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Lethal injection, although currently the preferred method of execution in the United States, causes more botched executions than any other method. Despite recorded instances of extreme pain and suffering, the United States Food and Drug Administration (“FDA”) does not regulate lethal injection drugs for safety and effectiveness because their use occurs “off-label” and thus outside of the purview of the FDA’s regulatory scope. Challengers to the FDA’s lack of regulation have thus far been unsuccessful in the courts due to the deference that the courts give to agency decisions. This Note discusses the ways in which administrative law can be used to bring about the demise of lethal injection. Existing FDA regulations require warning labels when a specific use of a drug causes harm. This Note proposes that concerned parties should file a citizen’s petition under Administrative Procedure Act § 553(e) to compel the FDA to require drug manufacturers to update the labels to warn of the harms of using the drugs for execution. These warning labels can then be used to support Eighth Amendment challenges to the constitutionality of lethal injection.


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6 Sep 2022
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  • Subject
    • Administrative Law

    • Food and Drug Law

    • Law Enforcement and Corrections

  • Journal title
    • Boston College Law Review

  • Volume
    • 59

  • Issue
    • 1

  • Pagination
    • 355

  • Date submitted

    6 September 2022