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 Mitigation Strategies (REMS) requirements, are a manifestation of abortion exceptionalism-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 pandemic. In other words, COVID-19 created a context so exceptional as to temporarily outweigh abortion exceptionalism. However, the reprieve did not last-in January 2021, the Supreme Court ruled to dissolve the injunction, allowing FDA to resume enforcement of the in-person requirements. In response, advocates 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.

Access to single-visit IUD insertion at obstetrician-gynecology practices in Ohio: An audit study.

OBJECTIVE: Single-visit intrauterine device (IUD) insertion protocols are recommended. We assessed the availability of single-visit IUD insertions, and whether access to these services varies by age, race or parity. STUDY DESIGN: Using audit study methodology, we called a random sample of 396 obstetrician-gynecology practices in Ohio while posing as a potential client seeking an IUD insertion appointment. Callers used eight standardized scripts and noted justifications for protocols offered by clinic staff. Practices were randomized to follow a balanced 3×2 factorial design, whereby practices were assigned to one of two conditions: (1) age (18 vs. 30 years of age); (2) race (white vs. black); and (3) parity. Multivariable logistic regression was used to control for clinics rural vs. urban location while considering the effects of these variables on service provision. RESULTS: Almost all (95%) of the practices called offered IUD placement, of which 92% required multiple appointments for IUD insertion. Although access to single-visit IUD services did not vary by age or race, we found that parity was associated with clinics' willingness to schedule a single-visit insertion visit (OR = 3.84, 95% CI = 1.23, 12.04). The most frequent justification provided by clinic staff for their multiple-appointment protocol was the need to verify insurance coverage or order the device directly through the patient's insurance company. CONCLUSION: Ohio patients seeking IUD placement must typically make more than one clinic visit. IMPLICATIONS: Efforts are needed to reassure Ohio clinics that IUDs are routinely covered by insurers and to increase access to same-day IUD placement for women in Ohio, as the requirement to attend multiple clinics appointments to obtain a desired contraceptive may pose an insurmountable barrier to care for those with the fewest resources.