Abbott Laboratories v. Gardner (1967)

8/13/2019 Abbott Laboratories v. Gardner (1967)

1/21

Supreme Court of the United StatesABBOTT LABORATORIES et al., Petitioners,

v.John W. GARDNER, Secretary of Health, Education, and Welfare et al.

No. 39.Argued Jan. 16, 1967.

Decided May 22, 1967.

Action by drug companies and their association against Secretary of Health, Education,and Welfare and Commissioner of Food and Drugs. Appeals were taken from a declaratoryjudgment and injunction granted in the United States District Court for the District of

Delaware,228 F.Supp. 855,which held that regulations issued and promulgated by defendantswere null and void. The United States Court of Appeals for the Third Circuit, 352 F.2d 286,reversed, and certiorari was granted. The Supreme Court, Mr. Justice Harlan, held, inter alia,that issues were fit for judicial resolution and hardship from precluding court consideration toplaintiffs, which were nearly all of prescription drug manufacturers, was demonstrated,warranting entertainment of action for pre-enforcement injunctive and declaratory judgmentremedies concerning statutory construction of Commissioner of Food and Drugs by way ofregulations requiring labels, advertisements, and other printed matter relating to prescriptiondrugs to designate the established name of the particular drug involved every time its tradename is used anywhere in such material.

Reversed and remanded.

Mr. Justice Fortas, Mr. Justice Clark and Mr. Chief Justice Warren, dissented. Forconcurring and dissenting opinions see87 S.Ct. 1530,87 S.Ct. 1544.

West Headnotes

[1]Health 198H 312

198HHealth198HIRegulation in General

198HI(E)Drugs; Medical Devices and Instruments198Hk309Labeling Requirements

198Hk312k. Requisites and adequacy of labeling.Most Cited Cases(Formerly 138k8 Drugs and Narcotics)Underlying purpose of 1962 amendment of Federal Food, Drug, and Cosmetic Act

requiring manufacturers of prescription drugs to print established name of drug prominentlyand in type at least half as large as that used thereon for any proprietary name or designationof such drug on labels and other printed material was to bring to attention of doctors andpatients fact that many of drugs sold under familiar trade names are actually identical to drugs

87 S.Ct. 1507 FOR EDUCATIONAL USE ONLY Page 1387 U.S. 136, 87 S.Ct. 1507, 18 L.Ed.2d 681(Cite as: 387 U.S. 136, 87 S.Ct. 1507)

2014 Thomson Reuters. No Claim to Orig. US Gov. Works.
http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=345&FindType=Y&SerialNum=1964100007http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=350&FindType=Y&SerialNum=1965100003http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=708&FindType=Y&SerialNum=1967213092http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=708&FindType=Y&SerialNum=1967213093http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198Hhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198HIhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198HI%28E%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198HI%28E%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198Hk309http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198Hk312http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=198Hk312http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=198Hk312http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198Hk312http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198Hk309http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198HI%28E%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198HIhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198Hhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=708&FindType=Y&SerialNum=1967213093http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=708&FindType=Y&SerialNum=1967213092http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=350&FindType=Y&SerialNum=1965100003http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=345&FindType=Y&SerialNum=1964100007


2/21

sold under their established or less familiar trade names at significantly lower prices. FederalFood, Drug, and Cosmetic Act, 1 et seq., 502(e) (1) (B), (2) as amended 21 U.S.C.A. 301 etseq.,352(e)(1) (B), (2).

[2]Administrative Law and Procedure 15A 668

15AAdministrative Law and Procedure15AVJudicial Review of Administrative Decisions

15AV(A)In General15Ak665Right of Review

15Ak668k. Persons aggrieved or affected.Most Cited CasesJudicial 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 purpose of Congress. 5 U.S.C.A. 701704,702.


15AAdministrative Law and Procedure15AIIn General

15Ak4Constitutional and Statutory Provisions in General15Ak5k. Agencies and proceedings affected.Most Cited Cases

Congress intended that Administrative Procedure Act cover a broad spectrum ofadministrative actions.5 U.S.C.A. 701(a),704,701704,702.



15AV(A)In General15Ak651k. In general.Most Cited Cases

The Administrative Procedure Act's generous review provisions must be given ahospitable interpretation.5 U.S.C.A. 701(a),704,701704,702.



