中美创新时报

最高法院一致保留广泛使用的堕胎药物的使用权

【中美创新时报2024 年 6 月 13 日编译讯】(记者温友平编译)周四(13日),最高法院一致保留了去年美国近三分之二堕胎中使用的药物的使用权,这是自两年前保守派法官推翻罗诉韦德案以来,最高法院首次作出堕胎裁决。美联社马克·谢尔曼(MARK SHERMAN)对此作了如下报道。

法官裁定,堕胎反对者无权就联邦食品药品管理局批准米非司酮以及 FDA 随后为简化获取该药物而采取的行动提起诉讼。

该案威胁要限制全国范围内米非司酮的使用权,包括在堕胎仍然合法的州。

布雷特·卡瓦诺大法官代表法院写道:“联邦法院不是解决原告对 FDA 行动担忧的错误场所。”卡瓦诺是推翻罗诉韦德案的多数派成员之一。

最高法院正在单独审理另一起堕胎案,该案涉及在怀孕患者健康面临严重风险的罕见紧急情况下,联邦关于医院紧急治疗的法律是否会推翻州堕胎禁令。

米非司酮阻断激素黄体酮,使子宫对第二种药物米索前列醇的收缩作用作出反应。这种双药疗法已用于终止妊娠 10 周内的妊娠。

医疗保健提供者表示,如果米非司酮不再可用或太难获得,他们将改用仅使用米索前列醇,而米索前列醇在终止妊娠方面效果稍差。

乔·拜登总统的政府和药品制造商曾警告说,在这种情况下站在堕胎反对者一边可能会破坏 FDA 的药物审批程序,超越堕胎的背景,因为这会让法官质疑该机构的科学判断。民主党政府和生产米非司酮的纽约丹科实验室 (Danco Laboratories) 辩称,该药物是 FDA 批准的最安全的药物之一。

丹科发言人阿比盖尔·朗 (Abigail Long) 在一份声明中表示,这一决定“保障了数十年来安全有效使用药物的渠道”。

堕胎反对者在法庭文件中辩称,FDA 在 2016 年和 2021 年放宽获取该药物限制的决定是不合理的,并且“危及全国妇女的健康”。

卡瓦诺承认,他所描述的反对者“对选择性堕胎和 FDA 放松对米非司酮的监管提出了真诚的法律、道德、意识形态和政策反对”。

但他说,他们走错了论坛,应该把精力集中在说服立法者和监管机构做出改变上。

这些评论指出了 2024 年大选的利害关系,以及共和党人唐纳德·特朗普如果入主白宫,任命的 FDA 专员可能会考虑收紧米非司酮的获取。

米非司酮案始于最高法院推翻罗诉韦德案五个月后。堕胎反对者最初在近一年前从美国地区法官马修·卡克斯马里克(特朗普在德克萨斯州的提名人)手中赢得了一项全面裁决,该裁决将完全撤销该药物的批准。美国第五巡回上诉法院维持了 FDA 对米非司酮的最初批准。但它将推翻监管机构在 2016 年和 2021 年做出的放宽该药物使用条件的改变。

最高法院搁置了上诉法院的修改裁决,然后同意审理此案,不过推翻罗诉韦德案的裁决的作者塞缪尔·阿利托和克拉伦斯·托马斯法官将允许在案件审理期间实施一些限制。

题图:周四(13日)最高法院。马克·谢尔曼/美联社

附原英文报道:

Unanimous Supreme Court preserves access to widely used abortion medication

By MARK SHERMAN The Associated Press,Updated June 13, 2024

WASHINGTON (AP) — The Supreme Court on Thursday unanimously preserved access to a medication that was used in nearly two-thirds of all abortions in the U.S. last year, in the court’s first abortion decision since conservative justices overturned Roe v. Wade two years ago.

The justices ruled that abortion opponents lacked the legal right to sue over the federal Food and Drug Administration’s approval of the medication, mifepristone, and the FDA’s subsequent actions to ease access to it.

The case had threatened to restrict access to mifepristone across the country, including in states where abortion remains legal.

Justice Brett Kavanaugh wrote for the court that “federal courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions.” Kavanaugh was part of the majority to overturn Roe.

The high court is separately considering another abortion case, about whether a federal law on emergency treatment at hospitals overrides state abortion bans in rare emergency cases in which a pregnant patient’s health is at serious risk.

Mifepristone blocks the hormone progesterone and primes the uterus to respond to the contraction-causing effect of a second drug, misoprostol. The two-drug regimen has been used to end a pregnancy through 10 weeks gestation.

Health care providers have said that if mifepristone is no longer available or is too hard to obtain, they would switch to using only misoprostol, which is somewhat less effective in ending pregnancies.

President Joe Biden’s administration and drug manufacturers had warned that siding with abortion opponents in this case could undermine the FDA’s drug approval process beyond the abortion context by inviting judges to second-guess the agency’s scientific judgments. The Democratic administration and New York-based Danco Laboratories, which makes mifepristone, argued that the drug is among the safest the FDA has ever approved.

The decision “safeguards access to a drug that has decades of safe and effective use,” Danco spokeswoman Abigail Long said in a statement.

The abortion opponents argued in court papers that the FDA’s decisions in 2016 and 2021 to relax restrictions on getting the drug were unreasonable and “jeopardize women’s health across the nation.”

Kavanaugh acknowledged what he described as the opponents’ “sincere legal, moral, ideological, and policy objections to elective abortion and to FDA’s relaxed regulation of mifepristone.”

But he said they went to the wrong forum and should instead direct their energies to persuading lawmakers and regulators to make changes.

Those comments pointed to the stakes of the 2024 election and the possibility that an FDA commissioner appointed by Republican Donald Trump, if he wins the White House, could consider tightening access to mifepristone.

The mifepristone case began five months after the Supreme Court overturned Roe. Abortion opponents initially won a sweeping ruling nearly a year ago from U.S. District Judge Matthew Kacsmaryk, a Trump nominee in Texas, which would have revoked the drug’s approval entirely. The 5th U.S. Circuit Court of Appeals left intact the FDA’s initial approval of mifepristone. But it would reverse changes regulators made in 2016 and 2021 that eased some conditions for administering the drug.

The Supreme Court put the appeals court’s modified ruling on hold, then agreed to hear the case, though Justices Samuel Alito, the author of the decision overturning Roe, and Clarence Thomas would have allowed some restrictions to take effect while the case proceeded.

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