Boston Globe | Supreme Court blocks enactment of abortion pill restrictions

By Lissandra Villa de Petrzelka and Jessica Bartlett
Story Originally Appeared in the Boston Globe

WASHINGTON — The Supreme Court on Friday maintained access to a drug used to terminate pregnancies, blocking restrictions for now that would have been put in place by a lower court.

The highly anticipated order means access to a drug used to terminate pregnancies will remain broadly available while a challenge to its legality plays out, protecting rather than further curtailing abortion access.

The court’s order is a relief to abortion access advocates, who were already operating in a landscape where multiple states have dramatically rolled back access after the Supreme Court overturned Roe v. Wade last June. The issue reached the Supreme Court by way of a lawsuit in Texas, where antiabortion activists argued that the Food and Drug Administration erred in approving the drug, mifepristone, for abortion use.

Erik Baptist, senior counsel to the Alliance Defending Freedom, which represents the antiabortion plaintiffs in the case, called the stay from the Supreme Court “common practice” to “maintain the status quo” as the case plays out. “We look forward to a final outcome in this case that will hold the FDA accountable,” Baptist said in a statement.

In a statement, President Biden reiterated his support for the FDA and pledged to “continue to fight politically driven attacks on women’s health.”

Mifepristone is the first of two drugs used to end early pregnancies through a common and safe regimen, and is also used to manage miscarriages. The medicine’s safety was repeatedly highlighted by abortion access advocates, including the Department of Justice, which argued against curtailing access. Mifepristone was first approved for the purpose of abortions by the FDA in 2000.

On April 7, Judge Matthew Kacsmaryk, a Trump-nominated federal judge with a history of antiabortion positions, released an opinion that would have invalidated the 2000 FDA approval of mifepristone. In his 67-page opinion, Kacsmaryk cast mifepristone as dangerous and notably used rhetoric common among antiabortion activists.

The Biden administration’s first appeal met with limited success, with the appeals court issuing an order that would have invalidated the judge’s underlying order but reset access to mifepristone to 2016 standards. That’s when the FDA began making it more easily available, loosening restrictions such as the length of pregnancy that could be ended using the drug, and scaling back required in-person physician visits.

In its appeal to the Supreme Court, the Department of Justice argued that by ordering the FDA to withdraw approval of mifepristone, the courts would be overturning “a scientific judgment FDA has maintained across five administrations.” It noted that the drug had been used safely by millions of people, and to remove it would “upset” a health care system that has relied on its availability for more than two decades.

The maker of mifepristone, Danco Laboratories, also appealed, arguing in its filing to the court that it would be “irreparably” harmed by the appeals court order, making the company “unable to both conduct its business nationwide and comply with its legal obligations.”

As the lawsuit has played out across the courts, interested parties poured in with amicus briefs, from lawmakers, medical professionals, and others. A major point of concern for many, including the pharmaceutical industry, was that not only would this lawsuit restrict access to abortion further, but it would also open the door for challenges to the FDA approval process of many other drugs.

The decision Friday included two dissenters, Justices Samuel Alito and Clarence Thomas. Abortion providers praised the order, saying it would preserve access to essential health care for millions of people.

“This is the best case scenario we could have hoped for after the Texas decision and Fifth Circuit decision,” said Dr. Rachel Cannon, an OB-GYN at Boston Medical Center. “And it was unexpected.”

L. Glenn Cohen, a professor at Harvard Law School who signed an amicus brief supporting the FDA in the case, said it was a positive signal for the agency, but noted circumstances could change once the Supreme Court ultimately is asked to review the larger case.

“It’s not 100 percent. The court could hear arguments and make a different decision,” he said. “But compared to an alternative, this is the best the FDA could have hoped for.”

Still, some had a sense of trepidation as the larger case moves on. Rebecca Hart Holder, president of Reproductive Equity Now, a Massachusetts-based advocacy group, said it is impossible to read the tea leaves, given the court’s existing decision to overturn Roe vs. Wade and antiabortion groups’ attempts at a national ban on the procedure.

“We have to be clear-eyed that while we can breathe a sigh of relief now, antiabortion extremists are coming after a national ban. And this attack on mifepristone is part of that,” she said.

The case — as with the broader issue of abortion — has been divisive in Congress. More than 100 congressional Republicans signed on to an amicus brief supporting curtailed access to mifepristone. (Democrats also filed an amicus brief arguing for the opposite result.)

Though Republicans in Congress are broadly antiabortion, the divide was not strictly along party lines. “I disagree with that,” said Alaska Senator Lisa Murkowski, a Republican who supports abortion access, when asked about the brief signed by some of her conference colleagues.

Senator Susan Collins of Maine, who also has a history of supporting abortion rights, told the Globe on Wednesday that she was hoping the Supreme Court would protect access to mifepristone. “This is a drug that has been on the market for 23 years, and used safely by millions of Americans. It’s FDA approved, and I very much disagree with the judge in Texas’s decision,” Collins said.

Meanwhile, in a separate case, officials from several Democratic states and the District of Columbia sued the FDA in a federal court in Washington State to expand access to mifepristone. Though that lawsuit is on a separate track, a federal judge enjoined the FDA from changing availability of mifepristone in the areas involved in the lawsuit while that case plays out. That order came the same day as Kacsmaryk’s, setting up a potential conflict between the two cases. But the Washington court confirmed that the nearly 20 states and D.C. that are party in the suit must maintain access to mifepristone.

For providers and their patients, the mifepristone challenge has been a stressful and confusing situation since the case was first filed late last year. As they waited to hear from Kacsmaryk, providers attempted to preempt potential confusion that could result from court rulings; at least one pointed out that many patients seeking care often do not follow abortion politics until they are seeking care themselves.

There are other safe ways to end pregnancies, including taking the second drug in the regimen — misoprostol — alone, and abortion providers told the Globe they were prepared to switch to that if necessary. Some states, including Massachusetts, had begun to stockpile mifepristone.

Cannon worried the order would do little to clear the confusion caused by all the legal action swirling around the medication.

“Whenever a medication that we know is really safe is brought into a lawsuit, that in general can make people feel scared — why is everyone making such a big deal if this is so safe?” Cannon said. “We know this medication is safe and wouldn’t recommend something that wasn’t. I think we will still be fielding a lot of questions from patients.”