15AV(A)In General15Ak651k. In general.Most Cited Cases

Only upon a showing of clear and convincing evidence of a contrary legislative intent

should the courts restrict access to judicial review of administrative action. 5 U.S.C.A. 701(a),704,701704,702.




http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=21USCAS301&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=21USCAS301&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=21USCAS352&FindType=L&ReferencePositionType=T&ReferencePosition=SP_7fdd00001ca15http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=21USCAS352&FindType=L&ReferencePositionType=T&ReferencePosition=SP_7fdd00001ca15http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ahttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AVhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AV%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AV%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ak665http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ak668http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=15Ak668http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS702&FindType=Lhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ahttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AIhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ak4http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ak5http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=15Ak5http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=L&ReferencePositionType=T&ReferencePosition=SP_8b3b0000958a4http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS702&FindType=Lhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ahttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AVhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AV%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AV%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ak651http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=15Ak651http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=L&ReferencePositionType=T&ReferencePosition=SP_8b3b0000958a4http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS702&FindType=Lhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ahttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AVhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AV%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AV%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ak651http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=15Ak651http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=L&ReferencePositionType=T&ReferencePosition=SP_8b3b0000958a4http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=L&ReferencePositionType=T&ReferencePosition=SP_8b3b0000958a4http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS702&FindType=Lhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ahttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AVhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AVhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ahttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS702&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=L&ReferencePositionType=T&ReferencePosition=SP_8b3b0000958a4http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=L&ReferencePositionType=T&ReferencePosition=SP_8b3b0000958a4http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=15Ak651http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ak651http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AV%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AVhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ahttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS702&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=L&ReferencePositionType=T&ReferencePosition=SP_8b3b0000958a4http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=15Ak651http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ak651http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AV%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AVhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ahttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS702&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=L&ReferencePositionType=T&ReferencePosition=SP_8b3b0000958a4http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=15Ak5http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ak5http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ak4http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AIhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ahttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS702&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=Lhttp://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=15Ak668http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ak668http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ak665http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AV%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AVhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ahttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=21USCAS352&FindType=L&ReferencePositionType=T&ReferencePosition=SP_7fdd00001ca15http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=21USCAS301&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=21USCAS301&FindType=L


3/21


4/21

118AIISubjects of Declaratory Relief118AII(K)PublicOfficers and Agencies

118Ak203k. Federal officers and boards.Most Cited Cases

Health 198H 323


198HI(E)Drugs; Medical Devices and Instruments198Hk323k. Judicial review or intervention.Most Cited Cases

(Formerly 138k10, 138k8, 138k2, 138k2 Drugs and Narcotics)Congress by the Federal Food, Drug, and Cosmetic Act did not intend to forbid pre-

enforcement review, under Declaratory Judgment Act and Administrative Procedure Act, offinal agency action consisting of a promulgated regulation of Commissioner of Food andDrugs requiring labels, advertisements, and other printed matter relating to prescription drugsto designate the established name of the particular drug involved every time its trade name isused anywhere in such material. Federal Food, Drug, and Cosmetic Act, 1 et seq., 502(e)(1) (B), (2),701(e, f) and (6), as amended21 U.S.C.A. 301 et seq.,352(e)(1)(B), (2), 371(e, f) and (6).

[10]Declaratory Judgment 118A 5.1

118ADeclaratory Judgment118AINature and Grounds in General

118AI(A)In General118Ak5Discretion of Court

118Ak5.1k. In general.Most Cited Cases(Formerly 118Ak5)

Declaratory Judgment 118A 201

118ADeclaratory Judgment118AIISubjects of Declaratory Relief

118AII(K)PublicOfficers and Agencies118Ak201k. Officers and official acts in general. Most Cited Cases

Injunction 212 1009

212Injunction212IInjunctions in General; Permanent Injunctions in General

212I(A)Nature, Form, and Scope of Remedy212k1008Discretionary Nature of Remedy

212k1009k. In general.Most Cited Cases(Formerly 212k1)

