Source: http://openjurist.org/print/28513
Timestamp: 2015-10-07 02:51:48
Document Index: 269372694

Matched Legal Cases: ['§ 301', '§ 502', '§ 352', '§ 502', '§ 352', '§ 701', '§ 371', '§ 1', '§ 1', '§ 701', '§ 2201', '§ 702', '§ 701', '§ 704', '§ 701', '§ 701']

387 US 136 Abbott Laboratories v. W Gardner
Home > 387 US 136 Abbott Laboratories v. W Gardner
387 US 136 Abbott Laboratories v. W Gardner 387 U.S. 136
18 L.Ed.2d 681
ABBOTT LABORATORIES et al., Petitioners,v.John W. GARDNER, Secretary of Health, Education, and Welfare et al.
Gerhard A. Gesell, Washington, D.C., for petitioners.
In 1962 Congress 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 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, § 502(e)(1)(B), 21 U.S.C. § 352(e)(1)(B). The 'established name' is one designated by the Secretary of Health, Education, and Welfare pursuant to § 502(e)(2) of the Act, 21 U.S.C. § 352(e)(2); the 'proprietary name' is usually a trade name under which a particular drug is marketed. The underlying purpose of the 1962 amendment was to bring to the attention of doctors and patients the fact that many of the drugs sold under familiar trade names are actually identical to drugs sold under their 'established' or less familiar trade names at significantly lower prices. The Commissioner of Food and Drugs, exercising authority delegated to him by the Secretary, 22 Fed.Reg. 1051, 25 Fed.Reg. 8625, published proposed regulations designed to implement the statute, 28 Fed.Reg. 1448. After inviting and considering comments submitted by interested parties the Commissioner promulgated the following regulation for the 'efficient enforcement' of the Act, § 701(a), 21 U.S.C. § 371(a):
'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 prescription drugs. They challenged the regulations on the ground that the Commissioner exceeded his authority under the statute by promulgating an order requiring labels, advertisements, and other printed matter relating to prescription drugs to designate the established name of the particular drug involved every time its trade name is used anywhere in such material.
The District Court, on cross motions for summary judgment, granted the declaratory and injunctive relief sought, finding that the statute did not sweep so broadly as to permit the Commissioner's 'every time' interpretation. 228 F.Supp. 855. The Court of Appeals for the Third Circuit reversed without reaching the merits of the case. 352 F.2d 286. It held first that under the statutory scheme provided by the Federal Food, Drug, and Cosmetic Act pre-enforcement1 review of these regulations was unauthorized and therefore beyond the jurisdiction of the District Court. Second, the Court of Appeals held that no 'actual case or controversy' existed and, for that reason, that no relief under the Administrative Procedure Act, 5 U.S.C. §§ 701—704 (1964 ed., Supp. II), or under the Declaratory Judgment Act, 28 U.S.C. § 2201, was in any event available. Because of the general importance of the question, and the apparent conflict with the decision of the Court of Appeals for the Second Circuit in Toilet Goods Assn. v. Gardner, 360 F.2d 677, which we also review today, 387 U.S. 158, 87 S.Ct. 1520, 18 L.Ed.2d 697, we granted certiorari. 383 U.S. 924, 86 S.Ct. 928, 15 L.Ed.2d 844.
