Amicus brief of over 300 reproductive health researchers supports mifepristone's safety and effectiveness.

On January 30, 2024, over 300 researchers filed an amicus brief in FDA v. Alliance for Hippocratic Medicine, a United States (US) Supreme Court case concerning the regulatory status of mifepristone, one of two drugs used in medication abortion. In this Comment we summarize the legal challenge, responses from the FDA and drug manufacturer to these challenges, oral arguments presented before the Court, and the implications of the Court's decision on access to mifepristone in the US. We also summarize the content of the accompanying amicus brief.

Brief of over 300 reproductive health researchers as Amici Curiae in FDA v. Alliance for Hippocratic Medicine.

On January 30, 2024, over 300 researchers filed an amicus brief in FDA v. Alliance for Hippocratic Medicine, a United States (US) Supreme Court case that could have severely impacted access to mifepristone, one of the two drugs commonly used in medication abortion. The researchers summarize the legal challenges to the US Food and Drug Administration's (FDA's) original approval of mifepristone in 2000 and its 2016 and 2021 decisions modifying mifepristone's Risk Evaluation and Mitigation Strategy (REMS) Program and label, the responses from the FDA and drug manufacturer to the challenges, and the potential implications of the Court's decision on access to mifepristone in the US. The researchers detail how the FDA relied on a robust scientific record analyzing tens of thousands of patient experiences that conclusively demonstrated the safety and effectiveness of the changes to the mifepristone REMS Program and label and urge the Supreme Court to rely on the clear scientific record and preserve access to mifepristone without reimposing restrictions. What follows is a reprint of this brief.

Willingness of Pharmacists to Prescribe Medication Abortion in California.

Importance: Nearly half of US states have restricted abortion access. Policy makers are exploring pathways to increase access to abortion and reproductive health care more broadly. Since 2016, California pharmacists could prescribe hormonal birth control, providing an opportunity to learn about the implementation of pharmacist-provided reproductive health care. Objective: To explore the feasibility of broadening pharmacist scope of practice to include prescribing medication abortion. Design, Setting, and Participants: A cross-sectional online survey was conducted from October 11 to December 20, 2022, among a convenience sample of California licensed community pharmacists to examine their attitudes toward, knowledge of, and confidence in prescribing hormonal birth control and reports of pharmacy-level practices. Main Outcomes and Measures: Descriptive analyses and log-binomial regression models were used to compare medication abortion and contraceptive provision attitudes by pharmacist and pharmacy characteristics. Results: Among the 316 pharmacists included in the analysis who worked at community pharmacies across California (mean [SD] age, 40.9 [12.0] years; 169 of 285 [59.3%] cisgender women; and 159 of 272 [58.5%] non-Hispanic Asian individuals), most (193 of 280 [68.9%]) indicated willingness to prescribe medication abortion to pharmacy clients if allowed by law. However, less than half were confident in their knowledge of medication abortion (139 of 288 [48.3%]) or their ability to prescribe it (115 of 285 [40.4%]). Pharmacists who indicated that providing access to hormonal birth control as a prescribing provider was important (263 of 289 [91.0%]) and were confident in their ability to prescribe it (207 of 290 [71.4%]) were 3.96 (95% CI, 1.80-8.73) times and 2.44 (95% CI, 1.56-3.82) times more likely to be willing to prescribe medication abortion and to express confidence in doing so, respectively. Although most pharmacists held favorable attitudes toward hormonal birth control, less than half (144 of 308 [46.8%]) worked in a pharmacy that provided prescriptions for hormonal birth control, and 149 who did not reported barriers such as lack of knowledge or training (65 [43.6%]), insufficient staff or time to add new services (58 [38.9%]), and lack of coverage for services (50 [33.6%]). Conclusions and Relevance: The findings of this cross-sectional survey study of California pharmacists suggest that most pharmacists were willing to prescribe medication abortion. However, future efforts to expand pharmacists' scope of practice should include training to increase knowledge and confidence in prescribing medication abortion. Pharmacy-level barriers to hormonal birth control prescription, such as insurance coverage for pharmacist effort, should also be addressed, as they may serve as barriers to medication abortion access.

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.

Electronic interventions for changing knowledge, attitudes or practices regarding contraception: a systematic review.

OBJECTIVES: We conducted a systematic review of the effectiveness of electronic health education tools designed to improve knowledge, attitudes or practices related to contraception. METHODS: Eligible studies consisted of English-language reports published after 1990 that quantified the effects of an electronic intervention on any of the following outcomes: contraceptive knowledge, attitude toward contraceptives, contraceptive method choice, contraceptive use or pregnancy. We conducted a systematic search of multiple electronic databases including MEDLINE, Global Health, Academic Search Complete, Cochrane Library and Grey Literature Report. We followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines for reporting. RESULTS: Of 143 full-text reports assessed for eligibility, 13 studies described in 16 reports were eligible for inclusion. Of six studies that evaluated video interventions, all were randomized controlled trials, and four reported any statistically significant difference between intervention groups on knowledge, method choice or pregnancy. Of seven studies of interactive computer applications, five were randomized controlled trials, and two were nonrandomized comparison studies. Four of these seven studies found statistically significant difference between study arms in contraceptive knowledge, attitudes or contraceptive use. While most differences favored the intervention, effects were generally limited with respect to clinical relevance and the number of outcomes impacted. CONCLUSIONS: Published assessments of electronic interventions for improving contraception-related outcomes are limited. Formal evaluations of interventions and publication of results are needed to determine the efficacy of electronic tools for contraceptive education and guide development of new interventions.