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Updated Mifepristone REMS Requirements

  • Practice Advisory PA
  • January 2023

The Society of Family Planning endorses this Practice Advisory.


This Practice Advisory serves as an update to the following ACOG documents: Practice Bulletin No. 225, Medication Abortion Up to 70 Days of Gestation, originally published in October 2020 1 ; Practice Bulletin No. 200, Early Pregnancy Loss, originally published in November 2018 2 ; and Committee Opinion No. 815, Increasing Access to Abortion, originally published in December 2020 3 .

On January 3, 2023, updates to the U.S. Food and Drug Administration (FDA) risk evaluation and mitigation strategy (REMS) for mifepristone for reproductive health indications went into effect. The FDA has permanently removed the in-person dispensing requirement and added a new pharmacy certification process, which will enable retail pharmacies that meet certain qualifications to dispense mifepristone directly to patients who have a prescription from a certified prescriber. All other previous mifepristone REMS requirements remain in effect, including the need for prescriber certification and completion of Prescriber and Patient Agreement Forms 4 5 . How the updated mifepristone REMS will affect clinical practice will vary based on state-specific abortion laws and regulations (see Clinical Practice Implications below).

Background

Mifepristone is used in combination with misoprostol as part of a safe, effective FDA-approved drug regimen for medication abortion 1 . It also can be used for the evidence-based medical management of early pregnancy loss 2 . Despite the demonstrated safety of mifepristone, the FDA implemented the Mifepristone REMS Program in 2011, which placed several restrictions on the medication’s distribution and use, including an in-person dispensing requirement that mifepristone be dispensed in a clinic, medical office, or hospital by or under the direct supervision of a certified clinician 4 5 , which precluded patients from accessing mifepristone in retail pharmacies or by mail. ACOG has long advocated for the removal of the REMS restrictions on the use of mifepristone for reproductive health indications because they do not make the care safer; are not based on medical evidence or need; create barriers to clinician and patient access to medication abortion and medical management of early pregnancy loss; and disproportionately burden communities already facing structural barriers to care, including people of color and those living long distances from a health care professional 3 6 7 8 .

During the COVID-19 pandemic, in response to advocacy efforts by an ACOG-led coalition of medical organizations, the FDA halted enforcement of the REMS in-person dispensing requirement for mifepristone for the duration of the public health emergency, which enabled the provision of mifepristone by telemedicine and mail in some states 5 9 . In December 2021, the FDA completed a review of the Mifepristone REMS Program and determined that modifications were warranted to reflect the long-standing safety data, help improve patient access, and reduce the burden on the health care delivery system. Implementation of these changes was put on hold pending the drug manufacturers’ submission of updated prescribing information and REMS materials, which were approved by the FDA and went into effect on January 3, 2023 4 5 10 .

Mifepristone REMS Updates

The changes to the Mifepristone REMS Program include the following 4 5 :

  • Permanent removal of the in-person dispensing requirement. In addition to clinics, medical offices, and hospitals, certified pharmacies can now dispense mifepristone to patients with a prescription from a certified prescriber. Mifepristone may be dispensed in-person or by mail.

  • Addition of a pharmacy certification requirement. Retail pharmacies (brick-and-mortar and mail-order) that meet certain requirements and complete a Pharmacy Agreement Form can now dispense mifepristone to patients who have a prescription from a certified prescriber.

The updated Mifepristone REMS Program maintains the requirement for prescriber certification and completion of the Prescriber and Patient Agreement Forms. The revised REMS document and materials are available on the FDA website.

Clinical Practice Implications

The recent updates to the Mifepristone REMS Program have the potential to increase access to medication abortion and medical management of early pregnancy loss. However, the implications for clinical practice will depend on state-specific laws and the ability and willingness of retail pharmacies to achieve REMS certification to dispense mifepristone. The mifepristone REMS requirements remain a medically unnecessary barrier to safe, essential reproductive health care 3 6 7 8 . And access to medication abortion will continue to be limited by state-level abortion bans and restrictions, including statutes that explicitly restrict medication abortion through telemedicine, laws that require in-person administration of mifepristone, and regulations on the general dispensing of medications by mail 11 . ACOG encourages clinicians to seek out and obtain guidance specific to their state laws and regulations as well as institutional policies before making any changes to their clinical practice.

Although the FDA’s removal of the in-person dispensing requirement for mifepristone will not improve access for all individuals seeking medication abortion and medical management of early pregnancy loss, it is a positive step that comes amid increasing state abortion bans and restrictions. Consistent with the medical evidence, ACOG will continue to advocate for the complete removal of the mifepristone REMS restrictions so that obstetrician–gynecologists and other clinicians can deliver the highest-quality evidence-based reproductive health care for their patients.

For clinical questions about the use of mifepristone for medication abortion and/or early pregnancy loss, please contact [email protected] or ACOG’s Spontaneous and Induced Abortion Resource Center. For inquiries about state policies that affect access to medication abortion, please contact [email protected].

Resources

These materials are for information purposes only and are not meant to be comprehensive. Referral to external resources does not imply ACOG’s endorsement of the organization, the organization’s website, or the content of the resource. The resources may change without notice.

