What is Medication Abortion (MAB)?
Medical methods of abortion involve the administration of medications to cause cramping and bleeding and passage of the pregnancy. In general, the term “medical abortion” refers to the process in the early first trimester (usually limited to nine weeks) and induction abortion refers to the process in the second trimester. The process is used less frequently in the later first trimester and early second trimester. Mifepristone (Danco Laboratories, www.earlyoptionpill.com) is the only medication approved by the FDA for early medical abortion. It is followed by misoprostol one to three days later to cause cramping and bleeding. Misoprostol alone or methotrexate+misoprostol sometimes are used when mifepristone is not available. The FDA-approved regimen relies on evidence from 1995 and earlier. Subsequently many studies have led to evidence-based regimens. Organizations have produced guidelines for these evidenced-based regimens to help clinicians feel comfortable evaluating the evidence and changing their protocols or practice. The evidence-based regimens use a lower dose of mifepristone (200 mg versus the FDA’s 600 mg), home administration of misoprostol as well as alternative routes of administration of misoprostol, such as vaginal, buccal and sublingual routes. Many studies of these alternative regimens report a success rate of over 95%, with a continuing pregnancy rate of less than 0.5%.
Background: FDA & REMS for Medication Abortion
About FDA & REMS
The Risk Evaluation and Mitigation Strategy (REMS) is a set of restrictions imposed by the Food and Drug Administration (FDA), which seeks to ensure that a drug’s benefits outweighs its risks. The most burdensome type of REMS are “Elements to Assure Safe Use” (ETASU), which the FDA may impose on a drug that “has been shown to be effective” only if it is “associated with a serious adverse drug experience.”
REMS for MAB
The FDA requires all healthcare providers who prescribe brand name mifepristone (brand name Mifepristex) to be certified in the mifepristone REMS program. Of more than 20,000 drugs regulated by the FDA, mifepristone is the only one that patients must receive in person at a hospital, clinic, or medical office, yet may self-administer unsupervised at a location of their choice. The mifepristone REMS contains three ETASU:
- In-Person Dispensing ETASU (“ETASU C,” pursuant to 21 U.S.C. § 355-1(f)(3)(C)): Mifepristone may be dispensed only in a hospital, clinic, or medical office, by or under the supervision of a certified prescriber.
- Prescriber Certification ETASU (“ETASU A,” pursuant to 21 U.S.C. § 355-1(f)(3)(A)): Clinicians who seek to prescribe mifepristone fax to the drug distributor a form attesting to their clinical abilities, agreeing to comply with certain reporting requirements, and agreeing to comply with other REMS elements.
- Patient Form ETASU (“ETASU D,” pursuant to 21 U.S.C. § 355-1(f)(3)(D)): The prescriber and patient must review and sign a special form containing information regarding the mifepristone regimen and risks, and that the prescriber provide the patient with a copy of the form and place a copy of the form in the patient’s chart.
Information about the 2020 federal injunction on FDA REMS requirements coming soon.
 Approved Risk Evaluation and Mitigation Strategies (REMS), FDA.gov, https://www.accessdata.fda.gov/Scripts/Cder/Rems/index.cfm.
 Complaint, Am. Coll. of Obstetricians & Gynecologists v. United States Food & Drug Admin. at 18-19, 2020 WL 2771735 (D.Md.).
 The FDA approved a generic version of Mifeprex produced by GenBioPro, Inc. in April 2019. GenBioPro’s product, Mifepristone Tablets, 200 mg, can be safely used for the medical termination of intrauterine pregnancy through 70 days gestation. Questions and Answers on Mifeprex, FDA.gov (Apr. 19, 2019), https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/mifeprex-mifepristone-information.
 FDA.gov, supra note 1.
 Am. Coll. of Obstetricians & Gynecologists v. United States Food & Drug Admin., supra note 3, at 3.
 Risk Evaluation and Mitigation Strategy (REMS) Single Shared System for Mifepristone 200mg,FDA.gov (Apr. 2019), https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2019_04_11_REMS_Full.pdf.
 Am. Coll. of Obstetricians & Gynecologists v. United States Food & Drug Admin., supra note 3, at 19.