WASHINGTON — Experts worry two recent rulings challenging the Food and Drug Administration’s regulation of a drug used in medication abortions threaten to complicate the agency’s oversight and the pipeline for future research and drug approvals.
On Friday, Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas suspended the FDA’s approval of mifepristone, which the agency approved more than 20 years ago. The order, which would stop the manufacture and distribution of the drug, will go into effect Saturday without a higher court granting emergency relief.
Separately, U.S. District Judge Thomas Rice in the Eastern District of Washington ruled Friday that the agency should not modify the drug’s regulations as a case challenging the FDA’s risk mitigation restrictions specific to the drug moves forward.
