:

What is —

Gerhard A. Gessell:

— some of that.

William O. Douglas:

What is the definition of drug in the Act?

Gerhard A. Gessell:

Well, here we’re concerned with prescription drugs and those are the drugs you normally know Mr. Justice Douglas as sold by prescription and of course the audience to which this literature is directed, either advertising or labeling is to the position.

And not the public, and what they’re saying is that every time no matter what the circumstance we mentioned the brand name, we mustn’t mention the generic name, no matter how prominently we have made the generic name in conformity with the requirements of the statute.

William O. Douglas:

This has nothing to do with the label that appears upon the bottle that you get at the drugstore and the filling of prescription?

Gerhard A. Gessell:

It will be on that — it will be on that label.

But of course you can’t get that unless the doctor prescribes it, you can’t go take it off the shelf.

It’s not over the counter product.

William O. Douglas:

But prescription is used technically — do you mean that, which is prescribed by a physician —

Gerhard A. Gessell:

Yes.

William O. Douglas:

— don’t you?

Gerhard A. Gessell:

And sold only under — not only by pharmacists.

William O. Douglas:

Not drugs that are sold on the shelves of —

Gerhard A. Gessell:

That’s right.

It doesn’t apply to aspirin for example.

William O. Douglas:

Yes.

Gerhard A. Gessell:

Or things of that kind.

William O. Douglas:

That’s what I was getting.

Gerhard A. Gessell:

Right.

Byron R. White:

Mr. Gessell, I take it that there’s no question with what — even if you lose this case, but you can get judicial review to the validity of this regulation under the statute, just a question of when I take it —

William O. Douglas:

Or do you get into criminal cases?

Gerhard A. Gessell:

The government tries to avoid the criminal case by saying they’re not going to bring any even though the statute lets them do it.

The Solicitor General tries to duck under and out on that.

The answer to your question Mr. Justice White is yes but the factors that lead us to the view that review is necessary now are the desirability of uniformity in this industry and the desirability of avoiding the hazards and the disadvantages that come and attend in publicity to come if you’re sued criminally or if all your goods are involved in multiple seizures.

Byron R. White:

You’d be making — you’d still be here and making the same argument that there were no criminal enforcement procedures?

Gerhard A. Gessell:

I would be here making the argument in the event there was any particular move by the Government against a particular label or ad of a particular company at some particular time.

Byron R. White:

Yes, but you would be here now — or in this thing?

Gerhard A. Gessell:

That’s right, if they had done that I would be here.

Byron R. White:

Well, they have the — they haven’t done that yet.

Gerhard A. Gessell:

No say they’re going to enforce the statute and they say it’s an enforcement statute and the regulation says shall —

Byron R. White:

Well, how do you —

Gerhard A. Gessell:

— (Voice Overlap) of command.

Byron R. White:

How do you explain the Congress saying you may have pre-enforcement review in regulations under A, B, C, and D or whatever it was and one of the statutes listed is not this one?

Gerhard A. Gessell:

Well, what I say with respect to that is that the savings clause enabled us to —

Byron R. White:

Well, I know.

But they didn’t need those provisions at all if you could get to the general matter, it has to be enforcement review.

This would mean, we needed that to specify that the enforcement review could be had, and if that was a general matter — it was available.

Gerhard A. Gessell:

Well, there is a — the statute — is Your Honor referring to Section 502 (e)?

Byron R. White:

Maybe, I don’t know what the —

Gerhard A. Gessell:

Or —

Byron R. White:

I don’t remember the specific —

Gerhard A. Gessell:

Or are you referring to —

Byron R. White:

I thought Congress did say that there could be pre-enforcement review upon any sort of the regulation under a certain section?

Gerhard A. Gessell:

Yes, there are — under certain sections, there is a review in the Court of Appeals.

Byron R. White:

Yes.

Direct — direct review?

Gerhard A. Gessell:

Direct review in a Court of Appeals.

And I thought, that what’s Your Honor had in mind.

Now that occurs where there are factual issues, the provisions they talk about are where there would have been an evidentiary hearing prior to the rule making before the Board.

And then a review of the factual basis upon which the particular determination was made, the record would go up to the Court of Appeals.

We have nothing of that kind here at all.

There’re no factual issues.

Byron R. White:

But without that provision in the Act, do you say that — that under those sections you could go right in the District Court?

Gerhard A. Gessell:

Yes.

Yes, if it were not for the fact maybe I still can.

But certainly, without a special provisions for appeal or review to a Court of Appeals, the declaratory judgment statute, the Administrative Procedure Act would have put me in the District Court.

Gerhard A. Gessell:

I like to reserve the rest of my time unless there’s a —

Earl Warren:

You may.

Gerhard A. Gessell:

— any questions.

Earl Warren:

Mr. Lewin.

Nathan Lewin:

Mr. Chief Justice, may it please the Court.

