Over the years, the FDA has repeatedly removed safeguards around abortion drugs. Its most recent major change removed the requirement to dispense them in person. What evidence did it rely on to decide they were safe for women?
In part one of this two-part episode of OBservations, Dr. Christina Francis is joined by Dr. Ingrid Skop, a longtime friend of the podcast and the new Director of Research at AAPLOG. Her recent peer-reviewed paper critically analyzes the FDA’s 2021 mifepristone REMS modification rationale.
In this episode, we explore:
- Dr. Skop’s background and her new role, her 25 years in private practice, and her work at the Charlotte Lozier Institute. She also explains how AAPLOG’s research rapid response team is pushing back on flawed studies with letters to the editor.
- A timeline of FDA actions on mifepristone.
- What ETASU and REMS mean, and why they matter. The FDA says these requirements are needed to catch missed ectopic pregnancies and heavy bleeding, yet remote dispensing bypasses the pre-abortion testing they call for.
- The FDA’s claim of “no increase in complications” is questionable, since complication reporting was no longer required.
Stay tuned for part 2 next week, as we break down Dr. Skop’s newest, groundbreaking research on the issue with the lack of REMS.
