delivered the opinion of the Court.
In 1962 Cоngress amended the Federal Food, Drug, and Cosmetic Act (52 Stat. 1040, as amended by the Drug Amendments of 1962, 76 Stat. 780, 21 U. S. C. § 301
et seq.),
to require manufacturers of prescription drugs to print the “established name” of the drug “prominently
“If the label or labeling of a prescription drug bears a proprietary name or designation for the drug or any ingredient thereof, the established name, if such there be, corresponding to such proprietary name or designation, shall accompany each appearance of such proprietary name or designation.” 21 CFR §1.104 (g)(1).
A similar rule was made applicable to advertisements for prescription drugs, 21 CFR § 1.105 (b)(1).
The present action was brought by a group of 37 individual drug manufacturers and by the Pharmaceutical Manufacturers Association, of which all the petitioner companies are members, and which includes manufacturers of more than 90% of the Nation’s supply of pre
The District Court, on cross motions for summary judgment, granted the declaratory and injunctive reliéf sought, finding that the statute did not sweep so broadly as to permit the Commissioner’s “every time” interpretation.
I.
The first question we consider is whether Congress by the Federal Food, Drug, and Cosmetic Act intended to forbid pre-enforcement review of this sort of regulation
Given this standard, we are wholly unpersuaded that the statutory scheme in the food and drug area excludes this type of action. The Government relies on no explicit statutory authority for its argument that pre-enforcement review is unavailable, but insists instead that because the statute includes a sрecific procedure for such review of certain enumerated kinds of regulations, 3 not encompassing those of the kind involved here, other types were necessarily meant to be excluded from any pre-enforcement review. The issue, however, is not so readily resolved; we must go further and inquire whether in the context of the entire legislative scheme the existence of that circumscribed remedy evinces a congressional purpose to bar agency action not within its purview from judicial review. As a leading authority in this field has noted, “The mere fact that some acts are made reviewable should not suffice to support an implication of exclusion as to others. The right to review is too impоrtant to be excluded on such slender and indeterminate evidence of legislative intent.” Jaffe, supra, at 357.
The main issue in contention was whether these methods of review were satisfactory. Compare the majority and minority reports on the review provisions, H. R. Rep. No. 2139, 75th Cong., 3d Sess. (1938), both of which acknowledged that traditional judicial remedies were available, but disagreed as to the need for additional procedures. The provisiоns now embodied in a modified form in § 701 (f) were supported by those who feared the life-and-death power given by the Act to the executive officials, a fear voiced by many members of Congress. The supporters of the special-review section sought to include it in the Act primarily as a method of reviewing agency factual determinations. For example, it was argued that the level of tolerance for poisonous sprays on apple crops, which the Secretary of Agriculture had recently set, was a factual matter, not reviewable in equity in the absence of a special statutory review procedure. 8 Some congressmen urged that challenge to this type of determination should be in the form of a de novo hеaring in a district court, but the Act as it was finally passed compromised the matter by allowing an appeal on a record with a “substantial evidence” test, affording a considerably more generous judicial review than the “arbitrary and capricious” test available in the traditional injunctive suit. 9
Against this background we think it quite apparent that the special-review procedures provided in § 701 (f), applying to regulations embodying technical factual determinations, 11 were simply intended to assure adequate judicial review of such agency decisions, and that their enactment does not manifest a congressional purpose to eliminate judicial review of other kinds of agency action.
This conclusion is strongly buttressed by the fact that the Act itself, in § 701 (f)(6), states, “The remedies provided for in this subsection shall be in addition to and not in substitution for any other remedies provided by law.” This saving clause was passed over by the Court of Appeals without discussion. In our view, however, it bears heavily on the issue, for if taken at face value it would foreclose the Government’s main argument in this case. The Government deals with the clause by arguing that it should be read as applying only to review of
There is no support in the legislative background for such a reading of the clause. It was included in the House bill, whose report states that the provision . . saved as a method to review a regulation placed in effect by the Secretary whatever rights exist to initiate a historical proceeding in equity to enjoin the enforcement of the regulation, and whatever rights exist to initiate a declaratory judgment proceeding.” H. R. Rep. No. 2139, 75th Cong., 3d Sess., 11. The Senate conferees accepted the provision.