Injunction 212 1181


http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AIIhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AII%28K%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AII%28K%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ak203http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=118Ak203http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198Hhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198HIhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198HI%28E%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198HI%28E%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198Hk323http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=198Hk323http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS502&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS502&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=21USCAS301&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=21USCAS352&FindType=L&ReferencePositionType=T&ReferencePosition=SP_7fdd00001ca15http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=21USCAS352&FindType=L&ReferencePositionType=T&ReferencePosition=SP_7fdd00001ca15http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=21USCAS371&FindType=Lhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ahttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AIhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AI%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AI%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ak5http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ak5.1http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=118Ak5.1http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ahttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AIIhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AII%28K%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AII%28K%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ak201http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=118Ak201http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212Ihttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212I%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212I%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212k1008http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212k1009http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=212k1009http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=212k1009http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212k1009http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212k1008http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212I%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212Ihttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=118Ak201http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ak201http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AII%28K%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AIIhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ahttp://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=118Ak5.1http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ak5.1http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ak5http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AI%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AIhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ahttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=21USCAS371&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=21USCAS352&FindType=L&ReferencePositionType=T&ReferencePosition=SP_7fdd00001ca15http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=21USCAS301&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS502&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS502&FindType=Lhttp://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=198Hk323http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198Hk323http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198HI%28E%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198HIhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198Hhttp://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=118Ak203http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ak203http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AII%28K%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AII


5/21

212Injunction212IVParticular Subjects of Relief

212IV(B)Administrative Agencies and Proceedings212k1181k. In general.Most Cited Cases

(Formerly 212k74)Injunctive and declaratory remedies are discretionary, and courts are reluctant to apply

them to administrative determinations unless these arise in context of a controversy ripe forjudicial resolution. 5 U.S.C.A. 701704.

[11]Declaratory Judgment 118A 201


118AII(K)PublicOfficers and Agencies118Ak201k. Officers and official acts in general. Most Cited Cases

Injunction 212 1185


212IV(B)Administrative Agencies and Proceedings212k1185k. Judicial review.Most Cited Cases

(Formerly 212k74)Basic rationale of ripeness doctrine arising out of courts' reluctance to apply declaratory

judgment and injunctive remedies unless administrative determinations arise in context of acontroversy ripe for judicial resolution, is to prevent courts, through avoidance of prematureadjudication, from entangling themselves in abstract disagreements over administrativepolicies, and also to protect the agencies from judicial interference until an administrativedecision has been formalized and its effects felt in a concrete way by the challenging parties,and court is required to evaluate both fitness of issues for judicial decision and hardship toparties of withholding court consideration.5 U.S.C.A. 701704.



15AV(B)Decisions and Acts Reviewable15Ak704k. Finality; ripeness.Most Cited Cases

Health 198H 323



(Formerly 138k8, 138k10, 138k2 Drugs and Narcotics)Regulations of Commissioner of Food and Drugs requiring labels, advertisements, and


http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212IVhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212IV%28B%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212IV%28B%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212k1181http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=212k1181http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ahttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AIIhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AII%28K%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AII%28K%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ak201http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=118Ak201http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212IVhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212IV%28B%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212IV%28B%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212k1185http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=212k1185http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ahttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AVhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AV%28B%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AV%28B%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ak704http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=15Ak704http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198Hhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198HIhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198HI%28E%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198HI%28E%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198Hk323http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=198Hk323http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=198Hk323http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198Hk323http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198HI%28E%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198HIhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198Hhttp://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=15Ak704http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ak704http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AV%28B%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AVhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ahttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=Lhttp://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=212k1185http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212k1185http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212IV%28B%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212IVhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=118Ak201http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ak201http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AII%28K%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AIIhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ahttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=Lhttp://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=212k1181http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212k1181http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212IV%28B%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212IVhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212


6/21

other printed matter relating to prescription drugs to designate the established name of theparticular drug involved every time its trade name is used anywhere in such material wasfinal Agency action within Administrative Procedure Act. 5 U.S.C.A. 704.



15AV(B)Decisions and Acts Reviewable15Ak701k. In general.Most Cited Cases



118AII(K)PublicOfficers and Agencies

118Ak201k. Officers and official acts in general. Most Cited CasesWhere legal issue presented is fit for judicial resolution, and where a regulation requires

an immediate and significant change in plaintiffs' conduct of their affairs with seriouspenalties attached to noncompliance, access to courts under Administrative Procedure Act andDeclaratory Judgment Act must be permitted, absent a statutory bar or other unusualcircumstances. 5 U.S.C.A. 701704;28 U.S.C.A. 2201.



