美国国家公共电台 NPR--How an abortion pill ruling could threaten the FDA's regulatory authority

How an abortion¹ pill ruling could threaten the FDA's regulatory authority

Transcript²

Two contradictory³ court rulings are raising questions not only about the future of the abortion pill mifepristone, but the federal government's authority to approve and regulate drugs in general.

Mifepristone is widely used across the U.S. to end pregnancy⁴ in the first 10 weeks of gestation⁵ and help manage miscarriages⁶. The Food and Drug Administration (FDA) first approved it in 2000, after it evaluated data and concluded the drug's health benefits outweigh⁷ its risks.

More than two decades later, a federal judge in Texas refuted the FDA's approval, issuing an injunction that would suspend its approval nationwide. That pause is set to take effect on Friday, though the Justice Department has appealed to block it.

In Washington state on Friday, a different federal judge issued a separate ruling that prohibits the FDA from pulling the drug from the market.

Judges' decisions heighten uncertainty⁸

Uncertain about the future of mifepristone access, several states began stockpiling doses of the drug, major pharmaceutical⁹ companies expressed support for the FDA, and some Democrats¹⁰ and at least one Republican lawmaker urged the Biden administration to ignore the Texas ruling (a suggestion the White House dismissed as a potentially "dangerous precedent").

Holly¹¹ Fernandez Lynch, an assistant professor of medical ethics¹² and law at the University of Pennsylvania, calls the Texas ruling "truly an unprecedented¹³ decision."

She tells Morning Edition's Michel Martin that pharmaceutical companies that develop new products typically conduct clinical trials, evaluate drugs' safety and effectiveness, and submit a "massive dossier of data" to the FDA, the agency given authority by Congress to determine which products can go to market.

"What has happened in this case from the Northern District of Texas is that we have a single federal judge who has inserted himself, standing¹⁴ in for the agency to say FDA should have never approved mifepristone because they did not have adequate data to determine that it was safe," Fernandez Lynch says.

Plaintiffs revive questions, despite safety history

Fernandez Lynch says more than 100 studies over 30 years affirm the safety of mifepristone, which the FDA has evaluated multiple times over the decades (including approving a generic¹⁵ version in 2019).

But in November 2022, months after the Supreme¹⁶ Court overturned the federal abortion protections of Roe¹⁷ v. Wade¹⁸, a coalition¹⁹ of anti-abortion doctors and groups filed a lawsuit²⁰ seeking to undo²¹ the drug's approval, reviving an earlier attempt that had been denied in 2016.

Fernandez Lynch says the plaintiffs "cherry picked" a couple of those studies to make their argument.

"There was no new evidence that was presented to the court that would change FDA's determination about whether this product meets the statutory standard for approval," she adds. "What changed in this case was that ultimately the litigants²² were able to get their arguments in front of a federal judge."

What does it mean for the drug approval process?

Former FDA Commissioner²³ Jane Henney, who led the agency in 2000 when mifepristone was first approved, disputes allegations that its approval was improperly²⁴ fast-tracked.

"I can assure you that mifepristone was handled in a very proper way. It was given a very thorough review. It was not rushed," she told NPR's Juana Summers in an interview for All Things Considered on Tuesday.

She acknowledges that the mifepristone was approved under a section of the law that provides for an accelerated process, but denies that safety was compromised.

"The approval process, in terms of looking at all the scientific data, all of the clinical data, the data around how this drug was manufactured followed the normal process of how the FDA reviews every product that it has," Henney says.

Fernandez Lynch says if judges can weigh in on drug approvals, the pharmaceutical industry could choose to "stick to things that aren't going to ruffle²⁵ any feathers."

"What may happen, if this decision is allowed to stand, is that the industry is going to think, 'Hmm, maybe we shouldn't spend our resources on drugs that could be controversial, that might cause people to take us to court to say that FDA was wrong in approving this drug,'" Fernandez Lynch says.

Henney also says the Texas ruling is "disappointing" because it not only sends a "very chaotic²⁶" message to people seeking abortion care, but could call into question the validity of the FDA process, what she calls the "gold standard" for the U.S. and the world.

"If that is disrupted, it really causes chaos²⁷ not just in the marketplace, but chaos for medical providers and patients who need a sound and solid voice of authority to say this has been reviewed, these products are safe and effective," says Henney.

1 abortion   

n.流产，堕胎

参考例句：

• She had an abortion at the women's health clinic.她在妇女保健医院做了流产手术。
• A number of considerations have led her to have a wilful abortion.多种考虑使她执意堕胎。

2 transcript   

n.抄本，誊本，副本，肄业证书

参考例句：

• A transcript of the tapes was presented as evidence in court.一份录音带的文字本作为证据被呈交法庭。
• They wouldn't let me have a transcript of the interview.他们拒绝给我一份采访的文字整理稿。

3 contradictory   

adj.反驳的，反对的，抗辩的；n.正反对，矛盾对立

参考例句：

• The argument is internally contradictory.论据本身自相矛盾。
• What he said was self-contradictory.他讲话前后不符。

4 pregnancy   

n.怀孕，怀孕期

参考例句：

• Early pregnancy is often accompanied by nausea.怀孕早期常有恶心的现象。
• Smoking during pregnancy increases the risk of miscarriage.怀孕期吸烟会增加流产的危险。

5 gestation   

n.怀孕；酝酿

参考例句：

• The gestation period can be anything between 95 and 150 days.妊娠期从95天至150天不等。
• This film was two years in gestation.这部电影酝酿了两年。

6 miscarriages   

流产( miscarriage的名词复数 )

