美国食品和药物管理局（FDA）预计将于3月份完成其对流产药米费普罗斯定的安全性评估，据美司法部周三提交的一份法庭文件显示。
The Food and Drug Administration expects to complete its safety review of the abortion pill mifepristone in March, according to a court document the Justice Department filed Wednesday.
FDA在这份文件中表示，其计划将米费普罗斯定的安全性与10周胎龄以内的外科流产进行比较。
In the filing, the FDA said it plans to compare mifepristone’s safety to that of surgical abortions through 10 weeks’ gestation.
FDA称，其评估将测量约10万名服用米费普罗斯定的妇女的副作用发生率。
Its review will measure the frequency of side effects among roughly 100,000 women who took mifepristone, it said.
FDA评估结果预计将于12月中旬公布。
Results of the FDA’s review are expected in mid-December.
从那时起，该机构将分析数据并起草最终报告——这一过程预计将在3月份完成。
From there, the agency will analyze the data and draft a final report — a process it expects to wrap up in March.
FDA于2000年批准了米费普罗斯定的使用，数百项同行评审的研究表明它既安全又有效。
The FDA approved mifepristone in 2000, and hundreds of peer-reviewed studies have found it to be safe and effective.
FDA于2021年暂时取消了要求在-person配发米费普罗斯定的规定，然后在2023年正式确立这一改变。
The FDA temporarily eliminated a requirement to dispense mifepristone in person in 2021, then finalized the change in 2023.
FDA周四表示，其计划根据新收集的数据重新评估这一决定。
It said Wednesday that it plans to re-evaluate that decision based on the new data it collects.
它可能会考虑患者、提供者和药师的意见，以及2023年未考虑的其他研究。
It may weigh the views of patients, providers and pharmacists, as well as additional studies it did not consider in 2023.
该评估的预计完成日期远在11月3日的中期选举之后——当时堕胎访问是选民关注的议题之一。
The review’s expected completion date falls months after the Nov. 3 midterm elections — when abortion access is among the concerns for voters.
周四的更新是对路易斯安纳州联邦法官下达的要求提交安全评审进度报告的命令的回应。
The update Wednesday is in response to an order by a federal judge in Louisiana for a progress report on the safety review.
FDA是路易斯安纳州一项挑战其远程医疗规定的诉讼的被告，该规定自2022年最高法院推翻罗诉韦德案以来，largely负责维护全国范围内的堕胎访问。
The FDA is a defendant in a Louisiana suit challenging its telehealth provision, which has largely been responsible for preserving nationwide access to abortion since the Supreme Court overturned Roe v. Wade in 2022.
路易斯安纳州代表一位声称其男友订购了堕胎药并强迫她服用的女性提起了该诉讼。
Louisiana filed the case on behalf of a woman who said her boyfriend had ordered abortion pills and forced her to take them.
5月份，一家联邦上诉法院批准路易斯安纳州的请求，恢复要求在-person配发米费普罗斯定的全国性要求。
In May, a federal appeals court granted Louisiana’s request to reinstate a nationwide requirement that mifepristone be dispensed in person.
但最高法院在案件审理过程中迅速阻止了这一决定。
But the Supreme Court quickly blocked the decision while the case plays out.
卫生部长罗伯特·F·肯尼迪·托尼 Jr.去年委托进行安全评估，是因为一个保守智库声称发现了比FDA报告更高的米费普利酮严重并发症率。
Health Secretary Robert F. Kennedy Jr. commissioned the safety review last year after a conservative think tank claimed to have found a higher rate of serious complications from mifepristone than the FDA reported.
多位顶级共和党人，包括来自路易安纳州的参议员比尔·卡西迪，也敦促特朗普政府收紧对该药的访问权限。
Several top Republicans, including Sen. Bill Cassidy of Louisiana, have also pressured the Trump administration to tighten access to the drug.
研究生殖健康的研究人员表示，该智库的研究成果既未经过同行评审，也未发表在医学期刊上，属于伪科学。
Researchers who study reproductive health said the think tank’s findings, which were neither peer-reviewed nor published in a medical journal, amounted to junk science.
大量数据表明，服用米费普利酮的女性中不到0.5%出现严重不良反应。
A wealth of data has shown that less than 0.5% of women who take mifepristone have serious adverse reactions.
目前尚不清楚缺乏 permanent 委员会主席的FDA将从其新研究中得出何种结论。
It’s unclear what conclusion the FDA, which lacks a permanent commissioner, will draw from its new study.
唐纳德·特朗普总统提名的FDA负责人海蒂·奥弗顿博士是一名怀斯顾问，对堕胎权利持强烈反对态度，此前她曾将药物流产描述为“对女性有危险”。
President Donald Trump’s pick to lead the FDA, Dr. Heidi Overton, a White House adviser, is a fierce opponent of abortion rights, having previously described medication abortion as “dangerous to women.”
在上个月的参议院确认听证会上，奥弗顿多次回避了有关米费普利酮的问题，包括她是否认为堕胎药安全。
At her Senate confirmation hearing last month, Overton repeatedly sidestepped questions about mifepristone, including whether she believes the abortion pill is safe.