15AV(A)In General

15Ak665Right of Review15Ak666k. Interest ingeneral.Most Cited Cases

A possible financial loss is not by itself a sufficient interest to sustain a judicial challengeto governmental action.5 U.S.C.A. 701704.



118AI(C)OtherRemedies118Ak45k. Pendency of other action.Most Cited Cases

Injunction 212 1051212Injunction

212IInjunctions in General; Permanent Injunctions in General212I(B)Factors Considered in General

212k1050Availability and Adequacy of Other Remedies212k1051k. In general.Most Cited Cases


http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ahttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AVhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AV%28B%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AV%28B%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ak701http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=15Ak701http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ahttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AIIhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AII%28K%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AII%28K%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ak201http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=118Ak201http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=28USCAS2201&FindType=Lhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ahttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AVhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AV%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AV%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ak665http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ak666http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=15Ak666http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ahttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AIhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AI%28C%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AI%28C%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ak45http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=118Ak45http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212Ihttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212I%28B%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212I%28B%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212k1050http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212k1051http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=212k1051http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=212k1051http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212k1051http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212k1050http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212I%28B%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212Ihttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=118Ak45http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ak45http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AI%28C%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AIhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ahttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=Lhttp://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=15Ak666http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ak666http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ak665http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AV%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AVhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ahttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=28USCAS2201&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=Lhttp://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=118Ak201http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ak201http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AII%28K%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AIIhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ahttp://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=15Ak701http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ak701http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AV%28B%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AVhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ahttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=L


7/21

(Formerly 212k21)A court may even in its discretion dismiss a declaratory judgment or injunctive suit if the

same issue is pending in litigation elsewhere.



118AI(A)In General118Ak9k. Defenses and objections in general.Most Cited Cases


118ADeclaratory Judgment118AIIIProceedings

118AIII(A)In General

118Ak252Nature and Form118Ak253k. Legal or equitable.Most Cited Cases



118AIII(A)In General118Ak255k. Limitations and laches.Most Cited Cases

Injunction 212 1004

212Injunction212IInjunctions in General; Permanent Injunctions in General

212I(A)Nature, Form, and Scope of Remedy212k1004k. Equitable nature of remedy.Most Cited Cases

(Formerly 212k106)

Injunction 212 1169


212IV(A)Courts and Actions in General212k1168Abusive, Vexatious, or Harassing Litigation

212k1169k. In general.Most Cited Cases(Formerly 212k24)

Injunction 212 1514

212Injunction212VActions and Proceedings

212V(A)In General


http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ahttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AIhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AI%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AI%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ak9http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=118Ak9http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ahttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AIIIhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AIII%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AIII%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ak252http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ak253http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=118Ak253http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ahttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AIIIhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AIII%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AIII%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ak255http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=118Ak255http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212Ihttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212I%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212I%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212k1004http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=212k1004http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212IVhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212IV%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212IV%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212k1168http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212k1169http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=212k1169http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212Vhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212V%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212V%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212V%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212Vhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=212k1169http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212k1169http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212k1168http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212IV%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212IVhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=212k1004http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212k1004http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212I%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212Ihttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=118Ak255http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ak255http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AIII%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AIIIhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ahttp://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=118Ak253http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ak253http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ak252http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AIII%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AIIIhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ahttp://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=118Ak9http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ak9http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AI%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AIhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118A


8/21

212k1511Time for Proceedings212k1514k. Laches.Most Cited Cases

(Formerly 212k113)The declaratory judgment and injunctive remedies are equitable in nature, and other

equitable defenses may be interposed, and, if a multiplicity of suits are undertaken in order toharass the government or to delay enforcement of regulations, relief can be denied on thisground alone, and defense of laches could be asserted if government is prejudiced by a delay.5 U.S.C.A. 701704.

[17]Declaratory Judgment 118A 293.1


118AIII(C)Parties118Ak293Necessary and Indispensable Parties

118Ak293.1k. In general.Most Cited Cases(Formerly 118Ak293)Courts may even refuse declaratory relief for the nonjoinder of interested parties who are

not, technically speaking, indispensible.5 U.S.C.A. 701704.



