Pharma

The Supreme Court to weigh in on abortion pill access

The high court is set to consider a case that challenges the federal government’s approval of mifepristone.
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The fight over medication abortion access is heading to the Supreme Court.

Justices announced Wednesday that the high court will consider a case challenging the federal government’s approval of mifepristone, which is used as part of a two-drug regimen in more than half of US abortions.

The move comes about a year and a half after the court overturned its landmark Roe v. Wade decision. It marks the latest battle over abortion access in the US, and with a decision expected to come by next summer, the case will likely ensure that abortion remains a top issue heading into the 2024 elections.

In August, the US Court of Appeals for the 5th Circuit struck down part of a lower court’s ruling that put the FDA’s 2000 approval of mifepristone on hold, but it upheld restrictions on how the drug—which is also known as Mifeprex—could be used and prescribed. Legal experts and industry leaders widely expected the case to head to the Supreme Court because of a prior order from the court that allowed the pill to be sold.

Abby Long, a spokesperson for Danco Laboratories, said the company behind Mifeprex is “gratified” that the court will review the August decision, which it believes is “inconsistent with established Supreme Court principles governing standing and administrative law challenges.”

“Danco continues to be at the forefront of this fight and is working closely with the reproductive rights community and pharmaceutical industry to support the changes made by FDA,” Long said in a statement.

White House spokesperson Karine Jean Pierre said the Biden administration “will continue to stand by FDA’s independent approval and regulation of mifepristone as safe and effective.”

Danco and the Biden administration asked justices to review the case, particularly the appellate court’s decision to allow mifepristone to remain available under restrictions that were in effect before 2016, when the FDA loosened restrictions on who could prescribe the drug and how long into pregnancy it could be used.

The justices declined to hear a challenge of the FDA’s initial approval of mifepristone, the news site SCOTUSblog noted.

Navigate the healthcare industry

Healthcare Brew covers pharmaceutical developments, health startups, the latest tech, and how it impacts hospitals and providers to keep administrators and providers informed.