Abbott Laboratories v. Gardner (1966)
- Docket
- 39
- Decided
- 1966-01-01
- Category
- General
Summary
Question: 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? Conclusion: 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.