Peer-Reviewed Article: FDA Lacked Evidence to Drop In-Person Abortion Drug Requirement
New article shows FDA lacked justification for concluding safety of in-person dispensing requirement for mifepristone
Washington D.C. — 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.
Key Findings
- The FDA’s evidence didn’t justify removing the in-person dispensing requirement. The studies cited failed to adequately reflect real-world conditions in which the abortion drugs are used. Most of the studies included in-person exams, bloodwork, or ultrasounds before dispensing the drugs, all screenings which may not occur when drugs are available online. The FDA itself admitted the cited studies on their own were inadequate to demonstrate safety of mail-order for abortion drugs.
- The FDA’s analysis showed differential treatment of external stakeholder input, reflecting possible bias. The FDA cited or relied on letters, clinical guidance, and other input from groups with financial or political incentives to support a weakened REMS during the review, but input from groups concerned about the risks associated with mifepristone was largely excluded from the review.
- The FDA relied on inadequate adverse event reporting. In 2016, the FDA removed mandatory reporting of serious, non-fatal adverse events resulting from mifepristone. Additionally, the CLI paper notes the frequent guidance given to women to misrepresent their experience as a miscarriage if seeking treatment after taking mifepristone. This gap in complication reporting and miscoding of post-abortion treatment left regulators largely dependent on voluntary reports that fail to detect many real-world harms. Yet the FDA pointed to a limited number of complication reports as part of its justification for relaxing the REMS.
Dr. Ingrid Skop, CLI medical expert, board-certified OB-GYN, and co-author of the article, said:
“When federal agencies remove regulations designed to safeguard patient health, those decisions should be grounded in evidence that reflects real-world practice. Our analysis found that the FDA’s review fell well short of that standard. Safety decisions should reflect the conditions in which women are using the drugs, not tightly controlled study conditions that fail to mimic real-world use.”
Zachary Sluzala, CLI’s director of policy research and co-author of the article, said:
“This study is the first in-depth analysis of the evidence the FDA used to justify removing the in-person dispensing requirement for mifepristone. The FDA relied on studies that do not generalize to real-world conditions, and on complication reporting systems that are plagued by overarching limitations, in part due to previous deregulation. Our findings raise important questions about the scientific basis of the agency’s decision.”
Charlotte Lozier Institute was launched in 2011 as the education and research arm of Susan B. Anthony Pro-Life America. CLI is a hub for research and public policy analysis on some of the most pressing issues facing the United States and nations around the world. The Institute is named for a feminist physician known for her commitment to the sanctity of human life and equal career and educational opportunities for women.
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