The Food and Drug Administration (FDA) has begun a safety review of mifepristone, a medication used for abortions, as reported by the Wall Street Journal. This review follows increasing pressure from some anti-abortion advocates who feel that the Trump administration has not acted swiftly enough on revisiting federal regulations regarding abortion pills ahead of the midterm elections.
The FDA's study is expected to take approximately six months, which may delay its completion until after the elections. This review is seen as a positive development for anti-abortion activists and Republican lawmakers advocating for stricter regulations on the drug.
In 2023, the FDA removed the requirement for in-person screenings before patients could obtain mifepristone, a protocol that had been in place since the drug's approval in 2000. This change allowed for increased access to medication abortions through telehealth providers.
During their Senate confirmation hearings, former FDA Commissioner Marty Makary and Health and Human Services Secretary Robert F. Kennedy Jr. committed to conducting a thorough review of mifepristone's safety under the new telehealth framework. However, some anti-abortion groups have expressed skepticism about the administration's commitment to these promises.
Pressure on the FDA increased after the Supreme Court upheld the current regulations governing abortion pill access while a challenge to the agency's mifepristone regulations is ongoing in lower courts. The ruling maintained the status quo for telehealth prescriptions and mail delivery of the drug, prompting renewed focus on the FDA's regulatory authority.
Following the Supreme Court's decision, the FDA announced on social media that it would continue its science-based safety review and provide updates on the review's progress.
According to the Guttmacher Institute, medication abortions account for approximately 65% of all abortions in the United States. While many studies have indicated that mifepristone is safe and effective, particularly when prescribed remotely, anti-abortion groups contest these findings, claiming that existing research underrepresents serious complications and that federal reporting requirements inadequately track nonfatal adverse events.
Senator Bill Cassidy (R-LA), chairman of the Senate health committee, stated, "We already know chemical abortions kill babies and endanger women. The Trump administration needs to stop dragging their feet and immediately reinstate the in-person requirement."
