Abortion exceptionalism and the mifepristone REMS

Since its initial approval, mifepristone has been regulated with a strictness out of proportion to its risks. This paper explores how the regulation of mifepristone, specifically the Risk Evaluation and Mit-igation Strategies (REMS) requirements, are a manifestation of abortion exceptionalism & mdash;the phenomenon of abortion being treated differently under the law than other comparable health care. The weight of medical and public health evidence demonstrates that mifepristone is extremely safe and the REMS are unnecessary. In fact, the mifepristone REMS is neither justified by the absolute risk of the medication itself, nor comprehensible as a logical response to the risks actually posed by mifepristone. Nevertheless, the REMS remain in place. From July 2020 through January 2021, enforcement of the REMS elements requiring in-person distribution of mifepristone were enjoined by court order due the COVID-19 pan-demic. In other words, COVID-19 created a context so exceptional as to temporarily outweigh abortion exceptionalism. However, the reprieve did not last & mdash;in January 2021, the Supreme Court ruled to dissolve the injunction, allowing FDA to resume enforcement of the in-person requirements. In response, advo-cates called on the incoming Biden administration to direct FDA to suspend enforcement once more. This regulatory whiplash is itself further evidence that the REMS flow from political, rather than scientific, concerns. Abortion exceptionalism is apparent in the specific requirements of the REMS, and it is also apparent in the precarity of the regulatory scheme itself. (c) 2021 Elsevier Inc. All rights reserved.

Automated summary

This paper explores the excessive regulation of mifepristone and how REMS requirements manifest abortion exceptionalism. It also highlights the unnecessary nature of the mifepristone REMS and the influence of political concerns on regulatory decisions.