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Reviewing Refusal: Lethal Injection, the FDA, and the Courts

Most death row inmates today face execution by lethal injection through a series of compounded lethal drugs. Compounded lethal drugs are mixed by individuals at local shops according to their own specifications and are widely regarded to be less safe than manufactured drugs. These drugs receive little government oversight in their production. Although the Food and Drug Administration (FDA) has statutory authority to regulate compounded lethal drugs, it has consistently refused to do so. Non‐regulation of compounded lethal drugs has contributed to a disturbing series of botched executions. Non‐regulation of compounded lethal drugs also poses profound dangers to the public.

The FDA can refuse to regulate these drugs because the law insulates its inaction from judicial review. While courts regularly conduct arbitrary and capricious review of agency enforcement actions, they are far more reluctant to review agency inaction. In fact, the Supreme Court has created a presumption against judicial review of agency inaction.

The presumption against judicial review seems unreasonable when the stakes are so high for death row inmates and the public at large. Although the presumption against judicial review may be a sound principle generally, the FDA’s refusal to regulate compounded lethal drugs is the kind of agency inaction that one might think necessitates at least some judicial scrutiny.

I therefore propose creating a narrow avenue of judicial review for cases like these. My rule, what I will call “discrete look,” identifies opportunities for judicial review that are sensible and manageable for the courts to engage in, while also keeping these avenues sufficiently narrow to respect the underlying policy rationales of the existing doctrine. Under discrete look, when death row inmates sue the FDA for its failure to regulate compounded lethal drugs, courts can no longer treat the FDA’s inaction as an exercise of unreviewable enforcement discretion.