6 burning questions about how the FDA will handle conflicting abortion pill decisions
The FDA's drug approval process the “should stay as untouched by threats of litigation as possible," I. Glenn Cohen of Harvard said.
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.
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