Jan 24, 2024 - Health

DOJ tells SCOTUS curbing abortion pill access "threatens profound harms"

Packages of mifepristone tablets at a family planning clinic in Rockville, Maryland. Photo: Anna Moneymaker/Getty Images

The Biden administration told the U.S. Supreme Court Tuesday that a lower court's decision to curtail the widely used abortion pill mifepristone would have "disruptive consequences" for women and the FDA if it's allowed to stand.

The big picture: The Supreme Court has agreed to review the New Orleans-based federal appeals court's ruling — setting the stage for another significant abortion case following its June 2022 decision to end federal abortion protections and overturn Roe v. Wade.

  • The case also represents a direct challenge to the Food and Drug Administration's power to regulate drugs, Axios' Adriel Bettelheim notes.

Driving the news: Mifepristone maker Danco Laboratories and the Department of Justice asked justices in September to review the 5th U.S. Circuit Court of Appeals' finding that the FDA didn't take into account safety concerns when it made the pill more easily accessible in 2016.

  • Lawyers for both the federal government and Danco filed briefs Tuesday outlining arguments supporting FDA changes including extending when the drug could be used (from seven weeks into pregnancy to 10 weeks) and allowing patients to get the medication by mail.
  • "FDA's 2016 changes to mifepristone's approved conditions of use were supported by an exhaustive review of a record including dozens of scientific studies and decades of safe use of mifepristone by millions of women in the United States and around the world," attorneys for the Department of Justice said in their filing.

Zoom in: The 5th U.S. Circuit Court of Appeals' ruling "threatens profound harms to the government, the healthcare system, patients, and the public," per the DOJ filing.

  • "The loss of access to mifepristone would be damaging for women and healthcare providers around the nation," the attorneys wrote.
  • "For many patients, mifepristone is the best method to lawfully terminate their early pregnancies. They may choose mifepristone over surgical abortion because of medical necessity, a desire for privacy, or past trauma."

Meanwhile, lawyers for Danco argued in their brief that the lower court's decision "threatens to destabilize the pharmaceutical industry, which relies both on FDA's ability to make predictive judgments."

State of play: Mifepristone remains available under an order the Supreme Court issued in April maintaining the status quo, pending the outcome of legal challenges.

What we're watching: The Supreme Court has yet to announce a date for oral arguments in the case.

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