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Supreme Court halts restrictions on medication abortions

The justices' action prevents regulators from removing mifepristone from shelves nationwide.

WASHINGTON (CN) — The Supreme Court on Friday stopped new restrictions on a popular abortion pill from going into effect and limiting access to the procedure nationwide.

The court's pause on lower court rulings restricting the use of mifepristone will stay in place while the appeal proceeds. Should the case make its way back up to the high court, the stay will expire if the court declines a certiorari grant. Justice Clarence Thomas would not have granted the pause. Justice Samuel Alito dissented from the grants.

“At present, the applicants are not entitled to a stay because they have not shown that they are likely to suffer irreparable harm in the interim,” Alito wrote. 

Alito chastised the court for granting relief without considering the full merits of the case. He cited prior criticisms his colleagues — Justices Elena Kagan and Amy Coney Barrett — offered of the court’s use of its authority in this manner. While claiming to disagree with Kagan and Barrett’s assertions at the time, Alito says if those arguments were correct in those cases, they should also be held in this case. 

“I did not agree with these criticisms at the time, but if they were warranted in the cases in which they were made, they are emphatically true here,” Alito wrote. “As narrowed by the Court of Appeals, the stay that would apply if we failed to broaden it would not remove mifepristone from the market.” 

Alito said his dissent has no connection to how he might rule on the case in the future. 

“Contrary to the impression that may be held by many, that disposition would not express any view on the merits of the question whether the FDA acted lawfully in any of its actions regarding mifepristone,” Alito wrote. “Rather, it would simply refuse to take a step that has not been shown as necessary to avoid the threat of any real harm during the presumably short period at issue.” 

The battle over mifepristone — one of two drugs currently used in medication abortions — landed at the high court after two lower courts attempted to limit access to the drug nationwide. Both the Biden administration and mifepristone maker Danco Laboratories asked the justices for emergency relief to prevent what they viewed as a crisis in the heath care system. 

“The lower courts’ orders interfere with women’s ability to make that intensely personal medical decision for themselves,” U.S. Solicitor General Elizabeth Prelogar wrote in a brief before the court. 

Justice Samuel Alito temporarily halted — and then extended — a pause on the rulings to allow the full court to consider the case. 

President Joe Biden released a statement following the court’s ruling Friday afternoon. Biden said the ruling will prevent the FDA’s authority from being undermined and prevent risks to women’s health. 

“As a result of the Supreme Court’s stay, mifepristone remains available and approved for safe and effective use while we continue this fight in the courts,” Biden said. “I continue to stand by FDA’s evidence-based approval of mifepristone, and my Administration will continue to defend FDA’s independent, expert authority to review, approve, and regulate a wide range of prescription drugs.” 

The Alliance Defending Freedom said the Supreme Court’s decision to pause the rulings was common practice and it would continue to fight against mifepristone’s approval.

“As is common practice, the Supreme Court has decided to maintain the status quo that existed prior to our lawsuit while our challenge to the FDA’s illegal approval of chemical abortion drugs and its removal of critical safeguards for those drugs moves forward,” Erik Baptist, an attorney with ADF, said in a statement. “Our case seeking to put women’s health above politics continues on an expedited basis in the lower courts.”


Medication abortion stands as one of the last options for people seeking reproductive health care in areas where new restrictions have followed the Supreme Court’s decision to end the federal right to abortions. Without access to medication abortion, many people may be forced to undergo invasive surgical procedures or lose access to the procedure completely. 

Danco praised the decision to pause the lower court rulings while the company fights them in court. The drugmaker said millions of patients rely on mifepristone and today’s ruling allows them continued access to a crucial drug.

“We are confident that the FDA acted well within its authority, and in accordance with the law, in approving Mifeprex, and we will continue to defend Danco’s ability to distribute this important drug,” Jessica Ellsworth, Hogan Lovells partner representing Danco, said in a statement.

Mifepristone was approved by the U.S. Food and Drug Administration over two decades ago and has been used by over 5 million people since. Serious adverse reactions to the drug are rare, with its safety record rivaling those of ibuprofen and acetaminophen. For every million people who take mifepristone, only five dies from its use. The U.S. Centers for Disease Control and Prevention says the maternal mortality rate in the United States for 2021 was 39.2 deaths per 100,000 live births. 

Reproductive health care advocates have warned that targets on medication abortion are the next step to banning the procedure nationwide. A group of doctors opposed to abortion claims mifepristone should be pulled from the market because two decades ago the FDA rushed its approval, creating safety hazards that persist despite its subsequent approvals. Mifepristone was approved under Subpart H — an accelerated approval process for drugs for serious or life-threatening illnesses. The Alliance for Hippocratic Medicine claims pregnancy should not qualify under those standards. 

“To add mifepristone to this list, FDA characterized pregnancy as an ‘illness,’ even though it is actually a ‘natural process’ most women will experience,” John Bursch, an attorney with the Alliance for Defending Freedom, wrote in a brief before the court. 

