When ending these regulations, the FDA cited its adverse event (AE) reporting data. The FDA claimed that the safety risks were low enough that the change was justified. The issue with this logic is that AE data was coming directly from the abortion pill's manufacturer, Danco Laboratories. Planned Parenthood would report AE's to Danco, and Danco would report events to the FDA.
This is problematic because the abortion pill manufacturer can control the information that the FDA receives regarding the safety of its product. It is also notable that Danco has not been required to report any complications other than death since 2016.
The AAPLOG study used 2009-2010 data from the FDA's reporting system, actual adverse event reports obtained through the Freedom of Information Act, and previous studies utilizing Planned Parenthood data. After going through the data, AAPLOG found that the number of AE's reported by Planned Parenthood was significantly higher than the number reported by Danco to the FDA.
The study found that 1,530 AE's were reported by Planned Parenthood in 2009 and 2010. In that same period, the FDA Adverse Event Reporting System (FAERS) only recorded 664 AE's. This data suggests that over half of abortion pill complications reported by Planned Parenthood were not reported to the FDA.
Now, the FDA has ended regulations limiting the distribution of the abortion pill. In many states, it can legally be sent through the mail without first visiting a doctor in person. In making this decision, the FDA seemingly consulted flawed information.
