最高法院在周四保留了对米非司酮流产丸在没有医生亲自出诊的情况下,随着围绕FDA安全法规的诉讼继续进行,搁置下级法院的命令会限制该药物的可用性。
该决定意味着患者可以继续通过远程医疗获得药物处方,并在药房领取或通过邮件递送。根据美国公民自由联盟的数据,如今超过四分之一的堕胎妇女通过远程医疗获得药物。
法官克拉伦斯·托马斯和塞缪尔·阿利托不同意这一决定。
法院没有详细说明其决定,但这一行动符合两年前在一个由反堕胎医生团体提起的类似案件中采取的方法。
2021年,FDA停止了该药物的当面配药要求,引用了涉及55,000多名患者的15项研究的数据,该机构表示,轻松获取是安全的。
提起诉讼的路易斯安那州声称,政府监管机构在没有适当考虑健康风险的情况下任意行事。
该州要求法官确认——至少暂时确认——上诉法院的一项裁决,该裁决认为拜登政府没有合法地制定新的米非司酮指南,应该搁置。
制药商Danco Labs和GenBioPro在20个州的支持下,坚持认为这些指导方针经过了FDA的适当研究,并在过去五年中安全实施,几乎没有投诉或质疑。
他们指出,没有联邦法院曾质疑过FDA批准的药物法规。
“我们很高兴看到一种安全有效的美国药物依赖将继续可用虽然这场诉讼丹可发言人艾比·朗在一份声明中说。Danco还相信,FDA对所有最近可靠数据的审查将继续表明[米非司酮]是非常安全和有效的。"
路易斯安那州司法部长Liz Murrill在一份声明中说,“最高法院会阻止这种医学伦理实践和监督的常识性回归,这令人震惊。DOJ没有为大型制药公司辩护,这些公司从非法和不道德的流产药丸分销中获利。我们会继续战斗。”
Supreme Court preserves broad access to abortion drug mifepristone
The Supreme Court on Thursday preserved broad access to theabortion pill mifepristonewithout an in-person doctor visit, keeping on hold a lower court order that would have restricted the drug's availability as litigation over FDA safety regulations continues.
The decision means patients can continue to obtain a prescription for the medication via telehealth and pick it up at a pharmacy or have it delivered by mail. More than one in four women who get an abortion today obtain the medicine via telehealth, according to the ACLU.
Justices Clarence Thomas and Samuel Alito dissented from the decision.
The court did not elaborate on its decision, but the action matches the approach it took two years ago in a similar case brought by a group of anti-abortion doctors.
In 2021, the FDA discontinued an in-person dispensation requirement for the medicine, citing data from 15 studies involving more than 55,000 patients the agency said showed that eased access was safe.
Louisiana, which brought the case, alleges government regulators acted arbitrarily without proper consideration of health risks.
The state had asked the justices to affirm -- at least temporarily -- an appeals court ruling which concluded the Biden administration did not lawfully develop the new mifepristone guidelines and that they should be put on hold.
Drugmakers Danco Labs and GenBioPro, backed by 20 states, insist the guidelines were properly studied by FDA and safely implemented over the past five years with little complaint or challenge.
No federal court has ever second-guessed FDA-approved drug regulations, they pointed out.
"We are pleased that a safe and effective drug Americansdepend on will continue to be availablewhile this litigationproceeds," Abby Long, a Danco spokesperson, said in a statement. "Danco also is confident that a review of all recent, reliable data by FDA will continue to show that [mifepristone] is very safe and effective."
Louisiana Attorney General Liz Murrill said in a statement, "It's shocking that the Supreme Court would block this common-sense return to medically ethical practices and oversight. DOJ did not defend Big Pharma, which is profiting from the illegal and unethical distribution of abortion pills. We will keep fighting."