118AII(K)PublicOfficers and Agencies118Ak203k. Federal officers and boards.Most Cited Cases

Injunction 212 1366


212IV(L)Tradeor Business212k1366k. Sales and marketing in general. Most Cited Cases

(Formerly 212k85(1))

Injunction 212 1491


212IV(T)OtherParticular Matters

212k1491k. In general.Most Cited Cases(Formerly 212k85(1))Issues were fit for judicial resolution and hardship from precluding court consideration to

plaintiffs, which were nearly all of prescription drug manufacturers, was demonstrated,warranting entertainment of action for pre-enforcement injunctive and declaratory judgmentremedies concerning statutory construction of Commissioner of Food and Drugs by way ofregulations requiring labels, advertisements, and other printed matter relating to prescription


http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212k1511http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212k1514http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=212k1514http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ahttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AIIIhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AIII%28C%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AIII%28C%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ak293http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ak293.1http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=118Ak293.1http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ahttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AIIhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AII%28K%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AII%28K%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ak203http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=118Ak203http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212IVhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212IV%28L%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212IV%28L%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212k1366http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=212k1366http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212IVhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212IV%28T%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212IV%28T%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212k1491http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=212k1491http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=212k1491http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212k1491http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212IV%28T%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212IVhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=212k1366http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212k1366http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212IV%28L%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212IVhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=118Ak203http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ak203http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AII%28K%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AIIhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ahttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=Lhttp://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=118Ak293.1http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ak293.1http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ak293http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AIII%28C%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118AIIIhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=118Ahttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=Lhttp://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=212k1514http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212k1514http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=212k1511


9/21

drugs to designate the established name of the particular drug involved every time its tradename is used anywhere in such material. Federal Food, Drug, and Cosmetic Act, 1 et seq.,502(e) (1) (B), (2)as amended21 U.S.C.A. 301 et seq.,352(e)(1)(B), (2);5 U.S.C.A. 701704,702.



15AV(A)In General15Ak674k. Supersedeas or stay.Most Cited Cases

Health 198H 323



(Formerly 138k10, 138k2 Drugs and Narcotics)Action for pre-enforcement injunctive and declaratory judgment remedies concerning

statutory construction of Commissioner of Food and Drugs by way of regulations would notby itself stay the effectiveness of the challenged regulation.5 U.S.C.A. 705.

[20]Federal Courts 170B 462

170BFederal Courts170BVIISupreme Court

170BVII(B)Review of Decisions of Courts of Appeals

170Bk462k. Determination and disposition of cause.Most Cited Cases(Formerly 30k1177(6))Although government pressed Supreme Court to reach merits of challenge to regulation of

Commissioner of Food and Drugs, in event it found that District Court had properlyentertained action, better practice required remand to Court of Appeals, which had reversedwithout considering merits, to review District Court's decision that regulation was beyondpower of Commissioner. Federal Food, Drug, and Cosmetic Act, 1 et seq., 502(e) (1) (B),(2)as amended21 U.S.C.A. 301 et seq.,352(e)(1) (B), (2).

**1509 *137Gerhard A. Gesell, Washington, D.C., for petitioners.

Nathan Lewin, Washington, D.C., for respondents.

Mr. Justice HARLAN delivered the opinion of the Court.[1]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. s 301 et seq.), torequire manufacturers of prescription drugs to print the established name of the drugprominently *138 and in type at least half as large as that used thereon for any proprietary