12
The Government argues that the clause is included as a part of § 701 (f), and therefore should be read to apply only to those sections to which the § 701 (f) special-review procedurе applies. But it is difficult to think of a more appropriate place to put a general saving clause than where Congress placed it — at the conclusion of the section setting out a special procedure for use in certain specified instances. Furthermore, the Government's reading would result in an anomaly. The §§ 701 (e)-(f) procedure was included in the Act in order to deal with the problem of technical determinations for which the normal equity power was deemed insufficient. See,
supra,
pp. 142-144. There would seem little reason for Congress to have enacted § 701 (f), and at the same time to have included a clause aimed only at preserving for such determinations the
Under the Government’s view, indeed, it is difficult to ascertain when the saving clause would even come into play: when the special provisions apply, presumably they must be used and a court would not grant injunctive or declaratory judgment relief unless the appropriate administrative procedure is exhausted. 13 When the special procedure does not apply, the Government deems the saving clause likewise inapplicable. The Government, to be sure, does present a rather far-fetched example of what it considers a possible application of the relief saved by § 701 (f)(6), but merely to state it reveals the weakness of the Government’s position. 14 We prefer to take the saving clause at its face value, and to read it in harmony with the policy favoring judicial review expressed in the Administrative Procedure Act and this Court’s decisions.
The only other argument of the Government requiring attention on the preclusive effect of the statute is that
Ewing
v.
Mytinger & Casselberry, Inc.,
The Court in
Ewing
first noted that the “administrative finding of probable cause required by § 304 (a) is merely the statutory prerequisite to the bringing of the lawsuit,” at which the issues are aired.
Second, the determination of probable cause in
Ewing
has “no effect in and of itself,”
The drug manufacturer in Ewing was quite obviously seeking an unheard-of form of relief which, if allowed, would have permitted interference in the early stages of an administrative determination as to specific facts, and would have prevented the regular operation of the seizure procedures established by the Act. That the Court refused to permit such an action is hardly authority for cutting off the well-established jurisdiction of the federal courts to hear, in appropriate cases, suits under the Declaratory Judgment Act and the Administrative Procedure Act challenging final agency action of the kind present here.
We conclude that nothing in the Food, Drug, and Cosmetic Act itself precludes this action.
h — ( 1 — 1
A further inquiry must, however, be made. The injunc-tive and declaratory judgment remedies are discretionary, and courts traditionally have been reluctant to apply them to administrative determinations unless these arise in the context of a controversy “ripe” for judicial resolution. Without undertaking to survey the intricacies of the ripeness doctrine
15
it is fair to say that its basic rationale is to prevent the courts, through avoidance of premature adjudication, from entangling themselves in abstract disagreements over administrative policies, and also to protect the agencies from judicial interference until an administrative decision has been formalized and its effects felt in a concrete way by the challenging
As to the former factor, we believe the issues presented are appropriate for judicial resolution at this time. First, all parties agree that the issue tendered is a purely legal one: whether the statute was properly construed by the Commissioner to require the established name of the drug to be used every time the proprietary name is employed. 16 Both sides moved for summary judgment in the District Court, and no claim is made here that further administrative proceedings are contemplated. It is suggested that the justification for this rule might vary with different circumstances, and that the expertise of the Commissioner is relevant to passing upon the validity of the regulation. This of course is true, but the suggestion overlooks the fact that both sides have approached this case as one purely of congressional intent, and that the Government made no effort to justify the regulation in factual terms.
Second, the- regulations in issue we find to be “final agency action” within the meaning of § 10 of the Administrative Procedure Act, 5 U. S. C. § 704, as construed in judicial decisions. An “agency action” includes any “rule,” defined by the Act as “an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy,” §§ 2 (c), 2 (g), 5 U. S. C. §§ 551 (4), 551 (13). The cases dealing with judicial review of administrative actions have interpreted the “finality” element in a pragmatic way. Thus in
Columbia Broadcasting System
Two more recent cases have taken a similarly flexible view of finality. In
Frozen Food Express
v.
United States,
We find decision in the present case following
a fortiori
from these precedents. The regulation challenged here, promulgated in a formal manner after announcement in the Federal Register and consideration of comments by interested parties
17
is quite clearly definitive. There is no hint that this regulation is informal, see
Helco Products Co.
v.