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 promulgated by the Commissioner. The question is phrased in terms of 'prohibition' rather than 'authorization' because a survey of our cases shows that judicial review of a final agency action by an aggrieved person will not be cut off unless there is persuasive reason to believe that such was the purpose of Congress. Board of Governors v. Agnew, 329 U.S. 441, 67 S.Ct. 411, 91 L.Ed. 408; Heikkila v. Barber, 345 U.S. 229, 73 S.Ct. 603, 97 L.Ed. 972 B rownell v. We Shung, 352 U.S. 180, 77 S.Ct. 252, 1 L.Ed.2d 225; Harmon v. Brucker, 355 U.S. 579, 78 S.Ct. 433, 2 L.Ed.2d 503; Leedom v. Kyne, 358 U.S. 184, 79 S.Ct. 180, 3 L.Ed.2d 210; Rusk v. Cort, 369 U.S. 367, 82 S.Ct. 787, 7 L.Ed.2d 809. Early cases in which this type of judicial review was entertained, e.g., Shields v. Utah Idaho Central R. Co., 305 U.S. 177, 59 S.Ct. 160, 83 L.Ed. 111; Stark v. Wickard, 321 U.S. 288, 64 S.Ct. 559, 88 L.Ed. 733, have been reinforced by the enactment of the Administrative Procedure Act, which embodies the basic presumption of judicial review to one 'suffering legal wrong because of agency action, or adversely affected or aggrieved by agency action within the meaning of a relevant statute,' 5 U.S.C. § 702, so long as no statute precludes such relief or the action is not one committed by law to agency discretion, 5 U.S.C. § 701(a). The Administrative Procedure Act provides specifically not only for review of '(a)gency action made reviewable by statute' but also for review of 'final agency action for which there is no other adequate remedy in a court,' 5 U.S.C. § 704. The legislative material elucidating that seminal act manifests a congressional intention that it cover a broad spectrum of administrative actions,2 and this Court has echoed that theme by noting that the Administrative Procedure Act's 'generous review provisions' must be given a 'hospitable' interpretation. Shaughnessy v. Pedreiro, 349 U.S. 48, 51, 75 S.Ct. 591, 594, 99 L.Ed. 868; see United States v. Interstate Commerce Comm'n, 337 U.S. 426, 433—435, 69 S.Ct. 1410, 1414—1415, 93 L.Ed. 1451; Brownell v. We Shung, supra; Heikkila v. Barber, supra. Again in Rusk v. Cort, supra, 369 U.S. at 379—380, 82 S.Ct. at 794, the Court held that only upon a showing of 'clear and convincing evidence' of a contrary legislative intent should the courts restrict access to judicial review. See also, Jaffe, Judicial Control of Administrative Action 336—359 (1965).
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 specific 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 important to be excluded on such slender and indeterminate evidence of legislative intent.' Jaffe, supra, at 357.
In this case the Government has not demonstrated such a purpose; indeed, a study of the legislative history shows rather conlu sively that the specific review provisions were designed to give an additional remedy and not to cut down more traditional channels of review. At the time the Food, Drug, and Cosmetic Act was under consideration, in the late 1930's, the Administrative Procedure Act had not yet been enacted,4 the Declaratory Judgment Act was in its infancy,5 and the scope of judicial review of administrative decisions under the equity power was unclear.6 It was these factors that led to the form the statute ultimately took. There is no evidence at all that members of Congress meant to preclude traditional avenues of judicial relief. Indeed, throughout the consideration of the various bills submitted to deal with this issue, it was recognized that 'There is always an appropriate remedy in equity in cases where an administrative officer has exceeded his authority and there is no adequate remedy of law, * * * (and that) protection is given by the so-called Declaratory Judgments Act * * *.' H.R.Rep. No. 2755, 74th Cong., 2d Sess., 8. It was specifically brought to the attention of Congress that such methods had in fact been used in the food and drug area,7 and the Department of Justice, in opposing the enactment of the special-review procedures of § 701, submitted a memorandum which was read on the floor of the House stating: 'As a matter of fact, the entire subsection is really unnecessary, because even without any express provision in the bill for court review, any citizen aggrieved by any order of the Secretary, who contends that the order is invalid, may test the legality of the order by bringing an injunction suit against the Secretary, or the head of the Bureau, under the general equity powers of the court.' 83 Cong.Rec. 7892 (1938).
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 provisions 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 hearing 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
A second reason for the special procedure was to provide broader venue to litigants challenging such technca l agency determinations. At that time, a suit against the Secretary was proper only in the District of Columbia, an advantage that the Government sought to preserve. The House bill, however, originally authorized review in any district court, but in the face of a Senate bill allowing review only in the District of Columbia, the Conference Committee reached the compromise preserved in the present statute authorizing review of such agency actions by the courts of appeals.10