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American College of Obstetricians and Gynecologists v. United States Food & Drug Administration: Restricted Access to Medical Abortion Threatens Reproductive Rights during the COVID-19 Pandemic

American College of Obstetricians and Gynecologists v. United States Food & Drug Administration:... American Journal of Law & Medicine, 46 (2020): 507-517 © 2020 American Society of Law, Medicine & Ethics Boston University School of Law DOI: 10.1177/0098858820975536 Recent Case Development American College of Obstetricians and Gynecologists v. United States Food & Drug Administration: Restricted Access to Medical Abortion Threatens Reproductive Rights during the COVID-19 Pandemic — Mifepristone, also known by the brand name Mifeprex, and misoprostol are part of a common two-drug medical abortion regimen approved by the United States Food and Drug Administration (“FDA”) to assist in the termination of pregnancy for up to ten weeks of gestation. The FDA imposes distribution restrictions on certain drugs, like mifepristone, through the implementation of Risk Evaluation and Mitigation Strategy (“REMS”) and Elements to Assure Safe Use (“ETASU”) requirements. The in-person dispensing and in-person signature requirements (“In-Person Requirements”) contained in the ETASU provisions of mifepristone’s REMS became increasingly difficult for patients and providers to satisfy during the COVID-19 pandemic. On May 27, 2020, various medical associations and entities (“Plaintiffs”) challenged mifepristone’s In-Person Requirements by filing suit against several federal agencies and officials (“Government”), including the FDA, the Commissioner of Food and Drugs (“Commissioner”), the United States Department of Health and Human Services (“HHS”), http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png American Journal of Law & Medicine SAGE

American College of Obstetricians and Gynecologists v. United States Food & Drug Administration: Restricted Access to Medical Abortion Threatens Reproductive Rights during the COVID-19 Pandemic

Fuleihan, Christina
American Journal of Law & Medicine , Volume 46 (4): 11 – Nov 1, 2020
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References (13)

Publisher
SAGE
Copyright
© 2020 American Society of Law, Medicine & Ethics Boston University School of Law
ISSN
0098-8588
eISSN
2375-835X
DOI
10.1177/0098858820975536
Publisher site
See Article on Publisher Site

Abstract

American Journal of Law & Medicine, 46 (2020): 507-517 © 2020 American Society of Law, Medicine & Ethics Boston University School of Law DOI: 10.1177/0098858820975536 Recent Case Development American College of Obstetricians and Gynecologists v. United States Food & Drug Administration: Restricted Access to Medical Abortion Threatens Reproductive Rights during the COVID-19 Pandemic — Mifepristone, also known by the brand name Mifeprex, and misoprostol are part of a common two-drug medical abortion regimen approved by the United States Food and Drug Administration (“FDA”) to assist in the termination of pregnancy for up to ten weeks of gestation. The FDA imposes distribution restrictions on certain drugs, like mifepristone, through the implementation of Risk Evaluation and Mitigation Strategy (“REMS”) and Elements to Assure Safe Use (“ETASU”) requirements. The in-person dispensing and in-person signature requirements (“In-Person Requirements”) contained in the ETASU provisions of mifepristone’s REMS became increasingly difficult for patients and providers to satisfy during the COVID-19 pandemic. On May 27, 2020, various medical associations and entities (“Plaintiffs”) challenged mifepristone’s In-Person Requirements by filing suit against several federal agencies and officials (“Government”), including the FDA, the Commissioner of Food and Drugs (“Commissioner”), the United States Department of Health and Human Services (“HHS”),

Journal

American Journal of Law & Medicine – SAGE

Published: Nov 1, 2020

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