This Note will begin with an overview of fentanyl’s role in exacerbating the opioid crisis that has now claimed over a million American lives. It will then offer a partial explanation for why the crisis has gotten worse over the past few years: the Food and Drug Administration’s (“FDA”) refusal to initiate a prescription to over-the-counter (“OTC”) switch of at least one naloxone product. In addition to demonstrating why the FDA’s refusal to initiate an OTC switch has made the crisis worse, this Note will also explore how it highlights administrative law’s failure to provide Americans with meaningful recourse for agency inaction. This Note will then argue that the FDA has the legal authority to unilaterally initiate a prescription-to-OTC switch for at least one naloxone product and that its delay in making this switch emphasizes the urgent need for widespread adoption of supervised consumption sites throughout the United States. Finally, it will explore what is likely the most promising avenue for shielding those who operate supervised consumption sites from federal criminal liability: the addition of a policy rider to an appropriations bill that restricts the DOJ from using its budget to prosecute them. It will explore the obstacles harm reductionists may encounter if they pursue this avenue. However, it will ultimately argue that for those who devote their lives to giving drug users a second shot at life, it represents the most promising path to immunization from federal prosecution.
To read this Note, please click here: A Site to Save a Life.
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