On July 19, AAPLOG responded to a citizen petition filed by the American College of Obstetricians and Gynecologists (ACOG), the Society for Family Planning, and the Society for Maternal Fetal Medicine on the safety of mifepristone and asking for the high-risk drug to be removed from the Risk Evaluation and Mitigation Strategies (REMS) program. In their petition, the medical associations make several ideologically motivated claims and ignore the wealth of evidence on the dangers of mifepristone, particularly in the way it is currently being dispensed with essentially no medical oversight.
In our response, we highlight a few disturbing points made by ACOG, such as that the deaths of women after taking mifepristone are “extraneous” and “irrelevant”. As we point out in our response, this language
does not align with the excellent healthcare American women deserve. It ignores the reality that dozens of families mourn the loss of a loved one from a drug given for an elective indication and that they were assured was safe. Additionally, this kind of characterization by organizations that claim to care for women and their healthcare is problematic and troubling. Before any new action is taken regarding mifepristone, the FDA must conduct an impartial analysis of real-world data to assess the drug’s safety and true complication rate.
We also respond to the claim that eliminating in-person dispensing had no impact on complication rates:
[This] claim cannot be fully defended because there is not required reporting for all adverse events. Many studies comparing the two methods of distribution are plagued by large numbers of women lost to follow-up for whom outcomes and complications are unknown. Additionally, these abortion industry studies did not replicate the conditions of use the FDA has allowed.
To supplement our response, AAPLOG also submitted a copy of our 2019 citizen petition that asked for the reinstatement of the original REMS requirements for mifepristone. This citizen petition reveals that ACOG’s advocacy for unregulated mifepristone, which opens the door to dangerous self-managed abortions, contradicts its own clinical guidelines: “ACOG acknowledges that drug-induced abortion is contraindicated for patients who ‘are not available for follow-up contact or evaluation.’”
You can read our full response here.
It is crucial that the FDA hear from you as well about the complications you are seeing related to unregulated mifepristone! You are able to make a public comment on ACOG’s citizen petition by filling out the form at this link. Here is more info on how to submit a comment:
- When you click the link above, you’ll see the “Comment” button. Here you’ll input a comment and/or an attachment (if your comment is longer than 5,000 characters or there are other documents you’d like to attach).
- Make sure to list the docket number in your comment: FDA-2025-P-0377-0001
- Your comment can be as concise or extensive as you’d like. It can briefly address your concerns and opposition, or more broadly explain your stance. Up to you!
- Make sure you mention that you are a medical professional, even if you don’t feel comfortable with fully listing your credentials.
- You’ll also need to input a little information about yourself, or check that you are submitting Anonymously.
- If you decide to list your name, remember that your comment can be publicly accessed!
Share your medical expert opinion today to help protect your patients!
