U.S. Supreme Court temporarily blocks limits to abortion pill access
The FDA approved mifepristone under the brand-name Mifeprex in 2000, and an abortion-drug regimen that has seen few deaths and a low rate of adverse events in more than two decades of use. Peter Dazeley/Getty Images
WASHINGTON — U.S. Supreme Court Justice Samuel Alito has temporarily halted any changes in access to the abortion medication mifepristone from taking effect until Wednesday at midnight.
The one-page order from Alito, issued late Friday afternoon, will block for now the April 7 ruling from the U.S. District Court for the Northern District of Texas that suspended the U.S. Food and Drug Administration’s 2000 approval of mifepristone.
That was set to take effect Friday at midnight. However, in 17 states and the District of Columbia, the Texas ruling was in conflict with a separate ruling from the U.S. District Court for the Eastern District of Washington, where a judge ruled that the FDA couldn’t change access to mifepristone.
The 5th Circuit Court of Appeals in New Orleans had moved to partially block the Texas district court’s nationwide ruling from taking effect following an appeal from the federal government and manufacturer of the brand-name abortion pill, Danco Laboratories.
That ruling, from the three-judge panel, would have allowed mifepristone to stay on the market, though it would have required doctors to prescribe and administer the medication under guidelines that were in place before 2016.
The federal government and Danco Laboratories rejected that decision from the appeals court and appealed to the U.S. Supreme Court on Friday morning.
Solicitor General Elizabeth Prelogar wrote in the federal government’s appeal to the Supreme Court that the 5th Circuit’s partial stay would immediately “render all extant doses of mifepristone misbranded because their labeling would be inconsistent with the operative conditions of approval.”
“The generic version of the drug would cease to be approved altogether,” she added.
GenBioPro, Inc., the maker of the generic abortion pill, wrote in a brief to the Supreme Court the 5th Circuit’s partial stay “illustrates the essential folly and manifest danger of allowing federal drug approvals to be decided through nationwide injunctions rendered by individual district courts based on the claims of particular private litigants.”
GenBioPro also noted that about two-thirds of all medication abortions in the country use their generic version of the abortion pill.
The pre-2016 prescribing instructions for medication abortion, a two-dose regimen that includes misoprostol, would have reduced the ceiling for use from 10 weeks gestation to seven weeks.
It would have required only doctors to prescribe and administer it as opposed to other health care providers with licenses to prescribe pharmaceuticals. It would have required patients attend three in-person visits, banned telehealth and ended dispensation of the medication by mail.
Alito wrote in the order that “any response to the application be filed on or before Tuesday, April 18, 2023, by 12 p.m.”
NARAL Pro-Choice America President Mini Timmaraju said in a statement in reaction to Alito’s order that “while medication abortion remains legal for now, this case should never have been heard in the first place.”
“Nothing about the rulings from the lower courts’ Trump-appointed judges had any basis in medical science — both are steeped in reckless disinformation and total disregard for the law,” Timmaraju said. “As this case continues, safe and effective medication abortion in all 50 states is at severe risk.”
Alliance Defending Freedom Senior Counsel Erin Hawley said in a statement that Alito’s “brief administrative stay is standard operating procedure whenever the Supreme Court is asked to consider an emergency request like this one.”
“It gives the court sufficient time to consider the parties’ arguments before ruling,” Hawley said. “We look forward to explaining why the FDA has not met its heavy burden to pause the parts of the district court’s decision that restore the critical safeguards for women and girls that were unlawfully removed by the FDA.”
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