The Food and Drug Administration has launched a safety review of mifepristone, the drug used for medicated abortions, according to the Wall Street Journal.
The review comes as some anti-abortion advocates have grown increasingly frustrated with the Trump administration, arguing it has moved too slowly on promises to revisit federal abortion pill regulations ahead of the midterm elections.
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Administration officials said the study is expected to take roughly six months, making it unlikely to be completed before voters head to the polls. Still, the review hands a win to anti-abortion activists and Republican lawmakers who have pushed for tighter restrictions on the pill.
Administration officials said the FDA was preparing for a study by data collection, but sped up the process due to conversations with anti-abortion groups.
“The FDA has been actively working on a science-based safety review of the mifepristone REMS for months, as the agency has stated publicly and in court filings,” an administration official told the Washington Examiner. “Any reporting suggesting otherwise, including that a study is just being started, is either false or based on a fundamental misunderstanding of how complex scientific safety studies work.”
The FDA in 2023 eliminated requirements that patients receive in-person screening before obtaining mifepristone, a protocol that had been in place since the drug’s approval in 2000. The change expanded access to medication abortions by allowing telehealth providers to prescribe the drug and mail it directly to patients.
During their Senate confirmation hearings, former FDA Commissioner Marty Makary and Health and Human Services Secretary Robert F. Kennedy Jr. pledged to conduct a comprehensive review of mifepristone’s safety under the expanded telehealth framework. But anti-abortion groups have increasingly questioned whether the administration intended to follow through on those commitments.
Pressure on the FDA intensified after the Supreme Court last month left in place the current rules governing abortion-pill access while Louisiana’s challenge to the agency’s mifepristone regulations continued in lower courts. The decision preserved the status quo for telehealth prescriptions and mail delivery of the drug, shifting attention back to the FDA’s regulatory authority.
Following the ruling, the agency said on X that it would “press forward to complete the science-based safety review” and provide greater transparency about the review’s progress.
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Medication abortions account for roughly 65% of all abortions in the United States, according to the Guttmacher Institute. Many studies have found mifepristone to be safe and effective, including when prescribed remotely and taken at home. Anti-abortion groups dispute those findings, arguing existing research undercounts serious complications and that federal reporting requirements fail to track nonfatal adverse events adequately.
“We already know chemical abortions kill babies and endanger women,” said Sen. Bill Cassidy (R-LA), chairman of the Senate health committee. “The Trump administration needs to stop dragging their feet and immediately reinstate the in-person requirement.”
