No matter the season, AAPLOG will never stop fighting for our patients, born and preborn, and you, our members, who are dedicated to life-affirming healthcare.
That is why AAPLOG, in conjunction with the Charlotte Lozier Institute (CLI), submitted a joint citizens’ petition urging the FDA to ensure its current safety review of mifepristone is conducted thoroughly and transparently for the public, based on relevant, accurate data, and reviewed by outside experts.
AAPLOG has concerns, based on the FDA’s update report on the review to a Louisiana court, that the database being used is not only insufficient but potentially does not even evaluate complications in the most crucial years since the in-person dispensing requirement was removed. An insufficient and limited safety review is not only bad for our patients, but it also neglects the FDA’s duty to inform us as medical professionals and the American public of the true safety profile of approved medications. In our petition, we ask the FDA to consider our detailed concerns and suggestions in earnest and, while it proceeds with a review, implement our suggestions for the health and safety of women nationwide.
These are the immediate actions we’re asking the FDA to take:
- Conduct a safety review based on accurate, relevant data. The FDA reports that their main data source is Sentinel. This database critically does not include Medicaid data after 2021 – the year that the in-person dispensing requirement was removed. This missing data is the MOST crucial in looking at the safety of the current dispensing regime.
- Conduct a safety review evaluated by experts from both sides of the abortion issue who have studied mifepristone to evaluate the FDA’s findings and encourage scientific and public transparency.
- Conduct a safety review with transparency about the FDA’s study design, methodology, data sources, data volumes, and primary researchers.
Read the full citizen petition. We will keep you update on the FDA’s response.
