A dueling pair of federal court decisions has thrown the fate of the abortion pill mifepristone into jeopardy — and left regulators and drugmakers navigating uncharted territory.
The Food and Drug Administration approved the drug more than two decades ago. But that approval — and the agency’s broader authority — was cast into doubt with a decision on Friday by Texas judge Matthew Kacsmaryk which ruled that regulators had erred in letting the medicine onto the market. That long-awaited decision was swiftly followed by a Washington federal court ruling ordering the agency to ensure access to the pill going forward.
The two decisions throw the drug, also used to treat miscarriages, into legal limbo nationwide, regardless of state governments’ abortion protections. They also raise fundamental questions for regulators responsible for overseeing much of the country’s health care, and for the drugmakers that expend time and money to bring countless medicines to the market.
Exciting news! STAT has moved its comment section to our subscriber-only app, STAT+ Connect. Subscribe to STAT+ today to join the conversation or join us on Twitter, Facebook, LinkedIn, and Threads. Let's stay connected!
To submit a correction request, please visit our Contact Us page.