LOCATION: United States Food and Drug Administration
DOCKET NO.: 39
DECIDED BY: Warren Court (1965-1967)
LOWER COURT: United States Court of Appeals for the Third Circuit
CITATION: 387 US 136 (1967)
ARGUED: Jan 16, 1967
DECIDED: May 22, 1967
Facts of the case
In 1962, Congress amended the Federal Food, Drug, and Cosmetic Act ("FFDCA") to require manufacturers of prescription drugs to print the "established name" of the drug "prominently and in type at least half as large as that used thereon for any proprietary name or designation for such drug," on labels and other printed material. The purpose of this amendment was to alert doctors and patients about identical drugs that sold under separate names at different prices.
The act delegated authority to the Commissioner of Food and Drugs to publish proposed regulations designed to implement the statute. The Commissioner, George P. Larrick, published regulations mandating that drug manufacturers print the established drug name every time its corresponding proprietary name is used.
Abbott Laboratories brought suit against Anthony J. Celebrezze, the Secretary of Health, Education and Welfare and Larrick under the Declaratory Judgment Act ("DJA") and the Administrative Procedure Act ("APA"). Abbott Laboratories argued that the "every time" rule was outside of the scope of the authority given to the commissioner by Congress.
Chief Judge Caleb M. Wright of the district court granted the declaratory and injunctive relief sought by Abbott Labs, finding that the FFDCA did not permit the Commissioner's "every time" interpretation. The U.S. Court of Appeals, Third Circuit, reversed without touching upon the interpretation question. District court Judge Weber, writing for a unanimous court, held that Abbott Labs could not challenge the commissioner's rule under the DJA or APA. Abbott Laboratories and 37 other drug manufacturers appealed the decision.
Did Congress authorize judicial review of the commissioner of the FDA's authority to require Abbott Laboratories to print the established name of a drug every time its proprietary name is used?
Media for Abbott Laboratories v. Gardner
Audio Transcription for Oral Argument - January 16, 1967 in Abbott Laboratories v. Gardner
Number 39, Abbott Laboratories et al., Petitioners versus John W. Gardner, Secretary of Health Education Welfare et al.
Gerhard A. Gessell:
Mr. Chief Justice, May it please the Court.
This case is before the Court on a writ of certiorari from the Third Circuit.
It involves a question of the interpretation of the Federal Food, Drug and Cosmetic Act, the petitioners here plaintiffs below are group of drug companies who were confronted with a mandatory enforcement regulation which they believe was issued beyond the statute and beyond the authority of the Secretary of Health Education and Welfare and the Commissioner of Food and Drugs.
Accordingly, they filed a suit in the District Court at Wilmington under the declaratory judgment of the statute and the Administrative Procedure Act asking for relief from the mandatory enforced with requirements of this particular regulation alleging that they were seriously injured in their business in any way which I will refer to later in some more detail.
They asked for a declaratory judgment, didn't they?
Gerhard A. Gessell:
Declaratory judgment and an injunction Mr. Justice Stewart under the Administrative Procedure Act.
The case was heard on cross motions for summary judgment.
There are no facts in dispute.
It's a pure issue of law as to what this particular section of the statute means.
All administrative proceedings are over.
These petitioners or plaintiffs stand in the posture where they must conform with this regulation which they consider invalid or they must get to redress through this action in the Court or await being sued. If they simply await being sued and undertake to exist that they are paroled, they will be subject to criminal proceedings.
They will be subject to civil proceedings in the way of injunction.
They will be subject to seizure, indeed multiple seizure, of their products.
And they are also subject to what perhaps is the most reprehensible situation of all which undoubtedly some members of the Court would be familiar.
The indirect enforcement power of this agency to deny company's opportunity to put drugs on the market or denied on certifications and in other petty administrative ways prevent companies that wish to challenge this legislation from going about their otherwise lawful and normal business.
Reprehensible, Mr. Gessell?
Gerhard A. Gessell:
I think it's seriously reprehensible Mr. Justice Fortas.
The indirect type of enforcement of that kind puts a company in a position where it is unable to get the type of hearing which our type of society contemplates should be appropriate.
Now, the issue here is I believe quite narrow.
In the District Court, the District Court found that the companies had standing to sue that there was a right to bring an action under the declaratory judgment statute, the Administrative Procedure Act, and the District Judge then proceeded to the merits and held that the plaintiffs were correct with respect to the interpretations of the statute.
When the Government took the matter to the Third Circuit, the Third Circuit did not come to the issue on the merits.
The Third Circuit took the position that the Food and Drug Act did not provide a basis for a suit such as has been brought here and held that the controversy was not right that there was no threatened, haste or controversy and that therefore the action was premature.
And petitioners lost in the Court of Appeals on that ground without the Court of Appeals coming to the merits.
We accordingly are here on a – cert was granted on a procedural question as to the whether or not a case or controversy exists in the face of this allegedly illegal regulation and whether the statute permits if there is a right of controversy as we feel there is, whether the statute permits this particular type of action.
Now, the regulation in issue is designated by the defendants as an enforcement statute.
It is immediately operative and it applies to all prescription drugs and to all companies selling prescription drugs throughout the United States.
It is mandatory in its terms, it is stated in the words of command and it directs compliance.
And the statute is so worded and the regulation is so worded that if a company chooses not to comply, its drugs will be deemed misbranded and accordingly all of the consequences that flow upon a misbranded article under the statute criminal, civil and other types of sanctions apply.