Academic Journal
The US Food and Drug Administration's Regulation of Mifepristone.
| Τίτλος: | The US Food and Drug Administration's Regulation of Mifepristone. |
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| Συγγραφείς: | Dilek S; Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland., Rosen J; Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland., Levashkevich A; Department of Population, Family, and Reproductive Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland., Sharfstein JM; Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland., Alexander GC; Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.; Division of General Internal Medicine, Johns Hopkins Medicine, Baltimore, Maryland. |
| Πηγή: | JAMA [JAMA] 2026 Feb 17; Vol. 335 (7), pp. 619-625. |
| Τύπος έκδοσης: | Journal Article |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: American Medical Association Country of Publication: United States NLM ID: 7501160 Publication Model: Print Cited Medium: Internet ISSN: 1538-3598 (Electronic) Linking ISSN: 00987484 NLM ISO Abbreviation: JAMA Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: Chicago : American Medical Association, 1960- |
| Ιατρικοί όροι (MeSH): | Abortifacient Agents, Steroidal*/adverse effects , Abortifacient Agents, Steroidal*/history , Government Regulation*/history , Mifepristone*/adverse effects , Mifepristone*/history , United States Food and Drug Administration*/legislation & jurisprudence, Abortion, Induced/history ; Abortion, Induced/legislation & jurisprudence ; Abortion, Induced/methods ; COVID-19/epidemiology ; Drug Approval/legislation & jurisprudence ; Risk Evaluation and Mitigation/legislation & jurisprudence ; Female ; Humans ; Pregnancy ; Pandemics ; United States |
| Περίληψη: | Importance: Mifepristone, used with misoprostol, is the most common abortion regimen in the US. It is also a focal point of reproductive health policy and politics, with controversy over its legal status and regulation by the US Food and Drug Administration (FDA). Objective: To characterize the FDA's decision-making with respect to the regulation of mifepristone, with a particular interest in the agency's rationale for establishing, maintaining, or modifying key components of its regulatory approach over time. Evidence Review: Qualitative analysis of 5239 pages of FDA documents obtained through a Freedom of Information Act request, including sponsors' Risk Evaluation and Mitigation Strategy (REMS) assessment reports, FDA review of these reports, internal memos, and regulatory correspondence (2011-2023), supplemented by a review of publicly available information. Review focused on FDA justifications for implementing, maintaining, or modifying postapproval safety measures and the supporting evidence cited. Findings: Five key moments in the FDA's regulation of mifepristone that have led to the current state of oversight were identified: (1) conversion to the REMS framework in June 2011; (2) reevaluation of REMS necessity in October 2013; (3) a sponsor-requested label change in May 2015; (4) the response to the COVID-19 pandemic in 2020 and 2021; and (5) a comprehensive reassessment of the REMS in November 2021. Key themes across this period were consistent findings on safety, lack of ideological bias in staff scientists' recommendations, and the limited impact of political interference-to date-on the agency's oversight. Even as litigation, the COVID-19 public health emergency, and evolving practice standards changed the context of mifepristone regulation, the agency generally followed the policy approach favored by scientists at the agency. Conclusions and Relevance: FDA oversight of mifepristone, developed during key moments from 2011 to 2023, has been shaped by scientific evidence and a cautious regulatory approach led by scientists at the agency. |
| Σχόλια: | Comment in: JAMA. 2026 Feb 17;335(7):585-587. doi: 10.1001/jama.2025.24868.. (PMID: 41525060) |
| Substance Nomenclature: | 0 (Abortifacient Agents, Steroidal) 320T6RNW1F (Mifepristone) |
| Entry Date(s): | Date Created: 20260112 Date Completed: 20260217 Latest Revision: 20260319 |
| Update Code: | 20260319 |
| DOI: | 10.1001/jama.2025.23091 |
| PMID: | 41525083 |
| Βάση Δεδομένων: | MEDLINE |
| ISSN: | 1538-3598 |
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| DOI: | 10.1001/jama.2025.23091 |