McNutt,
78 U. S. App. D. C. 71,
The Government argues, however, that the present case can be distinguished from cases like
Frozen Food Express
on the ground that in those instances the agency involved could implement its policy directly, while here the Attorney General must authorize criminal and seizure actions for violations of the statute. In the context of this case, we do not find this argument persuasive. These regulations are not meant to advise the Attorney General, but purport to be directly authorized by the statute. Thus, if within the Commissioner’s authority,
This is also a case in which the impact of the regulations upon the petitioners is sufficiently direct and immediate as to render the issue appropriate for judicial review at this stage. These regulations purport to give an authoritative interpretation of a statutory provision thаt has a direct effect on the day-to-day business of all prescription drug companies; its promulgation puts petitioners in a dilemma that it was the very purpose of the Declaratory Judgment Act to ameliorate.
18
As the District Court found on the basis of uncontested allegations, “Either they must comply with the every time requirement and incur the costs of changing over their promotional material and labeling or they must follow their present course and risk prosecution.”
It is relevant at this juncture to recognize that petitioners deal in a sensitive industry, in which public confidence in their drug products is especially important. To require them to challenge these regulations only as a defense tо an action brought by the Government might harm them severely and unnecessarily. Where the legal issue presented is fit for judicial resolution, and where a regulation requires an immediate and significant change in the plaintiffs’ conduct of their affairs with serious penalties attached to noncompliance, access to the courts under the Administrative Procedure Act and the Declaratory Judgment Act must be permitted, absent a statutory bar or some other unusual circumstance, neither of which appears here.
The Government does not dispute the very real dilemma in which petitioners are placed by the regulation, but contends that “mere financial expense” is not a justification for pre-enforcement judicial review. It is of course true that cases in this Court dealing with the standing of particular parties to bring an action have held that a possible financial loss is not by itself a sufficient interest to sustain a judicial challenge to governmental action.
Frothingham
v.
Mellon,
The Government further contends that the threat of criminal sаnctions for noncomplianee with a judicially untested regulation is unrealistic; the Solicitor General has represented that if court enforcement becomes necessary, “the Department of Justice will proceed only civilly for an injunction ... or by condemnation.” We cannot accept this argument as a sufficient answer to petitioners’ petition. This action at its inception was properly brought and this subsequent representation of the Department of Justice should not suffice to defeat it.
Finally, the Government urges that to permit resort to the courts in this type of case may delay or impede effective enforcement of the Act. We fully recognize the important public interest served by assuring prompt and unimpeded administration of the Pure Food, Drug, and Cosmetic Act, but we do not find the Government’s argument convincing. First, in this particular case, a pre-enforcement challenge by nearly all prescription drug manufacturers is calculated to speed enforcement. If the Government prevails, a large part of the industry is bound by the decree; if the Government loses, it can more quickly revise its regulation.
The Government contends, however, that if the Court allows this consolidated suit, then nothing will prevent a multiplicity of suits in various jurisdictions challenging other regulations. The short answer to this contention
Further, the declaratory judgment and injunctive remedies are equitable in nature, and other equitable defenses may be interposed. If a multiplicity of suits are undertaken in order to harass the Government or to delay enforcement, relief cаn be denied on this ground alone.
Truly
v.
Wanzer, 5
How. 141, 142; cf.
Brillhart
v.
Excess Ins. Co.,
In addition to all these safeguards against what the Government fears, it is important to note that the institution of this type of action does not by itself stay the effectiveness of the challenged regulation. There is
Lastly, although the Government presses us to reach the merits of the challenge to thе regulation in the event we find the District Court properly entertained this action, we believe the better practice is to remand the case to the Court of Appeals for the Third Circuit to review the District Court’s decision that the regulation was beyond the power of the Commissioner. 20
Reversed and remanded.
Notes
That is, a suit brought by one before any attempted enforcement of the statute or regulation against him.
See H. R. Rep. No. 1980, 79th Cong., 2d Sess., 41 (1946): “To preclude judicial review under this bill a statute, if not specific in withholding such review, must upon its face give clear and convincing evidence of an intent to withhold it. The mere failure to provide specially by statute for judicial review is certainly no evidence of intent to withhold review.” See also S. Rep. No. 752, 79th Cong., 1st Sess., 26 (1945).
