The Supreme Court on Friday temporarily blocked lower court orders that would have rolled back the Food and Drug Administration’s approval of an abortion pill—preserving access to the medicine for now.
The decision means that the pill, mifepristone, can still be sent through the mail in the U.S., and used through the tenth week of pregnancy.
This could still change in the coming weeks. The rapid-fire series of decisions that had threatened two decades of clinical practice by obstetricians will be the subject of a series of oral arguments in the coming months, the first before the U.S. Court of Appeals for the Fifth Circuit in mid-May.
The court had been expected to issue an order on the matter on Wednesday, but delayed making a call. It had set a new deadline of 11:59 p.m. Eastern on Friday.
The court’s ultimate decision on what to do about the order from a federal district court judge in Texas has broad implications for reproductive rights in the U.S., for the power of the judicial system, and for the pharmaceutical industry. Drugmakers have said the judge’s call poses a threat to the FDA approval process around which the biopharma industry is built.
In an April 14 order, Supreme Court Justice Samuel Alito paused the implementation of an April 7 ruling by U.S. District Judge Matthew Kacsmaryk that invalidated the FDA’s two-decade-old approval of the drug, called mifepristone. That pause was due to expire on Wednesday; Justice Alito had extended it through Friday.
The Fifth U.S. Circuit Court of Appeals had said on April 12 that Kacsmaryk could not entirely overturn the FDA’s approval of mifepristone, but that he could put certain limits on its use, including banning it from being distributed by mail.
Kacsmaryk’s ruling comes in the context of a lawsuit brought by an antiabortion group challenging mifepristone’s approval. He granted a preliminary injunction to the antiabortion group, which was meant to invalidate the FDA’s approval of the drug while the trial proceeds.
The stakes are high for the biopharma industry. Getting drugs through the FDA approval process is much of what big pharma companies are designed to do. Companies spend hundreds of millions of dollars, and sometimes much more, on trials and tests meant to win approval for their drugs.
Kacsmaryk’s order, a decision by a single judge, presumes to erase an FDA approval that had been based on extensive review by the agency. Allowing that precedent to stand could raise the possibility of judges overturning other FDA approvals, and could throw the entire biopharma apparatus into disarray.
As Barron’s reported last week, antivaccine activists saw Kacsmaryk’s order as a positive sign for their own cause. Antivaccine groups are already in the midst of legal efforts to try to roll back vaccine approvals.
Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com
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