In this case and the one immediately following it, the company subject to regulation under the Federal Food, Drug and Cosmetic Act have brought actions in District Courts the challenge formal a regulation issued by the Food and Drug Administration which construe or interpret various terms of reason amendments for that Act.

In neither of the cases has the Food and Drug Administration or the Attorney General apply any of the challenge constructions in any concrete manner to any of the plaintiffs in the case.

In neither instance, have any of the three remedies authorized by the Act, seizure of misbranded or adulterated goods, injunction against their future distribution, or criminal prosecution been instituted by the Attorney General against any of the plaintiffs.

The plaintiffs in both cases contend however that since the regulations reflected the considered views of the agency and since obedience to these regulations would require them to change their way of doing business in some fashion, they are entitled to bring actions at this juncture to determine whether the regulations are valid.

Potter Stewart:

Now, either that in some fashion — you’re not implying, are you, that there’s any question of vagueness or uncertainty about what these regulations require?

Nathan Lewin:

No.

Potter Stewart:

Are you?

Nathan Lewin:

No, not at all.

Potter Stewart:

Very clear?

Nathan Lewin:

The only — the only thing I’m referring to Mr. Justice Stewart is just that this is not a total revolutionary change in the way, but —

Potter Stewart:

But it’s a very precise fact.

Nathan Lewin:

It’s a very precise change —

Potter Stewart:

It’s interesting —

Nathan Lewin:

Yes.

Potter Stewart:

— on how we have to change their way of doing business, isn’t it?

Nathan Lewin:

That’s right.

That is very precise.

Potter Stewart:

Very precise, ascertainable, no argument about what these regulations mean and they’re precise and narrow.

Nathan Lewin:

Yes sir.

Potter Stewart:

It’s just every time the word appears (Voice Overlap), it must have to appear in the other form.

Nathan Lewin:

That’s right.

But it — all that I’m referring to is just that they’re not — they’re not put out of business.

They’re not — they don’t suffer —

Potter Stewart:

Nor do they claim error?

Nathan Lewin:

And I hope that — pardon?

Potter Stewart:

They don’t claim that (Voice Overlap) —

Nathan Lewin:

No.

No, but I think, I think one of the — and I hope to elaborate on this, at a later portion of my argument, one of the factors I think going to whether the case is right at this juncture Mr. Justice Stewart is precisely whether the harm that caused by refusing to obey and by challenging this regulation at a later point rather at the present point whether that is an irreparable harm or whether it’s just a matter of challenging later rather than now.

Potter Stewart:

Yes.

Nathan Lewin:

And that’s —

Potter Stewart:

But some of the area of your argument, I’d like to hear what possible harm is there in getting the thing decided now, not harm in due course.

Nathan Lewin:

The issue of rightness which is common about these cases is one, which is this Court noted well ago in the Rochester Telephone case in 327 U.S. is not limited to administrative regulations or administrative law problems but applies across the Board to a variety of instances in which statutes maybe construed.

Let me turn first then to these generally applicable principles of rightness in the context of this case.

The statute involved in this case —

Hugo L. Black:

What do you mean precisely about rightness?

Nathan Lewin:

Whether, Mr. Justice Black, whether the issue presented the legal issue which is presented for decision by the Court is appropriate to be heard now or at some point when it’s more definite and certain who is hurt and how they’re hurt.

We submit that this Court has held in a variety of instances and properly so that hypothetical or future harms to a person or to a — to a plaintiff in any suit are not the stuff of which adjudication is made and that it’s appropriate ordinarily to wait until a party is individually and specifically harmed in some definite manner and —

Hugo L. Black:

Do you put that together with having the same meaning, hypothetical or future those words have the same meaning?

Nathan Lewin:

No.

No, we think they’re quite different.

Hugo L. Black:

I thought you used them that way.

Nathan Lewin:

No, we think they’re quite different but we think they’re both — both elements that enter into this question.

Byron R. White:

Would you think that the case or controversy?

Nathan Lewin:

I think there is a case or controversy in the — in maybe in a broad sense of what case or controversy means.

Of course this Court has at times —

Byron R. White:

Well, that’s.

Nathan Lewin:

— used to term case or controversy.

Byron R. White:

(Voice Overlap) District Court in its declaratory judgment action could the exercise of discretion and not to entertain.

Nathan Lewin:

Well, that –that’s established law under the Declaratory Judgment Act certainly.

But I think it goes beyond that Mr. Justice White, that Court generally exercise their discretion when cases are not exercised at discretion.

But they do not entertain premature suits.

They do not entertain actions which although there is according to the plaintiff’s complaint a present difference with the Government agency or with the defendant nonetheless a plaintiff is not adequately harmed at just that precise time and will be able to challenge the regulation in the future.