http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS502&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=21USCAS301&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=21USCAS352&FindType=L&ReferencePositionType=T&ReferencePosition=SP_7fdd00001ca15http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=21USCAS352&FindType=L&ReferencePositionType=T&ReferencePosition=SP_7fdd00001ca15http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS702&FindType=Lhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ahttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AVhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AV%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AV%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ak674http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=15Ak674http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198Hhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198HIhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198HI%28E%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198HI%28E%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198Hk323http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=198Hk323http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS705&FindType=Lhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=170Bhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=170BVIIhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=170BVII%28B%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=170BVII%28B%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=170Bk462http://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=170Bk462http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS502&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS502&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=21USCAS301&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=21USCAS352&FindType=L&ReferencePositionType=T&ReferencePosition=SP_7fdd00001ca15http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=21USCAS352&FindType=L&ReferencePositionType=T&ReferencePosition=SP_7fdd00001ca15http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=21USCAS301&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=21USCAS301&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=21USCAS352&FindType=L&ReferencePositionType=T&ReferencePosition=SP_7fdd00001ca15http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=21USCAS301&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS502&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS502&FindType=Lhttp://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=170Bk462http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=170Bk462http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=170BVII%28B%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=170BVIIhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=170Bhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS705&FindType=Lhttp://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=198Hk323http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198Hk323http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198HI%28E%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198HIhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=198Hhttp://international.westlaw.com/Digest/Default.wl?rs=WLIN1.0&vr=2.0&CMD=MCC&DocName=15Ak674http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ak674http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AV%28A%29http://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15AVhttp://international.westlaw.com/KeyNumber/Default.wl?rs=WLIN1.0&vr=2.0&CMD=KEY&DocName=15Ahttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS702&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=21USCAS352&FindType=L&ReferencePositionType=T&ReferencePosition=SP_7fdd00001ca15http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=21USCAS301&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS502&FindType=L


10/21

name or designation for such **1510 drug, on labels and other printed material, s502(e)(1)(B), 21 U.S.C. s 352(e)(1)(B). The established name is one designated by theSecretary of Health, Education, and Welfare pursuant to s 502(e)(2) of the Act, 21 U.S.C. s352(e)(2); the proprietary name is usually a trade name under which a particular drug ismarketed. The underlying purpose of the 1962 amendment was to bring to the attention ofdoctors and patients the fact that many of the drugs sold under familiar trade names areactually identical to drugs sold under their established or less familiar trade names atsignificantly lower prices. The Commissioner of Food and Drugs, exercising authoritydelegated to him by the Secretary, 22 Fed.Reg. 1051, 25 Fed.Reg. 8625, published proposedregulations designed to implement the statute, 28 Fed.Reg. 1448. After inviting andconsidering comments submitted by interested parties the Commissioner promulgated thefollowing regulation for the efficient enforcement of the Act, s 701(a),21 U.S.C. s 371(a):

If the label or labeling of a prescription drug bears a proprietary name or designation forthe 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 proprietaryname or designation. 21 CFR s 1.104(g)(1).

A similar rule was made applicable to advertisements for prescription drugs, 21 CFR s1.105(b)(1).

The present action was brought by a group of 37 individual drug manufacturers and by thePharmaceutical Manufacturers Association, of which all the petitioner companies aremembers, and which includes manufacturers of more than 90% of the Nation's supply ofprescription*139 drugs. They challenged the regulations on the ground that the Commissionerexceeded 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 insuch material.

The District Court, on cross motions for summary judgment, granted the declaratory andinjunctive relief sought, finding that the statute did not sweep so broadly as to permit theCommissioner's every time interpretation. 228 F.Supp. 855. The Court of Appeals for theThird Circuit reversed without reaching the merits of the case. 352 F.2d 286.It held first thatunder the statutory scheme provided by the Federal Food, Drug, and Cosmetic Act pre-enforcementFN1 review of these regulations was unauthorized and therefore beyond thejurisdiction of the District Court. Second, the Court of Appeals held that no actual case orcontroversy existed and, for that reason, that no relief under the Administrative ProcedureAct, 5 U.S.C. ss 701 704 (1964 ed., Supp. II), or under the Declaratory Judgment Act, 28

U.S.C. s 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 inToilet Goods Assn. v. Gardner, 360 F.2d 677,which we also review today, 387 U.S. 158, 87S.Ct. 1520, 18 L.Ed.2d 697,we granted certiorari. 383 U.S. 924, 86 S.Ct. 928, 15 L.Ed.2d 844.

