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HHS Orders FDA Review of Abortion Pill Following Controversial Analysis

The directive comes after a disputed study claimed higher complication rates, despite decades of research affirming mifepristone's safety.

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Sen. Josh Hawley speaks during a Senate Homeland Security and Governmental Affairs Committee hearing on Capitol Hill on April 18, 2024, in Washington, D.C.
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Overview

  • HHS Secretary Robert F. Kennedy Jr. has instructed the FDA to conduct a comprehensive review of mifepristone's safety and labeling.
  • The review was prompted by a contested Ethics & Public Policy Center (EPPC) analysis, which claims a nearly 11% serious adverse event rate.
  • Medical experts have criticized the EPPC study as flawed and unreviewed, with over 100 peer-reviewed studies affirming mifepristone's safety and efficacy.
  • Anti-abortion groups are leveraging the EPPC findings to push for reinstating restrictions, including telemedicine bans and earlier gestational limits.
  • Mifepristone, approved in 2000, is used in two-thirds of U.S. abortions and has been a target of ongoing legal and political battles.