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4mo ago

HHS Orders FDA Review of Mifepristone Amid Debate Over Flawed Safety Study

Reproductive-rights advocates and scientists challenge the validity of a conservative think tank's analysis cited by Robert F. Kennedy Jr. to justify the review.

U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. testifies before the Senate Committee on Health, Education, Labor, and Pensions on Capitol Hill on May 14, 2025.
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Overview

  • HHS Secretary Robert F. Kennedy Jr. directed the FDA to review mifepristone's safety following a report by the Ethics and Public Policy Center (EPPC) claiming a high rate of adverse events.
  • The EPPC study, which is neither peer-reviewed nor published in a medical journal, alleges nearly 11% of users experience serious complications—a figure far exceeding established data.
  • Critics, including medical experts, argue the study inflates risks by counting emergency room visits as adverse events, even when no treatment was required.
  • Decades of peer-reviewed research affirm mifepristone's safety, with a 99% success rate, a 0.4% serious complication risk, and a 0.001% mortality rate based on over 100 studies.
  • Reproductive-rights groups warn the FDA review could lead to new restrictions on mifepristone, which is used in two-thirds of U.S. abortions and has been taken by over 7.5 million people since its approval.