300 多名生殖健康研究人员在 FDA 诉希波克拉底医学联盟案中作为法庭之友提交的辩护状。

IF 3.4 2区 医学 Q1 DEMOGRAPHY Perspectives on Sexual and Reproductive Health Pub Date : 2024-07-29 DOI:10.1111/psrh.12281
Amanda Barrow, Cathren Cohen, Jaclyn Serpico, Melissa Goodman, Daniel Grossman, Sarah Raifman, Ushma Upadhyay
{"title":"300 多名生殖健康研究人员在 FDA 诉希波克拉底医学联盟案中作为法庭之友提交的辩护状。","authors":"Amanda Barrow, Cathren Cohen, Jaclyn Serpico, Melissa Goodman, Daniel Grossman, Sarah Raifman, Ushma Upadhyay","doi":"10.1111/psrh.12281","DOIUrl":null,"url":null,"abstract":"<p><p>On January 30, 2024, over 300 researchers filed an amicus brief in FDA v. Alliance for Hippocratic Medicine, a United States (US) Supreme Court case that could have severely impacted access to mifepristone, one of the two drugs commonly used in medication abortion. The researchers summarize the legal challenges to the US Food and Drug Administration's (FDA's) original approval of mifepristone in 2000 and its 2016 and 2021 decisions modifying mifepristone's Risk Evaluation and Mitigation Strategy (REMS) Program and label, the responses from the FDA and drug manufacturer to the challenges, and the potential implications of the Court's decision on access to mifepristone in the US. The researchers detail how the FDA relied on a robust scientific record analyzing tens of thousands of patient experiences that conclusively demonstrated the safety and effectiveness of the changes to the mifepristone REMS Program and label and urge the Supreme Court to rely on the clear scientific record and preserve access to mifepristone without reimposing restrictions. What follows is a reprint of this brief.</p>","PeriodicalId":47632,"journal":{"name":"Perspectives on Sexual and Reproductive Health","volume":" ","pages":""},"PeriodicalIF":3.4000,"publicationDate":"2024-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Brief of over 300 reproductive health researchers as Amici Curiae in FDA v. Alliance for Hippocratic Medicine.\",\"authors\":\"Amanda Barrow, Cathren Cohen, Jaclyn Serpico, Melissa Goodman, Daniel Grossman, Sarah Raifman, Ushma Upadhyay\",\"doi\":\"10.1111/psrh.12281\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>On January 30, 2024, over 300 researchers filed an amicus brief in FDA v. Alliance for Hippocratic Medicine, a United States (US) Supreme Court case that could have severely impacted access to mifepristone, one of the two drugs commonly used in medication abortion. The researchers summarize the legal challenges to the US Food and Drug Administration's (FDA's) original approval of mifepristone in 2000 and its 2016 and 2021 decisions modifying mifepristone's Risk Evaluation and Mitigation Strategy (REMS) Program and label, the responses from the FDA and drug manufacturer to the challenges, and the potential implications of the Court's decision on access to mifepristone in the US. The researchers detail how the FDA relied on a robust scientific record analyzing tens of thousands of patient experiences that conclusively demonstrated the safety and effectiveness of the changes to the mifepristone REMS Program and label and urge the Supreme Court to rely on the clear scientific record and preserve access to mifepristone without reimposing restrictions. What follows is a reprint of this brief.</p>\",\"PeriodicalId\":47632,\"journal\":{\"name\":\"Perspectives on Sexual and Reproductive Health\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.4000,\"publicationDate\":\"2024-07-29\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Perspectives on Sexual and Reproductive Health\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1111/psrh.12281\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"DEMOGRAPHY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Perspectives on Sexual and Reproductive Health","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/psrh.12281","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"DEMOGRAPHY","Score":null,"Total":0}
引用次数: 0

摘要

2024 年 1 月 30 日,300 多名研究人员在美国食品和药物管理局(FDA)诉希波克拉底医学联盟(Alliance for Hippocratic Medicine)一案中提交了一份法庭之友书状,该案可能会严重影响米非司酮(药物流产常用的两种药物之一)的使用。研究人员总结了美国食品和药物管理局(FDA)2000年最初批准米非司酮所面临的法律挑战、2016年和2021年修改米非司酮风险评估与缓解策略(REMS)计划和标签的决定、FDA和药品制造商对挑战的回应,以及法院的判决对美国人使用米非司酮的潜在影响。研究人员详细介绍了 FDA 是如何依据可靠的科学记录对数以万计的患者经历进行分析,从而确凿证明对米非司酮 REMS 计划和标签的修改是安全有效的,并敦促最高法院依据明确的科学记录,在不重新施加限制的情况下保留米非司酮的使用权。以下是本辩护状的重印本。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
Brief of over 300 reproductive health researchers as Amici Curiae in FDA v. Alliance for Hippocratic Medicine.

On January 30, 2024, over 300 researchers filed an amicus brief in FDA v. Alliance for Hippocratic Medicine, a United States (US) Supreme Court case that could have severely impacted access to mifepristone, one of the two drugs commonly used in medication abortion. The researchers summarize the legal challenges to the US Food and Drug Administration's (FDA's) original approval of mifepristone in 2000 and its 2016 and 2021 decisions modifying mifepristone's Risk Evaluation and Mitigation Strategy (REMS) Program and label, the responses from the FDA and drug manufacturer to the challenges, and the potential implications of the Court's decision on access to mifepristone in the US. The researchers detail how the FDA relied on a robust scientific record analyzing tens of thousands of patient experiences that conclusively demonstrated the safety and effectiveness of the changes to the mifepristone REMS Program and label and urge the Supreme Court to rely on the clear scientific record and preserve access to mifepristone without reimposing restrictions. What follows is a reprint of this brief.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
CiteScore
5.10
自引率
3.40%
发文量
24
期刊介绍: Perspectives on Sexual and Reproductive Health provides the latest peer-reviewed, policy-relevant research and analysis on sexual and reproductive health and rights in the United States and other developed countries. For more than four decades, Perspectives has offered unique insights into how reproductive health issues relate to one another; how they are affected by policies and programs; and their implications for individuals and societies. Published four times a year, Perspectives on Sexual and Reproductive Health includes original research, special reports and commentaries on the latest developments in the field of sexual and reproductive health, as well as staff-written summaries of recent findings in the field.
期刊最新文献
Sexual choking/strangulation and its association with condom and contraceptive use: Findings from a survey of students at a university in the Midwestern United States. Understanding abortion legality and trimester of abortion care in Ohio, West Virginia and Kentucky, three abortion‐restrictive states Abortion assistance fund staff and volunteers as patient navigators following an abortion ban in Texas. Abortion-related crowdfunding post-Dobbs. Medicaid's role in alleviating some of the financial burden of abortion: Findings from the 2021-2022 Abortion Patient Survey.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1