I think that’s a key element here, that there is really nobody is suggesting, and Mr. Gessell as at various times adverted to improper or suggested that there’s some impropriety in the Government putting off the decision in this case.

Now, of course this is not a case in which this regulation will never be tested.

The only question is whether it should be tested now or in a particular suit involving a particular label in which the Food and Drug Administration and the Attorney General determined that under the Food and Drug Administration’s construction of this Act, that label violates the statute.

Hugo L. Black:

Do you take this case as alleging that at this stage now that this is permitted to go on, at this stage he is already liable to suffer irreparable injury or that that’s not the case?

Nathan Lewin:

Well, we think he is alleging that he is going to be suffering irreparable injury but he’s focusing —

Hugo L. Black:

Suppose it’s true?

Nathan Lewin:

Well, we think — we think he’s focusing on the wrong thing Mr. Justice Black.

He’s saying he suffers irreparable injury if he obeys the regulation.

The real question is does he suffer irreparable injury if he waits until that later action when he can challenge the regulation.

And we say he does not suffer irreparable injury within the meaning of this Court’s ordinary rightness decisions if he waits until later.

In other words, there’s no question Mr. Justice Black that if he listens to this regulation and he follows it that he will have to change the label he is now using.

Hugo L. Black:

And that would —

Nathan Lewin:

— but the real issue —

Hugo L. Black:

— make him suffer irreparable injury?

Nathan Lewin:

Yes.

But the real issue is not, that injury, the real issue Mr. Justice Black is whether if he waits until the Food and Drug Administration and the Attorney General proceed against him will he because of waiting before to suffer some irreparable injury and our point is that the delay doesn’t cause them any injury —

Hugo L. Black:

Do you mean —

Nathan Lewin:

— other than —

Hugo L. Black:

Do you mean he doesn’t have to make any preparation?

Nathan Lewin:

He doesn’t — he doesn’t have to change his labels today if he in good faith believes that the Food and Drug Administration is an error in its construction of the statute, then he continues to use his own labels in labeling.

Hugo L. Black:

Could they be prosecuted criminally?

Nathan Lewin:

Theoretically, they could be prosecuted criminally Mr. Justice Black.

Hugo L. Black:

But why?

Don’t they not have a right to consider it?

Nathan Lewin:

Well, because we think —

Hugo L. Black:

What we theoretically might occur if that’s the law.

Nathan Lewin:

True.

But we think that danger of being prosecuted criminally is precisely the kind of injury that any person who is theoretically subject to a criminal statute can allege.

A very perfect recent instance we think Mr. Justice Black is what this Court did has done in the travel to Cuba regulations.

In Zemel and Rusk, the plaintiff in that suit brought an action against the Secretary of State seeking to have — the travel to Cuba restriction declared not only invalid in the sense that he wanted to have his passport validated to Cuba, but also seeking ruling from the Court, a declaratory judgment that would it would not violate Section 215, the Immigration Nationality Act for him to travel to Cuba.

This Court very clearly held that it was premature to consider that challenge to the Criminal statute at that point although he was subject to the harm of criminal prosecution if he then traveled to Cuba which he had every intention according to him —

Hugo L. Black:

And they went?

Nathan Lewin:

— there’s intention of doing.

Hugo L. Black:

And they went?

Nathan Lewin:

They went —

Hugo L. Black:

They went into trial?

Nathan Lewin:

Right.

Hugo L. Black:

And happened to win, supposed they hadn’t won?

Nathan Lewin:

Well, if they hadn’t won then — then that — and then the statute —

Hugo L. Black:

Then they had made a mistake in not trying to stop it before, wouldn’t they?

Nathan Lewin:

No.

In that case Mr. Justice Black, it seems that indicates why they should not be able to stop it before because if they’re wrong they should not be able to — this Court held that they could not in advance of their committing their Criminal Act obtained from a court a judgment as to whether the statute as officially construed by the Department of State would apply to their conduct.

Hugo L. Black:

Well, they could of course under the young doctrine if they had gone that far?

Nathan Lewin:

Oh, yes.

Yes, when — we — there’s no claim —

William O. Douglas:

On the civil side, how about the remedies that the administration would have against a drug company, on the civil side.

Nathan Lewin:

The remedies are two Mr. Justice Douglas, there is seizure or injunction, the Attorney General on —

William O. Douglas:

What is seizure in chaos (ph)?

Nathan Lewin:

Seizure in chaos (ph) in any case of misbranding, seizing a shipment or whatever product, a carton of the goods and having a suit, a viable action then in the District Court in which the Attorney General is required to establish that the drugs are misbranded and therefore subject to seizure.

Now, they would not be Mr. Gessell spoke of multiple seizures.

Multiple seizures are not authorized in these circumstances.

Multiple seizures are authorized under the statute only when the drug that’s being sold is hazardous or dangerous to health in some way.

