U.S. FDA says abortion pills can be sold at retail pharmacies

美国食品药品监督管理局表示,堕胎药可以在零售药店销售了
原创翻译:龙腾网 http://www.ltaaa.cn 转载请注明出处




新闻:

The U.S. Food and Drug Administration (FDA) will allow retail pharmacies to offer abortion pills in the United States for the first time, the agency said on Tuesday, even as more states seek to ban medication abortion.

美国食品和药物管理局周二表示,尽管越来越多的州寻求禁止药物流产,但该机构将首次允许零售药店在美国出售堕胎药。

The regulatory change will potentially expand abortion access as President Joe Biden's administration wrestles with how best to protect abortion rights after they were sharply curtailed by the Supreme Court's decision to overturn the landmark Roe v Wade ruling and the state bans that followed.

由于最高法院决定推翻具有里程碑意义的罗伊诉韦德案裁决,以及随后各州的禁令,堕胎权利受到了严重限制,美国总统乔·拜登的政府正在努力解决如何最好地保护堕胎权利的问题,监管改革可能会扩大堕胎的覆盖面。

Pharmacies can start applying for certification to distribute abortion pill mifepristone with one of the two companies that make it, and if successful they will be able to dispense it directly to patients upon receiving a prescxtion from a certified prescriber.

药店可以开始向生产堕胎药米非司酮的两家公司之一申请认证,如果成功,它们将能够在收到经过认证的处方师的处方后直接向患者配药。

The FDA had first said it would be making those changes in December 2021 when it announced it would relax some risk uation and mitigation strategies, or REMS, on the pill, that had been in place since the agency approved it in 2000 and were lifted temporarily in 2021 due to the COVID-19 pandemic.

食药管理局首次表示将在2021年12月做出这些改变,当时它宣布将放松对避孕药的一些风险评估和缓解策略,这些策略自该机构2000年批准以来一直存在,并在2021年因新冠大流行而暂时取消。

The changes included permanently removing restrictions on mail order shipping of the pills and their prescxtion through telehealth.

这些变化包括永久取消对通过远程医疗邮购药物及其处方的限制。

The agency finalized the changes on Tuesday after reviewing supplemental applications from Danco Laboratories and GenBioPro, the two companies that make the drug in the United States.

食药管理局在审查了在美国生产该药的两家公司Danco Laboratories和GenBioPro的补充申请后,于周二最终确定了这些变化。

"Under the Mifepristone REMS Program, as modified, Mifeprex and its approved generic can be dispensed by certified pharmacies or by or under the supervision of a certified prescriber," the agency said on its website on Tuesday.

该机构周二在其网站上表示:“根据修改后的米非司酮风险评估和缓解策略计划,米非司酮及其获批准的仿制药可以由认证药店、或由认证处方师开具或在其监督下发放。”

Mifeprex is the brand name version of mifepristone which, in combination with a second drug called misoprostol that has various uses including miscarriage management, induces an abortion up to 10 weeks into a pregnancy in a process known as medication abortion.

Mifeprex是米非司酮的品牌版本,它与另一种名为米索前列醇的药物结合使用,具有多种用途,包括流产管理,可在怀孕10周内诱导流产,这一过程被称为药物流产。

Abortion rights activists say the pill has a long track record of being safe and effective, with no risk of overdose or addiction. In several countries, including India and Mexico, women can buy them without a prescxtion to induce abortion.

堕胎权利活动人士表示,避孕药长期以来一直是安全有效的,没有过量服用或上瘾的风险。在包括印度和墨西哥在内的几个国家,女性可以在没有处方的情况下自行购买人工流产药。

"Today's news is a step in the right direction for health equity," Planned Parenthood President Alexis McGill Johnson said in a statement.

“今天的新闻是朝着健康公平的正确方向迈出的一步,” 生育计划主席亚历克西斯·麦吉尔·约翰逊在一份声明中说。

"Being able to access your prescribed medication abortion through the mail or to pick it up in person from a pharmacy like any other prescxtion is a game changer for people trying to access basic health care," Johnson added.

约翰逊补充说:“对于那些试图获得基本医疗保健的人来说,能够通过邮件或像其他处方一样亲自从药店领取堕胎处方药是一个改变游戏规则的事情。”
原创翻译:龙腾网 http://www.ltaaa.cn 转载请注明出处


NO EQUAL ACCESS
The regulatory change will, however, not provide equal access to all people, GenBioPro, which makes the generic version of mifepristone, said in a statement.

没有平等的机会
然而,生产米非司酮仿制药的GenBioPro公司在一份声明中表示,监管变化不会为所有人提供平等的机会。

Abortion bans, some targeting mifepristone, have gone into effect in more than a dozen states since the U.S. Supreme Court overturned the constitutional right to terminating pregnancies when it scrapped the 1973 Roe v. Wade ruling last year.

自从美国最高法院去年废除了1973年罗伊诉韦德案的裁决,推翻了宪法规定的终止怀孕的权利以来,堕胎禁令,其中一些针对米非司酮,已经在十几个州生效。

Women in those states could potentially travel to other states to obtain medication abortion.

这些州的妇女可能会前往其他州进行药物流产。

The president of anti-abortion group SBA Pro-Life America, Marjorie Dannenfelser, said the latest FDA move endangers women's safety and the lives of unborn children.

美国反堕胎组织SBA反生命协会主席马乔里·丹南费尔瑟表示,食药管理局的最新举措危及女性安全和未出生孩子的生命。

"State lawmakers and Congress must stand as a bulwark against the Biden administration's pro-abortion extremism," she said in a statement.

她在一份声明中说:“州议员和国会必须成为抵制拜登政府支持堕胎的极端主义的堡垒。”

FDA records show a small mortality case number associated with mifepristone. As of June 2021, there were reports of 26 deaths lixed with the pill out of 4.9 million people estimated to have taken it since it was approved in September 2000.

食药管理局记录显示与米非司酮相关的少量死亡病例数。据报道,自2000年9月批准使用该药物以来,截至2021年6月,估计有490万人服用了该药物,其中有26人死亡。

Retail pharmacies will have to weigh whether or not to offer the pill given the political controversy surrounding abortion, and determine where they can do so.

鉴于堕胎引发的政治争议,零售药店将不得不权衡是否提供这种药物,并决定在哪里可以提供这种药物。

A spokesperson for CVS Health (CVS.N) said the drugstore chain owner was reviewing the upxed REMS "drug safety program certification requirements for mifepristone to determine the requirements to dispense in states that do not restrict the dispensing of medications prescribed for elective termination of pregnancy."

CVS健康公司的一位发言人表示,连锁药店所有者正在审查更新的风险评估和缓解策略“米非司酮的药物安全计划认证要求,以确定在不限制选择性终止妊娠处方药物分发的州分发的要求。”

A spokesperson for Walgreens (WBA.O), one of the largest U.S. pharmacies, said the company was also reviewing the FDA's regulatory change. "We will continue to enable our pharmacists to dispense medications consistent with federal and state law."

美国最大的药店之一沃尔格林的发言人表示,该公司也在评估食药管理局的监管变化。“我们将继续使我们的药剂师能够按照联邦和州法律分发药物。”