By Ahmed Aboulenein
2026年3月25日 美国东部时间晚上9:57 更新于1小时前
节点运行失败
（注：此处为图片占位符，实际应替换为原文图片链接）
图片说明：2024年4月9日，美国伊利诺伊州卡本代尔的阿拉莫妇女诊所中，摆放着米非司酮（医疗堕胎的第一种药物）的药箱。路透社/Evelyn Hockstein/资料图 购买许可权，打开新标签页
华盛顿，3月25日（路透社） – 美国参议院共和党人周三对堕胎药生产商展开调查，并呼吁美国食品药品监督管理局（FDA）打击米非司酮（mifepristone）的在线销售。这是多年来围绕堕胎药获取权的政治斗争中的最新升级。
此次调查由参议院卫生、教育、劳工和养老金委员会主席、共和党人比尔·卡西迪（Bill Cassidy）领导。此前数月，保守派一直批评FDA在审查米非司酮安全协议方面行动过于迟缓，尤其是在拜登政府放宽亲自配药要求并扩大远程医疗获取渠道之后。
订阅路透社健康动态通讯，了解最新医疗突破和医疗趋势。点击此处注册
广告 · 滚动继续阅读
以下是一些细节：
- 参议员要求所有三家经FDA批准的生产商（Danco Laboratories、GenBioPro和Evita Solutions）提供详细的合规记录，包括生产地点、开方医生认证、药房审计、不良事件报告、销售数据以及任何开方医生或药房被吊销资质的原因。
- 议员们表示，在线远程医疗卖家存在安全、欺诈和胁迫风险，引用了一些网站的广告，这些网站在超过FDA批准的10周期限后仍销售堕胎药，或从国外运送未标记包装的未经监管的药物。
- 共和党人要求FDA动用执法工具，包括向在线卖家发出警告信、向域名注册商举报滥用行为、与美国海关和边境保护局及美国邮政服务部门合作拦截货物，以及效仿过去涉及非法药物分销案件的刑事起诉。
- 这一推动反映了更广泛的保守派努力，包括恢复更严格的风险评估和缓解策略（REMS）限制、撤销远程医疗开方政策，以及在联邦安全审查完成前暂停批准米非司酮的新仿制药产品。
- FDA正在审查米非司酮的安全协议，并计划完成这一流程，但一些共和党人表示审查进展过于缓慢。
- 美国卫生与公众服务部发言人表示：“FDA致力于保护公众免受药品非法营销的侵害，目前正在对米非司酮的开方标准进行安全研究。”
- Danco Laboratories拒绝置评。GenBioPro表示期待向议员们介绍医疗堕胎的相关情况。Evita Solutions未立即回应置评请求。
报道：Ahmed Aboulenein（华盛顿）；编辑：Matthew Lewis和Lincoln Feast
我们的标准：路透社信托原则，打开新标签页
（注：原文中的URL链接已保留格式，实际应用时需替换为有效链接）
US Senate Republicans launch probe of abortion pill makers, escalate pressure on FDA
By Ahmed Aboulenein
March 25, 2026 9:57 PM UTC Updated 1 hour ago
节点运行失败
Boxes of Mifepristone, the first pill in a medical abortion, are seen at Alamo Women’s Clinic in Carbondale, Illinois, U.S., April 9, 2024. REUTERS/Evelyn Hockstein/File Photo Purchase Licensing Rights, opens new tab
WASHINGTON, March 25 (Reuters) – U.S. Senate Republicans launched an investigation into abortion pill manufacturers on Wednesday and called on the U.S. Food and Drug Administration to crack down on online sales of the drug mifepristone, the latest escalation in a years‑long political battle over access to medication abortion.
The probe is led by Republican Bill Cassidy, chairman of the Senate Health, Education, Labor and Pensions Committee. It follows months of criticism by conservatives that the FDA has moved too slowly in reviewing the safety protocols surrounding mifepristone, particularly after former President Joe Biden’s administration eased in‑person dispensing requirements and expanded telehealth access.
Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here.
Advertisement · Scroll to continue
Report Ad
Here are some details:
- Senators seek detailed compliance records from all three FDA‑approved manufacturers: Danco Laboratories, GenBioPro and Evita Solutions, including production sites, prescriber certifications, pharmacy audits, adverse event reports, sales data and reasons for any prescriber or pharmacy decertifications.
- Lawmakers say online telehealth sellers pose safety, fraud and coercion risks, citing websites that advertise abortion pills past the FDA‑approved 10‑week limit or ship unregulated drugs from abroad in unmarked packaging.
- Republicans demand FDA enforcement tools, including warning letters to online sellers, abuse complaints to domain registrars, interdiction of shipments with U.S. Customs and Border Protection and the U.S. Postal Service, and criminal prosecutions modeled on past cases involving illegal pill distribution.
- The push reflects broader conservative efforts to reinstate tougher Risk Evaluation and Mitigation Strategies restrictions, undo telehealth prescribing policies, and suspend approval of new generic mifepristone products pending federal safety reviews.
- The FDA is reviewing mifepristone’s safety protocols and aims to complete the process but some Republicans say the review is moving too slowly.
- “The FDA is committed to protecting the public from the illegal marketing of drugs and is currently conducting its safety study of mifepristone’s prescribing standards,” a Department of Health and Human Services spokesperson said.
- Danco Laboratories declined to comment. GenBioPro said it looked forward to educating lawmakers about medication abortion. Evita Solutions did not immediately respond to requests for comment.
Reporting by Ahmed Aboulenein in Washington; Editing by Matthew Lewis and Lincoln Feast.
Our Standards: The Thomson Reuters Trust Principles., opens new tab
发表回复