When the only misbranding that’s involved is a violation of this kind of a statute or as construed by the regulation, there is no authority from multiple seizures.

So the only possibility here on the civil side and it’s been the consistent practice of the Attorney General of the Food and Drug Administration to apply civil remedies when there are litigable issues of construction of a statute of this kind.

The only remedies would be seizure or injunction.

Now, those are precisely the remedies — they don’t have to (Voice Overlap) —

Hugo L. Black:

But they don’t have to do that, do they?

Nathan Lewin:

No.

Abe Fortas:

These are the same remedies that are applicable generally under the Food and Drug Act —

Nathan Lewin:

Oh, yes.

Abe Fortas:

— are they not?

Nathan Lewin:

Yes sir.

Abe Fortas:

Now, has there been a successful injunction suit under the other applications of those remedies under Food and Drug Act in a decision of Court of Appeals or this Court supporting an injunction brought by drug company against the provisions under other parts of Food and Drug Act?

Nathan Lewin:

No, not by a drug company.

In other words, these remedies would be by the Attorney General —

Abe Fortas:

No, I’m talking of — as I remember that — then, let me ask you this I have forgotten.

Does Food and Drug Administration have a rule making jurisdiction with respect to deleterious substances in drugs?

Nathan Lewin:

Yes.

Abe Fortas:

Now, and they have issued rules, have they not?

Nathan Lewin:

Yes.

Abe Fortas:

Now, is there any precedent for an injunctive proceeding brought by a drug company to enjoin the enforcement of those rules?

Nathan Lewin:

No, none.

None.

Those rules ordinarily would be subject to the specific remedies outlined in the Act.

Abe Fortas:

And those remedies being the same as the remedies here, is that right?

That is —

Nathan Lewin:

No.

Abe Fortas:

— to say seizure?

Nathan Lewin:

Right.

Abe Fortas:

— or injunction or criminal prosecution?

Nathan Lewin:

When the Food and Drug Administration believes that a drug company is violating the Act, it has those remedies.

A drug company subject to an order which is of the legislative Congress before, and the one specifically enumerated in the statute where there is delegated to the Food and Drug Administration, the power to promulgate regulation regarding deleterious substances, ordinarily has review by way of the specific remedy provided in the statute which is in the Court of Appeals.

Abe Fortas:

I understand that.

Now, is there any way — the question I was trying to get at with Mr. Gessell is this, if this Court should hold that the injunctive remedy is available in the present case, would it also follow or would it not that an injunctive remedy is available in other cases under the Food and Drug Administration.

For example, suppose Food and Drug Administration decides that the inclusion of certain type of ingredient and the certain type of Drug may result in great injury to the population, maybe poisonous or cause all sorts of damage.

And somebody brings an injunctions suit to enjoin the enforcement of that, is that case the same as the case we have before us or is it different?

If we hold in the present case that an injunctive proceeding lies, does it follow that where Food and Drug says you cannot get out a drug and call it so and so if it contains such and such an ingredient, that injunctive proceeding wouldn’t be in that case, we’re just trying perhaps not very well —

Nathan Lewin:

As I understand —

Abe Fortas:

— as I have asked with Mr. Gessell.

Nathan Lewin:

Yes.

As I understand the petitioner’s rationale, I think it would have to apply in that case although in your circumstances Mr. Justice Fortas there are other remedies provide in the statute in which a drug company can review but I think that precisely in answer to Mr. Justice Stewart’s question that’s precisely our main ground of objection here Mr. Justice Stewart.

The Food and Drug Administration would be delighted to have an authoritative determination of — by a court of — at least the validity of this regulation.

And it turns out in this case that such a determination in this particular suit would affect and buying most of the large drug companies in the United States and would authoritatively settle the every time question.

Nathan Lewin:

The real problem though is what a holding of this kind opens the doors to because if this suit can be brought in this case by 27 of the large drug companies in the United States, there is nothing to prevent suit being brought tomorrow by any one of those drug companies against any other regulation of the federal — of the Food and Drug Administration.

Indeed, against any other interpretative regulation or indeed against even another clause in this very regulation.

This regulation was issued by the Food and Drug Administration as part of a whole sequence of regulations administering the drug amendments of 1962.

Drug companies were given the opportunity to provide to supply written comments to those proposed regulations.

They objected not merely that every time regulation but they objected also to the requirement in this regulation that the generic name appear in conjunction with the brand name that it appear in brackets or parenthesis.

Now, they are not involved in the suit, but as a matter of fact if this Court were to hold that this suit can be maintained is absolutely nothing to stop any one of these drug companies from bringing another suit tomorrow or the day after to declare that provision unjustified, impermissible under the statute.

Abe Fortas:

Mr. Lewin, are there in this record the labels of drugs that would be affected here?

Nathan Lewin:

No, Mr. Justice.

Abe Fortas:

Are there in this record copies of advertisements that would be affected here?

