Supreme Court protects access to widely used abortion drug

The Supreme Court handed a win to the defenders of the medication abortion drug mifepristone by pausing lower court rulings that would have disrupted access to the drug as a result – from a lawsuit filed by anti-abortion doctors seeking to wipe away the US Food and Drug Administration's two-decade-old approval of mifepristone. 

That means FDA's current regulatory scheme around the drug remains in place, ensuring that access to medication abortion — in the states where it is legal — is maintained at least for the next couple weeks, and likely longer. 

What comes next in the case? 

There is much still to play out in the litigation and Friday's Supreme Court order is unlikely to be the justices' final word on the FDA's approach to regulating the drug. 

The case now travels back to the Fifth Circuit federal appeals court, which has set an expedited briefing schedule to give a fuller review of Kacsmaryk's ruling. A three-judge panel from the Fifth Circuit will hold a hearing on May 17 and issue another decision sometime after. (There is no deadline for the Fifth Circuit to rule.)

The majority of judges on the Fifth Circuit are conservative, but it is unknown who the three judges will be. Notably, the three judges who will hear that step of the appeal will likely be different from those that issued the appellate order last week. 

The Supreme Court's Friday order maintains the status quo around the drug's regulations until that Fifth Circuit process plays out and until the justices have another chance to weigh in on how it handled the case. 

What do we know about how the justices are thinking about the dispute? 

The Supreme Court did not show its cards in the order it issued Friday night. 

While Justices Clarence Thomas and Samuel Alito made their dissents public, it is not otherwise clear how the justices voted or what the exact vote count was. The support of five justices is required for the court to grant a stay.

Only Alito wrote additionally to explain his dissent and stressed he was not expressing any views on the merits of whether the FDA broke the law in how it approached mifepristone. 

Instead, he aired grievances about how the Supreme Court's conservative majority has been criticized for handling the emergency disputes — on its so-called shadow docket — in the past. He also cast doubt on the claims by the government and the manufacturer that the Fifth Circuit order would have caused mass disruption to access to the drug. 

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Justice Samuel Alito, in his dissent Friday, said he voted to deny the request for a stay because the Fifth Circuit federal appeals court has scheduled such an expedited hearing on the merits of the dispute.

He suggested that allowing the restrictions to remain in place would not lead to “any real harm during the presumably short period at issue.”

Alito wrote that the stay would not “remove mifepristone from the market” but would have simply restored “the circumstances that existed” from the time the drug was approved in 2000 to when the FDA passed new regulations to ease access to the pill starting in 2016.

No other justice joined his dissent.

It’s almost guaranteed the case on medication abortion restrictions will land back before the justices of the Supreme Court after Friday's order protected access at least until legal appeals play out.

The next step in the litigation will be a hearing in front of the New Orleans-based Fifth Circuit federal appeals court on May 17. Regardless of that outcome, it is very likely the losing side will appeal again to the Supreme Court.

“The case could well come back to the justices once the Fifth Circuit rules,” said Steve Vladeck, CNN Supreme Court analyst and professor at the University of Texas School of Law.

But nothing will change in regard to access to mifepristone unless the justices decide to consider the lawsuit's merits and then side with the challengers, Vladeck continued.

“That’s not going to happen for a long time – if ever,” he said. 

Reaction poured in Friday evening from Democratic officials and lawmakers after the Supreme Court issued an order protecting access to a widely used abortion drug until the legal appeals process plays out.

Here's what some had to say:

Senate Majority Leader Chuck Schumer: The New York lawmaker issued a statement saying, "extreme MAGA Republicans will continue to pursue their nationwide abortion ban until they impose their anti-choice agenda on all Americans."

"Democrats won’t stop fighting and we will prevail," Schumer vowed.

California Gov. Gavin Newsom: "For now, the Court has followed science, data, and the law rather than an extreme and out of touch political agenda. Medication abortion is available and accessible here in California and we will continue to fight to protect people’s freedom to choose," Newsom wrote in a statement.

