The Supreme Court in Washington, D.C., is seen on Wednesday, April 19, 2023.
The Supreme Court is expected to weigh in at some point Friday on a challenge to the legality of the abortion pill mifepristone less than a year after the conservative majority overturned Roe v. Wade and ostensibly sent decisions on abortion laws to the states.
The decision could have sweeping ramifications about access to one of the two drugs used as part of the most common method of terminating a pregnancy.
Saga so far
The Biden administration and the company that manufactures a brand-name version of mifepristone have asked the high court to intervene and pause a ruling from U.S. District Judge Matthew Kacsmaryk earlier this month.
Kacsmaryk suspended the Food and Drug Administration’s (FDA) 23-year-old approval of mifepristone, ruling that the agency’s approval process was improperly rushed and resulted in an unsafe drug regimen getting on the market. The order was paused for a week, and the administration appealed.
That same day, a separate judge in Washington state ordered the FDA not to change anything regarding mifepristone access — but only for 17 states and D.C.
The 5th U.S. Circuit Court of Appeals last week preserved the FDA’s original approval of mifepristone as the Biden administration appeals, but it allowed other portions of Kacsmaryk’s decision to go into effect, which blocked steps the FDA has taken since 2015 to ease access to the drug.
The 5th circuit ruling would bar mailing the abortion pills and allow only doctors to prescribe it, along with other additional hurdles to access.
Justice Samuel Alito, who handles emergency requests from the 5th Circuit, issued a temporary pause last Friday. It was set to expire on Wednesday, but he extended it again until 11:59 p.m. Friday.
What comes next
Friday’s ruling likely won’t be the last time the justices will need to decide about mifepristone, but here’s a breakdown of some of the possibilities of what the high court could do:
Option 1: SCOTUS pauses the remainder of Judge Kacsmaryk’s ruling while the appeal proceeds
This is what the White House, Danco Laboratories, the pharmaceutical industry and abortion-rights advocates are asking the high court to do.
It would be a temporary victory for the Biden administration, ensuring mifepristone remains on the market at least until the 5th Circuit’s three-judge panel issues its ruling. The appellate court has scheduled oral argument in the government’s appeal for May 17.
Mifepristone access would remain unchanged, though abortion law experts note access to mifepristone is still limited in many parts of the country.
“Nothing changes for the third of the country that bans mifepristone because it bans all abortions,” said Rachel Rebouché, dean of Temple University Beasley School of Law.
Option 2: The court allows the 5th Circuit ruling to take effect while the appeal continues
This is what the anti-abortion challengers want the Supreme Court to do.
The decision sets up a complicated legal environment for the FDA, providers and the manufacturers of both the brand name and generic versions of the drug.
Those groups warned if the decision were allowed to stand, it would create “regulatory chaos” and put every FDA drug approval decision at risk of being challenged for political purposes.
Danco Laboratories, which makes the brand name version called Mifeprex, wrote in a court filing that it would need to completely change the drug’s packaging and label and then ask FDA to approve it, a process that could take months.
Abortion providers would need to decide whether to offer the drug off label to women further along in their pregnancies, since it would only be approved for use up to seven weeks into a pregnancy.
And the manufacturer of generic mifepristone could see its approval completely invalidated. Making things even more complicated, the generic manufacturer, GenBioPro, sued FDA to preemptively stop the agency from taking its drug off the market in the event the ruling is upheld.
The Biden administration would then take its fight back to the 5th Circuit.
Option 3: The court pauses the remainder of Judge Kacsmaryk’s ruling, takes up the case on its regular docket
Legal experts said they see this option as the least likely, though they said nothing can be ruled out.
“The Fifth Circuit has, of course, already set up an expedited hearing schedule. And so, it’s going to wrestle with issues of standing and issues of the statute of limitations and harm and the like,” said Rebouché, which is why letting the appeal play out without changing the status quo makes sense.
But, she said the conflicting district court decisions add a layer of uncertainty, because the Supreme Court is likely going to need to give some guidance about how the orders intersect or inform each other.
If the Supreme Court decides to take up the case itself, the anti-abortion groups challenging mifepristone’s approval asked the court to go even further.
They said the justices should look at additional questions that could limit impact abortion access even more, including whether the 150-year-old Comstock Act’s prohibition on mailing anything that could produce an abortion extends to mifepristone.
Advocates for abortion access are concerned a majority of the justices would look favorably on reopening the Comstock Act to question what were previously thought of as long-settled reproductive rights, like access to birth control.
Option 4: Something completely different
Alito extended the temporary pause once, and it’s possible he does it again.
The justices could send the case back with instructions to dismiss it outright due to lack of standing.
Legal experts were hesitant to predict what the justices could do, and just because an option makes sense doesn’t mean it’s likely.
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