Nathan Lewin:

No, there are none.

Abe Fortas:

So that is it fair to say that in the sense what is being — what petitioners are seeking to have the Court’s rule on is a there’s a question which can I use this without invading his abstract in the sense that they’re asking us to rule that the secretary’s construction of the statute is unjustified as an abstract matter and that we allow — we do no take into account whether in view of actual examples, actual factual record, the construction — the Secretary’s construction of the statute as within the area of rational judgment that some people urge is a factor in construing the propriety of the exercise of delegated power.

Nathan Lewin:

That now, that’s precisely our principal objection to what their claim is.

Hugo L. Black:

Well, is it your objection then that they could file proper cause at this juncture, under some circumstances to get the relief they asked but that the facts here led — were not sufficient, is that it?

Nathan Lewin:

We think they could if the Food and Drug Administration did something to any one of them that in any way raised a present controversy.

There were other remedies and as a matter of fact —

Hugo L. Black:

But I understood the allegation was that they adopted this and they did raise a present controversy because they claim, may not be equal to the Young ex parte, Young allegations.

But they claim to something approaching ex parte young allegations, do they not?

Nathan Lewin:

But nothing that — that harms any one of them —

Hugo L. Black:

I said —

Nathan Lewin:

— in such a way that they would not be harmed if they waited until something happened to them.

In other words, nothing has really —

Hugo L. Black:

I —

Nathan Lewin:

— there is —

Hugo L. Black:

I understood him to charge or maybe not that they do hit them now and that there will be such tremendous expenses and such tremendous change and such tremendous differences that will work irreparable harm.

And if ex parte Young does grant relief under those circumstances why isn’t a question not formed – a question of degree, if they reached that degree which Young says would make a good change?

Nathan Lewin:

We think it is a question of degree definitely Mr. Justice Black but we think that the allegations here —

Hugo L. Black:

Would you not —

Nathan Lewin:

— in the circumstance.

Hugo L. Black:

— take the position that is impossible for them —

Nathan Lewin:

No.

Hugo L. Black:

— under the present situation to file a good claim?

Nathan Lewin:

Well, to attack this regulation —

Hugo L. Black:

To attack this?

Nathan Lewin:

Without — yes, without the Food and Drug Administration doing anything more or the Attorney General doing anything more, we think they could not present the challenge —

Hugo L. Black:

Or there is always in effect criminal offense and they could be put in jail if they violate it.

Nathan Lewin:

That’s right and that’s true —

Hugo L. Black:

What’s the difference —

Nathan Lewin:

— of every criminal statute —

Hugo L. Black:

What’s the difference in that in principle in ex parte Young?

Nathan Lewin:

Because it’s true of every criminal statute Mr. Justice Black that if you violate it you may be put in jail and that’s doesn’t entitle you to go to court and say may I now violate the statute —

Hugo L. Black:

But if you —

Nathan Lewin:

— because I propose (Voice Overlap) —

Hugo L. Black:

(Voice Overlap) it does, doesn’t it?

Nathan Lewin:

Well, if it makes you today.

Hugo L. Black:

(Voice Overlap) number of offenses cumulated, piling up time after time.

Nathan Lewin:

Well, we — I don’t think this Court has ever held really in the — in the context of a criminal statute that you can do that, even if you — even if you could show you are a repeated offender —

Hugo L. Black:

I thought they had in criminal cases.

Now, that you could do something to stop them from having a lot of prosecution, I thought they had in the number of cases, is that wrong?

Nathan Lewin:

Not I think where — the only claim is that the party responsible for administering the criminal statute is construing it, it’s applicable to my case whereas really it shouldn’t – it’s certainly true where there are criminal statutes which in someway affect a constitutional right and —

Hugo L. Black:

Have they alleged that here?

Nathan Lewin:

I don’t think they do.

There’s no claim here.

Hugo L. Black:

They did not?

Nathan Lewin:

No.

There’s nothing —

William O. Douglas:

I think they have a — how could they have clarified — what you seem to agree with Justice Fortas, making it more specific?

Nathan Lewin:

Well, if they applied for example with a new drug or with an antibiotic for certification.

William O. Douglas:

No, well, I’m talking about this complaint.

Nathan Lewin:

No.

I have no — our objection — I don’t think — I don’t think what Mr. Justice Fortas was suggesting was something what that went to the — to the drafting of the complaint.

Nathan Lewin:

Our objection is not that the complaint was improperly drafted or failed to allege something — it’s just that nothing had happened yet.

The Food and Drug Administration or the Attorney General has not really brought this regulation to the point where any one of these plaintiffs is being —

William O. Douglas:

Have you — do you people say that they have misconstrued the regulations they — they read it the wrong way?

Nathan Lewin:

No.

Hugo L. Black:

Do you disclaim any preference to prosecute them if they refuse to do this?