FN1.That is, a suit brought by one before any attempted enforcement of the statute or


http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS502&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS502&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=21USCAS352&FindType=L&ReferencePositionType=T&ReferencePosition=SP_f570000012452http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS502&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=21USCAS352&FindType=L&ReferencePositionType=T&ReferencePosition=SP_1184000067914http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=21USCAS352&FindType=L&ReferencePositionType=T&ReferencePosition=SP_1184000067914http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1037&DocName=25FR8625&FindType=Yhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1037&FindType=Y&SerialNum=0306940122http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=L&ReferencePositionType=T&ReferencePosition=SP_8b3b0000958a4http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=21USCAS371&FindType=L&ReferencePositionType=T&ReferencePosition=SP_8b3b0000958a4http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=345&FindType=Y&SerialNum=1964100007http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=350&FindType=Y&SerialNum=1965100003http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=28USCAS2201&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=28USCAS2201&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=350&FindType=Y&SerialNum=1966121109http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=708&FindType=Y&SerialNum=1967106042http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=708&FindType=Y&SerialNum=1967106042http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=708&FindType=Y&SerialNum=1966204057http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=708&FindType=Y&SerialNum=1966204057http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=708&FindType=Y&SerialNum=1967106042http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=708&FindType=Y&SerialNum=1967106042http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=350&FindType=Y&SerialNum=1966121109http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=28USCAS2201&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=28USCAS2201&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS704&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=350&FindType=Y&SerialNum=1965100003http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=345&FindType=Y&SerialNum=1964100007http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=21USCAS371&FindType=L&ReferencePositionType=T&ReferencePosition=SP_8b3b0000958a4http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS701&FindType=L&ReferencePositionType=T&ReferencePosition=SP_8b3b0000958a4http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1037&FindType=Y&SerialNum=0306940122http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1037&DocName=25FR8625&FindType=Yhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=21USCAS352&FindType=L&ReferencePositionType=T&ReferencePosition=SP_1184000067914http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=21USCAS352&FindType=L&ReferencePositionType=T&ReferencePosition=SP_1184000067914http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS502&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=21USCAS352&FindType=L&ReferencePositionType=T&ReferencePosition=SP_f570000012452http://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS502&FindType=Lhttp://international.westlaw.com/Find/Default.wl?rs=WLIN1.0&vr=2.0&DB=1000546&DocName=5USCAS502&FindType=L


11/21

regulation against him.

I.[2][3][4][5] 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*140 promulgated by the Commissioner. The question is phrased in terms of prohibitionrather than authorization**1511 because a survey of our cases shows that judicial review ofa final agency action by an aggrieved person will not be cut off unless there is persuasivereason to believe that such was the purpose of Congress. Board of Governors v. Agnew, 329U.S. 441, 67 S.Ct. 411, 91 L.Ed. 408; Heikkila v. Barber, 345 U.S. 229, 73 S.Ct. 603, 97L.Ed. 972; Brownell 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 inwhich 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, whichembodies the basic presumption of judicial review to one suffering legal wrong because ofagency action, or adversely affected or aggrieved by agency action within the meaning of arelevant statute,5 U.S.C. s 702, so long as no statute precludes such relief or the action is notone committed by law to agency discretion, 5 U.S.C. s 701(a). The Administrative ProcedureAct provides specifically not only for review of (a)gency action made reviewable by statutebut also for review of final agency action for which there is no other adequate remedy in acourt, 5 U.S.C. s 704. The legislative material elucidating that seminal act manifests acongressional intention that it cover a broad spectrum of administrative actions,FN2 and thisCourt has echoed that theme by noting that the Administrative*141 Procedure Act's generousreview provisions' must be given a hospitable interpretation. Shaughnessy v. Pedreiro, 349U.S. 48, 51, 75 S.Ct. 591, 594, 99 L.Ed. 868; see United States v. Interstate Commerce

Comm'n, 337 U.S. 426, 433435, 69 S.Ct. 1410, 14141415, 93 L.Ed. 1451; Brownell v.We Shung, supra; Heikkila v. Barber, supra. Again in Rusk v. Cort, supra, 369 U.S. at379380, 82 S.Ct. at 794,the Court held that only upon a showing of clear and convincingevidence of a contrary legislative intent should the courts restrict access to judicial review.See also, Jaffe, Judicial Control of Administrative Action 336359 (1965).

FN2. See H.R.Rep. No. 1980, 79th Cong., 2d Sess., 41 (1946), U.S.Code Cong.Serv.1946, p. 1195: To preclude judicial review under this bill a statute, if not specific inwithholding such review, must upon its face give clear and convincing evidence of aninten

Documents

Abbott Laboratories v. Gardner (1967)