lifenews.com
2026-10-07
A new peer-reviewed article on the Food and Drug Administration's (FDA) 2021 complete review of mifepristone's Risk Evaluation and Mitigation Strategy (REMS) program provisions found the agency lacked sufficient evidence to justify removal of the in-person dispensing requirement. The paper, authored by Charlotte Lozier Institute (CLI) scholars and published in Issues in Law and Medicine, outlines the FDA's failure to consider the real-world conditions in which the drug would be used and raises concerns about potential bias in the FDA's review process.
The article critically analyzed the FDA's 2021 REMS review and the sources it cited. The analysis highlights the limitations of the FDA's review and finds the evidence did not sufficiently show that removing the in-person dispensing requirement was safe.