Nathan Lewin:

We say we will not until the regulation — until the validity of the —

Hugo L. Black:

I —

Nathan Lewin:

— regulation has been —

Hugo L. Black:

Until the validity but — but in the meantime it would’ve been covering the situation.

And as I understand it what they’re complaining about is that it entered in part.

Nathan Lewin:

Right but —

Hugo L. Black:

You’re saying that they can’t get into protection until you first promulgate this particular regulation or see whether or not — that’s — but nevertheless that they have violated and that that year of the time they could be prosecuted, you do not disclaim purpose to prosecute, do you?

Nathan Lewin:

Well, we disclaim a purpose to prosecute in the sense of criminal prosecution, yes.

We say though that we will have this regulation tested either —

Hugo L. Black:

Civil forfeitures?

Nathan Lewin:

Either civil forfeitures or through the new drug clearance procedures provided for under the Act which any one of these companies can submit a new drug or an antibiotic for certification, refused to have it labeled in accordance with this regulation and then appeal from the refusal of Food and Drug Administration to certify the antibiotic or to approve a new drug for sale, appeal from that under the procedures in the Food and Drug Act which authorize to review directly in a Court of Appeals.

Byron R. White:

(Inaudible) I assume that it’s the revision, but the Congress didn’t intend to have this kind of an action —

Nathan Lewin:

Right.

Byron R. White:

— whether it’s a case of controversy or whether it’s right or anything of that kind.

Congress, you say, has pre-empted this kind of a case by its own procedures.

Nathan Lewin:

Right.

I was just coming to that Mr. Justice White, that irrespective of the questions of rightness that apply generally and would apply to none and to actions not affecting administrative agency, in this case, the Food and Drug Act, both Congress and this Court have recognized that suits of this kind brought out of the usual course, prematurely will do serious harm to the administration of an Act which had a substantial, remedial impact on the nation’s consumers in this entire area.

In Mytinger and Casselberry in 339, U.S., this Court specifically noted that really are held that in a case which was far more right really than this one in the sense that they were really two adversaries contesting a particular product at a point in time when the Food and Drug Administration was proceeding against that product.

Nonetheless this Court held that it would be undermining the intent of Congress under the Food and Drug and Cosmetic Act to allow review at that point.

And we think that the entire legislative history of this Act demonstrates as much because there was much tugging and pulling in Congress before Section 701 (f) which provides the judicial review of only very limited number of orders was finally enacted.

Byron R. White:

But Mr. Lewin, this —

William O. Douglas:

The natural tendencies of administrator and I don’t see it — I don’t say that’s in any disparaging way as to get submission rather than context and that this strategy was designed, I imagine, to get sufficient acceptance?

Nathan Lewin:

Yes.

Abe Fortas:

And, Mr. Lewin, is it fair — is it fair to say that that is the underlying idea of the Food and Drug Act and that the Act has somewhere in some respects a peculiar place in our regulatory system, that is to say I don’t know of hand of any other statute that has — this prompt seizure power (Inaudible), but isn’t that bound in with the purpose of the statute dealing with in their old days that was justified on the grounds you were dealing with dangerous drugs.

And they proved that it might be dangerous.

Abe Fortas:

And you do now have extra ordinary procedures here because of that, isn’t that right?

Nathan Lewin:

That’s right and we think that the — that the fact, the review scheme that the statute provide we think is really exclusive at to these kinds of procedures the kind of proceeding is calculated to get expeditious resolution of this — of these kind of questions because if this suit had not been brought when it was it would’ve been a matter of weeks or months before an application would have been made for a new drug or would have been passed on by the Food and Drug Administration, it would’ve been up in the Court of Appeals, and this very regulation in all its parts would’ve been before the Court of Appeals for review.

Well, of course if you’re right on that statutory argument, that ends this case, wouldn’t it?

Nathan Lewin:

Yes sir.

And not suppose anybody would question you, it will be right to — if there isn’t a jurisdictional review at this stage.

But apart from that, let me ask you, do you think that the issue in this case is of rightness, (Inaudible) for your time too — is this case more or less right than one with the Broadcasting or Frozen Food or Storer?

Nathan Lewin:

We think it’s less right.

Less right?

Nathan Lewin:

Less right in those cases because in both Columbian Broadcasting and in Storer, those were the kind of situations which we think there was —

Yes.

Nathan Lewin:

— an irreparable harm.

There was a Fish or Cut Bait position that the defendants in those cases may have been put in to, where the people were subject to those regulations.

William O. Douglas:

And it hadn’t been applied to it, I don’t believe, isn’t it?

Nathan Lewin:

Pardon?

William O. Douglas:

They hadn’t even been applied to it?

Nathan Lewin:

They hadn’t been applied.

But on the other hand those particular individuals or plaintiffs in those suits had to make at that point decisions which –repercussions of which would be felt only later.