HHS Secretary Xavier Becerra: "Today's action from the Supreme Court is an important step in the right direction as we vigorously fight to defend the FDA’s independent, expert authority to review, approve, and regulate a wide range of prescription drugs," the secretary for the US Health and Human Services Department said in a statement. "We are confident the law is on our side and remain focused on prevailing in court." He added: "We will never stop fighting to preserve women’s rights to access the health care they need and Americans’ rights to access safe and effective medicine."

North Carolina Gov. Roy Cooper: "We must not be complacent as we continue to fight the legal and political attacks on women's health and freedom," Cooper tweeted Friday.

New York Gov. Kathy Hochul: "We will continue the fight to protect reproductive rights and keep New York a safe harbor for all," Hochul tweeted. "Under my watch, abortion — including medication abortion — will always be protected and available in New York."

Michigan Gov. Gretchen Whitmer: "We need to be clear about why this case came before the court in the first place: a fringe, extreme minority that refuses to follow science or respect Americans’ freedoms is judge shopping to impose their agenda on women," Whitmer tweeted.

Illinois Gov. JB Pritzker: "The Justices have recognized that this safe, tested drug should continue to be available to provide the gold standard of reproductive care and not be restricted based on a single ruling by an ideologically motivated judge," Pritzker tweeted.

A lawyer for the group of doctors that brought the abortion drug lawsuit downplayed Friday's Supreme Court order that protects access to the pill at least until appeals play out.

As the case moves forward in federal appeals court, Baptist said the FDA “must answer for the damage it has caused to the health of countless women and girls and the rule of law by failing to study how dangerous the chemical abortion drug regimen is and unlawfully removing every meaningful safeguard, even allowing for mail-order abortions.”

About the drug's safety: Data analyzed by CNN shows mifepristone, the medication abortion drug at the heart of the Texas abortion lawsuit, is even safer than some common, low-risk prescription drugs, including penicillin and Viagra.

Medication abortion has become the most common method for abortion, accounting for more than half of all US abortions in 2020, according to the Guttmacher Institute.

Vice President Kamala Harris applauded a Supreme Court ruling Friday temporarily protecting access to mifepristone, a medication abortion pill.

Prior to the ruling, Harris said in an interview airing on Telemundo Friday that the wave measures in red states restricting access to abortions could "criminalize doctors and nurses."

The American College of Obstetricians and Gynecologists praised the US Supreme Court’s order to freeze a lower-court ruling that would restrict access to a medical abortion drug but said the legal battle has created confusion for healthcare providers.

Even though the Texas federal judge's ruling has been on hold for the past several weeks, meaning that mifepristone has been available, the back and forth has left "clinicians uncertain as to whether and where they could prescribe the medication for abortion and miscarriage management,” said Iffath Abbasi Hoskins, the president of the American College of Obstetricians and Gynecologists, and Maureen G. Phipps, the CEO of the American College of Obstetricians and Gynecologists.

In light of the US Supreme Court protecting the use of mifepristone, Planned Parenthood is warning that while the drug will stay on the market for now, its availability to millions of women should not "be at the mercy of the court system."

Critics argue that if the original ruling by a federal judge in Texas is upheld – along with the Fifth Circuit’s limitations on the use of mifepristone – it would validate a decision of a single judge or panel with no medical expertise over standards of science and clinical analysis.

Mifepristone has been safely prescribed since the FDA approved it two decades ago. But anti-abortion doctors and medical associations argued in the case that the agency violated the law in how it approved the drug for abortions in 2000.

"Planned Parenthood will continue to fight so that everyone can make their own decisions about their bodies, lives, and futures," Johnson said.

The immediate effects of the Supreme Court's order on medication abortion access is a return to the status quo, said Elizabeth Cohen, CNN's senior medical correspondent.

The order means that the US Food and Drug Administration’s approval of the drug mifepristone will remain in place while appeals play out, potentially for months to come. Mifepristone is the first of a two-drug combination used in the majority of abortions in the US, and also used off-label to treat miscarriages.

Cohen said Friday's order clears things up for doctors who had been navigating their care decisions based on "haphazard, random decisions on a Friday night," referring to previous rulings that put the drug's access in doubt.