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Abbott Laboratories v. Celebrezze

decided: November 1, 1965.


Hastie and Freedman, Circuit Judges, and Weber, District Judge.

Author: Weber

WEBER, District Judge.

This is an appeal from a declaratory judgment and injunction granted to plaintiffs in the District Court which holds that regulations issued and promulgated by defendants, the Secretary of Health, Education and Welfare, and the Commissioner of Food and Drugs are null and void and not authorized by the statute on which they are based. The injunction restrains the defendants and all parties acting under them from enforcing or attempting to enforce the regulations.

The statute involved is popularly known as the "Drug Amendments of 1962", which added the provisions in question to the Federal Food, Drug and Cosmetic Act, as amended. 21 U.S.C. § 301 et seq. (The Act).

§ 502(e) (1) (B) of the Act, 21 U.S.C. § 352(e) (1) (B) provided that the labeling of a prescription drug shall be considered "misbranded" unless the established or generic name of the drug is printed prominently on the label in type half as large as any brand or proprietary name. § 502(n) of the Act contains a similar requirement for advertising matter concerning the drug. Penalties are provided for "misbranding."

The generic name or the established name of a drug is its chemical name, a common name, or an official name used in an official compendium. The proprietary name is the name given by the manufacturer to designate its source of manufacture and to differentiate its product from the same or chemically similar drugs from other manufacturers.

§ 502(e) (1) (B), 21 U.S.C. § 352(e) (1) (B) contains a provision that to the extent that compliance with the requirements is impracticable, exceptions shall be established by regulations promulgated by the Secretary.

§ 701(a), 21 U.S.C. § 371(a) grants the authority to the Secretary to promulgate regulations for the efficient enforcement of the Act, except as otherwise provided in that section.

§ 701(e) (1) of the Act provides the procedure to be employed for the issuance, amendment, or repeal of any regulations under specific sections of the Act, including the filing and disposition of objections thereto by full hearing, the issuance of final orders thereon by the Secretary, and the provision for appeal thereon to the Circuit Court of Appeals. The sections of the Act in question here were not covered by the hearing appeal process recited above.

Pursuant to the authority to promulgate regulations, the Commissioner, as the delegate of the Secretary, issued the regulations in question here, which provided that under the provisions of § 502 (e) (1) (B), (the labeling requirement), and § 502(n), (the advertising requirement) of the Act, each time the trade name is used on labels or labeling, or in advertisements of prescription drugs, the established name shall also be used prominently and in type half as large. (21 C.F.R. 1.104(g) (1) and 1.105(b) (1); 28 Fed.Reg. 6375 and 6376). These regulations were adopted in accordance with the procedure provided by § 4 of the Administrative Procedure Act, 5 U.S.C. § 1003, after publication of notice of intent, and the submission of comments and objections by interested parties.

Plaintiffs brought this action in the District Court praying for declaratory judgment and injunctive relief. They rely on the existence of a Federal question, 28 U.S.C. § 1331, the Declaratory Judgment Act, 28 U.S.C. § 2201, and § 10 of the Administrative Procedure Act, 5 U.S.C. § 1009 for jurisdiction. They contend that the each time requirements of the regulations are invalid as beyond the requirements of the Act.

The District Court found it unnecessary to rule whether § 10 of the Administrative Procedure Act provided a basis for review of the regulations. It took cognizance of the case under the Declaratory Judgment Act on the grounds that the regulations placed plaintiffs in a position of peril and imminent danger, and that the regulations in question were ripe for review. It not only declared the regulations void because the statute would not bear the interpretation placed upon it, but also issued a sweeping injunction against the enforcement thereof.

Questions of venue of the District Court for all of the many plaintiffs, the standing of a trade association as a party, the inclusion of the Attorney General as a necessary party, and the status of the case as an unconsented suit against the United States were disposed of by the Court, and by reason of the conclusions reached herein, will not be discussed.

The basic question on appeal here is one of justiciability. May the district court review, under the Declaratory Judgment Act, an interpretive regulation of the Commission issued under authority of the statute, where Congress has not provided for judicial review of the sections in question? Furthermore, was such review within the statutory scheme of regulation imposed by Congress when it specifically provided for judicial review of other regulations authorized under certain specific sections of the Act, as set forth in § 10(e) (1), 21 U.S.C. § 371? We believe that the answer would be the same under the ...

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