The U.S. Supreme Court says it will review a lower court decision that would make mifepristone less accessible, in a hearing set for next year.
If SCOTUS upholds the lower court ruling, the access restrictions on mifepristone that were eased in 2016 would be reinstated.
In 2016, in an effort to make the drug more accessible, the FDA changed the drug's REMS program. These changes increased the maximum gestational age to 70 days, eliminated the in-person dispensing requirement, allowed non-doctors to prescribe and administer mifepristone, and eliminated reporting of non-fatal adverse events.
Following the radical April ruling by a U.S. District Court Judge in Texas that suspended the FDA approval of mifepristone, SCOTUS weighed in, saying that mifepristone would have to remain available under the current rules until the appeals process played out. Then, in August, the 5th Circuit Court of Appeals in New Orleans ruled that while mifepristone should remain legal in the U.S., there should be significant restrictions on patient access — reverting to the 2016 requirements.
This past September, the DOJ and Danco Laboratories filed petitions for writ of certiorari asking the Supreme Court to review the August ruling by the Fifth Circuit. Now, the Court announced that it will hear the issue, consolidating the cases from Danco and the Biden administration.