Embodied in §§701 (e), (f), 21 U. S. C. §§371 (e), (f), and discussed hereafter. Section 701 (e) provides a procedure for the issuance of regulations under certain specifically enumerated statutory sections. Section 701 (f) establishes a procedure for direct review by a court of appeals of a regulation promulgated under § 701 (e).
The Administrative Procedure Act was enacted in 1946, 60 Stat. 237.
The Declaratory Judgment Act was enacted in 1934, 48 Stat. 955.
See, e. g., the discussion of judicial review under the equity power in the House of Representatives during the debate on these provisions. 83 Cong. Rec. 7891-7896 (1938).
See, e. g., 83 Cong. Rec. 7783 (remarks of Representative Leavy) (1938); Statement of Professor David F. Cavers before a Subcommittee of the Senate Committee on Commerce on S. 1944, 73d Cong., 2d Sess. (1933), reprinted in Dunn, Federal Food, Drug, and Cosmetic Act, A Statement of Its Legislative Record 1110 (1938).
See, e. g., 83 Cong. Rec. 7772-7773, 7781-7784, 7893-7899 (1938).
See, e. g., the discussion of the conference report, 83 Cong. Rec. 9096-9098 (1938).
See, e. g., 83 Cong. Rec. 7772, 7892, 9092-9093 (1938).
See
Toilet Goods Assn.
v.
Gardner,
H. R. Conf. Rep. No. 2716, 75th Cong., 3d Sess., 25 (1938); 83 Cong. Rec. 8731-8738 (1938) (Senate agreement to the conference report).
See Notes of the Advisory Committee on Federal Rule of Civil Procedure 57, reprinted in 28 U. S. C. App., at 6136: “A declaration may not be rendered if a special statutory proceeding has been provided for the adjudication of some special type of case . . . .” See also 6A Moore, Federal Practice §57.08[3] (2d ed. 1966).
The Government apparently views the clause as applying only when regulations falling within the special-review procedure are promulgated without affording the required public notice and opportunity to file objections and to request a public hеaring. In such a case alone, the Government asserts, “an equity proceeding or a declaratory judgment action . . . might be entertained on the ground that the statutory procedures had not been followed.” Brief, p. 28.
See 3 Davis, Administrative Law Treatise, c. 21 (1958); Jaffe, Judicial Control of Administrative Action, c. 10 (1965).
While the “every time” issue has been framed by the parties in terms of statutory compulsion, we think that its essentially legal character would not be different had it been framed in terms of statutory authorization for the requirement.
Compare similar procedures followed in Frozen Food Express, supra, at 41-42, and Storer, supra, at 193-194. The procedure conformed with that prescribed in § 4 of the Administrative Procedure Act, 5 U. S. C. § 1003.
See S. Rep. No. 1005, 73d Cong., 2d Sess., 2-3 (1934); Borchard, Challenging “Penal” Statutes by Declaratory Action, 52 Yale L. J. 445, 454 (1943).
Section 502 (e)(1)(B) declares a drug not complying with this labeling requirement to be “misbrаnded.” Section 301, 21 U. S. C. § 331, designates as “prohibited acts” the misbranding of drugs in interstate commerce. Such prohibited acts are subject to injunction, § 302, 21 U. S. C. § 332, criminal penalties, § 303, 21 U. S. C. § 333, and seizure, § 304 (a), 21 U. S. C. § 334 (a).
A totally separate issue raised in the petition for certiorari and argued by the parties in their briefs concerns the dismissal of the complaint as to certain of the plaintiffs on the ground that venue was improper as to them. All the petitioners asserted that venue was proper in Delaware not only because some of them are incorporated there but also under 28 U. S. C. § 1391 (e)(4), allowing an
This question is a difficult one, with far-reaching effects, and we think it is appropriate to dismiss our writ of certiorari as to this question for the following two reasons. First, the Court of Appeals in affirming the District Court on this issue did not explicitly endorse the lower court’s ruling but held only: “We find no prejudicial error in the dismissal of the complaint as to these plaintiffs
. . .
