The Supreme Court on Friday maintained access for a widely used abortion pill while a challenge to the Food and Drug Administration's approval plays out.
Why it matters: The ruling, which stays a lower court decision striking the drug's approval, comes less than a year after the justices overturned Roe v. Wade, ending federal protections on abortion.
What this means: Access to mifepristone, one of two drugs used in the most common regimen for medication abortion, will remain unchanged while the case continues to wind through the courts.
State of play: The Supreme Court returned the case, which originated in a U.S. district court in Amarillo, Texas, to the New Orleans-based 5th Circuit Court of Appeals.
- In doing so, justices fully stayed U.S. District Court Judge Matthew Kacsmaryk's March ruling, which not only added restrictions to mifepristone, but also halted the FDA's overall approval of the drug, which was granted in 2000.
- The 5th Circuit had partially blocked Kacsmaryk's ruling, saying that the 2000 approval could stand, but reinstated limitations that the FDA had lifted over the years, including an in-person dispensing requirement.
- Had the Supreme Court not issued its Friday order, the limitations would have taken effect at midnight on Saturday
By the numbers: Medication abortions account for 54% of abortions in the U.S., and 98% of those used mifepristone.
The big picture: The Supreme Court's latest ruling, for now, stops what would have been an unprecedented court-ordered rollback of FDA powers.
- Legal experts say that if a court eventually orders the agency to withdraw its approval of mifepristone, other FDA drug approvals could be challenged by people who disagree with them.
- PhRMA, a top drug industry trade group, called the developments a "welcome step," adding: "Allowing the courts to second-guess a decision by the FDA to approve a medicine would create significant uncertainty and harm for manufacturers, patients and physicians."
The other side: Justices Samuel Alito and Clarence Thomas publicly dissented, although the latter did not write a dissent.
- Alito wrote that the Biden administration and Danco Laboratories, maker of the brand-name version of mifepristone, "are not entitled to a stay because they have not shown they are likely to suffer irreparable harm."
- The justice said the FDA leveraged the federal ruling from a U.S. district court in Washington state, which separately prohibited the agency from rolling back access to mifepristone, "'as a basis' for implementing a desired policy while evading both necessary agency procedures and judicial review."
What they're saying: "As is common practice, the Supreme Court has decided to maintain the status quo that existed prior to our lawsuit while our challenge [...] moves forward," said Erik Baptist, senior counsel for Alliance Defending Freedom, which represents the anti-abortion groups that brought the initial lawsuit challenging the FDA approval.
- "The FDA must answer for the damage it has caused," Baptist added. "We look forward to a final outcome in this case that will hold the FDA accountable."
What we're watching: The justices' ruling is not a final decision on the case. The case could return to the Supreme Court, though an appeal would not be heard until next term.
- That means arguments before the court would play out as the 2024 campaign cycle hits a crescendo, with both abortion and courts as top-tier issues.
Don't forget: Last year, in striking down Roe, the justices argued that the Supreme Court did not have the authority to create national abortion policy.
- Alito wrote in the opinion that the court could not regulate abortion, adding that that power rested with the "people and their elected representatives."
Of note: GenBioPro on Wednesday sued the FDA to prevent its generic version of mifepristone from being removed from the market.
Editor's note: This story has been updated with additional details throughout.
