{"ID":61257,"name":"Abbott Laboratories v. Gardner","href":"https:\/\/api.oyez.org\/cases\/1966\/39","view_count":0,"docket_number":"39","additional_docket_numbers":null,"manner_of_jurisdiction":"Writ of \u003Ci\u003Ecertiorari\u003C\/i\u003E","first_party":"Abbott Laboratories","second_party":"Gardner","timeline":[{"event":"Argued","dates":[-93376800],"href":"https:\/\/api.oyez.org\/case_timeline\/case_timeline\/50229"},{"event":"Decided","dates":[-82494000],"href":"https:\/\/api.oyez.org\/case_timeline\/case_timeline\/50230"}],"lower_court":{"ID":8,"name":"United States Court of Appeals for the Third Circuit","href":"https:\/\/api.oyez.org\/taxonomy\/term\/8"},"facts_of_the_case":"\u003Cp\u003EIn 1962, Congress amended the Federal Food, Drug, and Cosmetic Act (\u0022FFDCA\u0022) to require manufacturers of prescription drugs to print the \u0022established name\u0022 of the drug \u0022prominently and in type at least half as large as that used thereon for any proprietary name or designation for such drug,\u0022 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.\u003C\/p\u003E\n\u003Cp\u003EThe 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.\u003C\/p\u003E\n\u003Cp\u003EAbbott Laboratories brought suit against Anthony J. Celebrezze, the Secretary of Health, Education and Welfare and Larrick under the Declaratory Judgment Act (\u0022DJA\u0022) and the Administrative Procedure Act (\u0022APA\u0022). Abbott Laboratories argued that the \u0022every time\u0022 rule was outside of the scope of the authority given to the commissioner by Congress.\u003C\/p\u003E\n\u003Cp\u003EChief 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\u0027s \u0022every time\u0022 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\u0027s rule under the DJA or APA. Abbott Laboratories and 37 other drug manufacturers appealed the decision.\u003C\/p\u003E\n","question":"\u003Cp\u003EDid Congress authorize judicial review of the commissioner of the FDA\u0027s authority to require Abbott Laboratories to print the established name of a drug every time its proprietary name is used?\u003C\/p\u003E\n","conclusion":"\u003Cp\u003EYes. 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\u0027 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 \u0022every time\u0022 rule. The legislature designed the statute\u0027s specific review provisions to provide additional remedies for parties in Abbott Laboratories\u0027 position, not to cut down traditional channels of review. The Court remanded the case to the court of appeals.\u003C\/p\u003E\n\u003Cp\u003EJustice 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\u0027s ruling would give federal district judges a \u0022roving commission to halt the regulatory process.\u0022 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.\u003C\/p\u003E\n\u003Cp\u003EJustice 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.\u003C\/p\u003E\n\u003Cp\u003EJustice William Brennan took no part in the consideration or decision of the case.\u003C\/p\u003E\n","advocates":[{"advocate":{"ID":25417,"name":"Gerhard A. 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