References
U.S. Food and Drug Administration. MIFEPREX® (mifepristone) Tablets, 200 mg. n.d. https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020687s010-lbl.pdf. Accessed 23 May 2023.
U.S. Food and Drug Administration. Korlym™ (mifepristone) 300 mg Tablets. n.d. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202107s000lbl.pdf. Accessed 23 May 2023.
Mazer-Amirshahi M, Ye P. Toxicity of abortifacients: a review for physicians in the post Roe era. Am J Emerg Med. 2022;61:7–11.
U.S. Food and Drug Administration. Questions and answers on Mifeprex. n.d. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation. Accessed 13 April 2023.
U.S. Food and Drug Administration. Milestones in US food and drug law. n.d. https://www.fda.gov/about-fda/fda-history/milestones-us-food-and-drug-law. Accessed 23 May 2023.
Center for Reproductive Rights. District CourtRuling. n.d. https://reproductiverights.org/wp-content/uploads/2023/04/TX-district-court-ruling-AHM-v-FDA-2023–04–07.pdf. Accessed 20 April 2023.
U.S. Food and Drug Administration. Development & Approval Process | Drugs. n.d. https://www.fda.gov/drugs/development-approval-process-drugs. Accessed 23 May 2023.
U.S. Food and Drug Administration. Medication Review. n.d. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/020687Orig1s020MedR.pdf. Accessed 20 April 2023.
Schummers L, Darling EK, Dunn S, McGrail K, Gayowsky A, Law MR, Laba TL, Kaczorowski J, Norman WV. Abortion safety and use with normally prescribed mifepristone in Canada. N Engl J Med. 2022;386:57–67.
AmericanCollege of Obstetricians and Gynecologists. Improving access to mifepristone for reproductive health indications. n.d. https://www.acog.org/clinical-information/policy-and-position-statements/position-statements/2018/improving-access-to-mifepristone-for-reproductive-health-indications. Accessed 23 May 2023.
Alliance for Hippocratic Medicine, on behalf of itself, its member organizations, their members, and these members’ patients, et al., Plaintiffs, v. U.S. FOOD AND DRUG ADMINISTRATION,et al. Brief amicus curiae of Medical and Public Health Societies. 2023. https://searchlf.ama-assn.org/case/documentDownload?uri=%2Funstructured%2Fbinary%2Fcasebriefs%2FAlliance_Fifth_Circuit_Court_of_Appeals_Brief.pdf. Accessed 19 July 2023.
Funding
No funding support was provided for this manuscript.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflicts of Interest
Dr. Amirshahi has served on advisory panels for the FDA and is an editorial board member for JMT. Dr. Amirshahi and Dr. Stolbach serve on the ACMT Board of Directors.
Disclaimer
While individual practices may differ, this is the position of the American College of Medical Toxicology at the time written, after a review of the issue and pertinent literature.
Additional information
Supervising Editor: Mark B. Mycyk, MD
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Rights and permissions
Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.
About this article
Cite this article
Mazer-Amirshahi, M., Stolbach, A.I. & Ye, P. ACMT Position Statement: Position on the Recent Judicial Challenge of U.S. Food and Drug Administration Approval of Mifepristone. J. Med. Toxicol. 19, 414–415 (2023). https://doi.org/10.1007/s13181-023-00960-4
Received:
Revised:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s13181-023-00960-4