Project 2025 Tracker / What’s done, what’s next

14. Department of Health and Human Services · Minor

Fix FAERS reporting of abortion pill complications

Not started

459 14. Department of Health and Human Services

“Address weaknesses in the current FAERS (FDA Adverse Events Reporting System). The Administration and policymakers should ensure that health care workers, particularly those in hospitals and emergency rooms, report abortion pill complications.”

What has happened

  1. Not started

    FAERS reporting of abortion pill complications is unchanged. The REMS document approved 2025-09-30 still requires prescribers to report only deaths to the sponsor, and no rule, guidance or reporting requirement in the window obliges hospitals or emergency departments to report abortion pill complications. FDA's only in-window action on adverse-event reporting is the routine renewal of the information collection for its Adverse Event and Product Experience Reporting Program (2025-06-25), which changes nothing about what must be reported.

Research log

What was searched, and what didn’t count as evidence

Research notes

  • The Mifepristone Shared System REMS was read directly at REMS@FDA. www.accessdata.fda.gov opened for us even though www.fda.gov and the rest of HHS’s sites did not, which is how these asks were settled from FDA’s own pages without a general web search.
  • The REMS update history shows exactly five modifications since 2019 and one inside the window (2025-09-30, “Modified to add ANDA 216616”).
  • Regulatory agenda, checked 2026-09-01. Checked against the full HHS agenda on reginfo.gov (183 active RINs in the 2026 Unified Agenda, published 2026-08-14), not the abbreviated version the Federal Register prints. The nearest entry is recorded here; it does not name this ask’s object, so the Status is unchanged — an agenda entry that states a general goal in the ask’s subject area does not move the Status.
    • FDA’s two adverse-event entries are 0910-AI61 (Postmarketing Safety Reporting Requirements, Pharmacovigilance Plans, and Pharmacovigilance Quality Systems, NPRM 07/2026) and 0910-AI30 (Adverse Drug Experiences on Marketed Prescription Drugs … Without Approved New Drug Applications, NPRM 11/2026). Both rewrite what application holders must report to FDA; neither names FAERS’s handling of abortion-pill complications, and neither puts any reporting duty on hospitals or emergency departments. “Mifepristone”, “Mifeprex” and “REMS” appear in none of the 183 entries.
Action
other
Object
FDA Adverse Events Reporting System (FAERS)
ID
1236