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Case Basics
Docket No. 
Abbott Laboratories
John W. Gardner, Secretary of Health, Education and Welfare
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?

Decision: 5 votes for Abbott Laboratories, 3 vote(s) against
Legal provision: Federal Food, Drug, and Cosmetic, and related statutes

Yes. Writing for the majority in a 5-3 decision, Justice John Harlan wrote that where the legal issue is fit for judicial resolution and a regulation requires an immediate and significant change in plaintiffs’ conduct with potentially serious penalties, the law permits access to the courts under the APA and the DJA. The Court found that congress did not intend to forbid pre-enforcement review of regulations like the “every time” rule. The legislature designed the statute’s specific review provisions to provide additional remedies for parties in Abbott Laboratories’ position, not to cut down traditional channels of review. The Court remanded the case to the court of appeals.

Justice Abraham Fortas dissented, joined by Chief Justice Earl Warren and Justice Thomas Clark. He wrote that courts have jurisdiction over challenges to administrative action only when there is a specific statutory provision, when the agency acts unconstitutionally, or when it acts without jurisdiction. Justice Fortas feared that the majority’s ruling would give federal district judges a “roving commission to halt the regulatory process.” He reviewed the legislative history of the FFDCA and found that congress had consistently reserved judicial review for specific situations not including the present case.

Justice Clark wrote a separate dissent arguing that the commissioner was right to prevent drug manufacturers from misleading the public about the content of their proprietary drugs.

Justice William Brennan took no part in the consideration or decision of the case.

Cite this Page
ABBOTT LABORATORIES v. GARDNER. The Oyez Project at IIT Chicago-Kent College of Law. 25 August 2015. <>.
ABBOTT LABORATORIES v. GARDNER, The Oyez Project at IIT Chicago-Kent College of Law, (last visited August 25, 2015).
"ABBOTT LABORATORIES v. GARDNER," The Oyez Project at IIT Chicago-Kent College of Law, accessed August 25, 2015,