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

美國(guó)食品藥品監(jiān)督管理局表示,墮胎藥可以在零售藥店銷售了



新聞:

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.

美國(guó)食品和藥物管理局周二表示,盡管越來(lái)越多的州尋求禁止藥物流產(chǎn),但該機(jī)構(gòu)將首次允許零售藥店在美國(guó)出售墮胎藥。

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.

由于最高法院決定推翻具有里程碑意義的羅伊訴韋德案裁決,以及隨后各州的禁令,墮胎權(quán)利受到了嚴(yán)重限制,美國(guó)總統(tǒng)喬·拜登的政府正在努力解決如何最好地保護(hù)墮胎權(quán)利的問(wèn)題,監(jiān)管改革可能會(huì)擴(kuò)大墮胎的覆蓋面。

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.

藥店可以開(kāi)始向生產(chǎn)墮胎藥米非司酮的兩家公司之一申請(qǐng)認(rèn)證,如果成功,它們將能夠在收到經(jīng)過(guò)認(rèn)證的處方師的處方后直接向患者配藥。

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.

食藥管理局首次表示將在2021年12月做出這些改變,當(dāng)時(shí)它宣布將放松對(duì)避孕藥的一些風(fēng)險(xiǎn)評(píng)估和緩解策略,這些策略自該機(jī)構(gòu)2000年批準(zhǔn)以來(lái)一直存在,并在2021年因新冠大流行而暫時(shí)取消。
原創(chuàng)翻譯:龍騰網(wǎng) http://www.top-shui.cn 轉(zhuǎn)載請(qǐng)注明出處


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

這些變化包括永久取消對(duì)通過(guò)遠(yuǎn)程醫(yī)療郵購(gòu)藥物及其處方的限制。
原創(chuàng)翻譯:龍騰網(wǎng) http://www.top-shui.cn 轉(zhuǎn)載請(qǐng)注明出處


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.

食藥管理局在審查了在美國(guó)生產(chǎn)該藥的兩家公司Danco Laboratories和GenBioPro的補(bǔ)充申請(qǐng)后,于周二最終確定了這些變化。

"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.

該機(jī)構(gòu)周二在其網(wǎng)站上表示:“根據(jù)修改后的米非司酮風(fēng)險(xiǎn)評(píng)估和緩解策略計(jì)劃,米非司酮及其獲批準(zhǔn)的仿制藥可以由認(rèn)證藥店、或由認(rèn)證處方師開(kāi)具或在其監(jiān)督下發(fā)放?!?/b>

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,它與另一種名為米索前列醇的藥物結(jié)合使用,具有多種用途,包括流產(chǎn)管理,可在懷孕10周內(nèi)誘導(dǎo)流產(chǎn),這一過(guò)程被稱為藥物流產(chǎn)。

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.

墮胎權(quán)利活動(dòng)人士表示,避孕藥長(zhǎng)期以來(lái)一直是安全有效的,沒(méi)有過(guò)量服用或上癮的風(fēng)險(xiǎn)。在包括印度和墨西哥在內(nèi)的幾個(gè)國(guó)家,女性可以在沒(méi)有處方的情況下自行購(gòu)買人工流產(chǎn)藥。

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

“今天的新聞是朝著健康公平的正確方向邁出的一步,” 生育計(jì)劃主席亞歷克西斯·麥吉爾·約翰遜在一份聲明中說(shuō)。

"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.

約翰遜補(bǔ)充說(shuō):“對(duì)于那些試圖獲得基本醫(yī)療保健的人來(lái)說(shuō),能夠通過(guò)郵件或像其他處方一樣親自從藥店領(lǐng)取墮胎處方藥是一個(gè)改變游戲規(guī)則的事情。”

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.

沒(méi)有平等的機(jī)會(huì)
然而,生產(chǎn)米非司酮仿制藥的GenBioPro公司在一份聲明中表示,監(jiān)管變化不會(huì)為所有人提供平等的機(jī)會(huì)。

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.

自從美國(guó)最高法院去年廢除了1973年羅伊訴韋德案的裁決,推翻了憲法規(guī)定的終止懷孕的權(quán)利以來(lái),墮胎禁令,其中一些針對(duì)米非司酮,已經(jīng)在十幾個(gè)州生效。

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

這些州的婦女可能會(huì)前往其他州進(jìn)行藥物流產(chǎn)。

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.

美國(guó)反墮胎組織SBA反生命協(xié)會(huì)主席馬喬里·丹南費(fèi)爾瑟表示,食藥管理局的最新舉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.

她在一份聲明中說(shuō):“州議員和國(guó)會(huì)必須成為抵制拜登政府支持墮胎的極端主義的堡壘?!?/b>

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.

食藥管理局記錄顯示與米非司酮相關(guān)的少量死亡病例數(shù)。據(jù)報(bào)道,自2000年9月批準(zhǔn)使用該藥物以來(lái),截至2021年6月,估計(jì)有490萬(wàn)人服用了該藥物,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.

鑒于墮胎引發(fā)的政治爭(zhēng)議,零售藥店將不得不權(quán)衡是否提供這種藥物,并決定在哪里可以提供這種藥物。

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健康公司的一位發(fā)言人表示,連鎖藥店所有者正在審查更新的風(fēng)險(xiǎn)評(píng)估和緩解策略“米非司酮的藥物安全計(jì)劃認(rèn)證要求,以確定在不限制選擇性終止妊娠處方藥物分發(fā)的州分發(fā)的要求?!?/b>

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."

美國(guó)最大的藥店之一沃爾格林的發(fā)言人表示,該公司也在評(píng)估食藥管理局的監(jiān)管變化?!拔覀儗⒗^續(xù)使我們的藥劑師能夠按照聯(lián)邦和州法律分發(fā)藥物。”