The FDA says the evidence supported removing the in-person dispensing requirement for mifepristone. Dr. Ingrid Skop explains how the studies behind that decision show the opposite.
In part 2 of this conversation, Dr. Christina Francis continues her discussion with Dr. Ingrid Skop about a paper she co-authored that critically reviews the studies the FDA cited when it dropped the requirement. The findings raise serious concerns.
Learn:
- Why follow-up gaps matter, with some studies losing 30, 50, even 70 percent of women, and why she says complication reporting is incomplete.
- The issues with the largest study the FDA relied on, from the UK’s Pills by Post program.
- Why both Drs. Francis and Skop say the FDA’s adverse event reporting system was not designed to establish complication rates.
- How a colleague’s comparison of three data sources suggests it captures far less than 10 percent of actual complications.
This is essential listening for clinicians, policy watchers, and anyone who wants to understand the evidence behind the debate over how mifepristone is dispensed, how safeguards affect women’s healthcare, and why this conversation matters now.