References

  1. Medication abortion up to 70 days of gestation. ACOG Practice Bulletin No. 225. American College of Obstetricians and Gynecologists. Obstet Gynecol 2020;136:e31-47. doi: 10.1097/AOG.0000000000004082
    Article Locations:
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  2. Early pregnancy loss. ACOG Practice Bulletin No. 200. American College of Obstetricians and Gynecologists. Obstet Gynecol 2018;132:e197-207. doi: 10.1097/AOG.0000000000002899
    Article Locations:
    Article LocationArticle Location
  3. Increasing access to abortion. ACOG Committee Opinion No. 815. American College of Obstetricians and Gynecologists. Obstet Gynecol 2020;136:e107-15. doi: 10.1097/AOG.0000000000004176
    Article Locations:
    Article LocationArticle Location
  4. U.S. Food and Drug Administration. Information about mifepristone for medical termination of pregnancy through ten weeks gestation. Accessed January 9, 2023. Available at: https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-about-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation
    Article Locations:
    Article LocationArticle Location Article LocationArticle Location
  5. U.S. Food and Drug Administration. Questions and answers on mifepristone for medical termination of pregnancy through ten weeks gestation. Accessed January 9, 2023. Available at: https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation
    Article Locations:
    Article LocationArticle LocationArticle LocationArticle LocationArticle Location
  6. Improving access to mifepristone for reproductive health indications. Position Statement. American College of Obstetricians and Gynecologists; 2018. Accessed January 9, 2023. Available at: https://www.acog.org/clinical-information/policy-and-position-statements/position-statements/2018/improving-access-to-mifepristone-for-reproductive-health-indications
    Article Locations:
    Article LocationArticle Location
  7. Grossman D, Grindlay K, Altshuler AL, Schulkin J. Induced abortion provision among a national sample of obstetrician-gynecologists. Obstet Gynecol 2019;133:477-83. doi: 10.1097/AOG.0000000000003110
    Article Locations:
    Article LocationArticle Location
  8. Raymond EG, Blanchard K, Blumenthal PD, Cleland K, Foster AM, Gold M, et al. Sixteen years of overregulation: time to unburden Mifeprex. Mifeprex REMS Study Group. N Engl J Med 2017;376:790-4. doi: 10.1056/NEJMsb1612526
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  9. American College of Obstetricians and Gynecologists. The FDA's decision lifting the burdensome restriction on mifepristone during the pandemic: what you need to know. Accessed January 9, 2023. Available at: https://www.acog.org/news/news-articles/2020/07/courts-order-lifting-burdensome-fda-restriction-what-you-need-to-know
    Article Locations:
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  10. American College of Obstetricians and Gynecologists. Understanding the practical implications of the FDA’s December 2021 mifepristone REMS decision. Accessed January 9, 2023. Available at: https://www.acog.org/news/news-articles/2022/03/understanding-the-practical-implications-of-the-fdas-december-2021-mifepristone-rems-decision
    Article Locations:
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  11. Kaiser Family Foundation. The availability and use of medication abortion. Accessed January 9, 2023. Available at: https://www.kff.org/womens-health-policy/fact-sheet/the-availability-and-use-of-medication-abortion/
    Article Locations:
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The American College of Obstetricians and Gynecologists recognizes and supports the gender diversity of all patients who seek obstetric and gynecologic care. In original portions of this document, authors seek to use gender-inclusive language or gender-neutral language. When describing research findings, this document uses gender terminology reported by investigators. To review ACOG’s policy on inclusive language, see https://www.acog.org/clinical-information/policy-and-position-statements/statements-of-policy/2022/inclusive-language.

A Practice Advisory is a brief, focused statement issued to communicate a change in ACOG guidance or information on an emergent clinical issue (eg, clinical study, scientific report, draft regulation). A Practice Advisory constitutes ACOG clinical guidance and is issued only on-line for Fellows but may also be used by patients and the media. Practice Advisories are reviewed periodically for reaffirmation, revision, withdrawal or incorporation into other ACOG guidelines. This information is designed as an educational resource to aid clinicians in providing obstetric and gynecologic care, and for informational purposes only. It does not constitute legal advice; clinicians should be familiar with and comply with local restrictions on abortion, including medication abortion, and are encouraged to consult with a lawyer when navigating local abortion laws and regulations. The use of this information is voluntary. This information should not be considered as inclusive of all proper treatments or methods of care or as a statement of the standard of care. It is not intended to substitute for the independent professional judgment of the treating clinician. Variations in practice may be warranted when, in the reasonable judgment of the treating clinician, such course of action is indicated by the condition of the patient, limitations of available resources, or advances in knowledge or technology. The American College of Obstetricians and Gynecologists reviews its publications regularly; however, its publications may not reflect the most recent evidence. Any updates to this document can be found on www.acog.org/clinical.

While ACOG makes every effort to present accurate and reliable information, this publication is provided “as is” without any warranty of accuracy, reliability, or otherwise, either express or implied. ACOG does not guarantee, warrant, or endorse the products or services of any firm, organization, or person. Neither ACOG nor its officers, directors, members, employees, or agents will be liable for any loss, damage, or claim with respect to any liabilities, including direct, special, indirect, or consequential damages, incurred in connection with this publication or reliance on the information presented.

Publications of the American College of Obstetrician and Gynecologists are protected by copyright and all rights are reserved. The College's publications may not be reproduced in any form or by any means without written permission from the copyright owner.

The American College of Obstetricians and Gynecologists (ACOG) is the nation’s leading group of physicians providing evidence-based obstetric and gynecologic care. As a private, voluntary, nonprofit membership organization of more than 60,000 members, ACOG strongly advocates for equitable, exceptional, and respectful care for all women and people in need of obstetric and gynecologic care; maintains the highest standards of clinical practice and continuing education of its members; promotes patient education; and increases awareness among its members and the public of the changing issues facing patients and their families and communities. www.acog.org

Topics
Abortion Abortifacient agents Induced abortion Mifepristone Spontaneous abortion