{"title":"United Kingdom Data Deficiencies Influencing U.S. FDA Decisions.","authors":"Ingrid Skop, Calum Miller, Kevin Duffy","doi":"","DOIUrl":null,"url":null,"abstract":"<p><p>The U.S. FDA has permanently removed the in-person prescribing requirements that previously safeguarded the use of mifepristone/misoprostol medical abortions, allowing prescribing through telemedicine or on-line ordering and distribution through the mail and pharmacies, without standard pre-abortion testing. This will increase the risk of complications due to failure to adequately determine the gestational age or rule out ectopic pregnancy by ultrasound or physical exam, failure to perform labs to document whether RhoGAM is indicated, and failure to obtain appropriate informed consent to prevent unwanted abortions, among other concerns. The FDA justified this action by referencing flawed studies with significantly undercounted complications. The details of these study deficiencies are examined in this paper.</p>","PeriodicalId":48665,"journal":{"name":"Issues in Law & Medicine","volume":null,"pages":null},"PeriodicalIF":0.5000,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Issues in Law & Medicine","FirstCategoryId":"3","ListUrlMain":"","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"LAW","Score":null,"Total":0}
引用次数: 0
Abstract
The U.S. FDA has permanently removed the in-person prescribing requirements that previously safeguarded the use of mifepristone/misoprostol medical abortions, allowing prescribing through telemedicine or on-line ordering and distribution through the mail and pharmacies, without standard pre-abortion testing. This will increase the risk of complications due to failure to adequately determine the gestational age or rule out ectopic pregnancy by ultrasound or physical exam, failure to perform labs to document whether RhoGAM is indicated, and failure to obtain appropriate informed consent to prevent unwanted abortions, among other concerns. The FDA justified this action by referencing flawed studies with significantly undercounted complications. The details of these study deficiencies are examined in this paper.
美国 FDA 永久取消了之前保障米非司酮/米索前列醇药物流产使用的当面开具处方要求，允许通过远程医疗或在线订购开具处方，并通过邮件和药店分销，而无需进行标准的流产前检查。这将增加并发症的风险，原因包括未能通过超声波或体格检查充分确定孕龄或排除宫外孕，未能进行实验室检查以记录是否适用 RhoGAM，以及未能获得适当的知情同意以防止意外流产等。美国食品药品管理局引用了有缺陷的研究，这些研究对并发症的计算严重不足，从而为这一行动辩解。本文将详细分析这些研究缺陷。
期刊介绍：
Issues in Law & Medicine is a peer reviewed professional journal published semiannually. Founded in 1985, ILM is co-sponsored by the National Legal Center for the Medically Dependent & Disabled, Inc. and the Watson Bowes Research Institute.
Issues is devoted to providing technical and informational assistance to attorneys, health care professionals, educators and administrators on legal, medical, and ethical issues arising from health care decisions. Its subscribers include law libraries, medical libraries, university libraries, court libraries, attorneys, physicians, university professors and other scholars, primarily in the U.S. and Canada, but also in Austria, Australia, Belgium, Brazil, Italy, The Netherlands, New Zealand, Japan, Russia, South Korea, Spain, Taiwan, and the United Kingdom.
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