参考例句：

• Miscarriages are usually caused by abnormal chromosome patterns in the fetus. 流产通常是因为胎儿的染色体异常造成的。
• Criminals go unpunishedareconvicted and are miscarriages of justice. 罪犯会逍遥法外，法律会伤及无辜，审判不公时有发生。

7 outweigh   

vt.比...更重，...更重要

参考例句：

• The merits of your plan outweigh the defects.你制定的计划其优点胜过缺点。
• One's merits outweigh one's short-comings.功大于过。

8 uncertainty   

n.易变，靠不住，不确知，不确定的事物

参考例句：

• Her comments will add to the uncertainty of the situation.她的批评将会使局势更加不稳定。
• After six weeks of uncertainty,the strain was beginning to take its toll.6个星期的忐忑不安后，压力开始产生影响了。

9 pharmaceutical   

adj.药学的，药物的；药用的，药剂师的

参考例句：

• She has donated money to establish a pharmaceutical laboratory.她捐款成立了一个药剂实验室。
• We are engaged in a legal tussle with a large pharmaceutical company.我们正同一家大制药公司闹法律纠纷。

10 democrats   

n.民主主义者，民主人士( democrat的名词复数 )

参考例句：

• The Democrats held a pep rally on Capitol Hill yesterday. 民主党昨天在国会山召开了竞选誓师大会。
• The democrats organize a filibuster in the senate. 民主党党员组织了阻挠议事。 来自《简明英汉词典》

11 holly   

n.[植]冬青属灌木

参考例句：

• I recently acquired some wood from a holly tree.最近我从一棵冬青树上弄了些木料。
• People often decorate their houses with holly at Christmas.人们总是在圣诞节时用冬青来装饰房屋。

12 ethics   

n.伦理学；伦理观，道德标准

参考例句：

• The ethics of his profession don't permit him to do that.他的职业道德不允许他那样做。
• Personal ethics and professional ethics sometimes conflict.个人道德和职业道德有时会相互抵触。

13 unprecedented   

adj.无前例的，新奇的

参考例句：

• The air crash caused an unprecedented number of deaths.这次空难的死亡人数是空前的。
• A flood of this sort is really unprecedented.这样大的洪水真是十年九不遇。

14 standing   

n.持续，地位；adj.永久的，不动的，直立的，不流动的

参考例句：

• After the earthquake only a few houses were left standing.地震过后只有几幢房屋还立着。
• They're standing out against any change in the law.他们坚决反对对法律做任何修改。

15 generic   

adj.一般的，普通的，共有的

参考例句：

• I usually buy generic clothes instead of name brands.我通常买普通的衣服，不买名牌。
• The generic woman appears to have an extraordinary faculty for swallowing the individual.一般妇女在婚后似乎有特别突出的抑制个性的能力。

16 supreme   

adj.极度的，最重要的；至高的，最高的

参考例句：

• It was the supreme moment in his life.那是他一生中最重要的时刻。
• He handed up the indictment to the supreme court.他把起诉书送交最高法院。

17 roe   

n.鱼卵；獐鹿

参考例句：

• We will serve smoked cod's roe at the dinner.宴会上我们将上一道熏鳕鱼子。
• I'll scramble some eggs with roe?我用鱼籽炒几个鸡蛋好吗？

18 wade   

v.跋涉，涉水；n.跋涉

参考例句：

• We had to wade through the river to the opposite bank.我们只好涉水过河到对岸。
• We cannot but wade across the river.我们只好趟水过去。

19 coalition   

n.结合体，同盟，结合，联合

参考例句：

• The several parties formed a coalition.这几个政党组成了政治联盟。
• Coalition forces take great care to avoid civilian casualties.联盟军队竭尽全力避免造成平民伤亡。

20 lawsuit   

n.诉讼，控诉

参考例句：

• They threatened him with a lawsuit.他们以诉讼威逼他。
• He was perpetually involving himself in this long lawsuit.他使自己无休止地卷入这场长时间的诉讼。

21 undo   

vt.解开，松开；取消，撤销

参考例句：

• His pride will undo him some day.他的傲慢总有一天会毁了他。
• I managed secretly to undo a corner of the parcel.我悄悄地设法解开了包裹的一角。

22 litigants   

n.诉讼当事人( litigant的名词复数 )

参考例句：

• Litigants of the two parties may reconcile of their own accord. 双方当事人可以自行和解。 来自口语例句
• The litigants may appeal against a judgment or a ruling derived from the retrial. 当事人可就重审案件的判决或裁定进行上诉。 来自口语例句

23 commissioner   

n.（政府厅、局、处等部门）专员，长官，委员

参考例句：

• The commissioner has issued a warrant for her arrest.专员发出了对她的逮捕令。
• He was tapped for police commissioner.他被任命为警务处长。

24 improperly   

不正确地，不适当地

参考例句：

• Of course it was acting improperly. 这样做就是不对嘛！
• He is trying to improperly influence a witness. 他在试图误导证人。

25 ruffle   

v.弄皱，弄乱；激怒，扰乱；n.褶裥饰边

参考例句：

• Don't ruffle my hair.I've just combed it.别把我的头发弄乱了。我刚刚梳好了的。
• You shouldn't ruffle so easily.你不该那么容易发脾气。

26 chaotic   

adj.混沌的，一片混乱的，一团糟的

参考例句：

• Things have been getting chaotic in the office recently.最近办公室的情况越来越乱了。
• The traffic in the city was chaotic.这城市的交通糟透了。

27 chaos   

n.混乱，无秩序

参考例句：

• After the failure of electricity supply the city was in chaos.停电后，城市一片混乱。
• The typhoon left chaos behind it.台风后一片混乱。