2026年10月8日 美国东部时间早上6:30 / 哥伦比亚广播公司/美联社
华盛顿——美国食品药品监督管理局（FDA）表示，针对美国主要堕胎药的持续安全审查将延续至明年，这一时间线很快遭到了希望限制该药物使用的堕胎权利反对者的谴责。
FDA在周三晚间的一份法律文件中提交了法院要求的审查进展情况，首次公开了由卫生部长小罗伯特·F·肯尼迪下令开展的这项备受争议的重新评估的具体信息。
米非司酮于2000年首次获得FDA批准。多年来，该机构多次重申这款药物的安全性和有效性，还放宽了多项对该药物的限制，其中包括取消了必须当面配药的要求。
但自特朗普总统重返白宫以来，反堕胎组织及其在国会的盟友一直敦促本届政府重新审查这款药物，以期限制其使用。
FDA在文件中表示，预计将在今年12月中旬完成对该药物的安全研究。相关结果报告预计“不晚于2027年3月”发布，之后FDA将决定是否对该药物的使用施加新的限制或做出其他调整。
反堕胎组织“美国生命联合组织”的加文·奥克斯利批评此举是特朗普政府官员缺乏“真正的领导力”。
“本届政府在女性健康问题上始终站在错误的一边，显然无意减轻堕胎药持续带来的危害，”奥克斯利说道。
米非司酮与另一种药物米索前列醇组成的两药联合疗法是美国最常见的堕胎方式。
联邦法官在路易斯安那州提起的一桩诉讼中要求FDA提供最新进展。该诉讼称，米非司酮的邮寄递送破坏了该州的堕胎禁令。这是多起与米非司酮相关、正在法院审理的州级诉讼之一。
上个月，美国第五巡回上诉法院的一个三人法官小组对路易斯安那州诉讼案的合理性提出了质疑，包括该州是否具备起诉FDA对米非司酮监管行为的法律资格。
第五巡回法院对路易斯安那州案件的任何裁决都不会立即改变当前局面，因为最高法院已暂停对该药物的相关调整，直到其再次审理此案。
FDA周三表示，正在采用“统计数据挖掘方法”来发现该药物可能存在的“未知安全隐患”。这些数据来自一个电子数据库，该数据库收集了来自主要医疗网络和保险公司的医疗损伤和药物副作用报告。
除了这项安全研究外，FDA还表示正在审议多项提议，旨在调整米非司酮的处方和配药方式。
堕胎反对者的大部分努力都集中在2021年的一项裁决上，该裁决允许医生在线开具该药物处方，并在新冠疫情期间通过邮寄方式配送。这项在乔·拜登总统任期内于2023年被定为永久政策的裁决，实际上破坏了多个州的堕胎禁令，因为女性可以通过邮寄方式获取该药物。
2025年，当被问及对米非司酮的审查是否会导致药物被禁时，哥伦比亚广播公司新闻医疗记者塞琳·冈德博士表示，FDA要撤回批准将非常困难——这一非常规举措很快会引发法律挑战。
不过，冈德表示，根据安全审查的结果，可能会让药物更难获取，比如限制通过远程医疗或邮寄方式提供该药物，或者限制只能由医生开具处方，而非目前也具备处方权的医师助理或护士。
FDA’s abortion pill safety review continuing into next year angers abortion rights opponents
October 8, 2026 6:30 AM EDT / CBS/AP
Washington— The Food and Drug Administration says its ongoing safety review of the nation’s main abortion pill will continue into next year, a timeline that was quickly condemned by abortion rights opponents hoping to see the drug’s use curtailed.
The FDA gave a court-ordered update on its progress in a legal filing late Wednesday, providing the first substantive information about the controversial reevaluation ordered by Health Secretary Robert F. Kennedy Jr.
Mifepristone was first approved by the FDA in 2000. The agency has repeatedly reaffirmed the pill’s safety and effectiveness over the years, in addition to easing a number of restrictions on the drug, including dropping a requirement that it be dispensed in person.
But since President Trump returned to the White House, anti-abortion rights groups and their allies in Congress have pushed the administration to revisit the pill, in the hopes of restricting its use.
The FDA said in its filing that it expects to complete a safety study of the pill by mid-December this year. A report on the findings is expected “no later than March 2027,” after which the agency will decide whether to impose new restrictions or other changes on the drug’s use.
Gavin Oxley, of Americans United for Life, an anti-abortion group, criticized the move as a lack of “true leadership” by Trump administration officials.
“The administration continues to find itself on the wrong side of women’s health, clearly uninterested in mitigating the ongoing harms caused by the abortion pill,” Oxley said.
The two-drug regimen of mifepristone, combined with a second drug, misoprostol, is the most common form of abortion in the U.S.
The FDA was directed to provide the latest update by a federal judge in a case brought by the state of Louisiana alleging that mail delivery of mifepristone undermines the state’s abortion ban. It’s one of several state lawsuits related to mifepristone winding their way through the courts.
Last month, a three-judge panel for the 5th U.S. Circuit Court of Appeals questioned the merits of Louisiana’s case, including whether the state had the legal standing to challenge the FDA’s oversight of mifepristone.
Any ruling from the 5th Circuit on the Louisiana case wouldn’t immediately change the landscape because the Supreme Court has blocked changes to the drug until it sees the case again.
The FDA said Wednesday it is using a “statistical data mining method” to discover “unknown safety concerns” that may exist with the drug. The data comes from an electronic database that collects reports of medical injuries and drug side effects from major health networks and insurers.
In addition to the safety study, the agency said it is considering a number of petitions proposing changes to how mifepristone is prescribed and distributed.
Abortion opponents have focused most of their efforts on a 2021 decision allowing doctors to prescribe the drug online and send it through the mail during COVID-19. That decision, made permanent under President Joe Biden in 2023, had the effect of undermining a number of state abortion bans, since women can receive the drug through the mail.
Asked in 2025 whether a review of mifepristone could lead to a ban, CBS News medical correspondent Dr. Celine Gounder suggested it would be difficult for the FDA to withdraw approval, an extraordinary step that would quickly draw legal challenges.
However, Gounder said that depending on what the safety review finds, it could make access more difficult, limiting the drug’s availability through telehealth or by mail, or restricting the ability to prescribe it to doctors rather than physician assistants or nurses who are also currently able to prescribe it.
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