In other words, the Columbia Broadcasting System for example, the plaintiff in the Columbia Broadcasting System case would have to sever its contract with the variety of licensees if it was going to obey that order.

If it was going to wait until later to test it, assuming then that the time that had lapse that they waited until they actually felt the pinch of that regulation, they would have irrevocably loss certain options that were opened to them at that stage.

I think the clearest illustration of this is not a case in this Court but is in the Nash-Finch case which the petitioners —

William O. Douglas:

On what?

Nathan Lewin:

— rely on.

The Nash-Finch case in 288 F.2d, where the Federal Trade Commission had issued a regulation saying, that they construed the statute as in effect of waiving all rights unless the party sought review within 60 days in a Court of Appeals.

Now, if you waited until you felt the pinch of that regulation, you would lose your time to review in the Court of Appeals.

So, in those cases, those are the kinds of instances we think with the delay itself works the harm.

In other words, if delay really having those questions reviewed later rather than now is what causes harm, then we think you’re entitled to possibly to go in an earlier stage and seek — and seek relief at that stage.

But if there’s no harm caused from the delay other than possibility of seizure which this Court held in Mytinger and Casselberry under the Food and Drug Act was not enough to give you the right to go in and sue in advance even though it might harm your reputation, then we don’t have a right to go into that stage.

Frozen Food Express presents a closer question but we nonetheless think that in that case because the Commission has enforcement power itself because there was a separate statute authorized in review unlike — broadly of all Commission orders, for that reason we think Frozen Food Express might be distinguished from the present case.

Byron R. White:

Mr. Lewin, I think if the petitioners argue that the Congress specified certain pre-enforcement action should take place in the — pre-enforcement review action to take place in the Court of Appeals but except that for those all other pre-enforcement procedures, or actions, or review should be in the District Court, and you argue that the congressional selection of few to go into Court of Appeals and meant to work to be in the other?

Nathan Lewin:

Well, because we are – and we think it’s plain from the legislative history and we try to outline it in our brief that what Congress was concerned with was the delay that would be caused by pre-enforcement judicial review.

Nathan Lewin:

When Congress moved — at a very late stage, Congress moved the remedies from the District Courts to the Court of Appeals, it was doing to expedite the enforcement of Food and Drug Regulations, it would as the contrary in that (Voice Overlap) —

Byron R. White:

Do you mean the initial suggestion was that these specified pre-enforcement reviews action should be in the District Court?

Nathan Lewin:

That’s right.

And that was amended at a very late stage, put them up in the Court of Appeals and the purpose of that was to expedite it.

If, on the other hand, what you’re doing in the very same breadth is opening the door to a wide variety of actions in the District Courts, then all you’re doing is you’re adding another level of judicial review, you’re slowing down the proceeding, and we think this case and the one that follows it demonstrate quite clearly how that, why that’s true.

Byron R. White:

But your argument as I take is that if there was general pre-enforcement review procedures available in the District Court, the Congress didn’t need to do anything at all.

Nathan Lewin:

That’s right, Congress wouldn’t have any — we think the whole fight (Voice Overlap)

Byron R. White:

Unless they wanted to expedite certain ones of it?

Always it is clear that the legislative history I thought now that the briefs is quite a scrap, (Inaudible) no judicial review and broad judicial review unless it’s compromised.

Nathan Lewin:

Definitely.

But we think Mr. Justice Harlan if you take the reading of Section 701 (f) (6) that the petitioners in this case do and that the Second Circuit did in the Toilet Goods case, then that whole scrap becomes utterly meaningless because Congress in the one hand was fighting really tooth-and-nail about exactly which kinds of regulations, you should subject to review in a specific review provision when it was in the other hand just giving away or authorizing companies such as those that are involved in these two cases to institute an action at any time they like in the District Court.

That’s in effect the consequence of what a petitioner’s argument, that Congress was fighting about a specific review provision when it was at the same breadth intending to save a broad range of case and which could always be instituted in the District Court under Declaratory Judgments Act.

Well, do you have a broad reservation in the acts of doing that?

Nathan Lewin:

Yes, but we think what that was intended to reserve in light of the congressional uncertainty at that time as to what would be available, that was intended to preserve we think — really the remedies — first of all at (f) (6) Mr. Justice Harlan specifically refers to the remedy in this subsection.

In other words, saying that the remedy specifically provided for an (f) (1) are not to derogate from any other remedies available.

In other words — and we think Congress is referring only to review of those kinds of regulations and what Congress was saying we think is that their 90-day-limitations period and all the very specific provisions to review in the Court of Appeals were not to apply in cases where for example the Food and Drug Administration has not followed the procedures outlined in the prior subsection where for example, they hadn’t given notice to the parties, they hadn’t given them an opportunity to present evidence in those kind of cases or in substantive due process cases of some kind it was still permissible to go into a District Court after the 90-day-period had expired and bring an action.

