(WASHINGTON) — The Supreme Court on Wednesday was expected to decide whether to wade into a legal challenge to the Food and Drug Administration’s approval of the abortion pill, a case that could restrict access to the drug mifepristone nationwide — even in states where abortion is legal.
If the Supreme Court agrees to take up a Texas judge’s ruling that threatened to pull the drug from the market, it would be the second time in less than a year that the high court will deal with limits to abortion access, potentially paving the way for another blockbuster ruling this summer that could dramatically change how drugs are approved in the U.S.
“It is not a stretch to say that a judge can wake up in the morning and decide that they want to take a certain medication off the market,” including vaccines or anti-depressants, if the lower court rulings stand, said Josh Sharfstein, former principal deputy commissioner at the FDA.
The case has deeply divided the country, with Republican governors and lawmakers lining up behind the conservative plaintiffs in the case.
“Fundamentally, chemical abortion drugs pose serious health and safety risks to women and girls,” states a brief filed with the Supreme Court, signed by nearly 150 Republican lawmakers including Senate Minority Whip John Thune of South Dakota, Senate Republican Conference Chairman John Barrasso of Wyoming, and House Majority Leader Steve Scalise of Louisiana.
On the other side are Democratic governors, lawmakers and the nation’s largest medical associations, as well as hundreds of pharmaceutical executives and companies. They note mifepristone has been widely available for 23 years — used by an estimated five million women and accounting for more than half of all abortions in the US.
“There is a greater risk of complications or mortality for procedures like wisdom-tooth removals, tonsillectomies, colonoscopies, and plastic surgeries, than by any abortion method (medication or procedural),” the American Medical Association and American College of Obstetricians and Gynecologists, wrote in a court brief.
FDA Administrator Bob Califf was scheduled to testify before a Senate panel Wednesday, where he was expected to field questions about the drug’s safety.
Mifepristone is the sole drug approved by the FDA to end early pregnancies, typically given along with second drug misoprostol that helps empty the uterus.
Since the drug’s 2000 approval, the FDA later expanded access, greenlighting a generic version of the drug and allowing it to be given up to 10 weeks of pregnancy instead of seven and provided via telehealth and the mail.
The drug’s rise in popularity and widespread accessibility has made it a target of the anti-abortion rights movement. Last fall, the conservative legal group Alliance Defending Freedom sued the FDA, insisting that federal regulators ignored critical safety concerns during the drug’s 23 years on the market.
Earlier this month, the 5th Circuit Court of Appeals ordered the FDA to roll back its rules on the drug — only allowing the drug to be given to patients up to seven weeks of pregnancy instead of 10 after three in-person doctor visits and prohibiting it from being mailed.
The Biden administration appealed, and Justice Samuel Alito issued an administrative five-day stay of the ruling — keeping the FDA’s current rules on the drug in place through the end of the day Wednesday until the high court has a chance to consider how to address the case.
If the Supreme Court decides to weigh in, it is expected the justices also would decide Wednesday whether to keep the 5th Circuit ruling on hold — preserving the status quo — while the legal challenge plays out.
Depending upon what the Supreme Court decides, access to the abortion pill could potentially be severely restricted or even eliminated, including in states where abortion is legal — at least until the case has a chance to wind its way through the legal process.
Complicating the issue is an opposing ruling by a federal judge in Washington who ordered the FDA to keep the drug on the market under its current rules. Danco Labs, which makes the brand-name version of the drug Mifeprex, said the dueling rulings if left unaddressed would create “regulatory chaos.”
The company also warns that if left in place, the 5th Circuit ruling would result in all doses of mifepristone being “misbranded” because the labeling would no longer comply with the approval standard.
Adjusting the drug’s labeling “could take months,” they say, resulting in a stop of production.
The 5th Circuit ruling also would invalidate the 2019 FDA approval of the generic version of the drug — an estimated two-thirds of the market.
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