In the Press
December 12, 2022

What Will FDA Do In Battle Over Medication Abortion Access? (Pink Sheet)


The FDA is facing growing pressure from both those who want to expand access to medication abortion and those seeking to restrict or ban its use. As a result, the agency must address questions about the scope and enforcement of its Risk Evaluation and Mitigation Strategy (REMS) for mifepristone and how it responds to challenges of product approvals. Susan Lee, a Life Sciences and FDA partner, noted that well-meaning individuals and organizations are violating the mifepristone REMS requirements that those prescribed the medication get advice from a healthcare professional and that the medication be distributed by specified healthcare providers or certified pharmacies. “There have been well publicized and growing initiatives to make medication abortion available that really are overt violations of FDA’s regulatory framework,” Lee said, while speaking with Pink Sheet.