Earl Warren:

Mr. Gessell.

Gerhard A. Gessell:

I would like to deal with two words that have been used this afternoon “premature and abstract” and I’d like to simply give you one example of what the Government said as the way we should deal with this problem.

I suffer from gout Mr. Chief Justice and others too, suppose the company has developed a cure for gout and the drug has cleared, they say don’t lift that drug on the market because we will not approve the labeling because you don’t have generic every time and take that up through the Courts for a period of two to two-and a half years to get these regulations straightened out.

Abe Fortas:

If they do that now, won’t they Mr. Gessell, with all kinds of regulations and rulings you’re going there with the Food and Drug with the new drug application, then you’ve got to go through the varying process of getting a clearance on that but so far as I know, nobody is ever here before succeeded in getting an injunction against the enforcement of the class of regulations.

Now maybe there’s something in the legislative history here or the legislation itself that makes this a special case.

But I have two questions if so what is it and the second question is if we rule here that in this situation, an injunction proceeding can be maintained, does it or does it not follow that we’re giving the drug companies or anybody else who maybe affected an injunctive remedy in cases where for example, Food and Drug Administration says that you cannot market such and such a drug unless you show on the label and under certain uses it’s poisonous to people.

Gerhard A. Gessell:

My answer to that is very clear and simple.

In that context, you have to have an evidentiary hearing, you go to a Court of Appeals and that’s all there’s to it.

Abe Fortas:

Well, why is this different?

That’s my question.

Gerhard A. Gessell:

Because the statute does not cover a proceeding of this kind relating to this type of regulation which issued without any evidentiary hearing which — issued without any factual basis.

It’s an (Inaudible) —

Abe Fortas:

Do you think it have —

Gerhard A. Gessell:

— they just say business on what we think the statute means.

Abe Fortas:

You don’t have an adversary, evidentiary hearing generally in Food and Drug.

Gerhard A. Gessell:

You do with respect to the kind of case you put to be Mr. Justice.

Right now, it’s going on in the field of Vitamins and you may have seen in the newspapers.

Abe Fortas:

Well, that’s the legislative hearing.

Gerhard A. Gessell:

And that’s the type of regulation —

Abe Fortas:

The legislation had (Voice Overlap) —

Gerhard A. Gessell:

— that’s the type of regulation they issue on the questions of help of that kind after they taken evidence, after they have heard from technical people and after they have a fix on it.

I see my time is up.

Earl Warren:

You may explain those two words if you wish.

Gerhard A. Gessell:

Thank you Mr. Chief Justice.

Earl Warren:

Yes.

Gerhard A. Gessell:

I have dealt with the premature point.

Now, it is — now it is not abstract.

Mr. Justice Douglas asked, what is involved in seizure?

And he was advised that someone seizes libel-some goods, that isn’t all that’s involved.

We’ve had two reason seizures against drug companies banner headlines in the Washington Post, The Star, and all the newspapers of the country press releases, background statements, these companies are in the sensitive business.

And the necessity of having to meet that kind of publicity barrage or the company’s seizure I think is something that creates a real quarrel and a real problem.

And as far as multiple seizures are concerned there is plenty opportunity here to seize the drugs in any number of company at the same time, one company, three companies, five companies, 20 companies and the Government is trying to keep total chance to pick and choose to move to determine its strategy hoping in the meantime that by this jawbone enforcement, as Mr. Justice Douglas suggested, people will comply even though they probably clearly in view with the District Judge have gone beyond the law.

Hugo L. Black:

Is there any question before us, except premature?

Is there any question of sufficiency of your complaint to make other case?

Gerhard A. Gessell:

There is not Mr. Justice Black.

There is an argument that Congress precluded this type of action even if it is right.

Hugo L. Black:

Precluded the type of action?

Gerhard A. Gessell:

Yes.

Hugo L. Black:

You couldn’t bring the type of —

Gerhard A. Gessell:

Right.

Hugo L. Black:

— action at all?

Gerhard A. Gessell:

And we say that they never —

Hugo L. Black:

That’s always — they had always ruled on after now?

Gerhard A. Gessell:

The Court of Appeals so ruled.

Gerhard A. Gessell:

The District Judge ruled on the merits because he found we had a proper complaint for property in Court and he said we were right about the regulation.

The Court of Appeals said that it was not right and that Congress in addition had precluded this type of action.

Hugo L. Black:

Was that ruling based to any extent on the inadequacy of the complaint, the charge, the kind of case that would make out irreparable damages —

Gerhard A. Gessell:

No sir.

Hugo L. Black:

— and would prevent a challenge?

Gerhard A. Gessell:

No, and I don’t — the Government indicated they have no quarrel with our complaints.

It’s a good complaint Mr. Justice Black.