SCOTUS unanimously upholds abortion drug access
14 Jun 2024
Drug ApprovalAccelerated Approval
The U.S. Supreme Court unanimously upheld the availability of mifepristone, rejecting a lawsuit that sought to challenge the FDA's rules for prescribing and dispensing the abortion medication.
This decision marks the court’s first major ruling on abortion since conservative justices overturned Roe v. Wade two years ago. The court determined that the plaintiffs, anti-abortion doctors and their groups, lacked the legal standing to challenge the FDA’s approval and regulations of mifepristone. This ruling preserves access to the medication nationwide, including in states where abortion is still legal.
Currently, 14 states have total abortion bans, and three others prohibit abortion after about six weeks of pregnancy, often before women know they are pregnant. Justice Brett Kavanaugh, who voted to overturn Roe, wrote in the court’s opinion on mifepristone that “federal courts are the wrong forum for addressing the plaintiffs' concerns about FDA’s actions.”
The mifepristone case began soon after the Supreme Court overturned Roe v. Wade, with an initial ruling by a Texas judge to revoke the drug’s approval. The 5th U.S. Circuit Court of Appeals upheld the FDA’s original approval but sought to reverse the relaxed regulations, a move paused by the Supreme Court.
In 2016, to enhance accessibility, the FDA updated the drug's REMS program. These revisions extended the maximum gestational age to 70 days, removed the requirement for in-person dispensing, permitted non-doctors to prescribe and administer mifepristone, and stopped the reporting of non-fatal adverse events.
After a U.S. District Court Judge in Texas issued a radical ruling in April that suspended the FDA's approval of mifepristone, SCOTUS stepped in, asserting that mifepristone must remain available under the existing rules until the appeals process was complete. In August, the 5th Circuit Court of Appeals in New Orleans decided that while mifepristone should stay legal in the U.S., there should be significant restrictions on patient access, reverting to the 2016 requirements.
Just a few weeks ago, the Louisiana House approved a bill adding mifepristone and misoprostol to the state's list of controlled dangerous substances.
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