The mifepristone REMS: A needless and unlawful barrier to care✰.

Mifepristone (brand name Mifeprex) is a prescription drug that has been safely used in the United States for twenty years to end early pregnancies and, more recently, to treat early miscarriages. Although the U.S. Food and Drug Administration (FDA) acknowledges that mifepristone's safety and efficacy are "well-established by both research and experience" [1], it imposes a Risk Evaluation and Mitigation Strategy ("REMS") that severely restricts where, how, and from whom this medication can be obtained. Most notably, FDA requires that mifepristone be dispensed at a hospital, clinic, or medical office-not by mail or through a retail or mail-order pharmacy-even though patients can receive all evaluation and counseling via telemedicine and can self-administer the mifepristone tablet, unsupervised, at the location of their choice. Of more than 20,000 FDA-approved drugs [2], mifepristone is the only one FDA requires patients to pick up in a clinical setting even though they do not have to take it under clinical supervision [3]. FDA's singular restrictions on mifepristone are not only clinically unjustified, but unlawful. On behalf of leading medical associations, individual physicians, and reproductive justice advocates, our organization, the American Civil Liberties Union, has taken FDA to court-twice-because the agency's restrictions on mifepristone do not satisfy the strict constraints Congress established for REMS programs and erect profound and unnecessary barriers to care in violation of the U.S. Constitution.

Reasons for and Logistical Burdens of Judicial Bypass for Abortion in Illinois.

PURPOSE: Minors seeking abortion in states with parental involvement requirements can obtain judicial bypass (JB) as an alternative. Research on minors' reasons for choosing bypass and the logistical obstacles associated with bypass is limited, yet needed to assess potential burdens introduced by mandated parental involvement. METHODS: Using data from all minors represented in JB proceedings by the Illinois Judicial Bypass Coordination Project in 2017 and 2018, we present descriptive statistics summarizing minors' demographic characteristics, reasons for seeking bypass, individuals involved in decision-making, and distances traveled and time elapsed to attend the court hearing. RESULTS: Most minors obtaining bypass (n = 150) agreed to participate (n = 128). Just more than half (55%) were aged 17 years and lived with one parent (54%). A minority were already parenting (5%) and/or lived with someone besides a parent or on their own (16%). The reasons for bypass included concern about being forced to continue the pregnancy (50%), fear of being kicked out of their home and/or cut off financially (41%), having no/minimal relationship with parents (15%), and fear of physical/emotional abuse (13%). Minors traveled an average of 24 miles one-way (range 1-270 miles) to a courthouse for their hearing. On average, 6.4 days elapsed between contacting the Judicial Bypass Coordination Project and the hearing. CONCLUSIONS: Judicial bypass can offer young people an opportunity to retain autonomy in decision-making, potentially avoiding abuse and other negative outcomes. However, even in a state with a well-organized network of attorneys, JB contributes 1 week to minors' abortion-seeking timeline and necessitates traveling long distances.