The doctors do not actually prescribe mifepristone themselves. The harm, they claim, comes from the potential to treat one of the very rare serious adverse reactions to the drug. If one of those patients happened to show up at the workplace of one of the organization’s doctors and a member had to take care of them, the group argues they would be harmed by being forced to conduct a procedure that violates their beliefs. 

“Without a stay, mifepristone will result in more physical complications, emotional trauma, and even death for women,” Bursch wrote. “It will also harm plaintiffs by forcing them to perform elective abortions violating their conscience rights and interfering with their medical practice.” 

U.S. District Judge Matthew Kascmaryk, a Donald Trump appointee in the Northern District of Texas, ruled in favor of the doctors, halting mifepristone’s approval in a move that would take it off the shelves nationwide. On appeal, a panel of Republican appointees upheld most of Kascmaryk’s ruling limiting the use of mifepristone. 

The Biden administration says the suit lacks an essential element: standing. The government claims the doctors have not experienced any harm and are instead bringing a suit on supposed future harms, which the high court has previously rejected.

“Respondents still have not cited any prior decision, from any court, endorsing such a theory,” Prelogar wrote. “With good reason: To support a claim for prospective relief, this court’s precedents demand a showing that a specific, identified plaintiff (or association member) faces an imminent, concrete injury traceable to the defendant’s challenged action. Respondents have not even attempted to make that showing here.” 


Prelogar also notes that doctors can invoke federal conscience protections like the Church Amendments, the Weldon Amendment, and Consolidated Appropriations Act to avoid completely a procedure they disagree with. The government warns that if the ruling is allowed to stand, doctors could bring suits for having to treat all kinds of injuries. 

“Respondents’ allegations simply underscore how unbounded their standing theory is,” Prelogar wrote. “Surely some emergency room doctors find it stressful to treat gun-shot victims, drunk drivers, or individuals experiencing an opioid overdose, and they sometimes must divert resources to care for such patients — that is the nature of triaging patients in an emergency room. If respondents’ allegations permit them to challenge FDA’s actions with respect to mifepristone, other doctors would likewise have standing to sue a multitude of manufacturers and regulators.” 

Even if that theory of standing was endorsed by the court, the government argues the doctors are relying on inaccurate portrayals of data to claim mifepristone is riskier than it truly is. 

“Respondents ignore the mountain of evidence and experience validating the judgment of FDA and other regulators around the world that mifepristone is extremely safe when used in accordance with its approved conditions of use,” Prelogar wrote. “In lieu of scientific evidence, respondents point primarily to their own declarations, which are anecdotal, conclusory, or both.” 

The Fifth Circuit’s ruling would force the FDA to return to mifepristone approval standards prior to 2016. These changes include how it's prescribed and distributed. Under the appeals court’s order, mifepristone would only be prescribed up to seven weeks gestation instead of the current 10 weeks. Abortion seekers would also have to attend multiple in-office doctor’s visits — as opposed to telehealth consultations — to receive the pill and they would have to take the drug doctor’s supervision instead of receiving it through the mail. 

While the doctors claim these changes would only force the FDA to return to a previous administration of the drug, the government argues there is no easy way to return to these standards. 

“Every extant package of Mifeprex would instantly become misbranded and could not be lawfully introduced into interstate commerce,” Prelogar wrote. “The generic version of the drug, which accounts for most of the market, would cease to be approved altogether. And before Danco could resume introduction of the drug into interstate commerce, FDA would be forced to change the drug’s labeling and other regulatory materials — including by reinstating an obsolete dosing regimen that provides for women to take more of the drug than necessary.” 

GenBioPro — mifepristone’s generic maker — says it supplies two-thirds of the medication used in the U.S. The company filed a separate lawsuit against the FDA earlier this week seeking to keep its version of mifepristone available. 

The doctors claim the FDA violated the law by mailing mifepristone in violation of the Comstock Act — an 1873 law prohibiting “obscene” material from being sent through the mail. 

“Not only did FDA violate the APA, but its actions also run afoul of longstanding federal criminal laws,” Bursch wrote. “The Comstock Act prohibits the mailing or delivery of ‘[e]very article or thing designed, adapted, or intended for producing abortion’ and ‘[e]very article … which is advertised or described in a manner calculated to lead another to use or apply it for producing abortion.’” 

Only one year after passing the law, the government says Congress amended the Comstock Act only to apply to drugs causing unlawful abortion. 

The medication used alongside mifepristone — misoprostol — can be taken alone to induce an abortion. Misoprostol is widely available as it is also used to treat stomach ulcers and prevent postpartum hemorrhages. While the FDA has approved misoprostol alone for abortion use, it is not as effective as when combined with mifepristone. 

Follow @KelseyReichmann
Categories / Appeals, Health, National

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